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

Logo NIFEDALAT 20 SR (film coated tablets)

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

NIFEDALAT 20 SR (film coated tablets)

COMPOSITION:
Each film coated tablet contains 20 mg
Nifedipine in a sustained release formulation

PHARMACOLOGICAL CLASSIFICATION:
A 7.1 Vasodilators, hypotensive medicines.

PHARMACOLOGICAL ACTION:
Nifedalat 20 SR
is a calcium channel blocker which reduces myocardial contractability and myocardial oxygen demand. It reduces peripheral vascular resistance and increases peripheral blood flow.
Nifedalat 20 SR displays controlled release characteristics.

INDICATIONS:
Prophylaxis of chronic stable angina pectoris.
Treatment of mild to moderate hypertension.

CONTRA-INDICATIONS:
Sensitivity to nifedipine.
Pregnancy and lactation.
Nifedalat 20 SR must not be used in patients with cardiovascular shock.

DOSAGE AND DIRECTIONS FOR USE:
The usual dose is 20 mg to 40 mg twice per day.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side effects:
Headache, facial flushing, dizziness, and nausea, a feeling of warmth, tiredness and gastrointestinal disturbances may occur.
Syncope has been reported, but a recurrence can be prevented by a reduction in the dose of Nifedalat 20 SR.
Tachycardia, peripheral oedema (unrelated to congestive cardiac failure), perspiration and nervousness have been reported.
An increased frequency of Angina may occur.
Myocardial infarction, reversible gynaecomastica and gingival hyperplasia have been reported.
There have been reports of abnormalities in liver function due to hypersensitivity reactions.
Special precautions:
Nifedalat 20 SR
does not replace the nitro-glycerines in an acute attack of Angina Pectoris. Pain may occur in the chest region about 15 to 30 minutes after taking Nifedalat 20 SR, 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 Nifedalat 20 SR, especially if patients are on anti-hypertensive therapy. Some patients may have hypotension, witch may be severe.
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.
A transient 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 Nifedalat 20 SR may increase the risk of developing heart failure. Nifedalat 20 SR 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 Nifedalat 20 SR, therapy should be discontinued.
Interactions:
Nifedalat 20 SR
can enhance the action of blood pressure lowering medicines such as the beta-receptor blockers.
The anti-hypertensive effect of Nifedalat 20 SR may be potentiated by concomitant administration of cimetidine.

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

IDENTIFICATION:
Uniform pink to light red, round biconvex film coated tablets.

PRESENTATION:
Blister packs, containing 60 tablets.

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

REGISTRATION NUMBER:
28/7.1/0014

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Hexal Pharma
Unit A
10 Fangio Road
Mahogany Ridge
Westmead
3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
May 1997

Updated on this site: February 2000

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