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 Contraindications and Precautions): 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 Precautions and Pharmacology: Pharmacokinetics under Actions): Older people can be treated with Natrixam according to renal function.
Patients with hepatic impairment (see Contraindications and Precautions): 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 Precautions and Pharmacology: Pharmacokinetics under Actions).
Method of administration: Oral administration.