DUOFLOW CAPSULE 0.5mg/0.4mg

INTEGA PTE LTD

INTEGA PTE LTD

Therapeutic

Prescription Only

CAPSULE

**Dosage and Administration** Where appropriate, _DUOFLOW_ may be used to substitute concomitant dutasteride and tamsulosin hydrochloride in existing dual therapy to simplify treatment. Where clinically appropriate, direct change from dutasteride or tamsulosin hydrochloride monotherapy to _DUOFLOW_ may be considered. **Adult males (including elderly)** The recommended dose of _DUOFLOW_ is one capsule (0.5 mg/0.4 mg) taken orally approximately 30 minutes after the same meal each day. Capsules should be swallowed whole and not chewed or opened. Contact with the contents of the dutasteride capsule contained within the hard-shell capsule may result in irritation of the oropharyngeal mucosa. Patients should be advised that _DUOFLOW_ should not be taken on an empty stomach as this may increase the potential for cardiovascular related adverse events such as orthostatic hypotension ( _see Pharmacodynamics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Renal impairment** The effect of renal impairment on dutasteride-tamsulosin pharmacokinetics has not been studied. However, no adjustment in dosage is anticipated for patients with renal impairment ( _see Pharmacokinetics_ – _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-tamsulosin pharmacokinetics has not been studied ( _see Warnings and Precautions and Pharmacokinetics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _DUOFLOW_ is contraindicated in patients with severe hepatic impairment.