Posology: One Triplixam film-coated tablet per day as a single dose, preferably to be taken in the morning and before a meal.
The fixed dose combination is not suitable for initial therapy.
If a change of the posology is required, titration should be done with the individual components.
Special population: Patients with renal impairment (see Contraindications and Precautions): In severe renal impairment (creatinine clearance below 30 mL/min), treatment is contraindicated.
In patients with moderate renal impairment (creatinine clearance 30-60 mL/min), Triplixam at the doses 10mg/2.5mg/5mg and 10mg/2.5mg/10mg is contraindicated. It is recommended to start treatment with the adequate dosage of the free combination.
Usual medical follow-up will include frequent monitoring of creatinine and potassium.
Concomitant use of perindopril with aliskiren is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2) (see Contraindications).
Patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions, Contraindications and Precautions): In severe hepatic impairment, Triplixam is contraindicated.
In patients with mild to moderate hepatic impairment, Triplixam should be administrated with caution, as dosage recommendations for amlodipine in these patients have not been established.
Older people (see Precautions): Elimination of perindoprilat is decreased in the older people (Pharmacology: Pharmacokinetics under Actions).
Older people can be treated with Triplixam according to renal function (see Contraindications).
Paediatric population: The safety and efficacy of Triplixam in children and adolescents have not been established. No data are available.
Method of administration: Oral use.