Posology : מינונים

4.2 Posology and method of administration

Posology

It is recommended that TRITACE COMP is taken once daily, at the same time of the day, usually in the morning.
TRITACE COMP can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2).
TRITACE COMP has to be swallowed with some liquid. The tablet must not be chewed or crushed.
Adults
The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control. The administration of the fixed combination of ramipril and hydrochlorothiazide is usually recommended after dosage titration with one of the individual components.

TRITACE COMP should be started at the lowest possible dosage.
If necessary, the dose can be gradually increased to achieve target blood pressure; the maximum permitted doses are 10 mg of ramipril and 25 mg of hydrochlorothiazide daily.

Special populations

Patients treated with diuretics
Caution should be exercised in patients on diuretics, as hypotension may occur at the start of therapy. Prior to initiating treatment with TRITACE COMP, a dose reduction or discontinuation of the diuretic should be considered.

Should discontinuation not be possible, it is recommended that treatment be initiated with the smallest possible dosage of ramipril (1.25 mg daily) in a free combination. It is recommended that, subsequently, a changeover be made to an initial daily dose of not more than 2.5 mg ramipril/12.5 mg hydrochlorothiazide.

Patients with renal impairment
TRITACE COMP is contraindicated in severe renal impairment due to the hydrochlorothiazide component (creatinine clearance < 30 ml/min) (see section 4.3).
Patients with impairment of renal function may require reduced doses of TRITACE COMP. Patients with creatinine clearance levels between 30 and 60 ml/min should only be treated with the lowest fixed dose combination of ramipril and hydrochlorothiazide after administration of ramipril alone. The maximum permitted doses are 5 mg of ramipril and 25 mg of hydrochlorothiazide daily.

Patients with hepatic impairment
In patients with mild to moderate hepatic impairment, treatment with TRITACE COMP must be initiated only under close medical supervision and the maximum daily doses are 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide.
TRITACE COMP is contraindicated in severe hepatic impairment (see section 4.3).

Elderly
Initial doses should be lower and subsequent dose titration should be more gradual because of greater chance of undesirable effects especially in very old and frail patients.

Paediatric population
TRITACE COMP is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.

Method of administration

Oral use.