Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
DEXKETOPROFEN TROMETAMOL
Rowex Ltd
DEXKETOPROFEN TROMETAMOL
12.5 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
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. WHAT IS IN THIS LEAFLET 1. What Dexketoprofen Rowex is and what it is used for 2. What you need to know before you take Dexketoprofen Rowex 3. How to take Dexketoprofen Rowex 4. Possible side effects 5. How to store Dexketoprofen Rowex 6. Contents of the pack and other information 1. WHAT DEXKETOPROFEN ROWEX IS AND WHAT IT IS USED FOR Dexketoprofen Rowex 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEXKETOPROFEN ROWEX DO NOT TAKE DEXKETOPROFEN ROWEX: • If you are allergic to dexketoprofen trometamol 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 wh Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dexketoprofen Rowex 12.5mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Dexketoprofen trometamol 18.45 mg corresponding to dexketoprofen 12.5 mg. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film coated tablets. White, biconvex cylindric shaped unscored tablets embossed with DT1 on one side. Tablet dimensions are: 3.4 mm x 7.1 mm ± 0.3 mm 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 _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 minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Dexketoprofen Rowex tablets are not intended for long term use and the treatment must be limited to the symptomatic period. Concomitant administration with food delays the absorption rate of the drug (see Pharmacokinetic Properties), thus in case of acute pain it is recommended that administration is at least 30 minutes before meals. _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 dysfunction:_ Patients with mild to moderate hepatic dysfunction should start therapy at reduced doses (50 mg total daily dose) and be closely monitored. Dexketoprofen Rowex Đọc toàn bộ tài liệu