מדינה: ישראל
שפה: אנגלית
מקור: Ministry of Health
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
GLAXO SMITH KLINE (ISRAEL) LTD
G04CA02
CAPSULES
DUTASTERIDE 0.5 MG; TAMSULOSIN HYDROCHLORIDE 0.4 MG
PER OS
Required
CATALENT GERMANY SCHORNDORF GMBH
TAMSULOSIN
TAMSULOSIN
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.
2016-05-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed according to a physician's prescription only DUODART CAPSULES EACH CAPSULE CONTAINS 0.5 MG DUTASTERIDE AND 0.4 MG TAMSULOSIN HYDROCHLORIDE. For a list of the inactive and allergenic ingredients in the preparation, see section 2 “Important information about some ingredients of the medicine” and section 6 “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any other questions, refer to the physician or the pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. This medicine is intended for men only. 1. WHAT IS THE MEDICINE INTENDED FOR? - 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. THERAPEUTIC GROUP: Duodart 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. DUODART 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. Growth of the prostate 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 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 dihydrotes קרא את המסמך השלם
_ _ _ _ _Page 1 of 19 _ DUODART 1. NAME OF THE MEDICINAL PRODUCT DUODART 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: Each capsule contains lecithin (which may contain soya oil) and Sunset Yellow (E 110). Each capsule contains ≤ 0.1 mg sunset yellow. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard Oblong, hard capsules with a brown body and an orange cap imprinted with GS 7CZ in black ink. 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 of Duodart is one capsule (0.5 mg/ 0.4 mg) once daily. Where appropriate, Duodart may 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 Duodart may be considered. _ _ _ _ _Page 2 of 19 _ _ _ _Renal impairment _ The effect of renal impairment on dutasteride-tamsulosin pharmacokinetics has not been studied. No 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 dutasteride-tamsulosin pharmacokinetics has not been studied so caution should be used in patients with mild to moderate hepatic impairment (see section 4.4 and section 5.2). In patients with severe hepatic impairment, the use of קרא את המסמך השלם