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Logo CEPACOL COUGH DISCS

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

CEPACOL COUGH DISCS

COMPOSITION:
Each cough disc contains:
Dextromethorphan hydrobromide         4,98 mg
Cetylpyridinium chloride         0,50 mg
Benzocaine         1,25 mg
in a candy base.

PHARMACOLOGICAL CLASSIFICATION:
A 10.1. Antitussives.

PHARMACOLOGICAL ACTION:
Dextromethorphan hydrobromide n(HBr) : Is a non-narotic antitussive agent which is believed to inihibit the cough reflex by acting on the cough centre in the medulla. Clinical studies in patients with both acute and chronic cough have demostrated significant cough suppression. It has a relatively long antitussive action lasting from 6 to 8 hours.
Benzocaine: Has a mild local anaesthetic action which helps to alleviate sore or irritated throats.
Cetylpyridinium chloride: Laboratory studies show that cetylpyridinium chloride has as marked bactericidal action against a wide range of bacteria and is effective against pathogenic organisms which are associated with sore throats due to colds. It also has anti-fungal properties. By lowering surface tension (detergent action) it spreads over the oral and pharyngeal mucosa to loosen and disperse bacterial laden mucous in the mouth and throat.

INDICATIONS:
Cepacol cough discs
provide rapid and continuous relief of coughs due to colds. Cepacol cough discs alleviate and soothe sore throats irritated by continual coughing and inflammation caused by colds and other throat irritations associated with dust, allergy, smoke, ect.

CONTRA-INDICATIONS:
Known idiosyncrasy or hypersensitivity to dextromethorphan HBr, cetylpyridinium chloride, benzocaine or related substances. Benzocaine is contra-indicated in patients with low plasma cholinesterase concentrations or in those receiving antichlolinesterases.

DOSAGE AND DIRECTIONS FOR USE:
Repeat every three hours as needed.
Adults and children over 12 years old: Dissolve 2 cough discs in the mouth one at a time.
Children 6 - 12 years old: Dissolve 1 cough disc in the mouth.
Do not exceed the recommended dosage.
Do not use in the children under six years of age.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Severe sore throats or sore throat accompanied by high fever or headache or nausea and vomiting, or any sore throat persisting for more than two days, may be serious. In such cases, consult a doctor.
Dextromethorphan HBr: Gastrointestinal disturbances, drowsiness, dizziness and excitation have very occasionally been associated with dextromethorphan therapy. Dextromethorphan should not be given to patients with or at risk of developing respiratory failure. Administration of dextromethorphan to patients receiving monoamine oxidase inhibitors may produce severe reactions; hyperpyrexia and fatalities have been reported.
Dextromethorphan has been subject to abuse but there does appear to be any evidence of dependence of the morphine type.
Benzocaine: Systemic adverse effects may occur with benzocaine, as results of the absorption of large amounts through mucous membranes or damaged skin or from highly vascular areas.
Excitation of the central nervous system (CNS) may be manifested by yawning, restlessness, excitement, nervous, dizziness, tinnitus, blurred vision, nystagmus, nausea and vomiting, muscle twitching and tremors and convulsions. Numbness of the tongue and perioral regions is an early sign of systemic toxicity. Excitation may be transient and followed by depression with drowsiness, respiratory failure and coma.
There may be simultaneous effects on the cardiovascular system with myocardial depression and peripheral vasodilation resulting in hypotension and bradycardia, arrythmias and cardiac arrest may occur.
Idiosyncratic reactions have been reported. Allergic reactions may occur. Benzocaine should be given cautiously to the elderly, and to children, to patients with epilepsy, impaired cardiac conduction or respiratory function, shock, or with liver damage; patients with myasthenia gravis are particularly sensitive to the effects of local anaesthetics.
When used in the mouth or throat, local anaesthetics may impair swallowing and increase the risk of aspiration.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage may cause nausea and vomiting. It has depolarising muscle relaxant properies and toxic symptoms include dyspnoea and cyanosis due to paralysis of the respiratory muscle, possibly leading to asphyxia. Depression of the CNS with convulsions, hypotension and coma may occur. Dextromethorphan overdosage may cause excitation, confusion and respiratory depression.
Treatment is symptomatic and supportive.

IDENTIFICATION:
Round dark brown hard candy lozenge embossed with "M".

PRESENTATION:
Blister pack of 16 lozenges.

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

REGISTRATION NUMBER:
B/10.1/163

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Ltd
Adcock Ingram Park
17 Harrison Avenue
Bryanston, Ext 77
Private Bag X69, Bryanston,
2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
14/10/1969

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

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