ARIPSA SOFT CAPSULES 0.5MG

CAPSULE, LIQUID FILLED

**4.2. Posology and Method of Administration** _Adult males (including elderly):_ _ARIPSA_ can be administered alone or in combination with the alpha-blocker tamsulosin (0.4 mg). The recommended dose of _ARIPSA_ 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. _ARIPSA_ 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).