Topogel may be available in the countries listed below.
Ingredient matches for Topogel
Ketoprofen
Ketoprofen is reported as an ingredient of Topogel in the following countries:
- Bulgaria
- Georgia
International Drug Name Search
Tuesday, October 25, 2016
Amoxil Syrup Sucrose-Free / Dye-Free 250mg / 5ml
1. Name Of The Medicinal Product
Amoxil® Syrup Sucrose-Free/Dye-Free 250 mg/5 ml
2. Qualitative And Quantitative Composition
Amoxil Syrup SF/DF 250 mg contains 250 mg amoxicillin per 5 ml dose.
The amoxicillin is present as the trihydrate.
3. Pharmaceutical Form
Amoxil Syrup SF/DF 250 mg/5 ml: citrus-flavoured sucrose-free/Dye Freesuspension in a sorbitol base. Presented as powder in bottles for preparing 100 ml.
4. Clinical Particulars
4.1 Therapeutic Indications
Treatment of Infection: Amoxil is a broad spectrum antibiotic indicated for the treatment of commonly occurring bacterial infections such as:
Upper respiratory tract infections
Otitis media
Acute and chronic bronchitis
Chronic bronchial sepsis
Lobar and bronchopneumonia
Cystitis, urethritis, pyelonephritis
Bacteriuria in pregnancy
Gynaecological infections including puerperal sepsis and septic abortion
Gonorrhoea
Peritonitis
Intra-abdominal sepsis
Septicaemia
Bacterial endocarditis
Typhoid and paratyphoid fever
Skin and soft tissue infections
Osteomyelitis
Dental abscess (as an adjunct to surgical management)
In children with urinary tract infection the need for investigation should be considered.
Prophylaxis of endocarditis: Amoxil may be used for the prevention of bacteraemia, associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis.
The wide range of organisms sensitive to the bactericidal action of Amoxil include:
Gram-positive Gram-negative
Streptococcus faecalis Haemophilus influenzae
Streptococcus pneumoniae Escherichia coli
Streptococcus pyogenes Proteus mirabilis
Streptococcus viridans Salmonella species
Staphylococcus aureus Shigella species
(penicillin-sensitive) Bordetella pertussis
Clostridium species Brucella species
Corynebacterium species Neisseria gonorrhoeae
Bacillus anthracis Neisseria meningitidis
Listeria monocytogenesVibrio cholerae
Pasteurella septica
4.2 Posology And Method Of Administration
Treatment of Infection:
Adult dosage (including elderly patients):
Oral:
Standard adult dosage: 250 mg three times daily, increasing to 500 mg three times daily for more severe infections.
High dosage therapy (maximum recommended oral dosage 6 g daily in divided doses): A dosage of 3 g twice daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection of the respiratory tract.
Short course therapy: Simple acute urinary tract infection: two 3 g doses with 10-12 hours between the doses. Dental abscess: two 3 g doses with 8 hours between the doses. Gonorrhoea: single 3 g dose.
Injectable:
500 mg IM eight hourly (or more frequently if necessary) in moderate infections. (This dose may be given by slow IV injection if more convenient.)
1 g IV six hourly in severe infections.
Children's dosage (up to 10 years of age):
Oral:
Standard children's dosage: 125 mg three times daily, increasing to 250 mg three times daily for more severe infections.
Amoxil Paediatric Suspension is recommended for children under six months of age.
Prophylaxis of endocarditis:
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In severe or recurrent acute otitis media, especially where compliance may be a problem, 750 mg twice a day for two days may be used as an alternative course of treatment in children aged 3 to 10 years.
Injectable:
50-100 mg/kg body weight a day, in divided doses.
Parenteral therapy is indicated if the oral route is considered impracticable or unsuitable, and particularly for the urgent treatment of severe infection.
In renal impairment the excretion of the antibiotic will be delayed and, depending on the degree of impairment, it may be necessary to reduce the total daily dosage.
Prophylaxis of endocarditis: see table on previous page.
Administration:
Oral
4.3 Contraindications
Amoxil is a penicillin and should not be given to penicillin-hypersensitive patients. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics eg. cephalosporins.
4.4 Special Warnings And Precautions For Use
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of hypersensitivity to beta-lactam antibiotics (see 4.3).
Erythematous (morbilliform) rashes have been associated with glandular fever in patients receiving amoxicillin.
Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.
In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria (see Section 4.9 Overdose).
Dosage should be adjusted in patients with renal impairment (see 4.2).
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
In common with other broad spectrum antibiotics, amoxicillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly.
Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.
Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.
It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods.
4.6 Pregnancy And Lactation
Use in pregnancy:
Animal studies with Amoxil have shown no teratogenic effects. The product has been in extensive clinical use since 1972 and its suitability in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, Amoxil may be considered appropriate when the potential benefits outweigh the potential risks associated with treatment.
Use in lactation:
Amoxicillin may be given during lactation. With the exception of the risk of sensitisation associated with the excretion of trace quantities of amoxicillin in breast milk, there are no known detrimental effects for the breast-fed infant.
4.7 Effects On Ability To Drive And Use Machines
Adverse effects on the ability to drive or operate machinery have not been observed.
4.8 Undesirable Effects
The following convention has been utilised for the classification of undesirable effects:-
Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000,<1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000)
The majority of side effects listed below are not unique to amoxycillin and may occur when using other pencillins.
Unless otherwise stated, the frequency of adverse events has been derived from more than 30 years of post-marketing reports.
Blood and lymphatic system disorders
Very rare: Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia.
Prolongation of bleeding time and prothrombin (see Section 4.5 - Interaction with other Medicaments and other Forms of Interaction)
Immune system disorders
Very rare: As with other antibiotics, severe allergic reactions, including angioneurotic oedema, anaphylaxis (see Section 4.4 - Special Warnings and Precautions for Use), serum sickness and hypersensitivity vasculitis.
If a hypersensitivity reaction is reported, the treatment must be discontinued. (See also Skin and subcutaneous tissue disorders).
Nervous system disorders
Very rare: Hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.
Gastrointestinal disorders
Clinical Trial Data
*Common: Diarrhoea and nausea.
*Uncommon: Vomiting.
Post-marketing Data
Very rare: Mucocutaneous candidiasis and antibiotic associated colitis (including pseudomembraneous colitis and haemorrhagic colitis).
Superficial tooth discolouration has been reported in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing.
Hepato-biliary disorders
Very rare: Hepatitis and cholestatic jaundice. A moderate rise in AST and/or ALT.
The significance of a rise in AST and/or ALT is unclear.
Skin and subcutaneous tissue disorders
Clinical Trial Data
*Common: Skin rash
*Uncommon: Urticaria and pruritus
Post-marketing Data
Very rare: Skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis and acute generalised exanthematous pustulosis (AGEP)
(See also Immune system disorders).
Renal and urinary tract disorders
Very rare: Interstitial nephritis.
Very rare: Crystalluria (see Section 4.9 Overdose).
*The incidence of these AEs was derived from clinical studies involving a total of approximately 6,000 adult and paediatric patients taking amoxicillin.
4.9 Overdose
Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically with attention to the water/electrolyte balance. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4 Special warnings and special precautions for use).
Amoxicillin may be removed from the circulation by haemodialysis.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Amoxil is a broad spectrum antibiotic.
It is rapidly bactericidal and possesses the safety profile of a penicillin.
5.2 Pharmacokinetic Properties
Amoxil is well absorbed by the oral and parenteral routes. Oral administration, usually at convenient t.d.s. dosage, produces high serum levels independent of the time at which food is taken. Amoxil gives good penetration into bronchial secretions and high urinary concentrations of unchanged antibiotic.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Amoxil Syrup SF/DF 250 mg / 5ml
The powder contains disodium edetate, sodium benzoate (E211), saccharin sodium, silica (E551), xanthan gum (E415), peach, strawberry and lemon dry flavours and sorbitol (E420).
6.2 Incompatibilities
None.
6.3 Shelf Life
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6.4 Special Precautions For Storage
Store powder in a dry place. Once dispensed, Amoxil Syrup SF/DF should be used within 14 days. If dilution of the reconstituted SF/DF product is required, water should be used.
6.5 Nature And Contents Of Container
Amoxil Syrup SF/DF 250 mg/5 ml: Original Pack of 100 ml with Patient InformationLeaflet.
