Country: Belanda
Bahasa: Belanda
Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
IBUPROFEN
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
M01AE01
IBUPROFEN
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Ibuprofen
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MACROGOL 400; MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
2015-09-15
Sandoz B.V. Page 1/11 Ibuprofen Sandoz 200, 400 mg, filmomhulde tabletten RVG 117344-5 1313-v3 1.3.1.3 Bijsluiter november 2019 PACKAGE LEAFLET: INFORMATION FOR THE USER IBUPROFEN SANDOZ 200 MG FILMOMHULDE TABLETTEN IBUPROFEN SANDOZ 400 MG FILMOMHULDE TABLETTEN Ibuprofen READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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. 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, pharmacist or nurse 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 if you have fever or migraine headache and after 4 days for the treatment of pain. - You must talk to a doctor if children (from 6 to 12 years) and adolescents (from 12 to 18 years) do not feel better or feel worse after 3 days. WHAT IS IN THIS LEAFLET 1. What Ibuprofen Sandoz is and what it is used for 2. What you need to know before you take3. How to take Baca dokumen lengkap4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IBUPROFEN SANDOZ IS AND WHAT IT IS USED FOR belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSA
Sandoz B.V. Page 1/14 Ibuprofen Sandoz 200, 400, filmomhulde tabletten RVG 117344-5 1311-v3 1.3.1.1 Samenvatting van de Productkenmerken November 2019 1. NAME OF THE MEDICINAL PRODUCT Ibuprofen Sandoz 200 mg, filmomhulde tabletten Ibuprofen Sandoz 400 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg ibuprofen. Each film-coated tablet contains 400 mg ibuprofen Excipient(s) with known effect:contains 14mg lactose. Baca dokumen lengkapcontains 28mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 200mg White coloured, film coated pillow shaped tablets debossed with ‘235’ on one side and plain on the other. 400mg White coloured, film coated pillow shaped tablets debossed with ‘236’ on one side and plain on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic treatment of mild to moderate pain, such as headache, acute migraine headache with or without aura, period pain, dental 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)._ _ 200 mg strength: Suitable for adult and children from 20kg (around 6 years old) 400 mg strength: Suitable for adults and adolescents from 40 kg (12 years and older) If this product is required for more than 3 days in the case of fever or migraine headache, or for more than 4 days for pain relief, or if the symptoms worsen the patient is advised to consult a doctor. _ADULTS AND ADOLESCENTS ≥40 KG: _ Sandoz B.V. Page 2/14 Ibuprofen Sandoz 200, 400, filmomhulde tabletten RVG 117344-5 1311-v3 1.3.1.1 Samenvatting van de Productkenmerken November 2019 Initial dose, 200 mg or 400 mg ibuprofen. If necessary additional doses of 200 mg or 400 mg of ibuprofen can be taken. The respective dosing interval should be chosen in line with the observed sym