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

Logo COVAMET Syrup

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

COVAMET Syrup

COMPOSITION:
Contains per 5 mL:
Cyclizine hydrochloride         12,5 mg
Preservatives:        
Methyl hydroxybenzoate 0,12% m/v
Propyl hydroxybenzoate 0,02% m/v
Contains alcohol 6% v/v

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

PHARMACOLOGICAL ACTION:
Covamet syrup
is a piperazine type antihistamine with anti-emetic properties.

INDICATIONS:
The prevention and treatment of nausea and vomiting, particularly motion sickness and labyrinthine disorders (Meniere Syndrome).

CONTRA-INDICATIONS:
Individuals who have previously reacted adversely to cyclizine.

WARNINGS:
Drowsiness, dryness of mouth and blurred vision may occur and be aggravated by simultaneous intake of alcohol, and other central nervous system depressant agents. Patients should be warned against taking charge of vehicle or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents.

DOSAGE AND DIRECTIONS FOR USE:
To prevent motion sickness Covamet syrup should be taken about half an hour before the journey.
  Children 6 to 12 years         10 mL
  Children 1 to 5 years         5 mL
May be given three times daily

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Drowsiness, dryness of mouth and blurred vision may occur.
Other side-effects include inability to concentrate, lassitude, dizziness, hypotension, muscular weakness, inco-ordination, gastro-intestinal disturbance such as diarrhoea or constipation, epigastric pain, headache, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty with micturition, tightness of the chest and tingling, heaviness and weakness of the hand.
In children it may have the same effect as a central stimulant.
Blood disorders, including agranulocytosis and haemolytic anaemia, have been reported. Patients are warned that Covamet syrup may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquilizers. Since Covamet syrup has anticholinergic properties, it should be used with care in condition liable to be exacerbated or otherwise adversely affected by atropine, such as glaucoma and prostatic hypertrophy. The side-effects of anticholinergic drugs such as atropine and tricyclic antidepressants may be enhanced by the concomitant administration of Covamet syrup.
Covamet syrup may affect the metabolism of certain drugs in the liver. Covamet syrup may mask the warning symptoms of damage caused by ototoxic medicine.
Restlessness, dizziness and tachycardia may occur if atropine and Covamet syrup are used together.
Fixed drug eruptions generalised chorea, and sensitivity hepatitis have been reported.

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

IDENTIFICATION:
Clear yellow syrup with a naartjie flavour.

PRESENTATION:
Bottles containing 50 mL.

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

REGISTRATION NUMBER:
28/5.7/0533

NAME AND ADDRESS OF THE APPLICANT:
THE PREMIER PHARMACEUTICAL COMPANY LTD
Adcock Ingram office park
17 Harrison Avenue
Bryanston Ext 77
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
7 February 1994

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

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