Valsts: Malta
Valoda: angļu
Klimata pārmaiņas: Medicines Authority
KETOPROFEN LYSINE
Dompe Farmaceutici SpA Via San Martino 12, 20122, Milan, Italy
M01AE03
KETOPROFEN LYSINE 160 mg
SUPPOSITORY
KETOPROFEN LYSINE 160 mg
POM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Withdrawn
2009-01-21
Insert leaflet OKI 160 MG SUPPOSITORIES M01AE03 Ketoprofen lysine salt COMPOSITION One suppository contains: Active ingredient: ketoprofen lysine salt 160 mg. Excipients: semi-synthetic glycerides. PHARMACEUTICAL FORM AND CONTENT Suppositories - Box of 10 suppositories. THERAPEUTIC CLASS Non-steroidal anti-inflammatory drug. MARKETING AUTHORISATION HOLDER Dompé farmaceutici S.p.A., Via San Martino 12 20122 Milano Italy. MANUFACTURER Istituto de Angeli s.r.l. – Pharmaceutical Plant Reggello TERAPEUTIC INDICATIONS Symptomatic treatment of inflammatory conditions associated with pain, such as: rheumatoid arthritis, ankylosing spondylitis, painful arthrosis, extra-articular rheumatism, post-traumatic inflammation. CONTRAINDICATIONS Active peptic ulcer or an history of gastrointestinal bleeding, ulceration or perforation related to previous active treatment or history of recurrent haemorrhage/peptic ulcer (two or more different episodes of ulceration or haemmorrage demonstrated) or chronic dyspepsia. Gastritis, serious renal failure, leukopenia and thrombocytopenia, serious blood clotting disorders, colitis ulcerative and serious heart failure. The suppositories should not be administered to patients with haemorrhoid disturbances or who have recently suffered from proctitis. _HYPERSENSITIVITY TO KETOPROFEN _ There is a possibility of crossover hypersensitivity with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. This means that ketoprofen should not be taken by patients in whom acetylsalicylic acid or other non-steroidal anti-inflammatory drugs have provoked such symptoms as asthma, rhinitis or urticaria. Pregnancy and breast-feeding. PRECAUTIONS FOR USE The use of OKi 160 mg suppositories with concomitant NSAIDS, including cyclooxygenase-2 selective should be avoid. Undesiderables effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms. Gastrointestinal bleeding, ulceration and perforation: gastrointestinal bleeding, ulceration or pe Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT OKi 160 mg suppositories 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One suppository contains : active ingredient : ketoprofen lysine salt 160 mg 3. PHARMACEUTICAL FORM Suppositories 4. CLINICAL PARTICULARS _4.1 THERAPEUTIC INDICATIONS _ Symptomatic treatment of inflammatory states associated with pain, such as : rheumatoid arthritis, ankylosing spondilitis, painful arthritis, extra-articular rheumatism, post-traumatic inflammation _4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ Adults: 1 suppostory 2 times a day or according to medical prescription. The posology for the treatment of elderly patients must be carefully established by the physician, who will take into consideration the possibility of reducing the dosage mentioned above. The maximum daily dose is 200 mg of ketoprofen, corresponding to 320 mg of ketoprofen lysine salt. The balance of risks and benefits should be carefully considered before commencing treatment with 200 mg daily, and higher doses are not recommended (see also section 4.4) Undesiderables effects may be minimised by using the shortest duration necessary to control symptoms (see section 4.4) _4.3 CONTRA-INDICATIONS _ Active peptic ulcer or an history of gastrointestinal bleeding, ulceration or perforation related to previous active treatment or history of recurrent haemorrhage/peptic ulcer (two or more different episodes of ulceration or haemmorrage demonstrated) or chronic dyspepsia. Gastritis, serious renal failure, leukopenia and thrombocytopenia, serious blood clotting disorders and serious heart failure. Hypersensitivity to ketoprofen. There is the risk of cross-hypersensitivity reactions with acetylsalycilic acid or other non-steroidal anti-inflammatory drugs. For this reason ketoprofen should not be given to patients in whom acetylsalycilic acid or other non-steroidal anti-inflammatory drugs have caused the appearance of symptoms of asthma, rhinitis, urticaria. Pregnancy. Lactation _4.4 SPECIAL WARNINGS AND PRE Izlasiet visu dokumentu