Atenolol Tablets

ATENOLOL TABLETS

Please read this leaflet carefully before you start to take this medicine. It gives an outline of the more important things you need to know. If you want to know more about this medicine, or you are not sure about anything, ask your doctor or pharmacist. You should keep this leaflet throughout the course of treatment.

The Name Of Your Medicine Is Atenolol Tablets

Atenolol Tablets contain the active ingredient atenolol. The tablets come in three strengths 25mg, 50mg and 100mg.

Other ingredients in Atenolol 25mg Tablets include maize starch, heavy magnesium carbonate, povidone K30, sodium starch glycollate and magnesium stearate.

Other ingredients in Atenolol 50mg and 100mg Film-Coated Tablets include maize starch, heavy magnesium carbonate, povidone, sodium starch glycollate, magnesium stearate and opadry orange OY-3455 which consists of methylhydroxypropylcellulose (E464), titanium dioxide (E171), polyethylene glycol and quinoline yellow aluminium lake (E104). Also contains sunset yellow FCF (E110), which may cause allergic reactions.

Atenolol 25mg Tablets are white, circular, biconvex tablets with ATL25 on one face and CP or plain on the reverse and contain 25mg of atenolol.

Atenolol 50mg Film-Coated Tablets are orange, circular, biconvex film-coated tablets with ATL50 on one face and CP or plain on the reverse and contain 50mg of atenolol.

Atenolol 100mg Film-Coated Tablets are orange, circular, biconvex film-coated tablets with ATL100 on one face and CP or plain on the reverse and contain 100mg of atenolol.

Atenolol Tablets are available in calendar packs of 28 tablets.

Marketing Authorisation Holder:

Wockhardt UK Limited

Ash Road North

Wrexham

LL13 9UF

UK

Manufacturer:

CP Pharmaceuticals Limited

Ash Road North

Wrexham

LL13 9UF

UK

How Does Your Medicine Work?

Atenolol belongs to a group of medicines known as beta-blockers. These medicines control the heart rate and blood pressure.

What Are Atenolol Tablets For?

Atenolol Tablets are used to reduce high blood pressure, to relieve angina (pains in the chest), to control the rhythm of the heart beat if it has become irregular and to protect the heart after a heart attack.

Before Taking This Medicine

Do not take Atenolol Tablets if you:-

• have ever had a reaction or been told that you are allergic to atenolol or any of the other ingredients in the tablet. Check by reading the list of ingredients above



• have a history of wheezing or asthma. (Speak to your doctor or pharmacist first.)



• have a very slow heart beat or serious problems with the heart rhythm (second or third degree heart block) or if your heart is not pumping efficiently despite medication (uncontrolled heart failure)



• have very low blood pressure



• have intermittent claudication (leg cramps on walking) or other symptoms of very poor circulation



• have been told you have a tumour of the adrenal gland (phaeochromocytoma) and are not being treated with an alpha-blocker, such as doxazosin



• have been told that you have acidosis (excess acid in the blood)



• are under 12 years of age.

You should let your doctor know if you are pregnant or wish to become pregnant while taking this medicine.

You should let your doctor know if you are breast-feeding or wish to start breast-feeding whilst taking this medicine. If you breast-feed whilst taking atenolol your baby should be monitored for any side-effects.

Taking another medicine while you are taking atenolol can affect how it or the other medicine works. Make sure that your doctor or pharmacist knows what other medicines you are taking. Do not take any other medicines while you are taking atenolol unless you have told your doctor or pharmacist and asked their advice. This includes medicines you may have bought yourself.

Example of medicines that can affect atenolol are:

• Anaesthetics (make sure the anaesthetist knows you are taking atenolol)



• Adrenaline, ephedrine and noradrenaline, used to treat severe allergic reactions and to stimulate the heart



• Amphetamines which are used to treat rare sleep disorders



• Some non-steroidal drugs used for inflammation and pain such as ibuprofen and indometacin



• Carbenoxolone, a drug used to treat stomach ulcers



• Some drugs used to treat high blood pressure or heart problems, such as diltiazem, nifedipine, verapamil, doxazosin (an alpha-blocker), amiodarone, disopyramide, quinidine, digoxin, adrenaline, ephedrine, lisinopril (an ACE inhibitor) and losartan (an angiotensin II inhibitor)



• Ergotamine, used to treat migraine



• Clonidine (used for migraine, menopausal flushing and high blood pressure)



• Some indigestion tablets containing calcium or aluminium hydroxide may reduce the absorption of atenolol if they are taken at the same time



• Insulin and oral anti-diabetic drugs used to treat diabetes. With atenolol, there is a greater risk of hypoglycaemia (a "hypo" or low sugar levels) and you may not get the usual warning signs of a "hypo"



• Mefloquine, a drug used to treat malaria



• Tricyclic antidepressants (such as dosulepin), monoamine oxidase inhibitors (such as phenelzine) and tropisetron, used to treat depression



• Benzodiazepines (such as diazepam) used to treat anxiety



• Phenothiazines (such as thioridazine) used to treat schizophrenia



• Some drugs used to treat muscle disorders such as myasthenia gravis (includes neostigmine, pyridostigmine, distigmine) and glaucoma (includes pilocarpine)



• Oral contraceptives ('the pill') and oestrogen, a female sex hormone



• Some drugs used to treat wheezing, such as theophylline



• Ampicillin, an antibiotic used to treat infections



• Aldesleukin, used in chemotherapy



• Alprostadil, used to treat male impotence and heart defects in babies



• Tropisetron, used for nausea and vomiting



• Moxisylyte, used for poor circulation.

If you have any doubts about whether you should take this medicine then talk to your doctor or pharmacist.

Advice When Taking Atenolol Tablets

Care should be taken if:

• you are diabetic.


• You tend to suffer from serious allergies


• You have minor problems with heart rhythm (first degree heart block),


• You have thyroid, kidney or liver problems.


• You have a muscle disorder called myasthenia gravis or a skin condition called psoriasis; atenolol may make these conditions worse.


• You need an anaesthetic.

You should not drive or operate machinery if you feel dizzy or tired while taking Atenolol Tablets.

Drinking alcohol while taking Atenolol Tablets may cause dizziness.

You should not stop taking your tablets suddenly. When you need to stop taking them your doctor will gradually reduce your dose.

Taking This Medicine

The usual adult dose to treat hypertension (high blood pressure) is 50mg daily.

The usual adult dose to treat angina is 100mg a day or 50mg twice daily.

The usual adult dose to treat irregular heart beat is 50mg to 100mg daily, given as a single dose.

The usual adult dose following myocardial infarction (heart attack) is 50mg every 12 hours on the first day and thereafter 100mg daily.

If you are elderly or have liver or kidney problems you may need a lower dose. The tablets are not recommended for children under 12 years of age.

To obtain a tablet, press on the tablet from the blister (bubble) side, pushing it through the foil. Do not remove the tablet from the blister until you are ready to take it.

Your doctor will decide which dose is best for you. Always follow your doctor's instructions completely. Also, follow any special instructions or warnings which appear on the label that the pharmacist has put on the pack. If you do not understand, or are in any doubt, ask your doctor or pharmacist.

Unless told otherwise take your Atenolol Tablets with a glass of water.

