ADALAT LA 30 TABLET 30 mg

BAYER (SOUTH EAST ASIA) PTE LTD

BAYER (SOUTH EAST ASIA) PTE LTD

Therapeutic

Prescription Only

TABLET, FILM COATED

**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: 1\. For coronary heart disease: – Chronic stable angina pectoris (angina of effort) 1 Adalat LA 20 tablet once daily (1 x 20 mg/day) 1 Adalat LA 30 tablet once daily (1 x 30 mg/day)1 Adalat LA 60 tablet once daily (1 x 60 mg/day)2\. For hypertension:1 Adalat LA 20 tablet once daily (1 x 20 mg/day)1 Adalat LA 30 tablet once daily (1 x 30 mg/day)1 Adalat LA 60 tablet once daily (1 x 60 mg/day) 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_).