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

Logo DOCSED SYRUP

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

DOCSED SYRUP

COMPOSITION:
Each 5 mL contains:
Mepyramine Maleate 20 mg
Codeine Phosphate 5 mg
Pholcodine 5 mg
Ephedrine Hydrochloride 8 mg
Preservatives: 
Sodium Benzoate 0,120% m/v
Chloroform 0,319%m/v
Methyl Hydroxybenzoate 0,09% m/v
Propyl Hydroxybenzoate 0,01% m/v

PHARMACOLOGICAL CLASSIFICATION:
A. 10.1 Anti-tussives and expectorants.

PHARMACOLOGICAL ACTION:
Docsed syrup alleviates cough.

INDICATIONS:
Docsed syrup is indicated for the treatment of cough.

CONTRA-INDICATIONS:
Hypersensitivity to mepyramine maleate or codeine phosphate. Codeine phosphate is contra-indicated in respiratory depression, the presence of acute alcoholism or in patients with obstructive bowel disorders.
Ephedrine hydrochloride, a sympathomimetic agent, should be avoided or only used with great caution in hypersusceptible patients or those with hyperthyroidism, aneurysm, hypertension, arteriosclerosis, and cardiovascular disorders such as ventricular tachycardia, myocardial disease or bradycardia.
It should not be given to patients being treated with a monoamine oxidase inhibitor or within 14 days of stopping such treatment. It should also be avoided in patients receiving tricyclic antidepressants. Patients receiving guanethidine and similar adrenergic neurone blocking agents are extremely sensitive to the hypertensive effects of ephedrine; ephedrine may also markedly reverse the hypotensive effects of reserpine and methyldopa. In patients with prostatic enlargement, ephedrine may increase difficulty with micturition.
Chloroform should not be administered to patients with renal, hepatic or cardiovascular disease, diabetes, mellitus or severe anaemia.

WARNING:
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.
Exceeding the prescribed dose, together with prolonged and continuous use may lead to dependency.

DOSAGE AND DIRECTIONS FOR USE:
Adults: Two 5 mL medicine measures every 3 to 4 hours.
Children: 3 to 14 years - Half to one 5 mL medicine measure every 3 to 4 hours.
Under 3 years - Use under medical supervision.
SHAKE WELL BEFORE USE.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Codeine phosphate in normal doses may cause nausea, vomiting, constipation, drowsiness and confusion.
Side-effects with antihistamines vary in incidence and severity with each patient. The following side-effects have been reported for drugs in the antihistamine class: dizziness, lassitude, hypotension, muscular weakness and inco-ordination, nausea, vomiting, diarrhoea or constipation, colic and epigastric pain. Antihistamines may also produce headache, hallucinations, blurred vision, tinnitus, elation or depression, irritability, anorexia, difficulty in micturition, dryness of the mouth, tightness of the chest and weakness of the hands. Large doses of antihistamines may precipitate fits in epileptics. Blood dyscrasias, including agranulocytosis, haemolytic anaemia and thrombocytopenic purpura, though rare, have been reported.
Ephedrine hydrochloride may produce an undesirably high blood pressure with headache, vomiting and, rarely, palpitations. Reflex bradycardia may occur which can be prevented or abolished with atropine.
As with all drugs, care should be taken when administering this preparation during the first trimester of pregnancy.
Chloroform depresses respiration and may produce hypotension.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage symptoms of antihistamine include convulsions, drowsiness and hyperexcitability in children.
Large doses of codeine phosphate produce respiratory depression and hypotension with circulatory failure and deepening coma, excitement and, in children, convulsions may also occur.
Ephedrine may produce such reactions as headache, vomiting, perspiration, tremor and palpitation or collapse and hypertension.
Empty the stomach by gastric lavage. The patient should be kept quiet to minimise excitation which can occur, particularly in children. Respiratory depression should be treated with assisted respiration. In severe hypotension, the circulation should be maintained with infusions of plasma or suitable electrolyte solutions. Other treatment is symptomatic and supportive.

IDENTIFICATION:
A clear, amber-coloured syrup with characteristic odour and fruity taste.

PRESENTATION:
Bottles containing 100 mL, 200 mL and 2,5 L.

STORAGE INSTRUCTIONS:
Store below 25°C. KEEP OUT OF REACH OF CHILDREN.
Keep tightly closed. Protect from light.

APPLICATION NO.:
G616 (Act 101/1965).

NAME AND BUSINESS ADDRESS OF APPLICANT:
MDI cc
374 Anderson Street
Menlo Park
0081

DATE OF PUBLICATION:
13 June 1996

        6/96
        Melita Dbn.

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