COMPOSITION: Each tablet contains 50 mg cyclizine hydrochloride.
PHARMACOLOGICAL CLASSIFICATION: A 5.7.2. Anti-emetics and antivertigo preparations.
PHARMACOLOGICAL ACTION: Cyclizine is an antihistamine with anti-emetic properties.
INDICATIONS: Medazine T is 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 disease).
CONTRA-INDICATIONS: Medazine T is contra-indicated in individuals who have previously reacted adversely to cyclizine. Medazine T is contra-indicated in pregnancy.
WARNINGS: Medazine T 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 Medazine T 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 agranulocytosis and haemolytic anaemia have been reported.
Medazine T tablets have anticholinergic properties and should be used with care in conditions such as glaucoma and prostatic hypertrophy. The effects of atropine and tricyclic antidepressants may be enhanced by Medazine T. Restlessness, dizziness and tachycardia may occur if atropine and Medazine T are used together.
Medazine T tablets may mask the warning symptoms of damage caused by ototoxic drugs and may affect the metabolism of drugs in the liver.
Medazine T 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: Securitainer of 200 tablets. Also packed in push-through blister packs of 10 tablets in cartons of 10 and 20 tablets.
STORAGE INSTRUCTIONS: Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: A27/5.7.2/0203
NAME AND BUSINESS ADDRESS OF THE APPLICANT: MEDPRO PHARMACEUTICA (PTY) LTD
Rosen Heights, Rosenpark
DATE OF PUBLICATION OF THIS PACKAGE INSERT: March 1998