Nifegem Nifedipine Retard Tablet

Nifegem® retard
Nifedipine Cardioprotective coronary therapeutic agent/antihypertensive.

 
Composition

1 tablet of Nifegem retard contains 20mg nifedipine.

 
Properties

Nifegem retard contains nifedipine a calcium antagonist, i.e. a substance that inhibits the pathological entry of calcium ions into the cells of the mycocardium and vascular smooth muscle.

Cardioprotective coronary therapy, i.e. Protection against functional and structural heart damage by: the prevention of energy depletion and of disturbances affecting the normal metabolism of the myocardial fibres.

This is achieved by:

a considerable improvement in myocardial oxygen supply with simultaneous distinct reduction in the oxygen requirement; a pronounced and objectively demonstrable antianginal activity after oral administration;

a favourable ratio between the intensity and the duration of the effect, combined with good tolerability.

Antihypertensive effect, i.e. a lowering or normalization of high blood pressure by:

a reduction in the peripheral resistance due to dilation of the blood vessels;

a pronounced and objectively demonstrable antihypertensive activity after oral administration.

 
Indications

1. Treatment of coronary heart disease (states involving insufficient myocardial oxygen supply: chronic stable angina pectoris (stress – induced angina); angina pectoris after cardiac infarction (except for the 8 days after acute myocardial infarction).

2. Treatment of hypertension

 
Contraindications

Nifegem retard may not be used at any time during pregnancy or in the cases of hypersensitivity to the product. Nifedipine passes into breast milk. It is not yet known whether a drug – induced (pharmacological) effect can occur in infants, but as a precaution it is recommended to stop breastfeeding. Care should be exercised in patients with very low blood pressure (severe hypotension: systolic pressure below 90 mm Hg).

Nifegem retard must not be used in cardiovascular shock.

 
Side effects

Side effects occur predominantly at the beginning of treatment, and are generally mild and transient, Headache, flush, and a sensation of heat may occasionally occur. In isolated cases nausea, dizziness, tiredness, skin reactions, paraesthesia, a fall in blood pressure to below the norm (hypotensive reaction), palpitations, and an acceleration of the heart rate have been observed, especially after high doses. Accumulation of fluid in the lower legs (oedema) occurs occasionally as a result of dilation of the blood vessels.
Gum alterations (gingival hyperplasia), which regress completely on discontinuation of the treatment, may occur in isolated cases during prolonged therapy.

Pains in the chest region (possibly angina – pectoris – like symptoms) may develop in rare cases after taking Nifegem retard. In such an event the doctor should be consulted.
Care should be exercised in dialysis patients with malignant hypertension and irreversible kidney failure with hypovolaemia, since a distinct fall in blood pressure may occur as a result of vasodilation.

Functional disturbances of the liver (intrahepetic cholestasis, elevation of transaminases), reversible on discontinuation of the treatment, can occur in extreme cases under Nifegem retard therapy. In very rare cases a temporary increase has been observed in the blood glucose (hyperglycaemia) in acute studies. This is particularly important in patient suffering from diabetes mellitus. Nifegem retard is not diabetogenic.

In rare cases in older men on long – term Nifegem retard therapy an enlargement of the mammary glands can occur (gynaecomastia). which so far has always regressed completely on discontinuation of the drug.

Patients undergoing antihypertensive therapy with this drug should have regular medical check – ups. Reactions to the drug – which vary from individual to individual – may impair the ability to drive or to operate machinery. This applies particularly at the start of the treatment, on changing over to a different product, and in combination with alcohol.

 
Interactions

The blood – pressure – lowering effect of Nifegem retard may be potentiated by other antihypertensive drugs.

When Nifegem retard is administered simultaneously with beta – receptor blockers the patient should be carefully monitored, since severe hypotension may occur; heart failure has also been known to develop.

The antihypertensive effect may be potentiated when nifedipine and cimetidine are administered simultaneously.

 
Dosage

As far as possible the treatment should be tailored to the needs of the individual, according to the severity of the disease and the patient’s responsiveness.

Unless otherwise prescribed, the following dosage guidelines apply:

Adults: Basic dose:

1. For coronary heart disease:

– Chronic stable angina pectoris (stress-induced angina): 1 retard tablet of Nifegem retard twice a day

– Angina pectoris after cardiac infarction: 1 retard tablet of Nifegem retard twice a day

2. For hypertension: 1 retard tablet of Nifegem retard twice a day

In some cases a further increase in the dose to 2 x 2 Nifegem retard tablets (2 x 40mg) may be necessary.

 
Administration

Long – term treatment: the retard tablets are generally swallowed whole with a little liquid, independently of mealtimes.

The recommended interval between individual doses is about 12 hr and should not be less than 4hr.

 
Notes

If, in angina pectoris, an adequate antianginal effect has not been achieved after about 14 days of the treatment, the patient should change over to the fast – acting Nifegem capsules (10mg), as advised by the doctor. The drug should not be used after the expiry date.

The light – sensitive active substance contained in the retard tablet is essentially protected from light inside and outside its packaging: nevertheless, the retard tablets should only be removed from the foil immediately before use.

The retard tablet should not be divided owing to the light-sensitivity of the active substance, whose protection is then no longer ensured.

Keep all drugs out of the reach of children!

 
Presentation

20, 60, 100 tablets

 
Made by

Gemini Pharmaceuticals Nigeria Ltd.,

Plot 13, Block A, Industrial Estate,

Amuwo – Odofin,

Lagos, Nigeria.