NATRIXAM MODIFIED RELEASE TABLET 1.5 mg/5 mg

SERVIER (S) PTE LTD

SERVIER (S) PTE LTD

Therapeutic

Prescription Only

TABLET, MULTILAYER, EXTENDED RELEASE

**4.2 Posology and method of administration** Posology One tablet per day as single dose, preferably to be taken in the morning, to be swallowed whole with water and not chewed. The fixed dose combination is not suitable for initiation therapy. If a change of the posology is required, titration should be done with the individual components. Special populations _Paediatric population_ The safety and efficacy of Natrixam in children and adolescents have not been established. No data are available. _Patients with renal impairment (see sections 4.3 and 4.4_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _):_ In severe renal impairment (creatinine clearance below 30 ml/min), treatment is contraindicated. In patients with mild to moderate renal impairment, no dose adjustment is needed. _Older people (see section 4.4 and 5.2_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _):_ Older people can be treated with Natrixam according to renal function. _Patients with hepatic impairment (see sections 4.3 and 4.4_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _):_ In severe hepatic impairment, treatment is contraindicated. Dosage recommendations of amlodipine have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautious and should start at the lower end of the dosing range (see sections 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Method of administration** Oral administration.