ZEDRAST Capsule, soft Ref.[115221] Active ingredients: Dutasteride

Adult males (including elderly)

The recommended dose of ZEDRAST is one capsule (0,5 mg) taken orally once a day. The capsules should be swallowed whole.

ZEDRAST may be taken with or without food.

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

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 sections 4.4 and 5.2).

Symptoms of overdose

In volunteer studies, single daily doses of dutasteride up to 40 mg daily (80 times the therapeutic dose) administered for 7 days, did not result in significant safety concerns. In clinical studies, the administration of 5 mg daily for 6 months had no additional adverse effects in comparison to those seen at therapeutic doses of 0,5 mg daily.

Management of overdose

No specific treatment of overdosage with ZEDRAST can be recommended. In the event of an overdose, symptomatic and supportive measures should be employed as appropriate.

3 years.

Store at or below 25°C.

Keep the blister strip in the outer carton until required for use.

Aluminium-aluminium blister strips containing 6 soft gelatine capsules, packed in an outer container.

Pack size: 6

OR

Opaque PVC/PVDC and aluminium blister strips containing 10 soft gelatine capsules, packed in an outer container.

Pack size: 10

Dutasteride is absorbed through the skin. Women, children and adolescents must avoid contact with leaking capsules. In the event of contact with a leaking capsule, the contact area should immediately be washed with soap and water (see section 4.4).