Micropaque Côlon may be available in the countries listed below.
Ingredient matches for Micropaque Côlon
Barium Sulfate is reported as an ingredient of Micropaque Côlon in the following countries:
- France
International Drug Name Search
Micropaque Côlon may be available in the countries listed below.
Barium Sulfate is reported as an ingredient of Micropaque Côlon in the following countries:
International Drug Name Search
Placentol may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Oxytocin is reported as an ingredient of Placentol in the following countries:
International Drug Name Search
Klinotab may be available in the countries listed below.
Minocycline hydrochloride (a derivative of Minocycline) is reported as an ingredient of Klinotab in the following countries:
International Drug Name Search
Asthafen may be available in the countries listed below.
Ketotifen is reported as an ingredient of Asthafen in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Dichlorophen is reported as an ingredient of Pulvex Multipurpose Worm Caps in the following countries:
Toluene is reported as an ingredient of Pulvex Multipurpose Worm Caps in the following countries:
International Drug Name Search
Aceclofenac 100 mg Tablets
Each tablet contains Aceclofenac 100 mg
For excipients, see 6.1.
Film-coated tablets.
White, circular, film-coated tablets with 'LG' embossed on one side and '100' on the other side of the tablet.
Aceclofenac 100 mg Tablets are indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Aceclofenac tablets are supplied for oral administration and should be swallowed whole with a sufficient quantity of liquid. Aceclofenac should be taken preferably with or after food.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
Adults
The recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening.
Children
There are no clinical data on the use of Aceclofenac in children and therefore it is not recommended for use in children.
Elderly
The pharmacokinetics of Aceclofenac are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency.
As with other non-steroidal anti-inflammatory drugs (NSAIDs), caution should be exercised in the treatment of elderly patients, who are at increased risk of the serious consequences of adverse reactions, and who are more likely to be suffering from impaired renal, cardiovascular or hepatic function and receiving concomitant medication. The elderly should be monitored regularly for GI bleeding during NSAID therapy.
Renal insufficiency
There is no evidence that the dosage of Aceclofenac needs to be modified in patients with mild renal impairment, but as with other NSAIDs caution should be exercised (See also Precautions).
Hepatic insufficiency
There is some evidence that the dose of Aceclofenac should be reduced in patients with hepatic impairment and it is suggested that an initial daily dose of 100 mg be used.
Hypersensitivity to any of the constituents.
NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.
Severe hepatic and cardiac failure (See section 4.4 - Special warnings and precautions for use).
Moderate to severe renal failure.
During the last trimester of pregnancy (See section 4.6 - Pregnancy and lactation)
Active or previous peptic ulcer.
History of upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Use with concomitant NSAIDs including cyclooxygenase 2 specific inhibitors (See section 4.5 Interactions).
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below).
Elderly:
The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (See section 4.2 - Posology and administration).
Respiratory disorders:
Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.
Cardiovascular, Renal and Hepatic Impairment:
The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients (See also section 4.3 – Contraindications). Effects on renal function are usually reversible on withdrawal of Aceclofenac.
If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Aceclofenac should be discontinued. Hepatitis may occur without prodromal symptoms.
Use of Aceclofenac in patients with hepatic porphyria may trigger an attack.
Gastrointestinal bleeding, ulceration and perforation:
GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.
The risk of GI bleeding, ulceration or performation is higher with increasing NSAID doses, in patients with a history of ulcers, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients shouls commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring conconminant low dose asprin, or other drugs likely to increase gastrointestinal risk (see below and section 4.5).
Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
Cardiovascular and cerebrovascular effects:
Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for Aceclofenac.
Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with Aceclofenac after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).
Caution should be advised in patients receiving concomitant medications which could increase the risk of gastrotoxicity or bleeding, such as corticosteroids, or anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (See section 4.5).
When GI bleeding or ulceration occurs in patients receiving Aceclofenac the treatment should be withdrawn.
NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (See section 4.8 – Undesirable effects).
Close medical surveillance is imperative in patients with bleeding diathesis or haematological abnormalities.
SLE and mixed connective tissue disease:
In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (See section 4.8 – Undesirable effects).
Dermatological:
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Aceclofenac should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Female fertility:
The use of Aceclofenac may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Aceclofenac should be considered.
Hypersensitivity reactions:
As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur without earlier exposure to the drug.
Haematological:
Aceclofenac may reversibly inhibit platelet aggregation (See anticoagulants under 'Interactions').
Long-term treatment:
All patients who are receiving NSAIDs should be monitored as a precautionary measure e.g. renal function, hepatic function (elevation of liver enzymes may occur) and blood counts.
