Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Dexketoprofen
Laboratorios Menarini S.A.
M01AE; M01AE17
Dexketoprofen
12.5 milligram(s)
Granules for oral solution
Product subject to prescription which may be renewed (B)
Propionic acid derivatives; dexketoprofen
Not marketed
2011-07-08
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ENANTYUM 12.5 MG GRANULES FOR ORAL SOLUTION _ _ 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 Enantyum is and what it is used for 2. What you need to know before you take Enantyum 3. How to take Enantyum 4. Possible side effects 5. How to store Enantyum 6. Contents of the pack and other information 1. WHAT ENANTYUM IS AND WHAT IT IS USED FOR Enantyum is a pain killer from the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is used for short term symptomatic treatment of mild to moderate acute pain, such as acute muscular pain or joint pain, painful periods (dysmenorrhoea), toothache. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENANTYUM DO NOT TAKE ENANTYUM: If you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6); If you are allergic to the 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 blistering of the skin exposed to sunlig Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Enantyum 12.5 mg granules for oral solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of granules for oral solution contains dexketoprofen 12.5 mg as dexketoprofen trometamol. Excipients with known effect: Sucrose with colloidal silica: 1.20 – 1.22 g. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Granules for oral solution, lemon yellow coloured granules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short term symptomatic treatment of acute pain of mild to moderate intensity, such as acute musculo-skeletal pain, dysmenorrhoea and dental pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ Adults According to the nature and severity of pain, the recommended dosage is 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.). Enantyum is only intended for short 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 adult only after good general tolerance has been ascertained. Due to the possible adverse effect profile (see section 4.4), elderly individuals should receive particularly close monitoring. Hepatic impairment Patients with mild to moderate hepatic dysfunction should start therapy at reduced doses (50 mg total daily dose) and be closely monitored. Enantyum should not be used in patients with severe hepatic dysfunction. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Прочетете целия документ