6.6 Special Precautions For Disposal And Other Handling
None
Administrative Data
7. Marketing Authorisation Holder
Beecham Group plc
Great West Road, Brentford
Middlesex TW8 9GS
Trading as:
GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT
And/or
Bencard or SmithKline Beecham Pharmaceuticals all at Mundells Welwyn Garden City, Hertfordshire AL7 1EY
8. Marketing Authorisation Number(S)
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9. Date Of First Authorisation/Renewal Of The Authorisation
14 May 1985 / 16 January 1998
10. Date Of Revision Of The Text
5th July 2005
11. Legal Status
POM
Celeston valerat
Celeston valerat may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Celeston valerat
Betamethasone
Betamethasone 17α-valerate (a derivative of Betamethasone) is reported as an ingredient of Celeston valerat in the following countries:
- Denmark
- Sweden
International Drug Name Search
Ibufen-L
Ibufen-L may be available in the countries listed below.
Ingredient matches for Ibufen-L
Ibuprofen
Ibuprofen lysine (a derivative of Ibuprofen) is reported as an ingredient of Ibufen-L in the following countries:
- Switzerland
Lidocaine
Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Ibufen-L in the following countries:
- Switzerland
International Drug Name Search
Non-ionic iodinated contrast media
A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.
See also
Medical conditions associated with non-ionic iodinated contrast media:
- Angiocardiography
- Aortography
- Arthrography
- Body Imaging
- Cerebral Arteriography
- Computed Tomography
- Coronary Arteriography
- Cystourethrography
- Digital Subtraction Angiography
- Endoscopy or Radiology Premedication
- Gastrointestinal Tract Examination
- Head Imaging
- Hysterosalpingography
- Intra-arterial Digital Subtraction Angiography
- Intravenous Digital Subtraction Angiography
- Intravenous Urography
- Left Ventriculography
- Myelography
- Pediatric Angiocardiography
- Peripheral Angiography
- Peripheral Arteriography
- Renal Arteriography
- Urography
- Venography
- Visceral Arteriography
Drug List:
Aciclovir Tablets BP
ACICLOVIR TABLETS
Please read this leaflet carefully before you start to take this medicine. It gives an outline of the more important things you should 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 your course of treatment.
THE NAME OF YOUR MEDICINE IS ACICLOVIR TABLETS
Aciclovir Tablets contain the active ingredient aciclovir. The tablets come in three strengths, 200mg, 400mg and 800mg.
Other ingredients in your tablets are gelatin, lactose, maize starch, microcrystalline cellulose, sodium starch glycollate and magnesium stearate.
Aciclovir 200mg Tablets are white, circular tablets marked ACV 200 on one face, CP on the reverse.
Aciclovir 400mg Tablets are white, oval tablets marked with ACV 400 and a breakline on one face, CP on the reverse.
Aciclovir 800mg Tablets are white, oval tablets marked with ACV 800 and a breakline on one face, CP on the reverse.
Aciclovir 200mg Tablets are available in blister packs of 25 tablets.
Aciclovir 400mg Tablets are available in blister packs of 56 tablets.
Aciclovir 800mg Tablets are available in blister packs of 35 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?
Aciclovir belongs to a group of medicines called antivirals. These medicines work by stopping viruses from
spreading in the body.
What Are Aciclovir Tablets For?
Aciclovir Tablets are used to treat shingles in adults and infections of the lips or nose (“cold sores”), skin and genitals caused by herpes virus. Aciclovir tablets are also used to prevent repeated herpes infections and to protect people who have a low resistance to disease and have been in contact with herpes.
Doctors sometimes prescribe this medicine for other purposes. If you think this applies to you, ask your doctor.
Before Taking This Medicine
You should not take Aciclovir Tablets if you have ever had a reaction or been told that you are allergic to aciclovir or any of the other ingredients in the tablets. Check by reading the list of ingredients above.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Before taking this medicine, you should let your doctor know if you are pregnant or breast-feeding or planning to become pregnant or start breast-feeding.
Taking another medicine while you are taking Aciclovir Tablets can affect how it or the other medicine works. Make sure that your doctor knows what other medicines you are taking. Do not take any other medicines while you are taking Aciclovir Tablets unless you have told your doctor or pharmacist and asked their advice. This includes medicines you may have bought yourself.
Examples of medicines that can affect Aciclovir Tablets are:
- Probenecid, a drug used to prevent gout.
- Zidovudine, another antiviral drug.
- Theophylline, used in asthma.
If you have any doubts about whether you should take this medicine then talk to your doctor.
Advice When Taking Aciclovir Tablets
- It is important to drink plenty of water while you are taking aciclovir.
