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

Logo LINCTODYL SYRUP

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

LINCTODYL SYRUP

COMPOSITION:
Each 5 mL medicine measure contains:
  Dextromethorphan hydrobromide 15 mg
  Ephedrine hydrochloride 7,5 mg
  Ammonium chloride 125 mg
Preservative (hydroxybenzoate esters) 0,04% m/v
Alcohol (96 %) 6% v/v
PHARMACOLOGICAL CLASSIFICATION:
10.1 Anti-tussive and expectorants

PHARMACOLOGICAL ACTION:
Linctodyl Syrup is anti-tussive and expectorant.

INDICATIONS:
Linctodyl Syrup is recommended for the symptomatic treatment of coughs.

CONTRA-INDICATIONS:
Because of its ephedrine content Linctodyl is contra-indicated in the presence of coronary thrombosis, hypertension and thyrotoxicosis. It should be used with caution in patients with organic heart disease and those receiving digitalis.

Because of its ammonium chloride content Linctodyl is contraindicated in the presence of renal and hepatic disease. Linctodyl (because of its ephedrine content) must not be given simultaneously with M.A.O. inhibitors.

WARNINGS:
KEEP OUT OF THE REACH OF CHILDREN

Linctodyl Syrup may cause slight drowsiness in some susceptible patients. The effect is aggravated if alcohol is taken at the same time. Initial doses should be small in patients who are driving vehicles or who are in charge of machinery where loss of attention may lead to accidents.

DOSAGE AND DIRECTIONS FOR USE:
Adults: 10 mL (2 medicine measures)
Children: 5 mL (1 medicine measure)
Infants: 2,5 mL (½ medicine measure)
All three or four times a day

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Sympathomemetics (ephedrine) may produce a wide range of adverse effects most of which mimic the results of excessive stimulation of the sympathetic nervous system. Central effects of sympathomimetic agents include fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, weakness and psychotic states. Appetite may be reduced and nausea and vomiting may occur. Effects on the cardio-vascular system are complex: stimulation of alpha-adrenergic receptors produces vasoconstriction; the rise in blood pressure may produce cerebral haemorrhage and pulmonary oedema. There may also be a reflex bradycardia but stimulation of the B1 adrenergic receptors of the heart may produce tachycardia and cardiac arrhythmias, anginal pain, palpitations and cardiac arrest; hypotension with dizziness and flushing may occur. Other effects which may occur include difficulty in micturition and urine retention, dyspnoea, altered metabolism, including disturbances of glucose metabolism, sweating and hypersalivation. Headache is also common. Large doses of ammonium chloride may cause gastric irritation and headache but this also is unlikely to occur with the amounts contained in Linctodyl Syrup.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See under side-effects.

IDENTIFICATION:
A red, raspberry-flavoured syrup.

PRESENTATION:
Bottles of 100 mL and 200 mL.

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

REGISTRATION NUMBER:
H/10.1/192

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmaceutical Enterprises (Pty) Ltd
Howard Studios,
Howard Drive,
Pinelands 7405

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
October 1993

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