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

Logo COUGHCOD SENIOR Syrup

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

COUGHCOD SENIOR Syrup

COMPOSITION:
Each 5 mL contains:
Ephedrine hydrochloride 10 mg
Ammonium chloride 125 mg
Sodium citrate 50 mg
Codeine phosphate 10 mg
Mepyramine maleate 12,5 mg
Alcohol 2,4% v/v
Preservatives
Methylparaben 0,1% m/v
Propylparaben 0,01% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 10.1 Antitussives and expectorants

INDICATIONS:
For the relief of cough

CONTRA INDICATIONS:
COUGHCOD SENIOR is contra-indicated in the presence of coronary thrombosis, hypertension, hyperthyroidism, closed-angle glaucoma and impaired hepatic or renal function, and should not be used by epileptics or in conjunction with mono-amineoxidase inhibiters or within 10 days after cessation of such treatment.

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 dangerous machinery or drive motor vehicles while using this medication.

DOSAGE AND DIRECTIONS FOR USE:
Adults: 1 –2 medicine measures (5 –10 mL) three times daily and at night or as prescribed.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The safety of the use of this medicine during pregnancy has not been established.

Ephedrine hydrochloride:
In large doses giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tremors, anxiety, restlessness and insomnia may occur. Administer with caution in patients with organic heart disease, cardiac decompensation or angina of effort and in patients receiving digitalis. In patients with prostatic enlargement it may increase difficulty with micturition.
Use with caution in patients receiving chloroform, cyclopropane, halothane or other halogenated anaesthetics.

Mepyramine maleate:
The most common side-effect of antihistamines is sedation, varying from slight drowsiness to deep sleep and including inability to concentrate, lassitude, dizziness, hypotension, muscular weakness and inco-ordination. Sedative effects may diminish after a few days.
Other side-effects include gastrointestinal disturbances such as nausea, vomiting, diarrhoea or constipation, and epigastric pain. Antihistamines may also produce headache, blurred vision, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, tightness of the chest, and tingling heaviness, and weakness of the hands.
Symptoms of stimulation include insomnia, nervousness, tachycardia, tremors, muscle twitching, and convulsions. Large doses of antihistamines may precipitate fits in epileptics. Administration of antihistamines may occasionally cause allergy. Blood disorders, including agranulocytosis and haemolytic anaemia, though rare have been reported.

Ammonium chloride:
Large doses of ammonium chloride may cause nausea, vomiting, thirst, headache, hyperventilation and progressive drowsiness and lead to profound acidosis and hypokalaemia.

Sodium citrate:
Hypernatraemia may occur.

Codeine phosphate:
Nausea, vomiting, constipation, drowsiness and confusion. Micturition may be difficult and there may be ureteric or biliary spasm; there is also an antidiuretic effect. Dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood and miosis may occur. Very rarely skin rashes may occur in patients hypersensitive to codeine.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See symptoms mentioned under side-effects. Treatment is supportive and symptomatic.

CONDITIONS OF REGISTRATION:
To be imposed by the Council.

IDENTIFICATION:
Deep amber coloured syrup with blackcurrent flavour.

PRESENTATION:
COUGHCOD SENIOR is obtainable in 200 mL amber glass bottles, and 2,5 L in plastic containers.

STORAGE DIRECTIONS:
Store in a cool (below 25°C) dark place. Keep out of reach of children.

REFERENCE NUMBER:
G 1071 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
Compu Pharmaceutical Products Ltd.
476 Kings Highway
Lynnwood
Pretoria 0081

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
27 May 1975

        CG107195
        05/95
        Britepak

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