País: Holanda
Língua: holandês
Origem: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DICLOFENAC NATRIUM
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
M01AB05
DICLOFENAC SODIUM
Maagsapresistente tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHYLMETHACRYLAAT (2:1) ; DIMETICON (E 900) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MACROGOLGLYCEROLHYDROXYSTEARAAT ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; SILICA, HYDRATE FORM UNKNOWN (E 551) ; SILICIUMDIOXIDE (E 551) ; SIMETICON EMULSIE ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHYLMETHACRYLAAT (2:1) ; DIMETICON (E 900) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MACROGOLGLYCEROLHYDROXYSTEARAAT ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201) ; SILICA, HYDRATE FORM UNKNOWN (E 551) ; SILICIUMDIOXIDE (E 551) ; SIMETICON EMULSIE ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Diclofenac
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); COPOLYMEER VAN ETHYLACRYLAAT-METHYLMETHACRYLAAT (2:1); DIMETICON (E 900); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; MACROGOL 8000; MACROGOLGLYCEROLHYDROXYSTEARAAT; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 30 (E 1201); SILICA, HYDRATE FORM UNKNOWN (E 551); SILICIUMDIOXIDE (E 551); SIMETICON EMULSIE; TALK (E 553 B); TITAANDIOXIDE (E 171);
1999-03-15
Sandoz B.V. Page 1/9 Diclofenacnatrium Sandoz ® 25/50, maagsapresistente tabletten 25/50 mg; RVG 23242-3 V30 1.3.1.3 Bijsluiter April 2020 BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER DICLOFENACNATRIUM SANDOZ ® 25, MAAGSAPRESISTENTE TABLETTEN 25 MG DICLOFENACNATRIUM SANDOZ ® 50, MAAGSAPRESISTENTE TABLETTEN 50 MG diclofenacnatrium 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. 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 Diclofenac sodium, the active substance in [nationally completed name] belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to treat pain and inflammation. Diclofenac relieves symptoms of inflammation, such as swelling and pain, and also reduces fever. It has no effect on the causes of inflammation or fever. [nationally completed name] can be used to treat the following conditions: • rheumatism, including inflammatory joint pain (arthritis) and juvenile rheumatoid arthritis joint degeneration (arthrosis) and certain types of back pain (vertebral joint disease) • painful, inflamed so called frozen shoulder • painful inflammation and swelling e.g. after dental or orthopaedic surgery • severely painful menstrual periods • Leia o documento completo
Sandoz B.V. Page 1/16 Diclofenacnatrium Sandoz 25, maagsapresistente tabletten 25 mg; RVG 23242 V19 1.3.1.1 Samenvatting van de Productkenmerken April 2020 SAMENVATTING VAN DE PRODUCTKENMERKEN 1. NAAM VAN HET GENEESMIDDEL Diclofenacnatrium Sandoz 25, maagsapresistente tabletten 25 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 25 mg diclofenac sodium. Excipients with known effect: Each gastro-resistant tablet contains 15.2 mg of lactose (as lactose monohydrate). Each gastro-resistant tablet contains 0.13 mg of polyoxyl hydrogenated castor oil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablet. Yellow, round, slightly biconvex, with bevelled edges 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of: - Inflammatory and degenerative forms of rheumatism such as rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis including spondylarthritis - Periarthritis humeroscapularis - Painful postoperative and post-traumatic inflammation, and swelling, e.g. following dental or orthopaedic surgery - Primary dysmenorrhoea - Diseases accompanied by fever, especially for short term use as adjuvant in chemotherapy in inflammatory infections - Fever as such is not an indication Since the formulation of this medicinal product is a delayed release formulation, the product is not indicated when a quick onset of efficacy (relief of pain) is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Sandoz B.V. Page 2/16 Diclofenacnatrium Sandoz 25, maagsapresistente tabletten 25 mg; RVG 23242 V19 1.3.1.1 Samenvatting van de Productkenmerken April 2020 General information The dose should be individually adjusted. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Posology _ADULTS _ There is no general dosage information for adults. For the dose regimen in adults we refer to the paragraphs containing specific information Leia o documento completo