Country: Նիդերլանդեր
language: հոլանդերեն
source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
PARACETAMOL 500 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
N02BE01
PARACETAMOL 500 mg/stuk
Tablet
MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; STEARINEZUUR (E 570), MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; STEARINEZUUR (E 570), MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201) ; STEARINEZUUR (E 570),
Oraal gebruik
Paracetamol
Hulpstoffen: MAÏSZETMEEL, GEPREGELATINEERD; NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 30 (E 1201); STEARINEZUUR (E 570);
2012-04-17
Sandoz B.V. Page 1/8 Paracetamol Sandoz 500 mg, tabletten RVG 111619 V9 1.3.1.3 Bijsluiter April 2022 v BIJSLUITER: INFORMATIE VOOR DE PATIËNT PARACETAMOL SANDOZ ® 500 MG, TABLETTEN paracetamol _[For medicines available only on prescription:] _ 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. _[For medicines available without a prescription:] _ 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 5 days for pain or after 3 days for fever. [To be completed nationally] 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 paracetamol. It is a pain relieving, fever reducing medicine (analgesic and antipyretic). _ _ _<[Nationally completed na read_full_document
Sandoz B.V. Page 1/10 Paracetamol Sandoz 500 mg, tabletten RVG 111619 V8 1.3.1.1 Samenvatting van de Productkenmerken April 2022 1. NAAM VAN HET GENEESMIDDEL Paracetamol Sandoz 500 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg paracetamol. Excipient with known effect: Each tablet contains up to 1.87 mg of sodium. Each tablet contains 1000 mg paracetamol. Excipient with known effect: Each tablet contains up to 3.74 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM _500 mg tablet: _ Tablet. White, caplet-shaped tablets, debossed “500” on one side and plain on the other side (17.5 mm x 7.3 mm). _1000 mg tablet: _ Tablet. White to off-white, caplet-shaped tablets, debossed with scoreline between “10” and “00” on one side and scoreline between “PA” and “RA” on the other side (21.4 mm x 9.0 mm). The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _<[Nationally completed name] 500 mg, tablets> _ Mild to moderate pain and fever. [Nationally completed name] is indicated for adults, adolescents and children aged 9 years and older. _<[Nationally completed name] 1000 mg, tablets> _ Mild to moderate pain associated with osteoarthritis of the hip and knee. [Nationally completed name] is indicated for adults and adolescents aged 15 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Sandoz B.V. Page 2/10 Paracetamol Sandoz 500 mg, tabletten RVG 111619 V8 1.3.1.1 Samenvatting van de Productkenmerken April 2022 Posology The lowest effective dose should be used. Do not exceed the recommended dose because of the risk of serious liver damage (see sections 4.4 and 4.9) _<[Nationally completed name] 500 mg, tablets:> _ _Adults and adolescents aged 15 years and older (above 55 kg body weight) _ Start with 1 tablet (500 mg of paracetamol), if necessary 2 tablets (1000 mg) at a time, up to a maximum of 6 tablets (3000 mg of paracetamol) per 24 hours. _Paediatric population _ _Adolescents betw read_full_document