NATRIXAM MODIFIED RELEASE TABLET 1.5 MG/10 MG [SIN14902P]

Product Info

NATRIXAM MODIFIED RELEASE TABLET 1.5 MG/10 MG

[SIN14902P]

4.1 Therapeutic indications

Natrixam is indicated as substitution therapy for treatment of essential hypertension in patients already controlled with indapamide and amlodipine given concurrently at the same dose level.

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.

4.3 Contraindications

• hypersensitivity to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

• severe renal failure (creatinine clearance below 30 ml/min)

• hepatic encephalopathy or severe impairment of liver function

• hypokalaemia

• severe hypotension

• shock (including cardiogenic shock)

• obstruction of the outflow tract of the left ventricle (e.g., high grade aortic stenosis) – haemodynamically unstable heart failure after acute myocardial infarction