País: Malta
Língua: inglês
Origem: Medicines Authority
DEXKETOPROFEN
Menarini International Operations Luxembourg S.A 1 Avenue de la Gare, L-1611, Luxembourg
M01AE17
DEXKETOPROFEN 25 mg
FILM-COATED TABLET
DEXKETOPROFEN 25 mg
OTC
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Authorised
2013-09-27
1 Package Leaflet: Information For The User KERAL 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. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • 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. • You must talk to a doctor if you do not feel better or if you feel worse after 3-4 days WHAT IS IN THIS LEAFLET : 1. What Keral is and what it is used for 2. What you need to know before you take Keral 3. How to take Keral 4. Possible side effects 5. How to store Keral 6. Contents of the pack and other information 1. WHAT KERAL IS AND WHAT IT IS USED FOR Keral is a pain killer from the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is used 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 KERAL DO NOT TAKE KERAL: • 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 particular form of reddening and/or bli Leia o documento completo
_ _ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Keral 25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: dexketoprofen 25 mg as dexketoprofen trometamol. For the full list of _ _ excipients, see section _ _ 6.1. 3. PHARMACEUTICAL FORM Film coated tablet. White, round, scored film-coated tablet, with convex sides. The tablets 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. 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 (half a tablet) 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). Dexketoprofen is 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 impairment should start therapy at reduced doses (50 mg total daily dose) and be closely monitored. Dexketoprofen should not be used in patients with severe hepatic impairment. _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). Dexketoprofen should not _ _ be used in patients with moderate to severe renal impairment (creatinine clearance <59 ml / min) (see section 4.3). _Paediatric population: _ Dexketoprofen has not been studied in children and adoles Leia o documento completo