You should continue to take your medicine for as long as your doctor tells you to.

It is dangerous to stop taking Atenolol Tablets suddenly. If your doctor decides to stop your Atenolol Tablets the dose will be reduced gradually.

If you forget to take a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all.

Never double the next dose to make up for the one missed.

If you accidentally take too many tablets contact your doctor or pharmacist or nearest hospital.

Take this leaflet and any tablets you have left to show the doctor or pharmacist.

Are There Any Side-Effects?

Like many medicines Atenolol Tablets may cause side-effects in some patients, particularly when you first start taking them.

The side-effects that some patients have had with Atenolol Tablets include very slow heart rhythm (heart block), cold hands and feet, worsening of Raynaud's disease (where your fingers turn white) and intermittent claudication (leg cramps which develop on walking), changes in the fat content of the blood, high or low blood glucose, blood disorders (with a tendency to bleed or bruise easily or sore throat and mouth ulcers), tiredness, dizzy spells, depression, anxiety, nervousness, confusion, mental disturbance, hallucinations, sleep problems, "pins and needles", numbness of the extremities, weakness of the muscles, muscle cramps, painful joints, headache, dry mouth, feeling sick, being sick, diarrhoea, constipation, stomach cramps, fever, itching, scaly rash, worsening of psoriasis, blurred vision, sore eyes or conjunctivitis, impotence, Peyronie's disease (a condition in men affecting the penis), and (rarely) temporary thinning of the hair. Atenolol may increase the levels of some liver enzymes in the blood but this is unlikely to cause you any problems. Stopping Atenolol Tablets suddenly can cause serious heart problems.

If taken in pregnancy, Atenolol Tablets may affect the baby's growth in the womb and cause premature delivery or stillbirth. Atenolol Tablets may also slow down the baby's heart beat, cause low blood pressure or breathing problems, or lower the amount of glucose in the baby's blood.

If you experience any of the side-effects listed, especially wheezing, cough, coughing up blood, breathlessness on exertion or when lying down, extreme tiredness, swelling of the ankles, blue lips or fingernails, a rash and and/or dry eyes, or feel that the medicine is affecting you badly, tell your doctor immediately.

Do not be alarmed by the list of possible side-effects. You may not have any of them.

As Atenolol Tablets may cause dizziness and tiredness, if you are affected you should not drive or operate machinery.

Safe Keeping For The Medicine

Do not take this medicine if the expiry date on the label has passed or if the tablets show signs of deterioration such as discoloration.

Do not store this medicine above 25°C. Keep the tablets in the package or container in which they were given to you. Do not transfer Atenolol Tablets to another container.

Keep out of the reach and sight of children.

Remember this medicine is for you only. Never give it to anyone else. It may harm them, even if their symptoms are the same as yours.

Unless your doctor tells you to, do not keep tablets that you no longer need. Give them back to your pharmacist.

DATE OF REVISION OCTOBER 2007

CPI

103606/2

Visto

Visto may be available in the countries listed below.

Ingredient matches for Visto

Tetryzoline

Tetryzoline hydrochloride (a derivative of Tetryzoline) is reported as an ingredient of Visto in the following countries:

• Indonesia

International Drug Name Search

Vostar

Vostar may be available in the countries listed below.

Ingredient matches for Vostar

Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Vostar in the following countries:

• Iceland


• Malta

International Drug Name Search

Lo-Lyndiol

Lo-Lyndiol may be available in the countries listed below.

Ingredient matches for Lo-Lyndiol

Lynestrenol

Lynestrenol is reported as an ingredient of Lo-Lyndiol in the following countries:

• Japan

Mestranol

Mestranol is reported as an ingredient of Lo-Lyndiol in the following countries:

• Japan

International Drug Name Search

Pacetcool

Pacetcool may be available in the countries listed below.

Ingredient matches for Pacetcool

Cefotiam

Cefotiam dihydrochloride (a derivative of Cefotiam) is reported as an ingredient of Pacetcool in the following countries:

• Japan

International Drug Name Search

Contac Cold+Flu

Generic Name: acetaminophen, chlorpheniramine, and phenylephrine (a SEET a MIN oh fen, KLOR fen EER a meen, FEN ill EFF rin)

Brand Names: Alka-Seltzer Plus Cold, Allergy Relief Multi-Symptom, Comtrex Flu Therapy, Comtrex Severe Cold & Sinus, Contac Cold+Flu, Dristan Cold Multi Symptom Formula, Protid, Robitussin Nighttime Nasal Relief, Sinus Congestion & Pain Nighttime, Tylenol Allergy Multi-Symptom, Tylenol Children's Plus Cold, Tylenol Sinus Congestion and Pain Cool Burst Day Night, Tylenol Sinus Congestion Nighttime

What is Contac Cold+Flu (acetaminophen, chlorpheniramine, and phenylephrine)?

Acetaminophen is a pain reliever and fever reducer.

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of acetaminophen, chlorpheniramine, and phenylephrine is used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Acetaminophen, chlorpheniramine, and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Contac Cold+Flu (acetaminophen, chlorpheniramine, and phenylephrine)?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You should not use this medicine if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen and can increase certain side effects of chlorpheniramine. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose.

What should I discuss with my healthcare provider before taking Contac Cold+Flu (acetaminophen, chlorpheniramine, and phenylephrine)?

You should not use this medicine if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• 
  

  liver disease, cirrhosis, or a history of alcoholism;

  
  


• 
  

  a blockage in your digestive tract (stomach or intestines);

  
  


• 
  

  diabetes;

  
  


• 
  

  kidney disease;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;

  
  


• 
  

  enlarged prostate or urination problems;

  
  


• 
  

  low blood pressure;

  
  


• 
  

  pheochromocytoma (an adrenal gland tumor); or

  
  


• 
  

  if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

  
  

It is not known whether acetaminophen, chlorpheniramine, and phenylephrine will harm an unborn baby. Do not use this medicine without your doctor's advice if you are pregnant. This medication may pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without your doctor's advice if you are breast-feeding a baby.

How should I take Contac Cold+Flu (acetaminophen, chlorpheniramine, and phenylephrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Drop the effervescent tablets into a glass of water (at least 4 ounces, or one-half cup). Stir this mixture and drink all of it right away.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1 800 222 1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking Contac Cold+Flu (acetaminophen, chlorpheniramine, and phenylephrine)?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen, and can increase certain side effects of chlorpheniramine. This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Contac Cold+Flu (acetaminophen, chlorpheniramine, and phenylephrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  chest pain, rapid pulse, fast or uneven heart rate;

  
  


• 
  

  confusion, hallucinations, severe nervousness;

  
  


• 
  

  tremor, seizure (convulsions);

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness;

  
  


• 
  

  mild headache;

  
  


• 
  

  dry mouth, nose, or throat;

  
  


• 
  

  constipation;

  
  


• 
  

  blurred vision;

  
  


• 
  

  feeling nervous; or

  
  


• 
  

  sleep problems (insomnia);

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Contac Cold+Flu (acetaminophen, chlorpheniramine, and phenylephrine)?

Ask a doctor or pharmacist before using this medicine if you regularly use other medicines that make you sleepy (such as narcotic pain medication, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by chlorpheniramine.

