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

Logo ACULOID Syrup

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ACULOID Syrup

COMPOSITION:
Each 5 mL contains:
Cyclizine HCl         12,5 mg
Preserved with: Methyl Hydroxybenzoate 0,12% m/v; Propyl Hydroxybenzoate 0,02% m/v
Contains Alcohol         6,00% v/v

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

PHARMACOLOGICAL ACTION:
ACULOID 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. Pregnancy.

WARNINGS:
Drowsiness, dryness of mouth and blurred vision may occur and be aggravated by the simultaneous intake of alcohol and 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:
To prevent motion sickness ACULOID 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 and dryness of mouth and blurred vision may occur.
Other side-effects include inability to concentrate, lassitude, dizziness, hypotension, muscular weakness, inco-ordination, gastro-intestinal disturbances 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 hands.
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 ACULOID Syrup may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillizers. Since ACULOID Syrup has anticholinergic properties, it should be used with care in conditions 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 ACULOID Syrup.
ACULOID Syrup may affect the metabolism of drugs in the liver. ACULOID Syrup may mask the warning symptoms of damage caused by ototoxic medicines.
Restlessness, dizziness, and tachycardia may occur if atropine and ACULOID Syrup are used together.
Fixed drug eruptions, generalised chorea and hypersensitivity hepatitis have been reported.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of acute overdosage arise from effects of the preparation 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:
Amber, glass bottles containing 50 mL, 100 mL and 500 mL.

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

REGISTRATION NUMBER:
X/5.7/5

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
APOTEX S.A.
PHARMACEUTICAL INNOVATION
Reg. Prop: Acupharm (Pty) Ltd
Cnr. Fleming & Watt Streets
Meadowdale Ext. 1

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
October 1991
                PX 5/2

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