Country: Malta
Lingwa: Ingliż
Sors: Medicines Authority
DUTASTERIDE
Galenicum Health, S.L.U Calle Sant Gabriel, 50 Esplugues de Llobregat 08950 Barcelona, Spain
G04CB02
DUTASTERIDE 0.5 mg
SOFT CAPSULE
DUTASTERIDE 0.5 mg
POM
UROLOGICALS
Authorised
2015-03-23
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DUTASTERIDE GALENICUM 0.5 MG SOFT CAPSULES Dutasteride 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Dutasteride Galenicum is and what it is used for 2. What you need to know before you take Dutasteride Galenicum 3. How to take Dutasteride Galenicum 4. Possible side effects 5. How to store Dutasteride Galenicum 6. Contents of the pack and other information 1. WHAT DUTASTERIDE GALENICUM IS AND WHAT IT IS USED FOR Dutasteride Galenicum 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. The active ingredient is dutasteride. It belongs to a group of medicines called 5-alpha reductase inhibitors. 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. In some situations surgery is necessary to remove or reduce the size of the prostate gland. Dutasteride Galenicum lowers the production of dihydrotestosterone, which helps to shrink the prostate and relieve the symptoms. This will reduce the risk of acute urinary retention and the need for surgery. Dutasteride Galenicum may also be used with another Aqra d-dokument sħiħ
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dutasteride Galenicum 0.5 mg soft capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains 0.5 mg dutasteride. Excipient with known effect: Each soft capsule contains lecithin (which may contain soya oil) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, soft. The soft capsules are opaque, yellow, oblong soft gelatin capsules filled with an oily and yellowish liquid, without printing. Soft capsules dimensions are: 19 ± 0.8 mm x 6.9 ± 0.4 mm 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 Dutasteride Galenicum can be administered alone or in combination with the alpha-blocker tamsulosin (0.4mg) (see sections 4.4, 4.8 and 5.1). _Adults (including elderly): _ The recommended dose of Dutasteride Galenicum is one capsule (0.5 mg) taken orally once a day. Although an improvement may be observed at an early stage, it can take up to 6 months before a response to the treatment can be achieved. No dose adjustment is necessary in the elderly. _Renal impairment _ The effect of renal impairment on dutasteride pharmacokinetics has not been studied. No adjustment in dosage is anticipated for patients with renal impairment (see section 5.2). _Hepatic impairment _ The effect of hepatic impairment on dutasteride 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 dutasteride is contraindicated (see section 4.3). METHOD OF ADMINISTRATION The capsules should be swallowed whole and n Aqra d-dokument sħiħ