Tell your doctor about all other medicines you use, especially:

• 
  

  leflunomide (Arava);

  
  


• 
  

  topiramate (Topamax);

  
  


• 
  

  zonisamide (Zonegran);

  
  


• 
  

  an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

  
  


• 
  

  an antidepressant;

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  bladder or urinary medications;

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  a bronchodilator;

  
  


• 
  

  cancer medicine;

  
  


• 
  

  cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

  
  


• 
  

  gout or arthritis medications (including gold injections);

  
  


• 
  

  HIV/AIDS medication;

  
  


• 
  

  medication for nausea and vomiting, stomach ulcers, or irritable bowel syndrome;

  
  


• 
  

  medicines to treat psychiatric disorders;

  
  


• 
  

  an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

  
  


• 
  

  seizure medication.

  
  

This list is not complete and other drugs may interact with acetaminophen, chlorpheniramine, and phenylephrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Contac Cold+Flu resources

• Contac Cold+Flu Use in Pregnancy & Breastfeeding
• Contac Cold+Flu Drug Interactions
• 0 Reviews for Contac Cold+Flu - Add your own review/rating

• Alka-Seltzer Plus Cold MedFacts Consumer Leaflet (Wolters Kluwer)


• Dryphen MedFacts Consumer Leaflet (Wolters Kluwer)


• Protid Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Tylenol Allergy Multi-Symptom MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Contac Cold+Flu with other medications

• Cold Symptoms
• Sinus Symptoms

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen, chlorpheniramine, and phenylephrine.

Atarax 25mg Tablets

1. Name Of The Medicinal Product

Atarax^® 25mg Film-coated tablets

2. Qualitative And Quantitative Composition

Hydroxyzine hydrochloride 25mg

3. Pharmaceutical Form

25mg film-coated tablets, coloured green and coded on one side with 'AX'.

4. Clinical Particulars

4.1 Therapeutic Indications

Atarax is indicated to assist in the management of anxiety in adults.

Atarax is indicated for the management of pruritus associated with acute and chronic urticaria, including cholinergic and physical types, and atopic and contact dermatitis in adults and children.

4.2 Posology And Method Of Administration

Method of administration: oral.

Dosage:

Anxiety

Adults 50-100mg four times daily.

Pruritus

Adults Starting dose of 25mg at night increasing as necessary to 25mg three or four times daily.

Use in the elderly Atarax may be used in elderly patients with no special precautions other than the care always necessary in this age group. The lowest effective maintenance dose and careful observation for side-effects are important.

Use in children From 6 months to 6 years 5-15mg rising to 50mg daily in divided doses and for children over 6 years, 15-25mg rising to 50-100mg daily in divided doses.

As with all medications, the dosage should be adjusted according to the patient's response to therapy.

Renal impairment The total daily dosage should be reduced by half (see 'Special Warnings and Precautions for Use').

4.3 Contraindications

Atarax is contra-indicated in patients who have shown previous hypersensitivity to it.

4.4 Special Warnings And Precautions For Use

Atarax should be used with caution in patients with impaired renal function (see 'Posology and Method of Administration'). It is uncertain whether the drug may accumulate or have other adverse effects in such patients. Atarax is completely metabolised and one of the metabolites is the active metabolite cetirizine. Cetirizine is renally excreted and clearance is reduced in patients with moderate renal impairment and on dialysis compared to normal volunteers.

Because of its potential anticholinergic effects, Atarax should be used with caution in patients with bladder outflow obstruction.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Patients should be warned that Atarax may enhance their response to alcohol, barbiturates and other CNS depressants.

4.6 Pregnancy And Lactation

Atarax is contra-indicated in early pregnancy. Hydroxyzine, when administered to the pregnant mouse, rat and rabbit, induced foetal abnormalities at doses substantially above the human therapeutic range. Clinical data in humans are inadequate to establish safety in early pregnancy. There is inadequate evidence of safety in the later stages of pregnancy. Use in pregnancy only when there is no safe alternative or when the disease itself carries risks for the mother or child.

Use in nursing mothers It is not known whether Atarax is excreted in human milk. Since many drugs are so excreted, Atarax should not be given to nursing mothers.

4.7 Effects On Ability To Drive And Use Machines

Patients should be warned that Atarax may impair their ability to perform activities requiring mental alertness or physical co-ordination such as operating machinery or driving a vehicle.

4.8 Undesirable Effects

Therapeutic doses of Atarax seldom produce marked impairment of mental alertness. Drowsiness may occur; if so, it is usually transitory and may disappear after a few days of continued therapy or upon reduction of the dose. Dryness of the mouth may be encountered at higher doses. Dizziness, weakness, headache and confusion, and urinary retention have been reported.

Extensive clinical use has substantiated the absence of toxic effects on the liver or bone marrow when administered for over four years of uninterrupted therapy. The absence of side-effects has been further demonstrated in experimental studies in which excessively high doses were administered.

Involuntary motor activity, including rare instances of tremor and convulsions, have been reported, usually with doses considerably higher than those recommended. Continuous therapy with over 1g/day has been employed in some patients without these effects having been encountered.

4.9 Overdose

The most common manifestation of Atarax overdosage is hypersedation. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. If vomiting has not occurred spontaneously in conscious patients it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient is indicated. Hypotension, though unlikely, may be controlled with intravenous fluids and noradrenaline, or metaraminol. Adrenaline should not be used in this situation as Atarax counteracts its pressor action.

There is no specific antidote. It is doubtful whether haemodialysis has any value in the treatment of overdosage with Atarax. However, if other agents such as barbiturates have been ingested concomitantly, haemodialysis may be indicated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Atarax is unrelated chemically to phenothiazine, reserpine and meprobamate.

Atarax has been shown clinically to be a rapid-acting anxiolytic with a wide margin of safety. It induces a calming effect in anxious tense adults. It is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system.

Antihistamine effects have been demonstrated experimentally and confirmed clinically; it is highly effective in alleviating pruritus.

5.2 Pharmacokinetic Properties

Atarax is rapidly absorbed from the gastro-intestinal tract and effects are usually noted within 15 to 30 minutes after oral administration.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet core:

• Lactose (anhydrous) • Calcium Hydrogen Phosphate Anhydrous • Starch, Pregelatinised. • Magnesium Stearate • Sodium Laurilsulphate • Silica, colloidal anhydrous.

Tablet coating:

Opadry II Green 85G24674 (25mg only) -contains:

• Poly (vinyl alcohol) • Talc • Macrogol 3350 • Quinoline yellow (E104) • Titanium dioxide (E171) • Brilliant blue (E1331) • Indigo carmine ( E132) • Lecithin (E322).

6.2 Incompatibilities

None stated.

6.3 Shelf Life

24 Months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

White opaque 250/5/120 micron PVC/TE/PVdC - 20 micron aluminium foil blister strips containing 28 x 25mg tablets (2 blister strips per carton).

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Alliance Pharmaceuticals Limited

Avonbridge House

Chippenham

Wiltshire

SN15 2BB

United Kingdom

8. Marketing Authorisation Number(S)

PL 16853/0095

9. Date Of First Authorisation/Renewal Of The Authorisation

24 July 1985/24 July 2002

10. Date Of Revision Of The Text

April 2010

Alfa D

Alfa D may be available in the countries listed below.