Lithium: Aceclofenac, like many NSAIDs, may increase plasma concentrations of lithium.
Cardiac Glycosides: Through their renal effects, NSAIDs may increase plasma glycoside (including digoxin) levels, exacerbate cardiac failure and reduce the glomerular filtration rate in patients receiving glycosides.
Diuretics: Aceclofenac, like other NSAIDs, may inhibit the activity of diuretics. Although it was not shown to affect blood pressure control when co-administered with bendroflumethiazide, interactions with other diuretics cannot be ruled out. When concomitant administration with potassium-sparing diuretics is employed, serum potassium should be monitored. Diuretics can increase the risk of nephrotoxicity of NSAIDs.
Anticoagulants: Like other NSAIDs, Aceclofenac may enhance the activity of anticoagulants such as warfarin (See section 4.4 - Special warnings and precautions for use). Close monitoring of patients on combined anticoagulant and Aceclofenac therapy should be undertaken.
Antidiabetic agents: Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of hypoglycaemic and hyperglycaemic effects. Thus with Aceclofenac, consideration should be given to adjustment of the dosage of hypoglycaemic agents.
Methotrexate: Caution should be exercised if NSAIDs and methotrexate are administered within 24 hours of each other, since NSAIDs may increase methotrexate plasma levels, resulting in increased toxicity.
Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.
Ciclosporin: Ciclosporin nephrotoxicity may be increased by the effect of NSAIDs on renal prostaglandins.
Quinolone antimicrobials: Convulsions may occur due to an interaction between quinolones and NSAIDs. This may occur in patients with or without a previous history of epilepsy or convulsions. Therefore, caution should be exercised when considering the use of a quinolone in patients who are already receiving a NSAID.
Other analgesics including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects (See section 4.3).
Anti-hypertensives: Reduced anti-hypertensive effect.
Corticosteroids: Increased risk of gastrointestinal ulceration or GI bleeding (See section 4.4).
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4)
Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
Ritonavir: plasma concentration of Aceclofenac possibly increased by ritonavir.
Pregnancy:
Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDs on the foetal cardiovascular system (risk of closure of the ductus arteriosus), use in the last trimester of pregnancy is contraindicated. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child (See section 4.3 Contraindications). NSAIDs should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus.
Animal studies indicate that there was no evidence of teratogenesis in rats although the systemic exposure was low and in rabbits, treatment with aceclofenac (10 mg/kg/day) resulted in a series of morphological changes in some foetuses.
Lactation:
There is no information on the secretion of Aceclofenac to breast milk; there was however no notable transfer of radio-labelled (14C) aceclofenac to the milk of lactating rats.
In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breast-feeding.
See section 4.4 Special warnings and precautions for use, regarding female fertility.
Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.
The majority of adverse reactions reported have been reversible and of a minor nature. The most frequent are gastro-intestinal disorders, in particular dyspepsia, abdominal pain, nausea and diarrhoea, and occasional occurrence of dizziness. Dermatological complaints including pruritus and rash and abnormal hepatic enzyme and serum creatinine levels have also been reported with the frequencies indicated in the following table.
If serious side effects occur, Aceclofenac should be withdrawn.
The following is a table of adverse reactions reported during clinical studies and after authorisation, grouped by System-Organ Class and estimated frequencies.
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Other rare or very rare class-effects reported with NSAIDs in general are:
Gastrointestinal System – Duodenal ulcer, Gastrointestinal perforation
Urinary System – Interstitial nephritis
Central and Peripheral Nervous System – Optic neuritis
Psychiatric – Hallucination, Drowsiness, Confusion
Skin and Appendages – Epidermal necrolysis, Erythema multiforme, Exfoliative dermatitis
Respiratory – Aggravated asthma
Haematological – Aplastic anaemia
Others – Tinnitus, Photosensitivity, Malaise
Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombic events (for example myocardial infarction or stroke (see section 4.4 Special warnings and precautions for use).
Other undesirable effects that have been reported are exacerbation of colitis and Crohn's disease, angioedema, aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation and also asthma (See section 4.4 Special warnings and precautions for use).
There are no human data available on the consequences of Aceclofenac overdose.
a) Symptoms
Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting, occasionally convulsions. In cases of significant poisoning acute renal failure and liver damage are possible.
b) Therapeutic measure
Patients should be treated symptomatically as required.
Within one hour of ingestion of a potentially toxic amount activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.
Good urine output should be ensured.
Renal and liver function should be closely monitored.
