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

Logo CORYX Paediatric syrup

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

CORYX Paediatric syrup

COMPOSITION:
Each 5 mL contains:
Triprolidine HCL 1,25 mg
Pseudoephedrine HCL 25,00 mg
Vitamin C 75,00 mg
Preservatives: 
Sodium benzoate 0,2% m/v
Potassium sorbate 0,2% m/v

PHARMACOLOGICAL CLASSIFICATION:
A.5.8 Preparations for the common cold including nasal decongestants and antihistaminics.

PHARMACOLOGICAL ACTION:
Coryx Paediatric syrup has antihistaminic and decongestant properties.

INDICATIONS:
Coryx Paediatric is indicated for the relief of symptoms associated with colds and influenza such as nasal congestion.

CONTRA-INDICATIONS:
Known hypersensitivity or intolerance to any of the ingredients. Coryx Paediatric is contra-indicated in patients who are taking or have taken monoamine oxidase inhibitors within the preceding weeks.
The safety of Coryx Paediatric syrup during pregnancy and lactation has not been established. Coryx Paediatric should not be administered to infants under the age of 6 months.

WARNINGS:
The use of Coryx Paediatric may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants.
Patients should be warned not to drive or operate dangerous machinery. Great care is needed in patients with cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia, occlusive vascular disorders, including arteriosclerosis, hypertension or aneurysms.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years: 2 medicine measures (10 mL) three times a day
Children 6 to 12 years: 1 medicine measure (5 mL) three times a day
Children 2 to 5 years: ½ medicine measure (2,5 mL) three times a day
Children 6 months to 2 years*: ¼ medicine measure (1,25 mL) three times a day
* A doctor's advice should be obtained before administering Coryx Paediatric syrup to children aged less than 2 years. Do not exceed the stated dose and if symptoms persist consult a doctor.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Pseudoephedrine Hydrochloride:
Central effects of pseudoephedrine include fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, weakness and psychotic states. Appetite may be reduced and nausea and vomiting may occur. Anginal pains may be precipitated in patients with angina pectoris. Pseudoephedrine causes vasoconstriction which may lead to a resultant rise in blood pressure and possibly to cerebral haemorrhage or pulmonary oedema.
Pseudoephedrine may also produce tachycardia, cardiac arrhythmias, anginal pain, palpitations, cardiac arrest, hypotension with dizziness and fainting and blushing.
Care is required when pseudoephedrine is given to patients with hyperthyroidism, diabetes mellitus; closed-angle glaucoma or prostatic enlargement. Caution should be exercised in the presence of severe renal or hepatic impairment. Symptoms of central nervous system excitation may occur including sleep disturbances and hallucinations.
Urinary retention has been reported in men receiving pseudoephedrine. Difficulty with micturition may also be experienced. Dyspnoea, altered metabolism, including disturbances of glucose metabolism, sweating and hypersalivation are possible. Headaches are also common.
Pseudoephedrine should be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics as they may induce ventricular fibrillation.
Triprolidine: is an antihistamine and may cause sedation, varying from slight drowsiness to deep sleep, and including lassitude, dizziness and inco-ordination. Blurred vision, dysuria, dryness of the mouth and tightness of the chest may occur. Gastrointestinal disturbances such as nausea, vomiting, diarrhoea or constipation, epigastric pain, anorexia or appetite increase may occur. Other central effects may include hypotension, muscular weakness, tinnitus, euphoria and headache. Paradoxical central nervous system stimulation may occur particularly in children, with insomnia, nervousness, tachycardia, tremors and convulsions. Allergic reactions and cross-sensitivity to related medicines are possible with systemic triprolidine administration. Blood disorders including agranulocytosis, leucopenia, thrombocytopenia and haemolytic anaemia have been reported. Care should be observed when tricyclic antidepressants, guanethidine, reserpine, methyldopa or atropine are taken concomitantly, as the antimuscarinic effect may be enhanced.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See 'side-effects'. Overdosage may be fatal, especially in children in whom the main symptoms are central nervous system stimulation and antimuscarinic effects: ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia. Deepening coma, cardiorespiratory collapse, drowsiness, coma and convulsions. Weakness, dizziness, inco-ordination, difficulty with micturition, respiratory depression, hypotension, agitation, irritability, hypertension, palpitations, restlessness and tachycardia, may occur.
Treatment is symptomatic and supportive: The patient must be taken to a doctor or hospital immediately as specialised treatment may be necessary.

IDENTIFICATION:
A clear blue coloured syrup with a black current smell and taste.

PRESENTATION:
Amber glass bottles of 100 mL.

STORAGE INSTRUCTIONS:
Store below 25°C in a well closed container. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
31/A.5.8/0055

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
MIRREN (Pty) Ltd
18 Golden Drive
Morehill
BENONI

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
3 February 1997

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