Ingredient matches for Alfa D

Alfacalcidol

Alfacalcidol is reported as an ingredient of Alfa D in the following countries:

• Chile

International Drug Name Search

Atenolol 25mg Tablets (Wockhardt UK Ltd)

1. Name Of The Medicinal Product

Atenolol 25mg Tablets or Totamol 25mg Tablets or Kentol 25mg Tablets

2. Qualitative And Quantitative Composition

Atenolol 25mg

For excipients, see 6.1.

3. Pharmaceutical Form

Tablet for oral use

4. Clinical Particulars

4.1 Therapeutic Indications

Atenolol is recommended for the treatment of hypertension, angina pectoris, cardiac dysrhythmia, and for early intervention in the acute phase of myocardial infarction.

4.2 Posology And Method Of Administration

Dosage

Adults:

Hypertension: Usually 50mg daily.

Angina: Usually 100mg daily or 50mg twice daily.

Dysrhythmias: Following control with intravenous atenolol, a suitable oral maintenance dosage is 50-100mg daily, given as a single dose.

Myocardial Infarction: Following treatment with intravenous atenolol, oral atenolol 50mg may be given approximately 15 minutes later, provided no untoward effects occur from the intravenous dose. This should be followed by a further 50mg orally 12 hours after the intravenous dose and subsequent dosage maintained, after a further 12 hours, with 100mg daily. If bradycardia and/or hypotension requiring treatment, or any other untoward effects occur, atenolol should be discontinued.

Renal impairment: The dose may need to be reduced.

Hepatic dysfunction: The dose may need to be reduced.

Elderly Patients:

Dosage requirements may be reduced, especially in patients with impaired renal function.

Children under 12 years of age:

There are inadequate clinical data available on the use of atenolol in children and for this reason it is not recommended.

4.3 Contraindications

Atenolol is contra-indicated in patients with a known hypersensitivity to atenolol, severe bradycardia, second degree or third degree heart block, uncontrolled heart failure, hypotension, severe peripheral vascular disease (including intermittent claudication), sick sinus syndrome, cardiogenic shock, phaeocromocytoma (without a concomitant alpha-blocker), metabolic acidosis.

Although cardioselective beta-blockers may have less effect on lung function than non-selective beta-blockers, as with all beta-blockers these should be avoided in patients with asthma or a history of reversible obstructive airways disease or bronchospasm (see 4.4 Special Warnings and Precautions for Use), unless there are compelling clinical reasons for their use.

4.4 Special Warnings And Precautions For Use

Care should be taken when using beta-blockers in patients with poor cardiac reserve. Myocardial contractility must be maintained and signs of failure controlled with digitalis and diuretics.

Therapy should not be withdrawn abruptly, especially in patients with ischaemic heart disease, and replacement therapy should be considered to prevent exacerbation of angina pectoris, rebound hypertension, myocardial infarction, ventricular arrhythmias and sudden cardiac death (see 4.8, Undesirable Effects). Treatment should not be discontinued abruptly in patients on long-term therapy, but should be discontinued over one to two weeks.

If a beta-blocker is withdrawn prior to surgery it should be discontinued for at least 24 hours, if the patient is being anaesthetised. If beta blockers are not discontinued before anaesthesia, the anaesthetist should be made aware of the beta-blocker therapy. A drug such as atropine may be given to counter increases in vagal tone. Anaesthetics causing myocardial depression such as ether, halothane and enflurane should be avoided (see 4.5, Interactions).

Atenolol reduces heart rate. In instances when symptoms may be attributable to the slow heart rate, the dose should be reduced. Beta-blockers should be used with caution in first degree AV block.

Beta-blockers may increase both the sensitivity towards allergens and seriousness of anaphylactic reactions and may also reduce the response to adrenaline. They may unmask myasthenia gravis or potentiate a myasthenic condition.

Patients with psoriasis should only be given beta-blockers after careful consideration, as psoriasis may be aggravated.

Atenolol should be used with caution in diabetics subject to frequent episodes of hypoglycaemia. Symptoms of hypoglycaemia and of hyperthyroidism may be masked (see 4.5 Interactions).

The product label will carry the warning " Do not take this medicine if there is a history of wheezing or asthma."

If the use of atenolol in patients with asthma or a history of obstructive airways disease is unavoidable, the risk of inducing bronchospasm should be appreciated and appropriate precautions taken. If bronchospasm occurs, this will usually be reversed by commonly used bronchodilators such as salbutamol or isoprenaline.

In patients with renal impairment or hepatic dysfunction, atenolol should be used with caution and reduction of dosage should be considered (see 4.2, Posology and Method of Administration).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Alcohol : Enhanced hypotensive effect

Aldesleukin : Enhanced hypotensive effect.

Alprostadil : Enhanced hypotensive effect.

Amphetamines: Avoid concomitant use.

Ampicillin: Reduces atenolol serum levels.

Anaethetics: Enhanced hypotensive effect. Avoid anaesthetics which cause myocardial depression, e.g. ether, halothane and enflurane (see 4.4 Special Warnings and Precautions for Use).

Analgesics: Antihypertensive effects of beta-blockers may be impaired by non-steroidal anti-inflammatory drugs (NSAIDs), particularly indomethacin – avoid concomitant use.

Antacids; Reduced absorption may occur if calcium or aluminium hydroxide is administered concurrently.

Antiarrhythmics and other drugs affecting cardiac conduction; (eg, disopyramide, amiodarone, quinidine) additive negative inotropic effects on the heart, with increased risk of bradycardia, hypotension, ventricular fibrillation, heart block or asystole - avoid concomitant use.

Anticholinesterase agents : Increased risk of bradycardia

Antidepressants and antipsychotics: Phenothiazines and tricyclic antidepressants and tropisetron may increase the risk of ventricular arrhythmias. Enhanced hypotensive effect with monoamine oxidase inhibitors (MAOIs).

Antidiabetics: Dosage of hypoglycaemic agents requirements may need to be increased (see 4.4 Special Warnings and Precautions for Use). There may be an enhanced hypoglycaemic effect and masking of warning signs with concurrent administration of insulin and oral antidiabetic drugs. Hypoglycaemia is more likely in Type I than in Type II diabetics and may be associated with delayed recovery.

Antihypertensives: including angiotensin-converting enzyme (ACE) inhibitors and angiotensin-II antagonists; enhanced hypotension; alpha-blockers; enhanced risk of first dose hypotension - avoid concomitant use. Cardiodepressant calcium channel blocking agents such as diltiazem, nifedipine and verapamil may induce negative inotropic effects such as severe hypotension, bradycardia, asystole and heart failure avoid concomitant use.

Antimalarials: Risk of bradycardia increased with mefloquine.

Anxiolytics and hypnotics : Enhanced hypotensive effect with benzodiazepines.

Cardiac glycosides; Risk of marked bradycardia and AV block.

Clonidine : Increased risk of hypertension on withdrawal – avoid concomitant use

Ergot alkaloids; Increased peripheral vasoconstriction - avoid concomitant use.

Moxisylyte: Increased risk of severe postural hypotension.

