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

Logo CARDIFEN™ –5 CAPSULES
CARDIFEN™ –10 CAPSULES

        D167

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

CARDIFEN™ –5 CAPSULES
CARDIFEN™ –10 CAPSULES

COMPOSITION:
Each capsule contains 5 mg or 10 mg
Nifedipine.

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

PHARMACOLOGICAL ACTION:
Cardifen is a calcium antagonist which inhibits excitation - contraction coupling in myocardial and smooth muscle by blocking the transmembrane carrier of calcium. This results in vasodilation as well as decreased myocardial contractility and myocardial oxygen demand. Cardifen is also reported to act by reducing peripheral resistance.
After oral administration of Cardifen, peripheral blood flow increases due to arterial dilatation. There is no change in venous tone. The increase in cardiac output is due to a decrease in arteriolar resistance coupled with the positive inotropic effect that results from the expected sympathetic reflexes.
Recent evidence suggests that sublingual Cardifen produces a more marked improvement in cardiac performance in patients with poor ventricular function (but without failure) than it does in patients with normal ventricular function.

INDICATIONS:
Treatment and prophylaxis of angina pectoris.

CONTRA-INDICATIONS:
The safety of Cardifen in pregnancy has not been established. The administration of Cardifen is contra-indicated in patients with porphyria.

WARNING:
In patients who experience ischaemic pain following administration of Cardifen, therapy should be discontinued.

DOSAGE AND DIRECTIONS FOR USE:
The usual oral dose is 10 mg thrice daily taken during or after meals increased, if necessary, to 20 mg thrice daily. A recommended dose for elderly patients or those on concomitant medication is 5 mg thrice daily. Cardifen may also be taken sublingually.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Cardifen may cause transient headache, flushing and lethargy. Other side-effects reported include dizziness, allergic reactions, hypotension, palpitations and sometimes precipitation of anginal pain. Nausea, gastro-intestinal disturbances, peripheral oedema - unrelated to congestive cardiac failure - perspiration and nervousness, have been reported. An increased frequency of angina may occur. Myocardial infarction has been reported.
Cardifen should be used with caution in patients with hypotension and in patients whose cardiac reserve is poor, and blood pressure should be monitored carefully during initiation and upward titration of Cardifen, especially in patients who are on antihypertension therapy.
Cardifen may enhance the antihypertensive effects of beta-adrenoceptor blocking agents. The use of Cardifen in diabetic patients may require adjustment of their control.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage with Cardifen may be associated with bradycardia and hypotension. In overdosage the stomach should be emptied by aspiration and lavage.
Treatment is symptomatic and supportive.

IDENTIFICATION:
5 mg Capsule
A clear pale-yellow liquid, encapsulated within a no. 6 oblong C, opaque orange-yellow soft gelatin capsule, imprinted with a Lennon logo centered on one side of the capsule.
10 mg Capsule
A clear, pale-yellow liquid, encapsulated within a no. 11 oblong K, opaque orange-yellow soft gelatin capsule, imprinted with a Lennon logo centered on one side of the capsule.

PRESENTATION:
5 mg Capsules - packs of 100 capsules.
10 mg Capsules - packs of 100 and 250 capsules.

STORAGE INSTRUCTIONS:
Store below 25°C in airtight containers and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
5 mg         V/7.1.4/100
10 mg         V/7.1.4/101

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacare Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
16 November 1988

                D167
                A & S PRINTERS

Updated on this site: February 2003
Source: Community Pharmacy

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