Quốc gia: Hà Lan
Ngôn ngữ: Tiếng Hà Lan
Nguồn: 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) ; IJZEROXIDE ROOD (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) ; IJZEROXIDE ROOD (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); IJZEROXIDE ROOD (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 ® 50, maagsapresistente tabletten 50 mg; RVG 23243 1313-V34 1.3.1.3 Bijsluiter December 2022 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT [NATIONALLY COMPLETED NAME] 50 MG GASTRO-RESISTANT TABLETS diclofenac sodium 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 • infectious diseases that are accompanied with fever, especially for s Đọc toàn bộ tài liệu
Sandoz B.V. Page 1/17 Diclofenacnatrium Sandoz 50, maagsapresistente tabletten 50 mg; RVG 23243 1313-V25a 1.3.1.1 Samenvatting van de Productkenmerken December 2022 1. NAAM VAN HET GENEESMIDDEL Diclofenacnatrium Sandoz 50, maagsapresistente tabletten 50 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 50 mg of diclofenac sodium. Excipients with known effect: Each gastro-resistant tablet contains 23.8 mg of lactose (as monohydrate) and 0.22 mg of polyoxyl hydrogenated castor oil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablet. Light brown, round, slightly biconvex. 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 2/17 Diclofenacnatrium Sandoz 50, maagsapresistente tabletten 50 mg; RVG 23243 1313-V25a 1.3.1.1 Samenvatting van de Productkenmerken December 2022 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 dose information for adults. For the dose regimen in adults we refer to the paragraphs containing specific information per indication. _Rheumatoid arthritis _ The initial dose for adults is 150 mg daily Đọc toàn bộ tài liệu