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

Logo PROMETHAZINE LINCTUS WITH CODEINE AND EPHEDRINE

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

PROMETHAZINE LINCTUS WITH CODEINE AND EPHEDRINE

COMPOSITION:
Each 5 mL contains:
Promethazine Hydrochloride 3,5 mg
Ephedrine Hydrochloride 7,0 mg
Codeine Phosphate 9,0 mg
Nipasept 0,14% m/v

PHARMACOLOGICAL CLASSIFICATION:
10.1 Antitussives and expectorants.

PHARMACOLOGICAL ACTION:
Contains 3 medicaments of established therapeutic value, i.e. codeine phosphate which is a C.N.S. acting cough suppressant; ephedrine hydrochloride which causes bronchial muscle relaxation; and the antihistamine promethazine hydrochloride.

INDICATIONS:
This product is indicated for the relief of cough and the spasm of whooping cough.

CONTRA-INDICATIONS:
Not to be given to patients suffering from coronary thrombosis; hypertension; hyperthyroidism and closed-angle glaucoma. Not to be used with monoamine oxidase inhibitors.

WARNINGS:
Persistent coughs should be investigated for the possible underlying cause by the patient's doctor. This medicine may lead to drowsiness and impaired concentration which may be aggravated by the simultaneous intake of alcohol or other C.N.S. depressant agents.

DOSAGE AND DIRECTIONS FOR USE:
Adults: 5 - 10 mL three times a day.
Children: 2 - 5 years: 2,5 mL twice or three times a day.
  5 - 10 years: 2,5 - 5 mL twice or three times a day.
  Over 10 years: 5 - 10 mL twice or three times a day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Slight drowsiness, lassitude and dizziness may occur occasionally. These effects may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents. It should be given with caution to patients with organic heart disease, cardiac decompensation or angina of effort, and in patients receiving digitalis.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Central stimulation with exhilaration. In children, convulsions followed by nausea, drowsiness, respiratory depression and cyanosis, and coma. In the event of overdosage, after inducing vomiting or washing out the stomach, treatment is symptomatic.

CONDITIONS OF REGISTRATION:

IDENTIFICATION:
A clear reddish-brown liquid with a fruity odour.

PRESENTATION:
Bottles of 100 mL, 2,5 L and 20 L.

STORAGE INSTRUCTIONS:
Store below 30°C out of direct sunlight. Keep out of reach of children.

APPLICATION NUMBER:
G 1087 (Act/Wet 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adco Drug Co. (Pty) Ltd.
491 Sydney Road
Durban 4001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

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