INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
FLUDACTIL CO LINCTUS

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

FLUDACTIL CO LINCTUS

COMPOSITION:
Each 5 mL contains: )

Triprolidine hydrochloride monohydrate	1,25 mg
Pseudoephedrine hydrochloride	30,00 mg
Codeine phosphate hemihydrate	10,00 mg
Preserved with:
Methyl hydroxybenzoate	0,12% m/v
Propyl hydroxybenzoate	0,02% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 10.1 Antitussives and Expectorants

PHARMACOLOGICAL ACTION:
FLUDACTIL CO LINCTUS has antihistaminic, decongestant and cough suppressant properties.

INDICATIONS:
For the alleviation of cough.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.
Patients suffering from cardiovascular disease (especially coronary insufficiency), hypertension, prostatism, thyrotoxicosis, bladder dysfunction, closed angle glaucoma and phaeochromocytoma.
Patients being treated with monoamine oxidase inhibitors and within two weeks of stopping such treatment; ephedrine and other sympathomimetic agents as a hypertensive response may result.
Acute alcoholism, during an acute attack of bronchial asthma, in patients with head injuries or where the intracranial pressure is raised, in heart failure secondary to chronic lung disease and in cases of respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion.
Safety in pregnancy and lactation has not been established.

WARNINGS:
FLUDACTIL CO LINCTUS may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents. Patients should not drive, climb dangerous heights or operate machinery as impaired decision-making could lead to accidents.
Pseudoephedrine should be given with caution to patients with organic heart disease, cardiac decompensation or angina of effort and in patients receiving digitalis.
Do not use this product without consulting a doctor or pharmacist if you are presently taking monoamine oxidase inhibitors or other medicines for depression, psychiatric or emotional conditions or hypertension.

DOSAGE AND DIRECTIONS FOR USE:

Adults and children over 12 years:	5 to 10 mL
Children 6 - 12 years:	5 mL
Children 2 - 6 years:	2,5 mL

May be given three times daily.
Children 1 to 2 years: 1,25 mL three times daily on advice of a physician only.
Not recommended for children under 1 year of age.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
SIDE-EFFECTS
Triprolidine
The side-effects of triprolidine include sedation varying from drowsiness to deep sleep, and including lassitude, dizziness and inco-ordination.
Paradoxical stimulation may occur particularly in children, with insomnia, nervousness, euphoria, irritability, tremors, and rarely, nightmares, hallucinations and convulsions.
Other effects include: dry mouth, thickened respiratory-tract secretions and tightness of the chest, blurred vision, urinary difficulty and retention, a reduction in tone and motility of the gastro-intestinal tract resulting in constipation and increased gastric reflux, in high doses, transient bradycardia followed by tachycardia with palpitations and arrhythmias; hypotension, tinnitus, headaches and paraesthesias.
Other gastro-intestinal disturbances include nausea, vomiting, diarrhoea and epigastric pain.
Blood disorders include agranulocytosis, leucopenia, haemolytic anaemia and thrombocytopenia.
Pseudoephedrine
Central effects include fear, anxiety, restlessness, tremor, insomnia, confusion, irritability and psychotic states. Appetite may be reduced, and nausea and vomiting may occur.
Cardiovascular effects include hypertension which may produce cerebral haemorrhage and pulmonary oedema and reflex bradycardia. Tachycardia, cardiac arrhythmias, anginal pain, palpitations, cardiac arrest, and hypotension with dizziness and fainting, and flushing may also occur.
Other side-effects include: difficulty in micturition and urinary retention, dyspnoea, weakness, altered metabolism including disturbances of glucose metabolism, sweating and hypersalivation, and headache.
Codeine Phosphate
The commonest side-effects are nausea, vomiting, constipation, drowsiness and confusion; tolerance generally develops with long-term use but not to constipation. Micturition may be difficult and there may be ureteric or biliary spasm; there is also an antidiuretic effect. Dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood, hallucinations and miosis also occur. Raised intracranial pressure occurs in some patients. Muscle rigidity has been reported following high doses. The euphoric activity of codeine has led to its abuse.
Larger doses cause respiratory depression and hypotension, with circulatory failure and deepening coma. Convulsions may occur especially in infants and children.
A dose-related histamine-releasing effect may be responsible in part for reactions such as urticaria and pruritis as well as hypotension and flushing.

