LOTUFLO-D CAPSULES 0.5 MG/0.4 MG

LOTUS INTERNATIONAL PTE. LTD.

LOTUS INTERNATIONAL PTE. LTD.

Therapeutic

Prescription Only

CAPSULE

**4.2 Posology and method of administration** Where appropriate, dutasteride-tamsulosin 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 dutasteride-tamsulosin may be considered. _Adults (including elderly)_ The recommended dose of dutasteride-tamsulosin 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 dutasteride-tamsulosin should not be taken on an empty stomach as this may increase the potential for cardiovascular related adverse events such as orthostatic hypotension. _Renal impairment_ The effect of renal impairment on dutasteride-tamsulosin pharmacokinetics has not been studied. No adjustment in dosage is anticipated for patients with renal impairment (see section 4.4 and 5.2 – _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 section 4.4 and section 5.2 – _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-tamsulosin is contraindicated (see section 4.3).