HYPOLAR RETARD

These tablets should be swallowed with a glass of water. They must be swallowed whole and not broken or chewed.

Adults:

The recommended starting dose of nifedipine is 10mg every 12 hours swallowed with water with subsequent titration of dosage according to response. The dose may be adjusted to 40mg every 12 hours.

Elderly:

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 with Hypolar* Retard 20 may be continued long term.

Children:

Nifedipine is not recommended for use in children. Route of administration Oral.

Exacerbation of angina pectoris may occur rarely at the start of treatment with modified release formulations of nifedipine. The occurrence of myocardial infarction has been described although it is not possible to distinguish such an event from the natural course of ischaemic heart disease.

The most common side effects reported are dizziness, flushing, headaches, hypotension, tachycardia and palpitations and ankle swelling. Other less common side effects include gastrointestinal disturbances, increased micturition, rash, pruritus and urticaria, nausea, lethargy, paraesthesiae, myalgia, tremor and visual disturbances.

Gingival hyperplasia has been reported to occur, and in older men gynaecomastia following long term therapy, however both these conditions are reversible on withdrawal of the drug. There have been reports of rare cases of hypersensitivity-type jaundice.

Liver function disturbances such as intra-hepatic cholestasis may also occur. Discontinuation of therapy will result in regression of these side effects. 6)

Hypolar* Retard 20 should be used with caution in patients with severe hypotension and in patients whose cardiac reserve is poor. Deterioration of heart failure has occasionally been observed with nifedipine. Cardiac ischaemic pain has been reported to have occurred in some patients within 1 to 4 hours of receiving nifedipine.

In such cases treatment should be discontinued. Care must be exercised in patients with very low blood pressure (severe hypotension with systolic pressure less than 90 mm Hg). V. magnesium sulphate, owing to the possibility of an excessive fall in blood pressure, which could harm both mother and foetus.

For further information regarding use in pregnancy, refer to section

Nifedipine has been shown to be teratogenic in animals and therefore Hypolar* Retard 20 tablets should not be administered to women who are pregnant or may become pregnant and to nursing mothers. Other contraindications: • Patients with cardiogenic shock.

• Hypersensitivity to nifedipine or other dihydropyridines because of the theoretical risk of cross reactivity. • Nifedipine should not be used in clinically significant aortic stenosis, unstable angina, or during or within one month of a myocardial infarction.

• Nifedipine should not be used for the treatment of acute attacks of angina. • The safety of nifedipine in malignant hypertension has not been established. • Nifedipine should not be used for secondary prevention of myocardial infarction.

• Nifedipine should not be administered concomitantly with rifampicin since effective plasma levels of nifedipine may not be achieved owing to enzyme induction. • Patients with acute porphyrias. Calcium channel blockers have been shown to be porphyrinogenic.