SPECIAL PRECAUTIONS:
Triprolidine
Should not be given to premature infants or neonates.
Should be used with care in the elderly who are more susceptible to many of the side-effects, patients with closed angle glaucoma, urinary retention, prostatic hypertrophy or pyloroduodenal obstruction, epilepsy, severe cardiovascular disorders.
Should not drive or operate machinery.
Should avoid alcoholic drinks.
Pseudoephedrine
Special care should be taken in patients with hyperthyroidism, cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia, occlusive vascular disorders, including arteriosclerosis, hypertension and aneurysms. Anginal pain may be precipitated in patients with angina pectoris.
Diabetes mellitus and closed-angle glaucoma.
Codeine Phosphate
Should be given with caution or in reduced doses to patients with hypothyroidism, adrenocortical insufficiency, impaired kidney or liver function, prostatic hypertrophy, shock, inflammatory or obstructive bowel disorders, or myasthenia gravis.
Should be given with great care to infants especially neonates. Babies born to dependant mothers may suffer withdrawal symptoms.
Dosage should be reduced in elderly and debilitated patients.

INTERACTIONS:
Pseudoephedrine
Pseudoephedrine should be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics, as they may induce ventricular fibrillation.
An increased risk of arrhythmias also occurs if given with cardiac glycosides, quinidine or tricyclic antidepressants.
Interaction with monoamine oxidase inhibitors and should not be given to patients receiving such treatment or within 14 days of its termination.
Pseudoephedrine increases blood pressure and therefore special care is advised in patients receiving antihypertensive therapy.
Codeine
The depressant effects of codeine may be enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, tricyclic antidepressants and phenothiazines. The gastro-intestinal effects may delay absorption as with mexiletine or may be counteractive as with metoclopramide. Quinidine can inhibit the analgesic effect of codeine.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF IT'S TREATMENT:
Triprolidine
Overdosage may be fatal especially in infants and children. In infants and children, CNS excitement predominates with ataxia, excitement, tremors, psychoses, hallucinations and convulsions; hyperpyrexia may also occur. Deepening coma and respiratory collapse may follow.
In adults, CNS depression is more common with drowsiness, coma and convulsions, progressing to respiratory failure and possibly cardiovascular collapse.
The stomach should be emptied. Emetics may be tried if the patient is alert and there is no symptoms of toxicity.
Other treatment should be symptomatic and supportive and may include artificial respiration, external cooling and IV fluids.
Codeine:
Larger doses cause respiratory depression and hypotension, with circulatory failure and deepening coma. Convulsions may occur especially in infants and children. Rhabdomyolysis progressing to renal failure has been reported in overdosage. Death may occur from respiratory collapse. The triad of coma, pinpoint pupils and repiratory depression is considered indicative of overdosage; dilatation of the pupils occur as hypoxia develops. Pulmonary oedema after overdosage is a common cause of fatalities.
The stomach should be emptied. A laxative may be given to aid peristalsis.
Intensive supportive therapy may be required to correct the respiratory failure and shock. In addition the specific antagonist naloxone hydrochloride is used to counteract the severe respiratory depression and coma caused by the excessive doses of codeine. A dose of 0,4 to 2,0 mg is given IV repeated at intervals of 2 to 3 minutes if necessary, up to 10 mg. The effect of naloxone may be of shorter duration than the opioid analgesic and additional doses may be required to prevent relapses.

IDENTIFICATION:
A red clear syrupy solution with a strawberry odour and taste. Sweet taste with a bitter aftertaste.

PRESENTATION:
Amber glass bottles containing 50 mL, 100 mL, 200 mL and 500 mL.

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

REGISTRATION NUMBER:
30/10.1/0049

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
GAREC (Pty) Limited
43 Richards Drive
Halfway House
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
13 November 1995

New addition to this site: May 2005
Source: Pharmaceutical Industry
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