Nchi: Uholanzi
Lugha: Kiholanzi
Chanzo: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
IBUPROFEN
Infirst Healthcare Limited
M01AE01
IBUPROFEN
Capsule, zacht
GELATINE (E 441) ; HYPROMELLOSE (E 464) ; KALIUMHYDROXIDE (E 525) ; MACROGOL 600 ; PROPYLEENGLYCOL (E 1520) ; SORBITOL VLOEIBAAR, GEDEELTELIJK GEDEHYDRATEERD ; TITAANDIOXIDE (E 171) ; WATER, GEZUIVERD ; WITTE INKT,
Oraal gebruik
Ibuprofen
Hulpstoffen: GELATINE (E 441); HYPROMELLOSE (E 464); KALIUMHYDROXIDE (E 525); MACROGOL 600; PROPYLEENGLYCOL (E 1520); SORBITOL VLOEIBAAR, GEDEELTELIJK GEDEHYDRATEERD; TITAANDIOXIDE (E 171); WATER, GEZUIVERD; WITTE INKT;
2012-07-18
1 Flarin 200 mg soft capsules November 2015 Version 5.0 PACKAGE LEAFLET: INFORMATION FOR THE USER FLARIN 200 MG CAPSULES, ZACHT Ibuprofen READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use 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.Adults: You must talk to a doctor if you do not feel better or if you feel worse after 3 days in fever and 5 days in pain. - Children and adolescents: You must talk to a doctor if a child or adolescent does not feel better or if they feel worse after 3 days in fever and pain. WHAT IS IN THIS LEAFLET: 1. What Flarin is and what it is used for 2. What you need to know before you use Flarin 3. How to use Flarin 4. Possible side effects 5. How to store Flarin 6. Contents of the pack and other information 1. WHAT FLARIN IS AND WHAT IT IS USED FOR Flarin contains ibuprofen which belongs to a group of medicinal products called NSAIDs (non-steroidal anti-inflammatory drugs). This medicinal product works by reducing pain, inflammation and fever. Flarin 200 mg soft capsules are used to provide relief from mild to moderate pain such as headache, including migraine headache, dental pain, period pain, back-, muscle- and joint pain and fever. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLARIN DO NOT USE FLARIN if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6) if you have had allergic reactions such as asthma, runny nose, itchy skin rash or swelling of the lips, face, tongue, or throat after you have taken medicines containing acetylsalicylic acid (such as aspirin) or other drugs for pain and inflammation (NSAIDs). if you have suffered from an ulcer or bleeding i Soma hati kamili
1 Flarin 200 mg soft capsules June 2015 Version 2.0 _ _ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Flarin 200 mg capsules, zacht 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _200 mg:_ Each soft capsule contains 200 mg ibuprofen. Excipients: _200 mg: _Sorbitol 55.6 mg/capsule._ _ _ _ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, soft. A pale yellow, oval-shaped transparent soft gelatin capsule printed with “Flarin” in white ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mild to moderate pain, such as headache including migraine headache, dental pain and back-, muscle- and joint pain. Fever. Primary dysmenorrhoea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). This product is for short-term use only. The ibuprofen dose depends on patient’s age and body weight. The capsules should be taken with an adequate amount of liquid (e.g. a glass of water). _MILD TO MODERATE PAIN AND FEVER_ _Adults and adolescents over 12 years (≥40 kg): _ 200 mg-400 mg given as a single dose or 3- 4 times daily with an interval of 4 to 6 hours. The dosage in migraine headache should be: 400 mg given as a single dose, if necessary 400 mg with intervals of 4 to 6 hours. The maximum daily dose should not exceed 1200 mg. In adults aged from 18 years this medicinal product is required for more than 3 days in fever and 5 days in pain or if symptoms persist or worsen, a doctor should be consulted. _Children 6 - 12 years (> 20 kg): _ Children 6-9 years (20-29 kg): 200 mg 1-3 times a day with intervals of 4 to 6 hours as required. The maximum daily dose should not exceed 600 mg. 2 Flarin 200 mg soft capsules June 2015 Version 2.0 Children 10-12 years (30-40 kg): 200 mg 1-4 times a day with intervals of 4 to 6 hours as required. The maximum daily dose should not exceed 800 mg . If in children aged from 6 years and in adolescents this m Soma hati kamili