国: スウェーデン
言語: スウェーデン語
ソース: Läkemedelsverket (Medical Products Agency)
dutasterid
GlaxoSmithKline (Ireland) Limited
G04CB02
dutasteride
0,5 mg
Kapsel, mjuk
glycerol Hjälpämne; dutasterid 0,5 mg Aktiv substans; butylhydroxitoluen Hjälpämne
Apotek
Receptbelagt
Dutasterid
Förpacknings: Blister, 1x60 tabletter; Blister, 1x50 tabletter; Blister, 1x10 tabletter; Blister, 1x30 tabletter; Blister, 1x90 tabletter
Avregistrerad
2004-08-27
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AVOLVE 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 Avolve is and what it’s used for 2. What you need to know before you take Avolve 3. How to take Avolve 4. Possible side effects 5. How to store Avolve 6. Contents of the pack and other information 1. WHAT IS AVOLVE AND WHAT IT IS USED FOR AVOLVE 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. Avolve 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. Avolve may also be used with another medicine called tamsulosin (used to treat the symptoms of an enlarged prostate). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AVOLVE 完全なドキュメントを読む
1 Produktinformationen för Avolve 0,5 mg kapsel, mjuk, MTnr 21029, gäller vid det tillfälle då läkemedlet godkändes. Informationen kommer inte att uppdateras eftersom läkemedlet inte marknadsförs i Sverige. Av samma anledning finns inte någon svensk produktinformation. Den engelska produktinformationen kommer dock att uppdateras för de produkter där Sverige är referensland. Om läkemedelsnamnet i följande produktinformation inte stämmer med namnet på dokumentet, beror det på att läkemedlet i Sverige är godkänt under ett annat namn. 2 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Avolve 0.5 mg soft capsules . 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 0.5 mg dutasteride. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsules, soft. The capsules are opaque, yellow, oblong soft gelatin capsules imprinted with GX CE2 on one side in red ink. 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 Avolve 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 Avolve is one capsule (0.5 mg) taken orally once a day. The capsules should be swallowed whole and not chewed or opened as contact with the capsule contents may result in irritation of the oropharyngeal mucosa. The capsules may be taken with or without food. 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 pharmacokin 完全なドキュメントを読む