Land: Nederland
Språk: nederlandsk
Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DUTASTERIDE 0,5 mg/stuk ; TAMSULOSINEHYDROCHLORIDE 0,4 mg/stuk SAMENSTELLING overeenkomend met ; TAMSULOSINE 0,37 mg/stuk
Teva B.V. Swensweg 5 2031 GA HAARLEM
G04CA52
DUTASTERIDE 0,5 mg/stuk ; TAMSULOSINEHYDROCHLORIDE 0,4 mg/stuk SAMENSTELLING overeenkomend met ; TAMSULOSINE 0,37 mg/stuk
Capsule, hard
AMMONIA (E 527) ; BUTYLHYDROXYTOLUEEN (E 321) ; CALCIUMSTEARAAT (E 470A) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; DIBUTYLSEBACAAT ; GELATINE (E 441) ; GLYCEROL (E 422) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; LECITHINE, SOYA (E 322) ; NATRIUMLAURILSULFAAT ; POLYSORBAAT 80 (E 433) ; PROPYLEENGLYCOL (E 1520) ; PROPYLEENGLYCOLMONOCAPRILAAT ; SCHELLAK (E 904) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; TITAANDIOXIDE (E 171) ; TRIGLYCERIDEN MIDDELLANGE KETEN ; ZWARTE INKT, AMMONIA (E 527) ; BUTYLHYDROXYTOLUEEN (E 321) ; CALCIUMSTEARAAT (E 470A) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; DIBUTYLSEBACAAT ; GELATINE (E 441) ; GLYCEROL (E 422) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; LECITHINE, SOYA (E 322) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; PROPYLEENGLYCOL (E 1520) ; PROPYLEENGLYCOLMONOCAPRILAAT ; SCHELLAK (E 904) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; TITAANDIOXIDE (E 171) ; TRIGLYCERIDEN MIDDELLANGE KETEN ; ZWARTE INKT
Oraal gebruik
Tamsulosin and dutasteride
1900-01-01
1 PACKAGE LEAFLET 2 BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER DUTASTERIDE/TAMSULOSINEHYDROCHLORIDE 0,5 MG/0,4 MG, HARDE CAPSULES Dutasteride/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 of the 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. Whatis and what it is used for 2. What you need to know before you take Les hele dokumentet3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR IS USED TO TREAT MEN WITH AN ENLARGED PROSTATE (benign prostatic hyperplasia) - a non-cancerous growth of the prostate gland, caused by producing too much of a hormone called dihydrotestosterone. is a combination of two different medicines called dutasteride and tamsulosin. Dutasteride belongs to a group of medicines called 5-alpha reductase inhibitors and tamsulosin belongs to a group of medicines called alpha-blockers. As the prostate grows, it can lead to urinary problems, such as difficulty in passing urine and a need to go to the toilet frequently. It can also cause the flow of the urine to be slower and less forceful. If left untreated, there is a risk that your urine flow will be completely blocked (acute urinary retention). This requires immediate medical treatment. Sometimes surgery is necessary to remove or reduce the size of the prostate gland. Dutasteride lowers the production of a hormone called dihydrotestosterone, which helps to shrink the prostate and r
1 rvg 123562 EU SPC R-001 met NL info-clean 1. NAAM VAN HET GENEESMIDDEL Dutasteride/Tamsulosinehydrochloride Teva 0,5 mg/0,4 mg, harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride (equivalent to 0.367 mg tamsulosin). Excipients with known effect Contains 299.46 mg propylene glycol monocaprylate, type II per capsule and traces of propylene glycol in the black ink. Also contains less than 1 mmol (23 mg) sodium per capsule and traces of lecithin (may contain soya oil). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Oblong hard capsules with brown body and beige cap printed with C001 in black ink and approximately 24 mm in length. Each hard capsule contains tamsulosin hydrochloride modified release pellets and one dutasteride soft gelatin capsule. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH. For information on effects of treatment and patient populations studied in clinical trials please see section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Adults (including elderly) _ The recommended dose ofis one capsule (0.5 mg/ 0.4 mg) once daily. Where appropriate, Les hele dokumentetmay be used to substitute concomitant dutasteride and tamsulosin hydrochloride in existing dual therapy to simplify treatment. Where clinically appropriate, direct change from dutasteride or tamsulosin hydrochloride monotherapy to may be considered. _Renal impairment _ The effect of renal impairment on dutasteride-tamsulosin pharmacokinetics has not been studied. No 2 rvg 123562 EU SPC R-001 met NL info-clean adjustment in dosage is anticipated for patients with renal impairment (see section 4.4 and 5.2). _Hepatic impairment _ The effect of hepatic impairment on dutaste