Oestrogens and Progesterones; Oestrogens and combined oral contraceptives may antagonise the antihypertensive effect.

Parasympathomimetics : Increased risk of bradycardia

Sympathomimetics : Risk of severe hypertension and bradycardia with such agents as adrenaline, noradrenaline and ephedrine - avoid concomitant use. Beta-blockers may also reduce the response to adrenaline in the management of anaphylaxis (see 4.4 Special Warnings and Precautions for Use).

Theophylline : Atenolol antagonises bronchodilator effect: avoid concomitant use

Ulcer healing drugs:Carbenoxolone may antagonise the hypotensive effect.

4.6 Pregnancy And Lactation

Atenolol crosses the placenta. The safety of atenolol if given in early pregnancy has not been established and its use should therefore be avoided. Beta-blockers reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries. In addition, adverse effects (especially hypoglycaemia and bradycardia) may occur in foetus and neonate in the postnatal period.

Administration of atenolol in pregnancy may be associated with reduced foetal growth, which is greatest when started in early pregnancy, such as in the second trimester and is related to the duration of treatment. The risk of adverse effects to the foetus or neonate is greater in severely hypotensive pregnancies.

However, atenolol has been used effectively under close supervision for the treatment of hypertension in the third trimester.

Atenolol is excreted in breast milk. Breast-feeding can be undertaken but infants should be monitored for bradycardia, respiratory depression, hypotension and hypoglycaemia.

4.7 Effects On Ability To Drive And Use Machines

Occasionally dizziness or fatigue may occur when taking atenolol tablets. If affected, patients should not drive or operate machinery

4.8 Undesirable Effects

Cardiovascular: heart failure, heart block, bradycardia, hypotension, dizziness, peripheral vasoconstriction with coldness of the extremities (including exacerbation of intermittent claudication and Raynaud's phenomenon). (see 4.4, Special Warnings and Precautions for Use).

Eye : visual disturbances including blurred vision, sore eyes, dry eyes (reversible on withdrawal; discontinuance of the drug should be considered if any such reaction is not otherwise explicable), conjunctivitis.

Gastrointestinal: nausea, vomiting, diarrhoea, constipation and abdominal cramps, sclerosing peritonitis and retroperitoneal fibrosis.

General: fatigue, headache, dry mouth, sleep disturbances of the type noted with other beta-blockers have been reported rarely. An increase in (A)nti (N)uclear (A)ntibodies has been seen: its clinical relevance is not clear.

Haemopoietic: thrombocytopenia, eosinophilia and leucopenia including agranulocytosis.

Hepatic : elevated liver enzymes and/or bilirubin

Metabolic: Lupus-like syndrome. Hyperglycaemia or hypoglycaemia. Non-diabetic patients susceptible to hypoglycaemia include those on regular dialysis, and long term patients who are nutritionally compromised or have liver disease. Atenolol may increase serum triglyceride levels.

Musculoskeletal, connective tissue and bone disorders: Myopathies including muscle cramps, arthralgia.

Nervous system : paraesthesia, peripheral neuritis.

Psychiatric : depression, psychosis, hallucinations, confusion, anxiety and nervousness.

Respiratory : bronchospasm, pneumonitis, pulmonary fibrosis and pleurisy.

Reproductive: impotence, Peyronie's disease;

Skin: Purpura, pruritus, reversible alopecia, skin rashes (reversible on withdrawal; discontinuance of the drug should be considered if any such reaction is not otherwise explicable), psoriasiform rash or exacerbation of psoriasis

.

Withdrawal: Sudden cessation of therapy with a beta-blockercan cause angina, myocardial infarction, ventricular arrhythmias and sudden cardiac death. (see 4.4 Special Warnings and Precautions for Use).

4.9 Overdose

Symptoms: Many cases of beta-blocker overdosage are uneventful, but some patients develop severe and occasionally fatal cardiovascular depression. Effects can include bradycardia, cardiac conduction block, hypotension, heart failure, acute cardiac insufficiency and cardiogenic shock. Convulsions, coma, bronchospasm, respiratory depression, and bronchoconstriction can also occur, although infrequently.

Treatment: Absorption of any drug material still present in the gastrointestinal tract can be prevented by gastric lavage and administration of activated charcoal.

Excessive (therapeutic) bradycardia can be countered by atropine sulphate 0.6 to 2.4 mg in divided doses of 600 micrograms.

Acute massive overdosage requires hospital management and expert advice should be obtained. Maintenance of a clear airway and adequate ventilation is mandatory. Excessive bradycardia and hypotension may be countered by atropine, (3 mg adult, 40 micrograms/kg child) intravenously. Cardiogenic shock unresponsive to atropine may be treated with an intravenous injection of glucagon (50-50 micrograms/kg in 5% glucose, with precautions to protect the airway in case of vomiting). A further dose of glucagon (or an intravenous infusion) may be required if the response is not maintained. If glucagon is not available intravenous isoprenaline is an alternative.

Administration of calcium ions, or the use of a cardiac pacemaker may also be considered. In patients intoxicated with hydrophilic beta-blocking agents, which include atenolol, haemodialysis or haemoperfusion may be considered.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Atenolol is a beta-adrenoceptor blocking agent for use in the management of hypertension and angina pectoris. It is a cardioselective beta-blocker selective for cardiac beta₁ receptors and has no partial agonist or membrane stabilising activity.

The mode of action of atenolol and other beta-blockers in the moderation of hypertension is still not fully understood although its effects on plasma renin and cardiac output are probably of primary importance. Atenolol reduces cardiac output, alters baroreceptor reflex sensitivity and blocks peripheral adrenoceptors. Atenolol has been found to reduce systolic and diastolic blood pressures by about 15% in patients with mild to moderate hypertension. Its beta-adrenoceptor antagonist properties reduce cardiac work. This property improves exercise tolerance in anginal patients.

5.2 Pharmacokinetic Properties

Atenolol is not completely absorbed from the gastrointestinal tract, its oral bioavailability being of the order 50-60%. It is approximately 5% bound to plasma proteins. The plasma half-life of atenolol is about 6 hours. However, the duration of therapeutic effect is much longer than this, allowing once daily dosing. Atenolol is excreted largely unchanged in the urine and its dosage should be adjusted in renal failure.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to those already included in other sections

6. Pharmaceutical Particulars

6.1 List Of Excipients

Maize Starch

Heavy Magnesium Carbonate

Povidone K30

Sodium Starch Glycollate

Magnesium Stearate

Purified Water

6.2 Incompatibilities

None known

6.3 Shelf Life

Three years

6.4 Special Precautions For Storage

Do not store above 25^oC

Store in the original container

6.5 Nature And Contents Of Container

Strip packs consisting of opaque white or clear UPVC coated with UPVDC, and aluminium foil with heat seal coating on bright side and colourless key coating on dull side. Strip packs contain 28 or 504 tablets.

Polypropylene or polyethylene tablet container of 500 tablets.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Wockhardt UK Ltd

Ash Road North

Wrexham Industrial Estate

Wrexham LL13 9UF

United Kingdom

8. Marketing Authorisation Number(S)

PL 29831/0020

9. Date Of First Authorisation/Renewal Of The Authorisation

14/08/2007

10. Date Of Revision Of The Text

28/03/2008

Actrapid 100 IU / ml, Solution for Injection in a vial

Actrapid

100 IU/ml solution for injection in a vial

Insulin human (rDNA)

Read all of this leaflet carefully before you start using your insulin.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor, diabetes nurse or your pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or your pharmacist.

