VICKS MEDINITE SYRUP

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

VICKS MEDINITE SYRUP

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

VICKS MEDINITE SYRUP

Composition
Each 30 mL contains

Paracetamol	600 mg
Ephedrine Sulphate	9 mg
Doxylamine Succinate	7,5 mg
Dextromethorphan Hydrobromide	15 mg
Alcohol Absolute	18% v/v
Sodium Benzoate (added as preservative) 0,1% m/v

Contains TARTRAZINE

PHARMACOLOGICAL CLASSIFICATION:
A 10.1 Antitussives and Expectorants

PHARMACOLOGICAL ACTION:
Paracetamol has an analgesic and antipyretic properties. Doxylamine Succinate has antihistamine properties with a prolonged effect. Dextromethorphan Hydrobromide has antitussive properties. Ephedrine Sulphate has sympathomimetic properties causing vaso-constriction. It also has smooth muscle relaxant effects.

INDICATIONS:
Vicks Medinite nighttime colds medicine may be taken at bedtime for relief of major symptoms associated with colds and influenza such as nasal congestion, sniffing, headache, minor aches and pains and coughing.

CONTRA-INDICATIONS:
Safety during pregnancy has not been established. Do not administer concurrently with monoamine oxidase inhibitors or in patients with known hypersensitivity to any of the active ingredients.

WARNINGS:
This medicine may lead to drowsiness and impaired concentration, which maybe aggravated by simultaneous intake of alcohol or other central nervous system depressant agents. Patients should be warned against taking charge of vehicles, or machinery or performing potentially hazardous tasks where loss on concentration may lead to accidents. If symptoms persist after five days, consult a doctor. Do not use continuously for more than 10 days without consulting a doctor.
Contains Tartrazine which may cause allergic-type reactions (including Bronchial Asthma) in certain individuals. The overall incidence of Tartrazine sensitivity is low, it is, however frequently seen in patients who also have aspirin sensitivity.

DOSAGE AND DIRECTIONS FOR USE:
Take at bedtime. Use the dose cup provided and wash after use.

Adults	12 years and over: 30 mL in the dose cup provided (6 medicine measuresful) at bedtime.
Children	10 to 12 years of age: 15 mL in the dose cup Provided (3 medicine measuresful) at bedtime.

Do not give this medicine to children under 10 years of age, unless directed by a doctor. Do not exceed the recommended dose.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
PARACETAMOL: Sensitivity reactions resulting in reversible skin rash or blood disorders may occur. Patients suffering from kidney or liver disease should take paracetamol under medical supervision.
DEXTROMETHORPHAN HYDROBROMIDE: May cause drowsiness, dizziness, excitation, mental confusion and gastro-intestinal disturbances. Should be administered with caution to patients with liver disease and to asthmatic patients. High doses cause respiratory depression.
DOXYLAMINE SUCCINATE: Doxylamine Succinate may cause 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. Doxylamine Succinate may also produce 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 stimulation may include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions.
Large doses may precipitate fits in epileptics. Allergy and dermatological reactions may occur. Blood disorders including agranulocytosis and haemolytic anemia, have been reported. Doxylamine Succinate may enhance the sedative effect of central nervous system depressants including alcohol barbiturates, hypnotic analgesics, sedatives and tranquillizers.
Effects of anticholinergic drugs such as atropine and tricyclic antidepressants, may be enhanced by the concomitant administration of Doxylamine Succinate. Doxylamine Succinate may effect the metabolism of drugs in the liver.
Doxylamine should be used with care in conditions such as glaucoma and prostatic hypertrophy.
EPHEDRINE SULPHATE: Ephedrine Sulphate may give rise to side-effects such as giddiness headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tremors, anxiety, restlessness and insomnia. Ephedrine Sulphate should be avoided in patients with most types of cardiovascular disease, hypertension, hyperthyroidism, hyperexcitability, phaechromocytoma and closed-angle glaucoma. In patients with prostatic enlargement, it may increase difficulty with micturition. It should be used with caution in patients receiving chloroform, cyclopropane, halothane or other halogenated anaesthetics.
The effects of Ephedrine are diminished by guanethidine, reserpine and probably methyldopa and may be diminished or enhanced by tricyclic antidepressants. Ephedrine may also diminish the effects of guanethidine and may increase the possibility of arrhythmias in digitalised patients.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See also "Side effects and Special Precautions".
PARACETAMOL: Symptoms of overdose include nausea and vomiting. Liver damage which may be fatal may only appear after a few days. Kidney failure has been described following acute intoxication. DEXTROMETHORPHAN HYDROBROMIDE: Respiratory depression.
DOXYLAMINE SUCCINATE: Symptoms of overdosage may include convulsions and excitation.
EPHEDRINE SULPHATE: Symptoms of overdosage may include paranoid psychosis, delusions and hallucinations.
In the event of overdosage, consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible. The latest information regarding the treatment of overdosage can be obtained from the nearest Poison Centre.

CONDITIONS OF REGISTRATION:
None.

IDENTIFICATION:
Vicks Medinite is an anise flavoured green liquid.

PRESENTATION:
Bottles containing 90 mL and 200 mL with special dose cup.

STORAGE DIRECTIONS:
Store below 25°C. Keep out of reach of children.

REGISTRATION NUMBER:
H/10.1/140.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Procter & Gamble SA (Pty) Ltd.,
Reg. No. 57/03295/07
25 Newton Street, Spartan, KEMPTON PARK 1619

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
30 September 1995

Manufactured by Procter & Gamble SA (Pty) Ltd.
VICKS MEDINITE is a registered trademark

DARK BLUE PMS 289C	R0
Rosside 29497	P13022