Država: Nizozemska
Jezik: nizozemski
Izvor: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
IBUPROFEN
Sandoz B.V.
M01AE01
IBUPROFEN
Capsule, zacht
AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MACROGOL 400 ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SORBITANMONOOLEAAT (E 494) ; SORBITOL (D-)(E 420) ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD,
Oraal gebruik
Ibuprofen
Hulpstoffen: AMMONIA (E 527); GELATINE (E 441); IJZEROXIDE ZWART (E 172); KALIUMHYDROXIDE (E 525); MACROGOL 400; POVIDON K 30 (E 1201); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); SORBITANMONOOLEAAT (E 494); SORBITOL (D-)(E 420); TRIGLYCERIDEN MIDDELLANGE KETEN; WATER, GEZUIVERD;
2012-04-13
V6 PACKAGE LEAFLET: INFORMATION FOR THE USER IBUPROFEN SANDOZ 200 MG CAPSULES, ZACHT IBUPROFEN SANDOZ 400 MG, CAPSULES, ZACHT Ibuprofen 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 has 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, or in adults treating pain after 4 days. WHAT IS IN THIS LEAFLET 1. What [Nationally completed name] is and what it is used for 2. What you need to know before you take [Nationally completed name] 3. How to take [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [Nationally completed name] contains the active substance ibuprofen. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body’s response to pain and high temperature. [200mg only] [Nationally completed name] is used for the short-term symptomatic treatment of mild to moderate pain, such as headache, dental pain, period pain and fever and pain in the common cold. [400 mg only] [Nationally completed name] is used for the short-term symptomatic treatment of mild to moderate pain, such as headache, acute migraine headache with or without aura, dental pain, period pain and fever and pain in the common cold. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] DO NOT TAKE [NATIONALLY COMPLETED NAME] IF YOU are allergic to ibuprofen or any of the other ingredients of this medicine (listed in secti Pročitajte cijeli dokument
V5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ibuprofen Sandoz 200 mg,capsules, zacht Ibuprofen Sandoz 400 mg, capsules, zacht 2. QUALITATIVE AND QUANTITATIVE COMPOSITION {[Nationally completed name] 200 mg, capsules soft} Each capsule contains 200 mg of ibuprofen. Excipient with known effect: Each capsule contains 38.92 mg of sorbitol (E420) {[Nationally completed name] 400 mg, capsules, soft} Each capsule contains 400 mg of ibuprofen. Excipient with known effect: Each capsule contains 50 mg of sorbitol (E420) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, soft {[Nationally completed name] 200 mg, capsules soft} Clear oval shaped soft gelatin capsules containing colourless to pale yellow coloured, transparent, viscous liquid, printed ‘200’ in black colour on capsule shell. Dimensions: 15 mm x 8 mm {[Nationally completed name] 400 mg, capsules soft} Clear oval shaped soft gelatin capsules containing colourless to pale yellow coloured, transparent, viscous liquid, printed ‘400’ in black colour on capsule shell. Dimensions: 15 mm x 10 mm 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [200 mg only] For the short-term symptomatic treatment of mild to moderate pain, such as headache, dental pain, period pain and fever and pain in the common cold. [400 mg only] For the short-term symptomatic treatment of mild to moderate pain, such as headache, acute migraine headache with or without aura, dental pain, period pain and fever and pain in the common cold. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). _ _ _Adults and adolescents ≥ 40 kg body weight (12 years of age and above): _ V5 [200 mg only] Initial dose: 200 mg or 400 mg. If necessary, an additional dose of 1 to 2 capsules (200 mg to 400 mg) may be taken. The corresponding dosing interval should be chosen based on the symptoms and the recommende Pročitajte cijeli dokument