देश: माल्टा
भाषा: अंग्रेज़ी
स्रोत: Medicines Authority
IBUPROFEN, PARACETAMOL
Rontis Hellas Medical and Pharmaceutical Products S.A. 38, Sorou Str., Athens, Maroussi, 15125, 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
Authorised
2020-05-08
PACKAGE LEAFLET: INFORMATION FOR THE USER PARACETAMOL/IBUPROFEN RONTIS 500 MG/200 MG FILM-COATED TABLETS paracetamol/ibuprofen [For OTC:] 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 Paracetamol/Ibuprofen Rontis is and what it is used for 2. What you need to know before you take Paracetamo/Ibuprofen Rontis 3. How to take Paracetamol/Ibuprofen Rontis 4. Possible side effects 5. How to store Paracetamol/Ibuprofen Rontis 6. Contents of the pack and other information 1. WHAT PARACETAMOL/IBUPROFEN RONTIS IS AND WHAT IT IS USED FOR Paracetamol/Ibuprofen Rontis contains two active ingredients (which make the medicine work). These are paracetamol and ibuprofen. 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 has not been relieved by paracetamol or ibuprofen alone. 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/Ibuprofen Rontis 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 in mild forms of arthritis, cold and flu symptoms, sore throat and fever. [ _For _ _OTC:_ ] _ _ _For _ _relief _ _of _ _rheumatic _ _pain _ _and _ _pain _ _of _ _mild _ _forms _ _of _ _arthritis, _ _Paracetamol/Ibuprofen Rontisshoul पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Paracetamol/Ibuprofen Rontis 500 mg/200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg paracetamol and 200 mg ibuprofen. 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 in mild forms of arthritis, cold and flu symptoms, sore throat and fever. This medicinal product is especially suitable for pain which has not been relieved by paracetamol or ibuprofen alone. Paracetamol/Ibuprofen Rontis is indicated in adults aged 18 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The patient should consult a doctor if the symptoms persist or worsen or if the medicinal product is required for more than 3 days. This medicine is for short-term use and is not recommended for use beyond 3 days. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). _Adults _ One tablet to be taken up to three times per day. 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 daily dose is six tablets (3000 mg paracetamol, 1200 mg ibuprofen) and should not be exceeded 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 पूरा दस्तावेज़ पढ़ें