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

Logo BRONCLEER WITH CODEINE COUGH SYRUP
SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

BRONCLEER WITH CODEINE COUGH SYRUP

COMPOSITION:
Each 5 mL contains:
Codeine Phosphate         10 mg
Diphenhydramine HCL         12,5 mg
Ammonium chloride         125 mg
Sodium citrate         50 mg
Nipastat 0,02% m/v as preservative

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. Patients with impaired renal or hepatic function.
Patients with respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, after operations on the biliary tract, acute alcoholism, head injuries and conditions in which intracranial pressure is raised. It should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease.

WARNINGS:
The use of 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:
Children 1 to 6 years: (2,5 mL) half a medicine measure every four hours.
Children 6 - 12 years: (5 mL) one medicine measure every four hours.
Adults:                One to two 5 mL medicine measures every four hours.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Codeine may cause vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood and miosis. Micturition may be difficult and there may be ureteric or biliary spasm. Raised intercranial pressure may occur.
Codeine should be given with caution to patients with hypothyroidism, adrenocortical insufficiency, impaired liver function, prostatic hypertrophy or shock. It should be used with caution in patients with inflammatory or obstructive bowel disorders. The dosage should be reduced in elderly and debilitated patients.
The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, and phenothiazines.
Larger doses produce respiratory depression and hypotension, with circulatory failure and deepening coma. Convulsions may occur in children.
Prolonged use of high doses of codeine has produced dependence of the morphine type.
Diphenhydramine HCL may give rise to the following side-effects : sedation, varying 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.
Diphenhydramine HCL may also cause headache, blurred vision, 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.
Symptoms of cerebral stimulation may arise in some adults and they include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions.
Large doses of diphenhydramine HCL may precipitate fits in epileptics.
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 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, vomiting, thirst, headache, hyperventilation, and progressive drowsiness, and lead to profound acidosis and hypokalaemia.
Sodium citrate - hypernatraemia may occur and the symptoms include resltessness, weakness, thirst, reduced salivation and tear production, swollen tongue, flushing of the skin, pyrexia, dizziness, headache, oliguria, hypotension, tachycardia, delirium, hyperpnoea and respiratory arrest.
Sodium citrate should be used cautiously in patients with cardiac failure, hypertension, impaired renal function, peripheral and pulmonary oedema, and in toxaemia of pregnancy.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms as under side-effects. In addition symptoms of codeine overdosage, are the development of coma, respiratory depression, cyanosis and hypotension together with pin-point non-reactive pupils.
Symptoms of overdosage in infants and children may include convulsions and hyperpyrexia.
Treatment is supportive and symptomatic.

IDENTIFICATION:
Brown viscous syrup. Sweet chloroform and raspberry odour, fading with age as is often to be expected with scents.

PRESENTATION:
Glass bottles of 100 mL, Polykan 2,5L and 100 mL and 200 mL plastic bottles.

STORAGE INSTRUCTIONS:
Keep bottle tightly closed. Protected from light. Store in a cool place (below 25°C)
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
G/10.1/1112

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Ave
Bryanston

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
14th June 1982.

New addition to this site: April 2004
Source: Pharmaceutical Industry

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