국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dutasteride
Milpharm Ltd
G04CB02
Dutasteride
500microgram
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06040200; GTIN: 8901175029716
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 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 Dutasteride is and what it is used for 2. What you need to know before you take Dutasteride 3. How to take Dutasteride 4. Possible side effects 5. How to store Dutasteride 6. Contents of the pack and other information 1. WHAT DUTASTERIDE IS AND WHAT IT IS USED FOR DUTASTERIDE 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 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 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 DUTASTERIDE DO NOT TAKE DUTASTERIDE • IF YOU’RE ALLERGIC TO DUTASTE 전체 문서 읽기
OBJECT 1 DUTASTERIDE 0.5 MG SOFT CAPSULES Summary of Product Characteristics Updated 07-Jun-2018 | Aurobindo Pharma - Milpharm Ltd. 1. Name of the medicinal product Dutasteride 0.5 mg soft capsules 2. Qualitative and quantitative composition Each soft, capsule contains 0.5 mg dutasteride. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Capsule, soft. Dull yellow, opaque, oblong shaped, size '6' soft gelatin capsule containing clear colorless to pale yellow viscous oil. The size is approximately 18.4 X 6.4 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 can be administered alone or in combination with the alpha-blocker tamsulosin (0.4 mg) (see sections 4.4, 4.8 and 5.1). _Adults (including elderly):_ The recommended dose of dutasteride 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 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 impa 전체 문서 읽기