ACUGEST SYRUP

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

ACUGEST SYRUP

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ACUGEST SYRUP

COMPOSITION:
Each 5 mL contains:

Triprolidine hydrochloride	1,25 mg
Pseudoephedrine hydrochloride	30 mg

Preservatives:

Methyl hydroxybenzoate	0,12% m/v
Propyl hydroxybenzoate	0,02% m/v

PHARMACOLOGICAL CLASSIFICATION:
A5.8 Preparations for the common cold, including nasal decongestants and antihistaminics.

PHARMACOLOGICAL ACTION:
ACUGEST SYRUP has antihistaminic and decongestant properties.

INDICATIONS:
The symptomatic, relief of mucosal congestion of the upper respiratory tract associated with colds and influenza.

CONTRA-INDICATIONS:
Patients who have previously exhibited intolerance to it or to any of its constituents. ACUGEST SYRUP should not be administered to patients suffering from cardiovascular disease (especially coronary insufficiency), hypertension, prostatism, thyrotoxicosis, bladder dysfunction, narrow angle glaucoma, phaeochromocytoma and during an attack of asthma in asthmatic patients.
Patients being treated with monoamine oxidase inhibitors and within two weeks of stopping such treatment; ephedrine and other sympthomimetic agents as a hypertensive response may result.
Safety in pregnancy and lactation has not been established.

WARNING:
ACUGEST SYRUP may lead to drowsiness and impaired concentration, which may be aggrevated 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 to 12 years	5 mL
Children 2 to 6 years	2,5 mL

May be given 3 times a day.
Children 6 months to 2 years: 1,25 mL three times daily on the advice of a medical doctor only.

SIDE-EEFECTS AND SPECIAL PRECAUTIONS:
Sedation or insomnia may occur.
Fixed drug eruption due to pseudoephedrine, taking the form of erythematous nummular patches, and lichenoid skin eruption due to triprolidine have been reported.
Pseudoephedrine 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.
Pseudoephedrine may cause hypertension resulting in intracranial haemorrhage. In patients with prostatic enlargement it may increase difficulty with micturation. The following side-effects may also occur: agitation, anginal pain, especially in patients suffering from angina pectoris, loss of appetite, reflex bradycardia, cardiac arrhythmias, cardiac arrest, confusion, dizziness, dyspnoea, fainting, fear, flushing, disturbance of glucose metabolism, irritability, miosis, dry mouth, psychotic states, tachycardia, vasoconstriction which may result in hypertension, cerebral haemorrhage and pulmonary oedema, and weakness.
Triprolidine can 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, colic and epigastric pain, 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 cerebral stimulation in adults include insomnia, nervousness, tachycardia, tremors, muscle twitching, and convulsions. Large doses may precipitated fits in epileptics. Allergy, anaphylaxis, and dermatological reactions may occur. Blood dyscrasias, including agranylocytosis and haemolytic anaemia have been reported.
Deepening coma, extrapyramidal effects, leucopenia and photosensitisation of the skin may also occur.

INTERACTIONS:
Pseudoephedrine should be used with caution in patients receiving chloroform, cyclopropane, halothane, or other halogenated anaesthetics. The effects of pseudoephedrine are diminished by guanethidine, reserpine and probably methyldopa and may be diminished or enhanced by antidepressants. It may also diminish the effects of guanethidine and may increase the possibility of arrythmias in digitalised patients.
Triprolidine may enhance the sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives, and tranquillisers. The effects of anticholinergic drugs, such as atropine and tricyclic antidepressants may be enhanced by the concomitant administration of triprolidine. Triprolidine may effect the metabolism of drugs in the liver.
Concomitant use of ACUGEST SYRUP with sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants, or with monoamine oxidase inhibitors which interfere with the catabolism of sympathomimetic amines, may cause a rise in blood pressure largely because of interaction with pseudoephedrine.
Because of it pseudeophedrine content, ACUGEST SYRUP, may partially reverse the hypotensive action of drugs which interfere with sympathetic activity including bretylium, bethanidine, guanethidine, debrisoquine, methyldopa and beta adrenergic blocking agents.
Do not give together with quinidine.
Do not give together with tricyclic antidepressant agents.
MAO-inhibitors may enhance the anticholinergic effects. The warning signs of damage caused by ototoxic agents may be masked.

PRECAUTIONS:
ACUGEST SYRUP should be used with caution in patients with diabetes mellitus and in patients with occlusive vascular disorders (arteriosclerosis).
Use ACUGEST SYRUP carefully in elderly and debilitated patients. ACUGEST SYRUP should also be used with caution in cardiovascular disease, in patients with glaucoma, patients with liver impairment, patients with prostatic hypertrophy and in patients with urinary retention. Elderly patients are more susceptible to the central nervous system depressant and hypotensive effects. The positive results of skin test may also be suppressed.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The effects of acute overdosage from ACUGEST SYRUP may include drowsiness, weakness, inco-ordination, difficulty with micturition, respiratory depression, hypotension, agitation, irritability, convulsions, hypertension, palpitation and tachycardia.
Overdosage may be fatal, especially in infants and children in whom main symptoms are central nervous system stimulation and hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia. Respiratory collapse may occur.
Treatment is symptomatic and supportive.

IDENTIFICATION:
A clear yellow syrup with liquorice taste and odour.

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:
X/5.8/3.

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

May 1991

ACP 008
94H0994
Highland Print