INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo NIFEDALAT 10 mg Capsules

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

NIFEDALAT 10 mg Capsules

COMPOSITION:
NIFEDALAT 10 mg:        Each capsule contains 10 mg of
nifedipine.

PHARMACOLOGICAL CLASSIFICATION:
A 7.1.4 Vasodilators, hypotensive medicines.

PHARMACOLOGICAL ACTION :
Nifedipine is a calcium channel blocker which reduces myocardial contractability and myocardial oxygen demand. It reduces peripheral vascular resistance and increases peripheral blood flow.

INDICATIONS:
Treatment and prophylaxis of angina pectoris, including Prinzmetal's angina. Intermittent arterial vasospasm (Raynaud's) in the absence of any underlying collagen, arteriosclerotic or other vascular disease. Initial management of hypertensive emergency.

CONTRA-INDICATIONS:
Sensitivity to nifedipine. Pregnancy and lactation.
Nifedalat must not be used in patients with cardiovascular shock.

DOSAGE AND DIRECTIONS FOR USE:
The usual dose is 10 mg to 20 mg three times daily.
Prinzmetal's angina
Doses of 20 mg four times daily may be required. Usually the capsules are swallowed whole with some fluid before meals.
Threat of angina pectoris attack:
As a more rapid onset of action is required for impending attacks of angina pectoris, the capsule should be bitten and the contents allowed to remain in the mouth for a short while. The active substance can then be rapidly absorbed through the buccal mucosa.
Intermittent arteriolar vasospasm (Raynaud's)
The recommended dosage regimen is 10 mg to 20 mg three times daily according to the response.
Hypertensive emergency
10 - 20 mg orally, sublingually or buccally.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects
Headache, facial flushing, dizziness and nausea, a feeling of warmth, tiredness and gastro-intestinal disturbances may occur.
Syncope has been reported but a recurrence can be prevented by a reduction in the dose of nifedipine. Tachycardia, peripheral oedema (unrelated to congestive cardiac failure), perspiration and nervousness and myocardial infarction have been reported. An increased frequency of angina may occur.
Reversible gynaecomastia and gingival hyperplasia have been reported. There have been reports of abnormalities in liver function due to hypersensitivity reactions.
Precautions
Nifedipine does not replace the nitro-glycerines in an acute attack of angina pectoris. Pain may occur in the chest region about 15 - 30 minutes after taking nifedipine, possibly due to a fall in perfusion pressure and increase in heart rate. In such a case a reduction in dosage or discontinuation of the preparation is recommended. Any accompanying medication should be checked. Blood pressure should be monitored carefully during initiation and upward titration of nifedipine, especially if patients are on anti-hypotensive therapy.
Some patients may have hypotension including excessive and poorly tolerated hypotension.
Care should be exercised in dialysis patients with malignant hypertension and irreversible kidney failure with hypovolaemia as a marked fall in blood pressure may. occur.
An increase in blood glucose has been noted. Care must be taken in patients with diabetes mellitus. Adjustment of the control of diabetes patients may be required.
In patients with severe aortic stenosis, nifedipine may increase the risk of developing heart failure. It should be used with caution in patients with hypotension and in patients whose cardiac reserve is poor. In patients who experience ischaemic pain following administration of nifedipine, therapy should be discontinued.
Interactions
Nifedipine can enhance the action of blood-pressure lowering medicines such as beta-receptor blockers. The antihypertensive effect of nifedipine may be potentiated by concomitant administration of cimetidine.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Flushing, headaches, lowering of blood pressure and bradycardia. In overdosage the stomach should be emptied by aspiration and lavage. Further treatment is symptomatic and supportive.

IDENTIFICATION:
NIFEDALAT 10 mg: Dark-brown, oblong capsules or alternatively with slightly varying brown tones of the lower and upper gelatin shell.

PRESENTATION:
NIFEDALAT 10 mg:        Securitainers of 100 capsules

STORAGE INSTRUCTIONS:
Store in a dry place below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
NIFEDALAT 10 mg:        27/7.1.4/0210

NAME AND BUSINESS ADDRESS OF APPLICANT:
Hexal Pharma (SA) (Pty) Ltd
Unit A, 10 Fangio Road
Mahogany Ridge
Westmead
3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
May, 1998

NFP2

Updated on this site: February 2000

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