Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Medicines Authority
NIMESULIDE
PIAM Farmaceutici S.p.A. Via Fieschi, 8/7 1-16124, Genoa, Italy
M01AX17
NIMESULIDE 100 mg
GRANULES FOR ORAL SUSPENSION
NIMESULIDE 100 mg
POM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Withdrawn
2006-08-04
Page 1 of 4 REMOV 100 MG TABLETS REMOV 100 MG GRANULATE FOR ORAL SUSPENSION READ THIS LEAFLET CAREFULLY BEFORE TAKING THE MEDICINE: - Keep this leaflet. You may need to read it again. - If you have any doubts, ask your doctor or pharmacist. - This medicine was prescribed to you. You should not give it to others: the medicine may be harmful to them even if they have the same symptoms. - If You notice the worsen of side effects or a side effect not mentioned in this leaflet, inform the doctor or the pharmacist In this leaflet: 1- What Remov is and what it is used for 2- Before you take Remov 3- How to take Remov 4- Possible side effects 5- How to store Remov 6- Other information 1- WHAT REMOV IS AND WHAT IT IS USED FOR Remov is a non-steroidal anti-inflammatory drug (NSAID), with pain-killing properties. It is used for treatment of acute pain, for the treatment of symptoms of painful osteoarthritis, and for the treatment of period pains. Before prescribing Remov your doctor will assess the benefits this medicine may give you against your risks of developing side effects. 2- BEFORE YOU TAKE REMOV DO NOT TAKE REMOV IF: - are hypersensitive (allergic) to nimesulide or any of the other ingredients of Remov (see. Par. 6) - have had allergic reactions (e.g. wheezing, runny or blocked nose, hives or nettle rash) after aspirin or other non-steroidal anti-inflammatory drugs; - had a reaction to nimesulide affecting the liver in the past; - are taking other medicines that are known to affect the liver, e.g. paracetamol or any other pain- killers or NSAID treatment - are taking drugs of addiction, or have developed a habit that makes you dependent on drugs or other substances - are a regular heavy drinker (alcohol), - if you have liver disease or increased liver enzymes - have a peptic ulcer (stomach or duodenal ulcer) now or had one in the past; - have had bleeding from the stomach or bowel; - have had bleeding into the brain (a stroke); - have any other problem with bleeding or any problems due to your blood not clotting; - Đọc toàn bộ tài liệu
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT REMOV 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100mg nimesulide Each sachet contains 100mg nimesulide For excipients, see section 6.1 3. PHARMACEUTICAL FORM 100mg Tablets - 30 tablets 100mg Granules for oral suspension - 30 sachets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of acute pain (see section 4.2.). Symptomatic treatment of painful osteoarthritis (see section 4.2.). Primary dysmenorrhoea. Nimesulide should only be prescribed as second line treatment. The decision to prescribe nimesulide should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The minimum effective dose should be used for the shortest duration to reduce the undesirable effects. The maximum duration of a treatment course with nimesulide is 15 days. Nimesulide-containing medicinal products should be used for the shortest possible duration, as required by the clinical situation. Adults: 100mg nimesulide tablets 100mg granules bid after meal Elderly: in elderly patients there is no need to reduce the daily dosage (see section 5.2). Children (< 12 years): Nimesulide containing medicinal products are contraindicated in these patients (see also section 4.3). Adolescents (from 12 to 18 years): on the basis of the kinetic profile in adults and on the pharmacodynamic characteristics of nimesulide, no dosage adjustment in these patients is necessary. Impaired renal function: on the basis of pharmacokinetics, no dosage adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance of 30-80 ml/min), while REMOV are contraindicated in case of severe renal impairement (creatinine clearance < 30ml/min) (see sections 4.3 and 5.2). Hepatic impairment: the use of REMOV is contraindicated in patients with hepatic impairment (see section 5.2). 4.3 CONTRAINDICATIONS Known hypersensitivity to nimesulide or to any of the e Đọc toàn bộ tài liệu