देश: नीदरलैंड
भाषा: डच
स्रोत: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
IBUPROFEN-(D,L)-LYSINE 684 mg/stuk SAMENSTELLING overeenkomend met ; IBUPROFEN 400 mg/stuk
Mylan B.V. Dieselweg 25 3752 LB BUNSCHOTEN
M01AE01
IBUPROFEN-(D,L)-LYSINE 684 mg/stuk SAMENSTELLING overeenkomend met ; IBUPROFEN 400 mg/stuk
Filmomhulde tablet
AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT, AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT,
Oraal gebruik
Ibuprofen
Hulpstoffen: AMMONIA (E 527); CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); IJZEROXIDE ZWART (E 172); MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 30 (E 1201); PROPYLEENGLYCOL (E 1520); SCHELLAK GLAZE, GEDEELTELIJK VERESTERD; SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171); ZWARTE INKT;
2013-09-09
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER IBUPROFEN (ALS LYSINE) MYLAN OTC 200 MG FILM-COATED TABLETS IBUPROFEN (ALS LYSINE) MYLAN OTC 400 MG FILM-COATED TABLETS Ibuprofen (as lysine) 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 in the case of fever or after 4 days for the treatment of pain. WHAT IS IN THIS LEAFLET: 1. What Ibuprofen (als lysine) Mylan OTC is and what it is used for. 2. What you need to know before you take Ibuprofen (als lysine) Mylan OTC. 3. How to take Ibuprofen (als lysine) Mylan OTC. 4. Possible side effects. 5. How to store Ibuprofen (als lysine) Mylan OTC. 6. Contents of the pack and other information. 1. WHAT IBUPROFEN (ALS LYSINE) MYLAN OTC IS AND WHAT IT IS USED FOR Ibuprofen (als lysine) Mylan OTC 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. _ _ Ibuprofen (als lysine) Mylan OTC tablets are used for the symptomatic treatment of mild to moderate pain, such as headache, dental pain, period pain and fever and pain as the result of a cold. 2. WHAT DO YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN (ALS LYSINE) MYLAN OTC DO NOT TAKE IBUPROFEN (ALS LYSINE) MYLAN OTC : • if you are allergic to ibuprofen or any other ingredients of this medicine (listed in section 6) • if you have had an allergic reaction such as asthma, difficulty in breathing, swelling of the face, tongue or पूरा दस्तावेज़ पढ़ें
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ibuprofen (als lysine) Mylan OTC 200 mg, filmomhulde tabletten Ibuprofen (als lysine) Mylan OTC 400 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of ibuprofen (as lysine) Each tablet contains 400 mg of ibuprofen (as lysine) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White to off-white, film-coated, round, biconvex, bevelled edge tablet imprinted with “M” over “IL1” in black ink on one side of the tablet and blank on the other side. Dimension: 10.5mm ± 0.3mm. White to off-white, film-coated, oval biconvex, bevelled edge tablet imprinted with “M IL2” in black ink on one side of the tablet and blank on the other side Dimension: 17.9mm ± 0.3mm x 9.2mm ± 0.3mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ For the symptomatic treatment of mild to moderate pain, such as headache, dental pain, period pain and fever and pain in the common cold . 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and adolescents≥ 40 kg body weight (12 years of age and above): _[200 mg only]_ Initial dose: 200 mg or 400 mg. If necessary, an additional dose of 1 to 2 tablets (200 mg to 400 mg) may be taken. The corresponding dosing interval should be chosen based on the symptoms and the recommended daily maximum dose. It should not be less than 6 hours for a 400 mg dose, and not less than 4 hours for a 200 mg dose. Do not exceed 1200 mg dose in any 24 hour period. _[400 mg only] _ Initial dose: 400 mg. If necessary, an additional dose of 400 mg may be taken. The corresponding dosing interval should be chosen based on the symptoms and the recommended daily maximum dose. It should not be less than 6 hours for a 400 mg dose. Do not exceed 1200 mg dose in any 24 hour period. _Paediatric population _ _[200 mg only] _ Children over 6 years (20 kg – 40 kg body weight): Ibuprofen should only be used in children with a body weight of at least 20 kg. 3 पूरा दस्तावेज़ पढ़ें