LENAZINE® FORTE COUGH LINCTUS

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

LENAZINE® FORTE COUGH LINCTUS

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

LENAZINE^® FORTE COUGH LINCTUS

COMPOSITION:
Each 5 mL contains:

	Codeine Phosphate	9,0 mg
	Ephedrine Hydrochloride	7,2 mg
	Promethazine Hydrochloride	3,6 mg
	In a flavoured syrup base

Preservative:

Methyl hydroxybenzoate

0,1 % m/v

PHARMACOLOGICAL CLASSIFICATION:
A 10.1 Antitussives and expectorants

INDICATIONS:
For the alleviation of cough.

CONTRA-INDICATIONS:
Contra-indicated in respiratory depression, acute alcoholism, head injuries and conditions in which intracranial pressure is raised.
Lenazine Forte Cough Linctus should not be given to patients receiving mono-amine oxidase inhibitors or within 14 days of its termination.
It should also not be given to premature infants or neonates.
It is contra-indicated during acute attacks of asthma and in heart failure secondary to chronic lung disease
Safety in pregnancy has not been established

WARNING:
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol, or any other central nervous system depressant agents.
Patients should be warned not to drive a motor vehicle, operate dangerous machinery or climb dangerous heights, as impaired decision making could lead to accidents.

DOSAGE AND DIRECTIONS FOR USE:
Adults -

One to two (5 mL) medicine measures 2 to 3 times a day.

Children -

	12 years:	One to one and a half (5 mL) medicine measures 2 to 3 times a day.
	7 years:	Half to one (5 mL) medicine measure 2 to 3 times a day.
	1 year:	Quarter to half a (5 mL) medicine measure 2 to 3 times a day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Codeine Phosphate:
The most common side-effects are nausea, vomiting, constipation, drowsiness and confusion.
Difficulty in micturition, ureteric or biliary spasm, anti-diuretic effect, dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood and miosis may also occur.
Raised intracranial pressure, euphoria, urticaria and pruritis occur in some patients.

Ephedrine Hydrochloride:
Side-effects may include fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, weakness, psychotic states, decrease in appetite, nausea and vomiting.
Vasoconstriction with resultant hypertension, reflex bradycardia, tachycardia, cardiac arrhythmias, anginal pain, palpitations, cardiac arrest, hypotension with dizziness and fainting, and flushing have also been reported.
Other effects that may occur with sympathomimetic agents include difficulty in micturition and urinary retention, dyspnoea, altered metabolism including disturbances of glucose metabolism, sweating and hypersalivation. Headache is also common.

Promethazine Hydrochloride:
The most common effect is sedation, including lassitude, dizziness and inco-ordination. Other side effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation, anorexia or increased appetite and epigastric pain.
Blurred vision, difficulty in micturition, dysuria, dryness of the mouth, tightness of the chest, hypotension, muscular weakness, tinnitus, euphoria, photosensitivity, jaundice, thrombo-cytopenic purpura, angioedema and occasionally headache may also occur.
Paradoxical CNS stimulation may occur, especially in children.
Agranulocytosis, leucopenia and haemolytic anemia have been reported, though rare.

SPECIAL PRECAUTIONS:
Codeine Phosphate should be given with caution or in reduced doses to patients with hypothyroidism, adrenocortical insufficiency, impaired kidney or liver function, prostatic hypertrophy or shock. Patients with obstructive bowel disorders and myasthenia gravis also need to be cautious when taking codeine phosphate.
Ephedrine Hydrochloride should be used with care in patients with hyperthyroidism, cardiovascular disease, occlusive vascular disorders, aneurysms, diabetes mellitus or closed-angle glaucoma.
Anginal pain may be precipitated in patients with angina pectoris. Ephedrine Hydrochloride should be avoided or used with caution in patients undergoing anaesthesia with halogenated anaesthetics and may cause an increased risk of arrhythmias in patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.
Promethazine Hydrochloride should be used with care in patients with cardiovascular hepatic diseases, narrow angle glaucoma, urinary retention and prostatic hypertrophy. Promethazine may potentiate the hypotensive effect of some anti-hypertensives.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Excitation, convulsions, respiratory depression, hypotension, circulatory failure and deepening coma may occur. Overdose may be fatal, especially in children.
In the event of overdosage the stomach should be emptied by aspiration and lavage. Activated charcoal and laxatives may also be used.
Intensive supportive therapy may be required to treat respiratory failure and shock. Naloxone hydrochloride is used as an antagonist to codeine phosphate in dosages of 0,4 mg to 2 mg intravenously which may be repeated at intervals of 2 to 3 minutes if necessary, up to 10 mg.

IDENTIFICATION:
Bright, orange - brown syrupy liquid with the taste of orange.

PRESENTATION:
Bottles of 100 mL, 500 mL, 1L, 2,5L, 5L and 20L.

STORAGE DIRECTIONS:
Protect from light, and keep containers well closed.
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN

APPLICATION NUMBER:
G533 (Act 101/1965).

APPLICANT:
Lennon Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

5.7.74

K135A