NIFECARD XL TABLET 30 MG [SIN11720P]

Product Info

NIFECARD XL TABLET 30 MG

[SIN11720P]

4.1 Therapeutic indications
Treatment of:

• Hypertension:

  • Treatment of 6321 hypertensive patients with at least one additional risk factor followed over 3 to 4.8 years in a multi-national, randomized, double-blind, prospective study. Nifedipine was shown to reduce cardiovascular and cerebrovascular events to a comparable degree as a standard diuretic combination (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Coronary heart disease:

  • Chronic stable angina pectoris (angina of effort)

4.2 Posology and method of administration
Posology
As far as possible, the treatment must be tailored to the needs of the individual.
Depending on the clinical picture in each case, the basic dose must be introduced gradually.

Unless otherwise prescribed, the following dosage guidelines are recommended for adults:

For hypertension: one Nifedipine XL 30 mg tablet once daily.

For coronary heart disease: Chronic stable angina pectoris (angina of effort): one Nifedipine XL 30 mg tablet once daily.

In general, therapy should be initiated with 30 mg once daily.

Depending on the severity of the disease and the patient's response, the dose can be increased in stages to 120 mg once 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Duration of treatment
The attending doctor will determine the duration of use.

Additional information on special populations
Pediatric Patients
The safety and efficacy of nifedipine in children below 18 years has not been established.

Geriatric patients
The pharmacokinetics of nifedipine are altered in the elderly so that lower maintenance doses of nifedipine may be required compared to younger patients.

Patients with hepatic impairment
In patients with mild, moderate or severe impaired liver function, careful monitoring 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with renal impairment
Based on pharmacokinetic data no dose adjustment is required in patients with renal impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration
For oral use.

The tablets must not be chewed or broken up.

As a rule, the tablets are swallowed whole with a little liquid, irrespective of meal times.

Grapefruit juice is to be avoided (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

• Nifedipine must not be used in cases of known hypersensitivity to nifedipine 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).

• Nifedipine must not be used during pregnancy and breastfeeding (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Nifedipine must not be used in cases of cardiovascular shock.

• Nifedipine must not be used in patients with Kock pouch (ileostomy after proctocolectomy).

• Nifedipine must not be used in combination with rifampicin because no efficient plasma levels of nifedipine may be obtained due to enzyme induction (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).