What Actrapid is and what it is used for

Actrapid is human insulin to treat diabetes.

Actrapid is a fast-acting insulin. This means that it will start to lower your blood sugar about half an hour after you take it, and the effect will last for approximately 8 hours. Actrapid is often given in combination with longer-acting insulin products.

Before you use Actrapid

Do not use Actrapid

• 
  If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see 7 Further information). Look out for the signs of allergy in 5 Possible side effects


• 
  If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar). See 4 What to do in an emergency for more about hypos.

Take special care with Actrapid

• 
  If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands


• 
  If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty stomach


• 
  If you are exercising more than usual or if you want to change your usual diet


• 
  If you are ill: carry on taking your insulin


• 
  If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.

Using other medicines

Many medicines affect the way glucose works in your body and they may influence your insulin dose. Listed below are the most common medicines which may affect your insulin treatment. Talk to your doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.

Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta-sympathomimetics; growth hormone; danazol; octreotide or lanreotide.

Pregnancy and breast-feeding

If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice.

Driving and using machines

If you drive or use tools or machines: watch out for signs of a hypo. Your ability to concentrate or to react will be less during a hypo. Never drive or use machinery if you feel a hypo coming on. Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.

How to use Actrapid

Talk about your insulin needs with your doctor and diabetes nurse. Follow their advice carefully.

This leaflet is a general guide.

If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Eat a meal or snack containing carbohydrates within 30 minutes of the injection.

It is recommended that you measure your blood glucose regularly.

Before using Actrapid

• 
  Check the label to make sure it is the right type of insulin


• 
  Disinfect the rubber membrane with a medicinal swab.

Do not use Actrapid

• 
  In insulin infusion pumps
  


• 
  If the protective cap is loose or missing. Each vial has a protective, tamper-proof plastic cap. If it isn’t in perfect condition when you get the vial, return the vial to your supplier


• 
  If it hasn’t been stored correctly or been frozen (see 6 How to store Actrapid)


• 
  If it does not appear water clear and colourless.
  

How to use this insulin

Actrapid is for injection under the skin (subcutaneously). Always vary the sites you inject, to avoid lumps (see 5 Possible side effects). The best places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms. Your insulin will work more quickly if you inject it around the waist.

Actrapid vials are for use with insulin syringes with the corresponding unit scale.

Actrapid may also be administered intravenously in special situations by medical professionals.

To inject Actrapid on its own

• 1. Draw air into the syringe, in the same amount as the dose of insulin you need


• 2. Inject the air into the vial: push the needle through the rubber stopper and press the plunger


• 3. Turn the vial and syringe upside down


• 4. Draw the right dose of insulin into the syringe


• 5. Pull the needle out of the vial


• 6. Make sure there is no air left in the syringe: point the needle upwards and push the air out


• 7. Check you have the right dose


• 8. Inject straight away.

To mix Actrapid with long-acting insulin

• 1. Roll the vial of long-acting insulin between your hands. Do this until the liquid is uniformly white and cloudy


• 2. Draw as much air into the syringe as the dose of long-acting insulin you need. Inject the air into the long-acting insulin vial, then pull out the needle


• 3. Draw as much air into the syringe as the dose of Actrapid you need. Inject the air into the Actrapid vial. Then turn the vial and syringe upside down


• 4. Draw the right dose of Actrapid into the syringe. Pull the needle out of the vial. Make sure there is no air left in the syringe: point the needle upwards and push the air out. Check the dose


• 5. Now push the needle into the vial of long-acting insulin


• 6. Then turn the vial and syringe upside down


• 7. Draw the right dose of long-acting insulin into the syringe


• 8. Pull the needle out of the vial


• 9. Make sure there is no air left in the syringe, and check the dose


• 10. Inject the mixture straight away.

Always mix fast-acting and long-acting insulin in this order.

Inject the insulin

• 
  Inject the insulin under the skin. Use the injection technique advised by your doctor or diabetes nurse


• 
  Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered.

What to do in an emergency

If you get a hypo

A hypo means your blood sugar level is too low.

The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

If you get any of these signs, eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.

Don’t take any insulin if you feel a hypo coming on.

Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.

Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and seek medical advice straight away. They must not give you any food or drink as it could choke you.

• 
  If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death


• 
  If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

Using glucagon

You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. Seek medical advice after an injection of glucagon; you need to find the reason for your hypo to avoid getting more.

Causes of a hypo

You get a hypo if your blood sugar gets too low.

This might happen:

• If you take too much insulin


• If you eat too little or miss a meal


• If you exercise more than usual.

If your blood sugar gets too high

Your blood sugar may get too high (this is called hyperglycaemia).

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.

If you get any of these signs, test your blood sugar level and test your urine for ketones if you can. Then seek medical advice straight away. These may be signs of a very serious condition called diabetic ketoacidosis. If you don’t treat it, this could lead to diabetic coma and death.

Causes of hyperglycaemia

• Having forgotten to take your insulin


• Repeatedly taking less insulin than you need


• An infection or a fever


• Eating more than usual


• Less exercise than usual.

Possible side effects

Like all medicines, Actrapid can cause side effects, although not everybody gets them. Actrapid may cause hypoglycaemia (low blood sugar). See the advice in 4 What to do in an emergency.

Side effects reported uncommonly

(in less than 1 patient in 100)

Vision problems. When you first start your treatment, it may disturb your vision, but the reaction usually disappears.

Changes at the injection site (Lipodystrophy). If you inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to prevent such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or diabetes nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.

Signs of allergy. Reactions (redness, swelling, itching) at the injection site may occur (local allergic reactions). These usually disappear after a few weeks of taking your insulin. If they do not disappear, see your doctor.

Seek medical advice immediately:

• if signs of allergy spread to other parts of the body, or


• if you suddenly feel unwell and you start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy; feel like fainting.

You may have a very rare serious allergic reaction to Actrapid or one of its ingredients (called a systemic allergic reaction). See also warning in 2 Before you use Actrapid.

Painful neuropathy (nerve related pain). If your blood glucose levels improve very fast it may cause a burning, tingling or electric pain. This is called acute painful neuropathy and it usually disappears. If it does not disappear, see your doctor.

Swollen joints. When you start taking insulin, water retention may cause swelling around your ankles and other joints. This soon disappears.

Side effects reported very rarely

(in less than 1 patient in 10,000)

Diabetic retinopathy (eye background changes). If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse. Ask your doctor about this.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or pharmacist.

How to store Actrapid

Keep out of the reach and sight of children.

Do not use Actrapid after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

The vials that are not being used are to be stored in a refrigerator (2°C - 8°C).

Do not store them in or too near the freezer section or cooling element.

Do not freeze.

Keep the vials in the original package.

The vials that are being used or about to be used are not to be kept in a refrigerator. You can carry them with you and keep them at room temperature (not above 25°C) for up to 6 weeks. Always keep the vial in the outer carton when you’re not using it in order to protect it from light.