- Care is required if you have kidney problems, any nervous disorder, liver disease, abnormal levels of electrolytes (salts) in the blood or severe breathing difficulties. Your dosage may be reduced.
- You should not drive or operate machinery until you are sure that the tablets are not affecting your ability to do so.
Taking This Medicine
The usual adult dose of Aciclovir Tablets for the treatment of cold sores, skin or genital herpes is 200mg five times daily (usually every four hours while awake) for five days. For children over two years the dose is the same as the adult dose. For children under two years, the usual dose is 100mg five times a day.
The usual adult dose of Aciclovir Tablets for the prevention of repeated herpes infections is 200mg four times daily or 400mg twice daily, which can be reduced to 200mg two or three times daily. For children over two years the dose is the same as the adult dose. For children under two years, the usual dose is 200mg twice daily. Treatment should be interrupted every 6 -12 months to see if you are free from infection.
The usual adult dose for protection from herpes infections in those with low resistance to disease is 200mg four times daily, which may be increased to 400mg four times daily for severe cases. For children over two years the dose is the same as the adult dose. For children under two years, the usual dose is 100mg four times daily. Treatment should be given for as long as there is a risk of herpes infection.
The usual adult dose for the treatment of shingles in adults is 800mg five times daily (usually every four hours while awake). This should start no later than three days after the first sign of infection and continue for seven days.
Your doctor will decide the dose that is best for you. Always follow your doctor’s instructions completely. Also, follow any instructions or warnings that 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.
To remove a tablet, press on the tablet from the blister (or bubble) side, pushing it through the foil. Do not remove the tablet from the blister until you are ready to take it.
Unless told otherwise, swallow your tablets whole with plenty of water.
You should take your medicine for as long as your doctor tells you to. 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. Do not stop taking the medicine without talking to your doctor first.
If you accidentally take too many tablets, you should contact your doctor, pharmacist or nearest hospital casualty department. Take this leaflet and any tablets you have left to show the doctor or pharmacist.
Are There Any Side-Effects?
Like many medicines, Aciclovir Tablets may cause side-effects in some patients, particularly when you first start taking them. The side-effects that some other patients have had with Aciclovir Tablets include kidney problems, blood problems (which could cause sore throats, mouth ulcers, or generally feeling tired or unwell), rashes, sore muscles, swelling of the feet or hands, visual disturbances, itching, fever, headaches, stomach pain, feeling sick, being sick and diarrhoea. There may be some increases in levels of chemicals in the blood, indicating kidney or liver disturbances.
Rarely, swollen glands, allergic reactions (sometimes with fever, rash, swelling of the face and difficulty breathing), liver problems, jaundice (with yellow skin and whites of eyes), thrombocytopenia (reduced blood platelets), hair loss, serious skin conditions such as Steven-Johnsons syndrome, erythema multiforme and toxic epidermal necrolysis, mental illness, psychosis, tiredness, dizziness, drowsiness, confusion, hallucinations, feeling agitated, shaking, “pins and needles”, fits and loss of consciousness have been reported, particularly in older patients or those with renal impairment.
If you experience any other side effects or feel that the medicine is affecting you badly, tell your doctor or pharmacist.
Safe Keeping For This Medicine
Do not take this medicine if the expiry date on the label has passed or if the tablets show signs of “going on” such as discoloration.
Do not store these tablets above 25°C. Keep them in the package or container in which they were given to you. Do not transfer Aciclovir Tablets to another container.
Keep Aciclovir Tablets 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 medicines that you no longer need. Give them back to your pharmacist.
Other formats:
To listen to or request a copy of the leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product Name - Reference Number
- Aciclovir 200mg Tablets - 29831/0002
- Aciclovir 400mg Tablets - 29831/0001
- Aciclovir 800mg Tablets - 29831/0003
This is a service provided by the Royal National Institute of the Blind.
DATE OF PREPARATION
August 2007
CP4
103799/1
Monday, October 24, 2016
Medibudget Abführdragées Bisacodyl
Medibudget Abführdragées Bisacodyl may be available in the countries listed below.
Ingredient matches for Medibudget Abführdragées Bisacodyl
Bisacodyl
Bisacodyl is reported as an ingredient of Medibudget Abführdragées Bisacodyl in the following countries:
- Switzerland
International Drug Name Search
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