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

Logo GOLDGESTANT ELIXIR
SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

GOLDGESTANT ELIXIR

COMPOSITION:
Each 5 mL contains chlorpheniramine maleate 2 mg, phenylpropanolamine hydrochloride 2,5 mg, phenylephrine hydrochloride 2,5 mg.
Preserved with sodium benzoate 0,2% (m/v). Contains no sugar or alcohol.

PHARMACOLOGICAL CLASSIFICATION:
A 5.8 Preparations for the common cold including nasal decongestants and antihistaminics.

PHARMACOLOGICAL ACTION:
The combination has antihistaminic and sympathomimetic properties.

INDICATIONS:
For the symptomatic relief of nasal congestion associated with colds and flu.

CONTRA-INDICATIONS:
Hypersensitivity to any of the active ingredients. Phenylephrine is contra-indicated in coronary disease, hypertension, cardiovascular disease, hyperthyroidism and during acute asthma attacks. It should not be given to patients being treated with mono-amine oxidase inhibitors or within 2 weeks of stopping such treatment. Phenylpropanolamine, in addition to the above, should not be given in diabetes mellitus.

GOLDGESTANT Elixir is contra-indicated in pregnancy, lactation and children under the age of two years.

WARNINGS:
The use of this medicine leads to drowsiness, which is aggravated by the simultaneous intake of alcohol, and other central nervous system depressant agents. Patients so affected should not drive or operate machinery.

DOSAGE AND DIRECTIONS FOR USE:
Children 6 - 12 years: one 5 mL medicine measureful 3 or 4 times daily.
Children 2 - 6 years: half a 5 mL medicine measureful 3 or 4 times daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Chlorpheniramine Maleate:
Side-Effects:
The most common effect is sedation, varying from slight drowsiness to deep sleep, and including lassitude, dizziness, and incoordination.
Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation, anorexia or increased appetite, and epigastric pain. Blood disorders, including agranulocytosis, leucopaenia, and haemolytic anaemia, though rare, have been reported.
Antihistamines may also produce antimuscarinic effects including blurred vision, difficulty in micturition, dysuria, dryness of the mouth, and tightness of the chest. Other central effects include hypotension, muscular weakness, tinnitus, euphoria, and headache. Paradoxical central nervous system stimulation may occur especially in children, with insomnia, nervousness, tachycardia, tremors, and convulsions. Antihistamines may precipitate epileptiform seizures in patients with focal lesions of the cerebral cortex.

Special Precautions:
Because of its antimuscarinic properties, chlorpheniramine should be used with care in conditions such as narrow angle glaucoma, urinary retention, bronchial asthma and prostatic hypertrophy. MAOIs may enhance the antimuscarinic effects of chlorpheniramine, and chlorpheniramine has an additive antimuscarinic action with other antimuscarinic agents, such as atropine and tricyclic antidepressants.
Chlorpheniramine may enhance the sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives, and tranquillisers. Patients should abstain from alcohol.
Chlorphehiramine may mask the warning signs of damage caused by ototoxic drugs such as aminoglycoside antibiotics. Chlorpheniramine may suppress positive skin test results and should be stopped several days before the test.

Phenylephrine and Phenylpropanolamine:
Side-Effects:
Phenylephrine and phenylpropanolamine may produce a wide range of adverse effects, most of which mimic the results of excessive stimulation of the sympathetic nervous system.
Central effects include fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, weakness, and psychotic states. Appetite may be reduced, and nausea and vomiting may occur.
Other effects that may occur include difficulty in micturition and urinary retention, dyspnoea, altered metabolism including disturbances of glucose metabolism, sweating, and hypersalivation. Headache is also common.

Special Precautions:
Phenylephrine and phenylpropanolamine should be used with caution in patients who may be hypersusceptible to their effects, particularly those with hyperthyroidism. Great care is also needed in patients with cardiovascular disease such as ischaemic heart disease; arrhythmia or tachycardia; occlusive vascular disorders, including arteriosclerosis; hypertension; or aneurysms. Anginal pain may be precipitated in patients with angina pectoris.
Care is also required when phenylephrine and phenylpropanolamine are given to patients with diabetes mellitus or closed-angle glaucoma.
Phenylephrine and phenylpropanolamine 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 may also occur if sympathomimetic agents are given to patients receiving cardiac glycosides, quinidine, or tricyclic antidepressants. Reversal of the action of many antihypertensive agents occurs in patients given phenylephrine and phenylpropanolamine and therefore special care is advisable in patients receiving antihypertensive therapy. Interactions with alpha- and beta- blocking agents may be complex.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms:
Chlorpheniramine Maleate:
Overdose may be fatal especially in infants and children in whom the main symptoms are central nervous system stimulation and antimuscarinic effects, including ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face, and hyperpyrexia. Deepening coma, cardiorespiratory collapse, and death may occur within 18 hours. In adults, the usual symptoms are of central nervous system depression with drowsiness, coma, and convulsions. Hypotension may also occur. Elderly patients are more susceptible to the central nervous system depressant and hypotensive effects even at therapeutic doses.

Phenylpropanolamine
Overdosage of phenylpropanolamine may cause giddiness, headache, nausea, vomiting, sweating, thirst, palpitations, difficulty in micturition, muscular weakness and tremors, anxiety, restlessness and insomnia.

Phenylephrine:
Overdosage with phenylephrine may cause headache, hypertension, palpitations and vomiting.

Treatment:
Treatment is symptomatic and supportive.

IDENTIFICATION:
A sweet light green cream-soda flavoured elixir.

PRESENTATION:
Amber glass bottles containing 100 mL. Sealed with a white tamper-evident closure.

STORAGE INSTRUCTIONS:
Store in a cool place (below 25 °C).
Protect from light.
Keep out of reach of children.

REGISTRATION NUMBER:
27/5.8/0272

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
G.D. Searle (South Africa) (Pty) Ltd.
14 Mandy Road
Reuven
Johannesburg.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
24 September 1993.

Rosside 28497        Code 4168 (ICR 9329)-1-11/93

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