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BRONCLEER CHILDREN'S COUGH SYRUP
BRONCLEER CHILDREN'S COUGH SYRUP
SCHEDULING STATUS:
S2
PROPRIETARY NAME
(and dosage form):
BRONCLEER CHILDREN'S COUGH SYRUP
COMPOSITION:
Each 5mL contains:
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Diphenhydramine HCl |
14,07mg |
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Ammonium chloride |
137mg |
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Sodium citrate |
57mg |
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Preservative: |
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Nipastat |
0,02% m/v |
PHARMACOLOGICAL CLASSIFICATION:
A 10.1 Medicines acting on respiratory system - Antitussives and expectorants
INDICATIONS:
For the alleviation of cough.
CONTRA-INDICATIONS:
Sensitivity to the components. Impaired hepatic or renal function.
WARNINGS:
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents. Patients should be warned against performing potentially hazardous tasks where loss of concentration may lead to accidents.
DOSAGE AND DIRECTIONS FOR USE:
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Children 1 to 5years: |
2,5mL (half a medicine measure) three to four hourly. |
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Children 6 - 12years: |
5mL (one medicine measure) three to four hourly. |
This medicine must not be given to children under one year of age.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Diphenhydramine HCl may give rise to the following side-effects: sedation, varying from slight drowsiness to deep sleep, and including lassitude, dizziness, hypotension, muscular weakness and inco-ordination.
Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation, anorexia or increased appetite and epigastric pain.
Diphenhydramine HCl may also cause headache, blurred vision, tinnitus, elation or depression, difficulty in micturition, dysuria, dryness of the mouth, tightness of the chest, and tingling, heaviness and weakness of the hands.
Symptoms of cerebral stimulation may arise in some children and they include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions.
Large doses of diphenhydramine HCl may precipitate fits in epileptics. Diphenhydramine hydrochloride may cause thrombocytopenia.
Diphenhydramine HCl may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers. It should be used with care in conditions which can be exacerbated or otherwise adversely affected by atropine, such as glaucoma, urinary retention and prostatic hypertrophy. The effects of anticholinergic drugs such as atropine and tricyclic antidepressants may be enhanced by concomitant administration.
Ammonium chloride - large doses may cause nausea and vomiting.
Sodium citrate may cause shortness of breath, muscle weakness and mental disturbances such as restlessness, convulsions, and coma. Muscle hypertonicity, twitching and tetany may develop especially in the absence of sufficient calcium.
Sodium citrate should be used cautiously in patients with congestive heart failure, hypertension and those receiving corticosteroid therapy.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms as under side-effects. In addition the symptoms of overdosage with diphenhydramine HCL in children may include ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia.
Large doses of ammonium chloride may cause profound acidosis and hypokalaemia.
Sodium overloading may occur.
Treatment is symptomatic and supportive. Contact a doctor or the nearest major hospital without delay.
IDENTIFICATION:
A clear, brown viscous syrup, sweet chloroform and raspberry odour.
PRESENTATION:
100mL, 200mL.
STORAGE INSTRUCTIONS:
Store in a cool place (below 25°C) in airtight containers, protected from light.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER:
G/10.1/1110
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston
2021
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
14th June 1982.
New addition to this site: April 2004
Source: Pharmaceutical Industry |
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