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

Logo COVAMET Tablets

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

COVAMET Tablets

COMPOSITION:
Each tablet contains
  Cyclizine hydrochloride         50 mg

PHARMACOLOGICAL CLASSIFICATION:
A. 5.7 Antihistaminics, anti-emetics and antivertigo preparations.

PHARMACOLOGICAL ACTION:
Cyclizine is an antihistamine with anti-emetic properties.

INDICATIONS:
Covamet tablets
are indicated in the prevention and treatment of nausea and vomiting. It is indicated in prophylaxis and treatment of motion sickness, in the symptomatic management of vertigo and labyrinth disorders (Meniere's syndrome).

CONTRA-INDICATIONS:
Covamet tablets
are contra-indicated in individuals who have previously reacted adversely to cyclizine. Covamet tablets are contra-indicated in pregnancy.

WARNINGS:
Covamet tablets
may lead to drowsiness and impaired concentration. Which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents. Patients should be warned against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years: 1 tablet three times a day
Children 6 to 12 years: ½ a tablet three times a day.
For the prevention of motion sickness, one tablet is taken 20 to 30 minutes before departure. This dose may be repeated every 4 to 6 hours if necessary. The dosage for children aged 6 to 12 years is half the adult dosage.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common side-effect of Covamet tablets is sedation which can vary from slight drowsiness to deep sleep, and including inability to concentrate, lassitude, dizziness, hypotension, muscular weakness and inco-ordination. Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation and epigastric pain. Headache, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of the mouth, tightness of the chest and tingling, heaviness and weakness of the hands may occur.
Fixed drug eruptions, generalised chorea and hypersensitivity hepatitis have been reported after oral administration.
In Children it may act as a cerebral stimulant. Symptoms of stimulation in adults include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions. Large doses may precipitate fits in epileptics. Allergy and anaphylaxis may occur. Blood dyscrasias including agranutocytosis and haemolytic anaemia have been reported. Covamet tablets have anticholinergic properties and should be used with care in conditions such as glaucoma and prostatic hypertrophy. The effects of tricyclic anti-depressants may be enhanced by Covamet tablets.
Restlessness, dizziness and tachycardia may occur if atropine and Covamet tablets are used together.
Covamet tablets may mask the warning symptoms of damage caused by ototoxic drugs and may affect the metabolism of drugs in the liver.
Covamet tablets may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of acute toxicity arise from effects of the preparation on the central nervous system and include drowsiness, dizziness, inco-ordination, weakness, convulsions, hyperpyrexia and respiratory depression.
Agitation, ataxia and hallucinations may occur. Treatment of overdosage is symptomatic and supportive.

IDENTIFICATION:
White scored tablets.

PRESENTATION:
Containers with 20 and 100 tablets.

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

REGISTRATION NUMBER:
28/5.7/0499

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
The Premier Pharmaceutical Co. Ltd.
Adcock Ingram Park
17 Harrison Avenue, Bryanston Ext 77
Private Bag X69,
Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
20 December 1993

New addition to this site: April 2004
Source: Pharmaceutical Industry

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