País: Malta
Língua: inglês
Origem: Medicines Authority
DEXKETOPROFEN TROMETAMOL
Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus
M01AE17
DEXKETOPROFEN TROMETAMOL 25 mg
FILM-COATED TABLET
DEXKETOPROFEN TROMETAMOL 25 mg
POM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-10-19
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FENODEX 12.5 MG FILM-COATED TABLETS FENODEX 25 MG FILM-COATED TABLETS {dexketoprofen} READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Fenodex is and what it is used for 2. What you need to know before you take Fenodex 3. How to take Fenodex 4. Possible side effects 5. How to store Fenodex 6. Contents of the pack and other information 1. WHAT FENODEX IS AND WHAT IT IS USED FOR Fenodex contains dexketoprofen, which is a pain killer from the group of medicines called non- steroidal anti-inflammatory drugs (NSAIDs). It is used in adults to treat mild to moderate pain, such as muscular pain, painful periods (dysmenorrhoea), toothache. You must talk to a doctor if you do not feel better or if you feel worse after 3-4 days 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FENODEX DO NOT TAKE FENODEX - If you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6). - If you are allergic to acetylsalicylic acid or to other non-steroidal anti-inflammatory medicines. - If you have asthma or have suffered attacks of asthma, acute allergic rhinitis (a short period of inflamed lining of the nose), nasal polyps (lumps within the nose due to allergy), urticaria (skin rash), angioedema (swollen face, eyes, lips, or tongue, or respiratory distress) or wheezing in the chest after taking acetylsalicylic acid or other non-steroidal anti-inflammatory medicines. - If you have suffered from photoallergic or phototoxic reactions (a partic Leia o documento completo
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fenodex 12.5 mg film-coated tablets Fenodex 25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains dexketoprofen 12.5 mg or 25 mg (as dexketoprofen trometamol). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Fenodex 12.5 mg film-coated tablets are yellow round, biconvex with diameter 7mm. Fenodex 25 mg film-coated tablets are white round, biconvex, scored, embossed “MC” with diameter 10mm. The 25mg tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of pain of mild to moderate intensity, such as musculo-skeletal pain, dysmenorrhoea, dental pain. Fenodex is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ According to the nature and severity of pain, the recommended dosage is generally 12.5 mg every 4-6 hours or 25 mg every 8 hours. The total daily dose should not exceed 75 mg. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Fenodex tablets are not intended for long-term use and the treatment must be limited to the symptomatic period. _Elderly _ In elderly patients it is recommended to start the therapy at the lower end of the dosage range (50 mg total daily dose). The dosage may be increased to that recommended for the general population only after good general tolerance has been ascertained. _Hepatic impairment _ Patients with mild to moderate hepatic dysfunction should start therapy at reduced doses (50 mg total daily dose) and be closely monitored. Fenodex tablets should not be used in patients with severe hepatic dysfunction. PAGE 2 OF 11 _Renal impairment _ The initial dosage should be reduced to 50 mg total daily dose in patients with mildly impaired renal function (creatinine clearance 60 - 89 ml/min) (see section 4.4). Fenodex tablets should not be used in patients with Leia o documento completo