国家: 马耳他
语言: 英文
来源: Medicines Authority
IBUPROFEN, PARACETAMOL
PharOS – Pharmaceutical Oriented Services Limited Lesvou str. (end), Thesi Loggos, Industrial Zone, 144 52 Metamorfossi Attikis,, Greece
M01AE51
IBUPROFEN 200 mg PARACETAMOL 500 mg
FILM-COATED TABLET
IBUPROFEN 200 mg PARACETAMOL 500 mg
OTC
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Licence number in the source country: NOT APPLICAPABLE
Withdrawn
2020-05-06
PACKAGE LEAFLET: INFORMATION FOR THE USER APAP INTENSE 200 MG/500 MG FILM-COATED TABLETS ibuprofen/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 APAP intense is and what it is used for 2. What you need to know before you take APAP intense 3. How to take APAP intense 4. Possible side effects 5. How to store APAP intense 6. Contents of the pack and other information 1. WHAT APAP INTENSE IS AND WHAT IT IS USED FOR APAP intense 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 temperatures. Paracetamol is an analgesic which works in a different way from ibuprofen to relieve pain and fever. This product is especially suitable for pain which requires stronger analgesia than ibuprofen or paracetamol alone. APAP intense is used for the temporary relief of mild to moderate pain associated with migraine, headache, backache, period pain, dental pain, rheumatic and muscular pain, pain of non-serious arthritis, cold and flu symptoms, sore throat and fever. APAP intense is used in adults aged 18 years and older. You must talk to a doctor if you do not feel better or if you feel worse after 3 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE APAP INTENSE DO NOT TAKE APAP INTENSE IF YOU - are already taking ANY OTHER PARACETAMOL-CONTAINING MEDICI 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT APAP intense 200 mg/500 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg ibuprofen and 500 mg paracetamol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). White to off-white, oval shaped, film-coated tablets, with dimensions 19.7 mm x 9.2 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the temporary relief of mild to moderate pain associated with migraine, headache, backache, period pain, dental pain, rheumatic and muscular pain, pain of non-serious arthritis, cold and flu symptoms, sore throat and fever. This medicinal product is especially suitable for pain which requires stronger analgesia than ibuprofen or paracetamol alone. APAP intense is indicated in adults aged 18 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For short term-use only. The patient should consult a doctor if the symptoms persist or worsen or if the medicinal product is required for more than 3 days. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). ADULTS: One tablet to be taken up to three times per day with water. The interval between single doses should be at least six hours. If single doses of one tablet do not control symptoms, a maximum of two tablets may be taken up to three times a day. The interval between single doses should be at least six hours. The maximum dose is six tablets (1200 mg ibuprofen, 3000 mg paracetamol) in any 24 hours period. ELDERLY: No special dosage modifications are required (see section 4.4). The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used for the shortest possible duration. The patient should be monitored regularly for gastrointestinal bleeding during NSAID therapy. _ _ _Paediatric population 阅读完整的文件