COMPOSITION: Each tablet contains: Cyclizine hydrochloride 50 mg
PHARMACOLOGICAL CLASSIFICATION: A 5.7.2 Anti-emetics and antivertigo preparations.
PHARMACOLOGICAL ACTION: Cyclizine is an antihistamine with anti-emetic properties.
INDICATIONS: NAUZINE® 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 syndrome).
CONTRA-INDICATIONS: NAUZINE® is contra-indicated in individuals who have previously reacted adversely to cyclizine. NAUZINE is contra-indicated in pregnancy.
WARNINGS: NAUZINE® 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.
INTERACTIONS: The effects of atropine and tricyclic antidepressants may be enhanced by NAUZINE®. Restlessness, dizziness and tachycardia may occur if atropine and NAUZINE® are used together.
NAUZINE® tablets may mask the warning symptoms of damage caused by ototoxic drugs and may affect the metabolism of drugs in the liver.
NAUZINE® tablets may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers.
PREGNANCY AND LACTATION: Nauzine is contra-indicated in pregnancy.
DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years:
1 tablet three times a day
Children 6 to 12 years:
half 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 NAUZINE® 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 sensitivity 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.
NAUZINE® tablets have anticholinergic properties and should be used with care in conditions such as glaucoma and prostatic hypertrophy.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Symptoms of acute toxicity arise from effects of the preparation of 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: Securitainers of 20 and 200 tablets. Patient ready packs of different pack sizes.
STORAGE INSTRUCTIONS: Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: 27/5.7.2/0535
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION: BE-TABS PHARMACEUTICALS (PTY) LTD
14 LAUTRE ROAD
STORMILL EXT. 1
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 22 MARCH 1993
Updated on this site: November 2005
Source: Hospital Pharmacy