Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2012 Publisher: GlaxoSmithKline UK Limited 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom Trading as: GlaxoSmithKline UK Ltd Stockley Park West Uxbridge Middlesex UB11 1BT
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.
Avodart can be administered alone or in combination with the alpha-blocker tamsulosin (0.4mg) (see sections 4.4, 4.8 and 5.1).
The recommended dose of Avodart 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 impairment, the use of dutasteride is contraindicated (see section 4.3).
In volunteer studies of Avodart, single daily doses of dutasteride up to 40 mg/day (80 times the therapeutic dose) have been administered for 7 days without significant safety concerns. In clinical studies, doses of 5mg daily have been administered to subjects for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.5 mg. There is no specific antidote for Avodart, therefore, in suspected overdosage symptomatic and supportive treatment should be given as appropriate.
4 years.
Do not store above 30°C.
Blisters of opaque PVC/PVDC film containing 10 soft gelatin capsules packed into containers of 10, 30, 60 and 90 capsules. Not all pack sizes may be marketed.
Dutasteride is absorbed through the skin, therefore contact with leaking capsules must be avoided. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water (see section 4.4).
Any unused product or waste material should be disposed of in accordance with local requirements.
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