Actrapid must be protected from excessive heat and sunlight.

Actrapid should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Actrapid contains

• 
  The active substance is insulin human made by recombinant biotechnology. 1 ml contains 100 IU of insulin human. 1 vial contains 10 ml equivalent to 1000 IU


• 
  The other ingredients are zinc chloride, glycerol, metacresol, sodium hydroxide, hydrochloric acid and water for injections.

What Actrapid looks like and contents of the pack

The solution for injection comes as a clear, colourless, aqueous solution.

It is supplied in packs of 1 or 5 vials of 10 ml or in a multipack of 5 × (1 × 10 ml) vials. Not all packs may be marketed.

Marketing Authorisation Holder and Manufacturer

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

This leaflet was last approved in 09/2007

Actrapid
is a trademark owned by Novo Nordisk A/S, Denmark

© 1998/2007

Novo Nordisk A/S

8-0201-01-088-3

Genapap Chewable Tablets

Pronunciation: a-seet-a-MIN-oh-fen
Generic Name: Acetaminophen
Brand Name: Examples include Genapap and Tylenol Junior

Genapap Chewable Tablets are used for:

Treating minor aches and pains due to the common cold, flu, headaches, sore throat, immunizations, and toothaches, and for temporarily reducing fever.

Genapap Chewable Tablets are an analgesic and antipyretic (lowers fever). It works by lowering a chemical in the brain that stimulates pain nerves and the heat-regulating center in the brain.

Do NOT use Genapap Chewable Tablets if:

• you are allergic to any ingredient in Genapap Chewable Tablets

Contact your doctor or health care provider right away if any of these apply to you.

Before using Genapap Chewable Tablets:

Some medical conditions may interact with Genapap Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of alcohol abuse or you drink more than 3 alcohol-containing drinks every day


• if you have liver or kidney problems, hepatitis, or phenylketonuria (PKU)

Some MEDICINES MAY INTERACT with Genapap Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Isoniazid because the risk of liver problems may be increased


• Anticoagulants (eg, warfarin) because the risk of their side effects, including bleeding, may be increased by Genapap Chewable Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Genapap Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Genapap Chewable Tablets:

Use Genapap Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Genapap Chewable Tablets by mouth with or without food.


• Chew tablets before swallowing.


• If you miss a dose of Genapap Chewable Tablets and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Genapap Chewable Tablets.

Important safety information:

• Genapap Chewable Tablets has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Genapap Chewable Tablets may harm your liver. Your risk may be greater if you drink alcohol while you are using Genapap Chewable Tablets. Talk to your doctor before you take Genapap Chewable Tablets or other fever reducers if you drink more than 3 drinks with alcohol per day.


• Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use for more than 2 days or give to children younger than 3 years old unless directed by a doctor.


• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.


• Genapap Chewable Tablets may cause the results of some in-home test kits for blood cholesterol to be wrong. Check with your doctor or pharmacist if you are taking Genapap Chewable Tablets and need to check your blood cholesterol at home.


• For pain and fever in CHILDREN: Stop use and ask a doctor if fever gets worse or lasts more than 3 days, pain gets worse or lasts more than 5 days, or redness or swelling is present or any new symptoms appear.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Genapap Chewable Tablets while you are pregnant. Genapap Chewable Tablets are found in breast milk. If you are or will be breast-feeding while you use Genapap Chewable Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Genapap Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine or pale stools; reduced liver or kidney function; unusual fatigue; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Genapap side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include: dark urine; excessive sweating; extreme fatigue; nausea and vomiting; stomach pain.

Proper storage of Genapap Chewable Tablets:

Store Genapap Chewable Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Genapap Chewable Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Genapap Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Genapap Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Genapap Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Genapap resources

• Genapap Side Effects (in more detail)
• Genapap Use in Pregnancy & Breastfeeding
• Genapap Drug Interactions
• Genapap Support Group
• 0 Reviews for Genapap - Add your own review/rating

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Toprol XL

Generic Name: metoprolol (Oral route)

met-oh-PROE-lol

Oral route(Tablet, Extended Release)

Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. The dosage should be gradually reduced over a period of 1 to 2 weeks and the patient should be carefully monitored when discontinuing chronic therapy. If angina markedly worsens or acute coronary insufficiency develops, metoprolol succinate administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician's advice .

Oral route(Tablet)

Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. The dosage should be gradually reduced over a period of 1 to 2 weeks and the patient should be carefully monitored when discontinuing chronic therapy. If angina markedly worsens or acute coronary insufficiency develops, metoprolol tartrate administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue metoprolol tartrate therapy abruptly even in patients treated only for hypertension .

Commonly used brand name(s)

In the U.S.

• Lopressor


• Toprol XL

Available Dosage Forms:

• Tablet, Extended Release


• Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Beta-Adrenergic Blocker, Cardioselective

Uses For Toprol XL

Metoprolol is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk for heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Metoprolol is also used to treat severe chest pain (angina) and lowers the risk of repeated heart attacks. It is given to people who have already had a heart attack. In addition, metoprolol is used to treat patients with heart failure.

This medicine is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart.

This medicine is available only with your doctor's prescription.

Before Using Toprol XL

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of metoprolol tablets in the pediatric population. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of metoprolol extended-release tablets in children younger than 6 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of metoprolol in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving metoprolol.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Albuterol