Patients should be observed for at least four hours after ingestion of potentially toxic amounts.
Frequent or prolonged convulsions should be treated with intravenous diazepam.
Other measures may be indicated by the patient's clinical condition.
Specific therapies such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to their high rate of protein binding and extensive metabolism.
ATC code: M01A B16
Aceclofenac is a non-steroidal agent with marked anti-inflammatory and analgesic properties.
The mode of action of aceclofenac is largely based on the inhibition of prostaglandin synthesis. Aceclofenac is a potent inhibitor of the enzyme cyclo-oxygenase, which is involved in the production of prostaglandins.
After oral administration, aceclofenac is rapidly and completely absorbed as unchanged drug. Peak plasma concentrations are reached approximately 1.25 to 3.00 hours following ingestion. Aceclofenac penetrates into the synovial fluid, where the concentrations reach approximately 57% of those in plasma. The volume of distribution is approximately 25 L.
The mean (geometrical) plasma elimination half-life is 2.30 hours. Aceclofenac is highly protein-bound (> 99%). Aceclofenac circulates mainly as unchanged drug. 4'-Hydroxyaceclofenac is the main metabolite detected in plasma. Approximately two-thirds of the administered dose is excreted via the urine, mainly as hydroxymetabolites.
No changes in the pharmacokinetics of aceclofenac have been detected in the elderly.
The results from preclinical studies conducted with aceclofenac are consistent with those expected for NSAIDs. The principal target organ was the gastro-intestinal tract. No unexpected findings were recorded.
Aceclofenac was not considered to have any mutagenic activity in three in vitro studies and an in vivo study in the mouse.
Aceclofenac was not found to be carcinogenic in either the mouse or rat.
Core:
Microcrystalline cellulose
Croscarmellose Sodium
Povidone
Glyceryl distearate (type I)
Film-coat:
Hypromellose
Titanium dioxide (E171)
Macrogol 400
Not applicable.
2 years.
Do not store above 25 °C. Store in the original package.
Aluminium/Aluminium blister in packs of 28, 30, 56, 60 and 100.
Not all pack sizes may be marketed.
No special requirements.
Sandoz Ltd
Woolmer Way
Bordon
Hants
GU35 9QE
PL 04416/0591
07/02/2006
11/11/2008
Lomustine (CCNU) is usually taken as a single dose only once every 6 weeks. Do NOT take a dose of Lomustine (CCNU) more than once within a 6-week period without first talking with your doctor.
Lomustine (CCNU) often decreases bone marrow function and lowers the number of white blood cells and platelets in your blood. This may increase your risk for severe infection or bleeding problems, especially if you already have bone marrow suppression. The risk is greater if you take Lomustine (CCNU) more often than once every 6 weeks, take it in high doses, or take it for a long period of time. Tell your doctor right away if you experience symptoms such as fever, chills or persistent sore throat, unusual bruising or bleeding, or unusual tiredness or weakness.
You will need to have blood tests every week for at least 6 weeks after each single dose of Lomustine (CCNU). Your doctor may change your dose of Lomustine (CCNU) based on these tests.
Treating certain types of cancer.
Lomustine (CCNU) is an alkylating agent used to treat cancer. It works by stopping or slowing the growth of cancer cells.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Lomustine (CCNU). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Lomustine (CCNU). Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Lomustine (CCNU) 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.
Use Lomustine (CCNU) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Lomustine (CCNU).
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Hair loss; loss of appetite; nausea; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion or disorientation; decreased amount of urine; decreased coordination; dry cough; fever, chills, or persistent sore throat; shortness of breath; sluggishness; swelling of feet or lower legs; swelling or sores of the mouth or tongue; symptoms of liver problems (eg, dark urine; pale stools; right-sided stomach pain; unusual loss of appetite, nausea, or tiredness; yellowing of the skin or eyes); trouble speaking; unusual bleeding or bruising; unusual tiredness or weakness; vision changes (eg, blindness).
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: Lomustine (CCNU) side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include cough; diarrhea; dizziness; fever, chills, or persistent sore throat; loss of appetite; severe or persistent vomiting; shortness of breath; sluggishness; stomach pain; symptoms of liver problems (eg, dark urine; pale stools; right-sided stomach pain; unusual loss of appetite, nausea, or tiredness; yellowing of the skin or eyes); unusual bruising or bleeding; unusual tiredness or weakness.
Store Lomustine (CCNU) at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Avoid temperatures higher than 104 degrees F (40 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lomustine (CCNU) out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Lomustine (CCNU). 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.