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

Logo TRIAZINE PAEDIATRIC SYRUP

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

TRIAZINE PAEDIATRIC SYRUP

COMPOSITION:
Each 5 mL syrup contains:
Cyclizine Hydrochloride 12,5 mg
Sucrose 500,0 mg
Alcohol 96% 7,78% v/v
Preservatives:
Methylhydroxybenzoate 0,12% m/v
Propylhydroxybenzoate 0,02% m/v

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

PHARMACOLOGICAL ACTION:
TRIAZINE (cyclizine hydrochloride) is a piperazine-type antihistamine with anti-emetic properties.

INDICATIONS:
TRIAZINE is indicated for the following:
- The prevention and treatment of nausea and vomiting, particularly motion sickness.
- Symptomatic treatment of vertigo due to Meniere's disease and other labyrinthine disturbances.

CONTRA-INDICATIONS:
- Individuals who have previously reacted adversely to cyclizine.
- Pregnancy and lactation.
- During an attack of asthma.
- Premature infants and neonates.

WARNINGS:
THIS MEDICINE 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 not operate hazardous machinery or drive motor vehicles or perform potentially hazardous tasks where loss of concentration may lead to accidents.

DOSAGE AND DIRECTIONS FOR USE:
Paediatric syrup:
Six to twelve years:       
two medicine measurefuls (10 mL) three times daily.
One to five years:        one medicine measureful (5 mL) three times daily.
To prevent motion sickness TRIAZINE should be taken about half an hour before departure. The dose for motion sickness may be repeated every four to six hours.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
- The most common side-effect is sedation varying from slight drowsiness to deep sleep. (Note that sedation is enhanced by alcohol and sedative medicines, narcotics and analgesics and tranquilizers.) See also WARNINGS.
- Other side-effects include dry-mouth, nausea, vomiting, gastro-intestinal disturbances such as diarrhoea or constipation, anorexia or increased appetite, epigastric discomfort, cholestatic jaundice, hypersensitivity hepatitis.
- Blood disorders, including agranulocytosis, leucopenia and haemolytic anaemia, have been reported.
- Tachycardia, hypotension and tightness in the chest may occur.
- Nervous system side-effects may include inability to concentrate, lassitude, headache, tinnitus, blurred vision, incoordination, euphoria or depression, irritability, insomnia, nightmares, tingling in the hands, muscular weakness, generalised chorea, extrapyramidal effects. Epileptiform seizures may be precipitated in patients with focal lesions of the cerebral cortex.
- Allergic reactions and skin photosensitivity. The positive results of skin tests may be suppressed. TRIAZINE should be used with caution under the following circumstances:
- Cyclizine may effect the metabolism of medicines in the liver.
- It may mask the warning signs of damage caused by ototoxic medicines such as aminoglycoside antibiotics.
- Because of its antimuscarinic properties cyclizine should be used with care in conditions such as narrow angle glaucoma, urinary retention and prostatic hypertrophy.
- The antimuscarinic effects may be enhanced by monoamine-oxidase inhibitors.
- As TRIAZINE has anticholinergic properties, other antimuscarinic medicines such as atropine and tricyclic antidepressants would enhance these effects and could be additive. Cyclizine used together with atropine may result in restlessness, dizziness and tachycardia.
- Elderly patients are more susceptible to CNS depressants and hypotensive effects.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdose may be fatal, especially in infants and children in whom the main symptoms are central nervous system stimulation and antimuscarinic effects, including ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia. Deepening coma, cardiorespiratory collapse and death may occur within 18 hours. In adults the usual symptoms are central nervous system depression with drowsiness, coma and convulsions. Hypotension may also occur.
Treatment of overdosage is symptomatic and supportive.

IDENTIFICATION:
Paediatric syrup:        clear, light yellow syrup with a pineapple odour and flavour.

PRESENTATION:
Paediatric syrup
:        50 mL in amber glass bottles.

STORAGE INSTRUCTIONS:
Paediatric syrup
:        Store below 25ºC and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Syrup
:        X/5.7/382

NAME AND BUSINESS ADDRESS OF APPLICANT:
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
2191

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
Syrup
:        15 March 1991

308758 090737
A&S PRINTERS

New addition to this site: February 2010
Source: Pharmaceutical Industry

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