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

Logo APO-NIFEDIPINE 5 mg
APO-NIFEDIPINE 10 mg

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

APO-NIFEDIPINE 5 mg
APO-NIFEDIPINE 10 mg
capsules

COMPOSITION:
APO-NIFEDIPINE 5 mg : 5 mg
Nifedipine preserved with 4,6% m/m benzyl alcohol and 0,2% m/m methyl/propyl paraben mixture (4:1).
APO-NIFEDIPINE 10 mg :10 mg Nifedipine preserved with 4,5% m/m benzyl alcohol and 0,2% m/m methyl/propyl paraben mixture (4:1).

PHARMACOLOGICAL CLASSIFICATION:
A 7.1.4 Vasodilators: Coronary and other medicines used in angina pectoris.

PHARMACOLOGICAL ACTION:
Nifedipine is a calcium antagonist, facilitating vasodilation on the peripheral artery beds. It decreases myocardial contractility and myocardial oxygen demand. The half-life is approximately 2 hours. Nifedipine is extensively bound to plasma proteins.

INDICATIONS:
The treatment and prophylaxis of angina pectoris.

CONTRA-INDICATIONS:
APO-NIFEDIPINE is contraindicated in pregnancy and in women of child-bearing potential.
Nifedipine should not be used by patients with a hypersensitivity to nifedipine.
Nifedipine should not be used in cardiogenic shock.

DOSAGE AND DIRECTIONS FOR USE:
The starting dose of APO-NIFEDIPINE is one 10 mg capsule, swallowed whole, 3 times a day with or after meals. This can be increased to 20 mg three times daily. APO-NIFEDIPINE 5 mg capsules provide for greater flexibility of dose titration, eg: in elderly patients, or in patients experiencing side-effects.
Nifedipine should be administered cautiously to elderly patients and a dosage of 5 mg three times daily is recommended.
In patients receiving concomitant medication, a dosage of 5 mg three times a day is recommended.
The dosage may require adjustment in hepatic impairment.
In acute attacks where a more rapid onset of action is required, the capsule should be bitten and the contents allowed to remain in the mouth for a shorn while before being swallowed.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
SIDE-EFFECTS
The following side-effects can be expected:
Tiredness
Paraesthesia
Headache
Flushing
Lethargy
Dizziness
Nervousness
Perspiration
Hypersensitivity reactions - including rashes, fever and abnormalities in liver function.
Hypotension - transient or may be excessive and poorly tolerated
Palpitations and precipitation of anginal pain
Nausea
Gastro-intestinal disturbances
Peripheral oedema unrelated to congestive heart failure
Reversible gynaecomastia in older men on long term nifedipine therapy
Myalgia
Tremor
Myocardial infarction has been reported
Syncope - this can be controlled by a reduction in the dosage of nifedipine
Tachycardia
An increased frequency of angina may occur
Increased micturition frequency
Eye pain and a slight change in optical perception
Mental depression
A feeling of warmth
Chest pain may be experienced a short while after ingesting nifedipine, probably due to a decrease in the perfusion rate and an increase in heart rate.
In a few patients an excessive fall in blood pressure has led to cerebral or myocardial ischaemia and transient blindness.
Skin reactions have been reported and these include pruritus, urticaria, exanthema and occasional exfoliative dermatitis.

PRECAUTIONS
Patients with impaired hepatic function should be closely monitored and if necessary the dosage of nifedipine should be reduced.
Nifedipine is not a replacement for the use of nitroglycerine in an acute attack of angina pectoris.
Patients with a poor cardiac reserve or hypotension should be administered nifedipine cautiously.
If any ischaemic pain is experienced by the patient after administration of nifedipine, administration of nifedipine should be discontinued.
The use of nifedipine in diabetic patients may require adjustment of their control, as nifedipine can cause an increase in blood glucose.
Nifedipine may enhance the anti-hypertensive effects of blood pressure lowering agents and beta-adrenoreceptor blocking agents.
During initiation and upward titration of nifedipine therapy, the patients blood pressure must be carefully monitored, especially if the patient is on antihypertensive therapy.
Gingival hyperplasia may occur which will regress upon discontinuation of therapy.
When treating dialysis patients with malignant hypertension and irreversible kidney failure with marked hypovolemia, care should be exercised, as a marked fall in blood pressure may occur.
Patients with severe aortic stenosis may be at an increased risk of developing heart failure.

INTERACTIONS
The antihypertensive effect of nifedipine may be potentiated by the concomitant administration of cimetidine and to a lesser extent, ranitidine.
Irrespective of the dosage, serum quinidine levels are reduced when quinidine is taken in combination with nifedipine.
Concomitant administration of nifedipine and digoxin may lead to reduced clearance of digoxin and hence increased plasma digoxin levels.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Bradycardia and hypotension may result from a nifedipine overdose. In overdosage the stomach should be emptied by aspiration and lavage. Activated charcoal may be administered if necessary.
Treatment is symptomatic and supportive.

IDENTIFICATION:
APO-NIFEDIPINE 5 mg are mustard-coloured, opaque soft gelatin capsules, imprinted "5."
APO-NIFEDIPINE 10 mg are mustard-coloured, opaque soft gelatin capsules, imprinted "APO 10."

PRESENTATION:
Both strengths of APO-NIFEDIPINE capsules, 5 & 10 mg, are available in white plastic bottles of 100 and 500.

STORAGE INSTRUCTIONS:
APO-NIFEDIPINE capsules, 5 & 10 mg, should be stored below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
5 mg : 30/7.1.4/0121
10 mg : 30/7.1.4/0127

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ACUPHARM (PTY) LTD t/a APOTEX SA
43 RICHARDS DRIVE
HALFWAY HOUSE
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
10 January 1996

8005A-1

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