Država: Malta
Jezik: engleski
Izvor: Medicines Authority
IBUPROFEN, PARACETAMOL
Alkaloid-INT d.o.o. Šlandrova ulica 4, 1231 Ljubljana-Crnuce, Slovenia
M01AE51
PARACETAMOL 500 mg IBUPROFEN 200 mg
FILM-COATED TABLET
PARACETAMOL 500 mg IBUPROFEN 200 mg
OTC
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2020-06-22
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER IBUPROFEN/PARACETAMOL ALKALOID-INT 200 MG/500 MG FILM-COATED TABLETS Ibuprofen and paracetamol 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 days. WHAT IS IN THIS LEAFLET 1. What Ibuprofen/Paracetamol Alkaloid-INT is and what it is used for 2. What you need to know before you take Ibuprofen/Paracetamol Alkaloid-INT 3. How to take Ibuprofen/Paracetamol Alkaloid-INT 4. Possible side effects 5. How to store Ibuprofen/Paracetamol Alkaloid-INT 6. Contents of the pack and other information 1. WHAT IBUPROFEN/PARACETAMOL ALKALOID-INT IS AND WHAT IT IS USED FOR Your medicine is called Ibuprofen/Paracetamol Alkaloid-INT 200 mg/500 mg tablets (called Ibuprofen/Paracetamol Alkaloid-INT throughout the rest of this leaflet). Ibuprofen/Paracetamol Alkaloid-INT contains two active ingredients (which make the medicine work). These are IBUPROFEN and PARACETAMOL. Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work by reducing pain, reducing swelling and lowering high body temperature. Paracetamol is an analgesic which works in a different way from ibuprofen to relieve pain and fever. Ibuprofen/Paracetamol Alkaloid-INT is used for short term treatment of mild to moderate pain associated with migraine, headache, backache, menstrual pain, dental pain, muscular pain, cold and flu, sore throat and fever. You must talk to a doctor if you do not feel better or if you feel worse after 3 days. 2. WHAT YOU Pročitajte cijeli dokument
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ibuprofen/Paracetamol Alkaloid-INT 200 mg/500 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg ibuprofen and 500 mg paracetamol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets White to off white, oblong, biconvex film-coated tablets with dimensions of (21 mm x 10.5 mm) ± 0.5 mm and marked with double circle mark on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The medicinal product is used for temporary treatment of mild to moderate pain associated with migraine, headache, backache, menstrual pain, dental pain, muscular pain, cold and flu symptoms, sore throat and fever. This product is especially suitable for pain which requires stronger analgesia than ibuprofen or paracetamol alone. Ibuprofen/Paracetamol Alkaloid-INT is intended for adults from 18 years of age . 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For short term-use only. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). The patient should consult a doctor if the symptoms persist or worsen or if it is necessary to use this medicine for more than 3 days. ADULTS: One tablet to be taken up to three times per day with water. Leave at least six hours between doses. If the one tablet dose does not control symptoms, a maximum of two tablets may be taken up to three times a day. Leave at least six hours between doses. Do not take more than six tablets (3000 mg Paracetamol, 1200 mg Ibuprofen) within 24 hours period. Page 2 of 14 Adverse reactions can be reduced by using the lowest effective dose for the shortest period necessary to relieve symptoms (see section 4.4). To minimise side effects, it is recommended that patients take Ibuprofen/Paracetamol Alkaloid-INT with food. ELDERLY: No special dosage modifications are required (see section 4.4). The elderly are at increased risk of the serious consequenc Pročitajte cijeli dokument