PRODART Soft gelatin capsule Ref.[115228] Active ingredients: Dutasteride

Adult males (including elderly)

The recommended dose of PRODART is one capsule (0,5 mg) taken orally once a day.

Although an improvement may be observed at an early stage, treatment for at least 6 months may be necessary in order to assess objectively whether a satisfactory response to the treatment can be achieved.

Special populations

Renal impairment

The effect of renal impairment on dutasteride pharmacokinetics has not been studied. However, 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 (see section 4.4 and 5.2).

Method of administration

Oral use. The capsules should be swallowed whole (see section 4.4).

PRODART may be taken with or without food.

In volunteer studies, single doses of dutasteride up to 40 mg/day (80 times the therapeutic dose) for seven days have been administered without significant safety concerns. In clinical studies, doses of 5 mg daily have been administered to patients for 6 months with no additional adverse effects to those seen at therapeutic doses of 0,5 mg. There is no specific antidote for dutasteride as in PRODART, therefore, in cases of suspected overdosage symptomatic and supportive treatment should be given as appropriate.

3 years.

Store at or below 30°C.

Capsules are packed in white opaque PVC/PVDC and Aluminium foil blister strips of 10, which are further packed in printed cartons, in pack sizes of 30 or 100 capsules.

Not all pack sizes may be marketed.

PRODART 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 medicinal product or waste material should be disposed of in accordance with local requirements.