Posology : מינונים

4.2     Posology and method of administration

Method of administration

Oral Use.
As a rule, tablets are swallowed whole with a little liquid, either with or without food.
Pressolat should not be taken with grapefruit juice (see Section 4.5).
Dosage regimen
As far as possible the treatment must be tailored to the needs of the individual according to the severity of the disease and the patient's response.

Depending on the clinical picture in each case, the basic dose must be introduced gradually.

Pressolat 10 mg is particularly suitable for dose titration. Dose titration is particularly recommended for hypertensives with severe cerebrovascular disease and for patients, who because of low body weight or multiple therapies with other antihypertensive drugs, are likely to have an excessive reaction to nifedipine. In addition, patients in whom side effects in response to the nifedipine treatment make a finer dose adjustment desirable should be individually stabilised with Pressolat 10 mg.


Unless otherwise prescribed, the following dosage guidelines apply for adults: 
•   In hypertension:                       1 Pressolat 10 mg tablet twice daily (2 x 10 mg/day)
2 Pressolat 10 mg tablet twice daily
(2 x 20 mg/day)

If higher dosages are necessary, the dose can be increased in stages up to maximum 60 mg daily.

Co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers may result in the recommendation to adapt the nifedipine dose or not to use nifedipine at all (see section 4.5).

Duration of Treatment
Treatment may be continued indefinitely.
Additional information on special populations

Children and adolescents
The safety and efficacy of Pressolat in children below 18 years has not been established. Currently available data for the use of nifedipine in hypertension are described in section 5.1.

Elderly (>65 years)
The pharmacokinetics of Pressolat are altered in the elderly so that lower maintenance doses of nifedipine may be required.

Patients with hepatic impairment
Nifedipine is metabolised primarily by the liver and therefore patients with mild, moderate or severe liver dysfunction should be carefully monitored and a dose reduction may be necessary. The pharmacokinetics of nifedipine has not been investigated in patients with severe hepatic impairment (see section 4.4 and 5.2).

Patients with renal impairment
Based on pharmacokinetic data, no dosage adjustment is required in patients with renal impairment (see section 5.2).