Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Dutasteride; Tamsulosin hydrochloride
GlaxoSmithKline (Ireland) Limited
G04CA; G04CA52
Dutasteride; Tamsulosin hydrochloride
0.5 mg/0.4 milligram(s)
Capsule, hard
Product subject to prescription which may not be renewed (A)
Alpha-adrenoreceptor antagonists; tamsulosin and dutasteride
Marketed
2010-05-07
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT COMBODART 0.5 MG/0.4 MG HARD 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. Do not pass it on to others. It may harm them, even if their symptoms 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 Combodart is and what it is used for 2. What you need to know before you take Combodart 3. How to take Combodart 4. Possible side effects 5. How to store Combodart 6. Contents of the pack and other information 1. WHAT COMBODART IS AND WHAT IT IS USED FOR COMBODART 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. Combodart 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 relieve the symptoms. This will reduce the risk of acute urinary retention and the need for sur Soma hati kamili
Health Products Regulatory Authority 07 June 2023 CRN00DLL2 Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Combodart 0.5 mg/ 0.4 mg hard 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: 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 severesymptoms of BPH. For information on effects of treatment and patient populations studied in clinical trials please see section5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Adults (including elderly)_ The recommended dose of Combodart is one capsule (0.5 mg / 0.4 mg) once daily. Where appropriate, Combodart 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 Combodart may be considered. _ _ _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_ Health Products Regulatory Authority 07 June 2023 CRN00DLL2 Page 2 of 17 The effect of hepatic impairment on dutasteride-tamsulosin pharmacokinetics has not been studied so caution shou Soma hati kamili