ADALAT LA 30 TABLET 30 MG [SIN07710P]

Product Info

ADALAT LA 30 TABLET 30 MG

[SIN07710P]

INDICATIONS

1. Treatment of coronary heart disease

   • Chronic stable angina pectoris (angina of effort)

2. 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, randomised, double-blind, prospective study. Adalat (Nifedipine GITS) was shown to reduce cardiovascular and cerebrovascular events to a comparable degree as a standard diuretic combination (see “Pharmacodynamic properties” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

DOSAGE AND METHOD OF ADMINISTRATION

Method of administration

Oral use

Dosage regimen

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:

In general therapy should be initiated with 30 mg once daily.
Where registered a starting dose of 20mg once daily may be considered when medically indicated. Interim doses i.e. 40mg, 50mg etc. can be applied by combinations of i.e. 20mg + 20mg or 20mg + 30mg tablets.
Depending on the severity of the disease and the patient's response, the dose can be increased in stages to 120 mg once daily.

Coadministration 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 “Interactions with other medicinal products and other forms of interaction” – 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.

Administration

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 “Interactions with other medicinal products and other forms of interaction” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Additional information on special populations

Pediatric Patients
The safety and efficacy of Adalat LA in children below 18 years has not been established.

Geriatric patients
The pharmacokinetics of Adalat LA 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 “Special Warnings and precautions for use” and “Pharmacokinetic properties” – 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 dosage adjustment is required in patients with renal impairment (see “Pharmacokinetic properties” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

CONTRAINDICATIONS

Adalat LA must not be used in cases of known hypersensitivity to nifedipine or to any of the excipients.(see “List of excipients” – 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 “Fertility, pregnancy and lactation” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Adalat LA must not be used in cases of cardiovascular shock.
Adalat LA 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 “Interaction with other medicinal products and other forms of interactions” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).