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

Logo VASOMIL - 40 TABLETS
VASOMIL - 80 TABLETS
VASOMIL - 120 TABLETS
SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

VASOMIL - 40 TABLETS
VASOMIL - 80 TABLETS
VASOMIL - 120 TABLETS

COMPOSITION:
Each tablet contains:
Vasomil - 40 Verapamil hydrochloride 40 mg
Vasomil - 80 Verapamil hydrochloride 80 mg
Vasomil - 120 Verapamil hydrochloride 120 mg

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

PHARMACOLOGICAL ACTION:
Verapamil hydrochloride is a calcium channel blocker that reduces myocardial oxygen consumption in vitro directly by intervening in the energy consuming metabolic processes of the myocardial cell, and indirectly by diminishing the peripheral resistance (afterload). It prolongs impulse conduction in the A.V. node.

INDICATIONS:
Angina pectoris, supraventricular tachydysrythmia.

CONTRA-INDICATIONS:
Hypersensitivity to verapamil. Safety in pregnancy and lactation has not been established.
Verapamil is contra-indicated in hypotension, cardiogenic shock, marked bradycardia, second and third-degree atrioventricular block and uncompensated heart failure. Verapamil is also contra-indicated in the sick-sinus syndrome unless a pacemaker is fitted.

DOSAGE AND DIRECTIONS FOR USE:
Adults: Vasomil - 40:         1 to 2 tablets three times daily.
  Vasomil - 80:         1 to 2 tablets three times daily.
  Vasomil - 120:         1 tablet three times daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Adverse effects connected with verapamil’s pharmacological effects on cardiac conduction can arise and may be particularly severe in patients with hypertrophic cardiomyopathies. Adverse effects on the heart include bradycardia, atrioventricular block, worsening heart failure and transient asystole.
The most troublesome non-cardiac adverse effect is constipation. Nausea may occur but is less frequently reported. Other adverse effects include hypotension, dizziness, flushing and headaches. There have been reports of skin reactions.
Some cases of abnormal liver function and hepatotoxicity have been reported.
Gingival hyperplasia has occurred. Gynaecomastia has been reported less frequently.
In patients with atrial flutter or fibrillation and an accessory pathway with antero-grade conduction, e.g. Wolff-Parkinsons White syndrome, verapamil may induce severe ventricular tachycardia.
Doses of verapamil should be reduced m patients with impaired liver function.
Sudden withdrawal of verapamil might be associated with an exacerbation of angina.

Interactions:
During the simultaneous administration of Vasomil and medication with cardio-depressive effect and/or inhibiting effect on atrioventricular conduction (e.g. beta-adrenergic blockers), the patient should be observed for additive effects.
Rises in digoxin plasma levels under concomitant administration of Vasomil have been reported. Doctors should be alert for symptoms of possible digitalis intoxication.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In overdosage there may be severe cardiotoxicity and profound hypotension.
In overdosage with verapamil by mouth the stomach should be emptied by lavage; activated charcoal may be administered. Treatment of cardiovascular effects is supportive and symptomatic.

IDENTIFICATION:
Vasomil - 40 A yellow, film-coated biconvex tablet.
Vasomil - 80 A yellow, film-coated biconvex tablet, bisected on one side
Vasomil - 120 A yellow, film-coated biconvex tablet, bisected on one side.

PRESENTATION:
Vasomil - 40 Blister packs with 100 tablets
Securitainers with 500 tablets
Vasomil - 80 Blister packs with 100 tablets
Securitainers with 250 tablets
Vasomil - 120 Blister packs with 100 tablets
Securitainers with 250 tablets

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

REGISTRATION NUMBERS:
Vasomil - 40         H/7.1.4/237
Vasomil - 80         M/7.1.4/179
Vasomil - 120         Y/7.1.4/328

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
19/06/1991

                        D202
                A & S PRINTERS.

Updated on this site: May 2000
Current: July 2003
Source: Community Pharmacy

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2003