Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
NIFEDIPINE
PCO Manufacturing
20 Milligram
Tablets
1987-08-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adalat Retard 20 mg Prolonged-Release Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated, prolonged release tablet contains 20mg nifedipine. Excipient: Lactose _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM o Prolonged release, film-coated tablet _Product imported from the UK:_ o Pink-grey circular tablets impressed with ‘I U’ on one face and the Bayer cross on the reverse. _Product imported from Spain:_ o Pink-grey circular tablets with ‘A 20’ embossed on one face and the Bayer cross on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Chronic stable angina Mild to moderate hypertension 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended starting dose of Adalat retard 10 mg and 20 mg is 10 mg every 12 hours swallowed with water with subsequent titration of dosage according to response. The dose may be adjusted to 40 mg every 12 hours. The pharmacokinetics of nifedipine are altered in the elderly so that lower maintenance doses of nifedipine may be required compared to younger patients. Nifedipine is metabolised primarily by the liver and therefore patients with liver dysfunction should be carefully monitored. Patients with renal impairment should not require adjustment of dosage. Treatment may be continued indefinitely. Nifedipine is not recommended for use in children. Adalat retard 20 mg should not be taken with grapefruit juice _(see section 4.5)._ IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 14/04/2011_ _CRN 2091269_ _page number: 1_ 4.3 CONTRAINDICATIONS Adalat retard 20 mg should not be administered to patients with known hypersensitivity to Read the complete document