Quốc gia: Hà Lan
Ngôn ngữ: Tiếng Hà Lan
Nguồn: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TAMSULOSINEHYDROCHLORIDE 0,4 mg/stuk SAMENSTELLING overeenkomend met ; TAMSULOSINE 0,37 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
G04CA02
TAMSULOSINEHYDROCHLORIDE 0,4 mg/stuk SAMENSTELLING overeenkomend met ; TAMSULOSINE 0,37 mg/stuk
Capsule met gereguleerde afgifte, hard
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; COPOLYMEER VAN ETHYLACRYLAAT-METHYLMETHACRYLAAT (2:1) (E 1206) ; NATRIUMLAURILSULFAAT ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B), CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; COPOLYMEER VAN ETHYLACRYLAAT-METHYLMETHACRYLAAT (2:1) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B), CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; COPOLYMEER VAN ETHYLACRYLAAT-METHYLMETHACRYLAAT (2:1) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; NATRIUMLAURILSULFAAT (E 487) ; PATENTBLAUW V (E131) ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Tamsulosin
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); COPOLYMEER VAN ETHYLACRYLAAT-METHYLMETHACRYLAAT (2:1); GELATINE (E 441); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); NATRIUMLAURILSULFAAT (E 487); PATENTBLAUW V (E131); POLYSORBAAT 80 (E 433); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
1900-01-01
Sandoz B.V. Pagina 1 Tamsulosine HCL Sandoz retard capsule 0,4 mg, capsules met gereguleerde afgifte, hard RVG 33747 1313-V16 1.3.1.3 Bijsluiter September 2019 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TAMSULOSINE HCL SANDOZ RETARD CAPSULE 0,4 MG, CAPSULES MET GEREGULEERDE AFGIFTE, HARD tamsulosin hydrochloride 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 The active substance of [Nationally completed name] is tamsulosin. This is an alpha-1-receptor blocker that reduces the ability to contract the muscles in the prostate and urethra. As a result, the urethra, which runs through the prostate, is less constricted so that urinating is easier. In addition, it diminishes sensations of urge. [Nationally completed name] is used by men for the treatment of complaints in the lower urinary tract that occur in benign prostate enlargement. These complaints may include difficulty urinating (poor stream), dribbling, urgency and having to urinate frequently at night as well as during the day. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] DO NOT TAKE [NATIONALLY COMPLETED NAME] − if you are allergic to tamsulosin or any of the other ingredients Đọc toàn bộ tài liệu
Sandoz B.V. Pagina 1/9 Tamsulosine HCI retard 0,4 mg, capsules met gereguleerde afgifte, hard RVG 33747 1311-V11 1.3.1.1 Samenvatting van de productkenmerken September 2019 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tamsulosine HCl Sandoz retard capsule 0,4 mg, capsules met gereguleerde afgifte, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard modified-release capsule contains 0.4 mg of tamsulosin hydrochloride. For the full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Hard modified-release capsule. Light green/yellow hard modified-release capsules filled with white to slightly yellowish pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION One capsule a day after breakfast or the first meal of the day. The capsule is swallowed whole with a glass of water while standing or sitting (not lying down). The capsule should not be broken or pulled apart as this may have an effect on the release of the long-acting active ingredient. No dose adjustment is warranted in renal impairment. No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency (see also 4.3 Contraindications). Paediatric population The safety and efficacy of tamsulosin in children <18 years have not been established. Currently available data are described in section 5.1 4.3 CONTRAINDICATIONS Sandoz B.V. Pagina 2/9 Tamsulosine HCI retard 0,4 mg, capsules met gereguleerde afgifte, hard RVG 33747 1311-V11 1.3.1.1 Samenvatting van de productkenmerken September 2019 Hypersensitivity to tamsulosin, including drug-induced angio-oedema, or to any of the excipients listed in section 6.1. Orthostatic hypotension observed earlier (history of orthostatic hypotension). Severe hepatic insufficiency. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As with other α1-blockers the use of tamsulosin may lower blood pressure, which in rare cases may cause fainting. If initial s Đọc toàn bộ tài liệu