SINUCLEAR COUGH SYRUP
(and dosage form):
SINUCLEAR COUGH SYRUP
Each 5 mL contains:
Triprolidine hydrochloride monohydrate 1,25 mg
Pseudoephedrine hydrochloride 30,00 mg
Dextromethorphan hydrobromide 10,00 mg
Methyl hydroxybenzoate 0,12% m/v
Propyl hydroxybenzoate 0,02% m/v
Contains alcohol 9,60% v/v
A 10.1 Antitussives and expectorants
SINUCLEAR COUGH SYRUP has cough suppressant, antihistaminic and decongestant properties.
SINUCLEAR COUGH SYRUP is indicated for alleviation of cough.
Hypersensitivity to any of the ingredients.
SINUCLEAR COUGH SYRUP should not be administered to patients suffering from cardiovascular disease (especially coronary insufficiency), hypertension, prostatism, thyrotoxicosis, bladder dysfunction, closed 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 sympathomimetic agents as a hypertensive response may result.
Safety in pregnancy and lactation has not been established.
SINUCLEAR COUGH SYRUP is contra-indicated in children under two years of age.
SINUCLEAR COUGH SYRUP may lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should not drive, climb dangerous heights or operate machinery, as impaired decision making could lead to accidents.
Pseudeophedrine 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: 10 mL three times daily.
The dosage must not be exceeded.
Not recommended for children under 12 years of age.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
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.
Central effects include fear, anxiety, relentlessness, 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, angina 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.
Dizziness and gastro-intestinal disturbances.
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 pyloro-duodenal obstruction, epilepsy, severe cardiovascular disorders.
Should not drive or operate machinery.
Should avoid alcoholic drinks.
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.
Should not be given to patients with or at risk of developing respiratory failure.
Patients receiving monoamine oxidase inhibitors may produce severe reactions; hyperpyrexia and fatalities have been reported.
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 tricylic 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 theraphy.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
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 are no symptoms of toxicity.
Other treatment should be symptomatic and supportive and may include artificial respiration, external cooling and IV fluids.
Excitation, confusion and respiratory depression may occur after overdosage.
Treatment is symptomatic and supportive.
A red, clear syrupy solution with a strawberry and menthol odour and taste and a bitter aftertaste.
Amber glass bottles containing 100 mL.
Store below 25 °C and protect from light.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
13 November 1995
Harrys Printers K 000000
New addition to this site: May 2014
Source: Pharmaceutical Industry -August 2011
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