Dutaserid 0,5 mg

Soft capsule

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

Adults (including elderly):
The recommended dose of Dutasteride Capsules is one capsule (0.5mg) 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 sections 4.4 and 5.2). In patients with severe hepatic
impairment, the use of dutasteride is contraindicated (see section 4.3)