• Amiodarone


• Arformoterol


• Bambuterol


• Bitolterol


• Broxaterol


• Clenbuterol


• Clonidine


• Colterol


• Diltiazem


• Dronedarone


• Fenoldopam


• Fenoterol


• Formoterol


• Hexoprenaline


• Indacaterol


• Isoetharine


• Levalbuterol


• Lidocaine


• Metaproterenol


• Pirbuterol


• Procaterol


• Reproterol


• Rimiterol


• Ritodrine


• Salmeterol


• Terbutaline


• Tretoquinol


• Tulobuterol


• Verapamil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose


• Aceclofenac


• Acemetacin


• Acetohexamide


• Alclofenac


• Alfuzosin


• Amlodipine


• Apazone


• Arbutamine


• Benfluorex


• Benoxaprofen


• Bromfenac


• Bufexamac


• Bunazosin


• Bupropion


• Carprofen


• Chlorpropamide


• Cimetidine


• Citalopram


• Clometacin


• Clonixin


• Dexketoprofen


• Diclofenac


• Diflunisal


• Digoxin


• Diphenhydramine


• Dipyrone


• Doxazosin


• Droxicam


• Escitalopram


• Etodolac


• Etofenamate


• Felbinac


• Felodipine


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Fluoxetine


• Flurbiprofen


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Guar Gum


• Hydralazine


• Hydroxychloroquine


• Ibuprofen


• Indomethacin


• Indoprofen


• Insulin


• Insulin Aspart, Recombinant


• Insulin Glulisine


• Insulin Lispro, Recombinant


• Isoxicam


• Ketoprofen


• Ketorolac


• Lacidipine


• Lercanidipine


• Lornoxicam


• Manidipine


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Metformin


• Mibefradil


• Miglitol


• Moxisylyte


• Nabumetone


• Naproxen


• Nicardipine


• Nifedipine


• Niflumic Acid


• Nilvadipine


• Nimesulide


• Nimodipine


• Nisoldipine


• Nitrendipine


• Oxaprozin


• Oxyphenbutazone


• Paroxetine


• Phenelzine


• Phenobarbital


• Phenoxybenzamine


• Phentolamine


• Phenylbutazone


• Pirazolac


• Piroxicam


• Pirprofen


• Pranidipine


• Prazosin


• Propafenone


• Propoxyphene


• Propyphenazone


• Proquazone


• Quinidine


• Repaglinide


• Rifampin


• Rifapentine


• Ritonavir


• St John's Wort


• Sulindac


• Suprofen


• Tamsulosin


• Telithromycin


• Tenidap


• Tenoxicam


• Terazosin


• Terbinafine


• Thioridazine


• Tiaprofenic Acid


• Tolazamide


• Tolbutamide


• Tolmetin


• Trimazosin


• Troglitazone


• Urapidil


• Venlafaxine


• Zomepirac

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (chest pain) or


• Hypotension (low blood pressure) or


• Peripheral vascular disease (clogged blood vessels) or


• Pheochromocytoma (adrenal gland tumor)—Use with caution. May make these conditions worse.

• Blood circulation problems, severe or


• Bradycardia, severe (slow heartbeat) or


• Heart block (heart rhythm problem) or


• Heart failure, acute and severe or


• Lung disease (e.g., asthma, bronchitis, emphysema) or


• Sick-sinus syndrome (heart rhythm problem)—Should not be used in patients with these conditions.

• Diabetes or


• Hyperthyroidism (overactive thyroid) or


• Hypoglycemia (low blood sugar)—May cover up some of the symptoms of these diseases, such as a fast heartbeat.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of metoprolol

This section provides information on the proper use of a number of products that contain metoprolol. It may not be specific to Toprol XL. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Your dose may need to be changed several times in order to find out what works best for you.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many patients feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, strokes, or kidney disease.

Do not interrupt or stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous.

Take this medicine with a meal or just after you eat. You may break the extended-release tablet into two pieces, but swallow the two pieces whole and do not crush or chew them.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For acute heart attack or heart failure:
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—At first, 25 milligrams (mg) once a day for 2 weeks. In patients with severe heart failure, the starting dose is 12.5 mg once a day. Your doctor may adjust your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults—At first, 50 milligrams (mg) every 6 hours for 2 days. Then, 100 mg two times a day. The medicine will be started in the hospital.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For chest pain:
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—At first, 100 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 400 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults—At first, 100 milligrams (mg) per day, given in two divided doses. Your doctor may adjust your dose if needed. However, the dose is usually not more than 400 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For high blood pressure:
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—At first, 25 to 100 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 400 mg per day.
    
    
    • Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 1 milligram (mg) per kilogram (kg) of body weight per day, given as a single dose. The first dose should not be more than 50 mg per day.
    
    
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults—At first, 100 milligrams (mg) per day, given as a single dose or in divided doses. Your doctor may adjust your dose if needed. However, the dose is usually not more than 450 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor. .
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Toprol XL

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly and to check for unwanted effects.

Metoprolol may worsen the symptoms of heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing.

This medicine may cause changes in blood sugar levels. Also, this medicine may cover up the symptoms of low blood sugar, such as a rapid pulse rate. Check with your doctor if you or your child notice a change in your normal symptoms or a change in the results of your blood or urine sugar tests.

Make sure any doctor or dentist who treats you or your child knows that you are using this medicine. You may need to stop using this medicine several days before having surgery.

This medicine may cause some people to become less alert than they are normally. If this side effect occurs, do not drive, use machines, or do anything else that could be dangerous if you are not alert.

Dizziness, lightheadedness, or even fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Toprol XL Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Blurred vision


• chest pain or discomfort


• confusion


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• shortness of breath


• slow or irregular heartbeat


• sweating


• unusual tiredness or weakness

Less common

• Bloating or swelling of the face, arms, hands, lower legs, or feet


• cough


• decreased urine output


• difficult or labored breathing


• difficulty with speaking


• dilated neck veins


• disturbed color perception


• double vision


• extreme fatigue


• fast, pounding, or racing heartbeat or pulse


• halos around lights


• headache


• inability to move the arms, legs, or facial muscles


• inability to speak


• irregular breathing


• loss of vision


• night blindness


• noisy breathing


• overbright appearance of lights


• pain, tension, and weakness upon walking that subsides during periods of rest


• paleness or cold feeling in the fingertips and toes


• rapid weight gain


• seeing, hearing, or feeling things that are not there


• short-term memory loss


• slow speech


• swelling of the face, fingers, feet, or lower legs


• tightness in the chest


• tingling of the hands or feet


• tingling or pain in the fingers or toes when exposed to cold


• troubled breathing


• tunnel vision


• unusual weight gain or loss


• wheezing

Rare

• Bluish color skin of the fingers or toes


• chills


• clay-colored stools


• continuing loss of appetite


• continuing or severe abdominal or stomach pain


• continuing or severe nausea and vomiting


• dark urine


• difficulty with moving


• fever


• general tiredness and weakness


• hoarseness


• increased frequency of urination


• itching skin


• light-colored stools


• lower back or side pain


• muscle pain or stiffness


• numbness of the fingers or toes


• pain, swelling, or redness in the joints


• painful or difficult urination


• rash


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• unpleasant breath odor


• unusual bleeding or bruising


• upper right abdominal or stomach pain


• vomiting of blood


• weakness


• yellow eyes and skin

Incidence not known

• Black, tarry stools


• bleeding gums


• blood in the urine or stools


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• cool, sweaty skin


• pinpoint red spots on the skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Bluish color of the fingernails, lips, skin, palms, or nail beds


• change in consciousness


• loss of consciousness


• no blood pressure or pulse


• stopping of heart


• unconsciousness


• very drowsy or sleepy

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Belching


• bloated


• decreased interest in sexual intercourse


• difficulty having a bowel movement (stool)


• discouragement


• dry mouth


• excess air or gas in stomach or intestines


• feeling of constant movement of self or surroundings


• feeling of indigestion


• feeling sad or empty


• full feeling


• inability to have or keep an erection


• irritability


• loss in sexual ability, desire, drive, or performance


• loss of interest or pleasure


• nightmares


• pain in the chest below the breastbone


• passing gas


• redness or other discoloration of the skin


• runny nose


• sensation of spinning


• sleeplessness


• sneezing


• stuffy nose


• tiredness


• trouble concentrating


• trouble sleeping


• unable to sleep

Rare

• Bone pain


• continuing ringing or buzzing or other unexplained noise in the ears


• dry eyes


• hair loss or thinning of the hair


• hearing loss


• increased sensitivity of the skin to sunlight


• pain of penis on erection


• severe sunburn

Incidence not known

• Change in taste or bad, unusual, or unpleasant (after) taste


• fear or nervousness


• hives or welts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Toprol XL side effects (in more detail)

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More Toprol XL resources

• Toprol XL Side Effects (in more detail)
• Toprol XL Use in Pregnancy & Breastfeeding
• Drug Images
• Toprol XL Drug Interactions
• Toprol XL Support Group
• 31 Reviews for Toprol XL - Add your own review/rating

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