AVODART SOFT CAPSULE 0.5 mg

4.1. Therapeutic Indications

AVODART is indicated for the treatment and control of benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce prostate size, reduce the risk of acute urinary retention, and reduce the need for BPH-related surgery.

In addition, AVODART in combination with the alpha-blocker tamsulosin is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.

4.3. Contraindications

AVODART is contraindicated for use in women, children and adolescents (see 4.6 Pregnancy and Lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

AVODART is contraindicated in patients with hypersensitivity to dutasteride, other 5-alpha- reductase inhibitors, or any of the excipients.

AVODART is contraindicated in patients with severe hepatic impairment.

4.2. Posology and Method of Administration

Adult males (including elderly):

AVODART can be administered alone or in combination with the alpha-blocker tamsulosin (0.4 mg).

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.

AVODART 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 5.2 Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 4.4 Special Warnings and Special Precautions for Use and 5.2 Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). In patients with severe hepatic impairment, the use of dutasteride is contraindicated (See section 4.3 Contraindications).