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

Logo SINUCLEAR PAEDIATRIC SYRUP/STROOP

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

SINUCLEAR PAEDIATRIC SYRUP/STROOP
(solution)

COMPOSITION:
Each 5 mL contains:

Triprolidine hydrochloride         0,625 mg
Pseudoephedrine hydrochloride         15,000 mg
Paracetamol         125,000 mg
Preserved with: 
Methyl hydroxybenzoate 0,12 % m/v
Propyl hydroxybenzoate 0,02 % m/v

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

PHARMACOLOGICAL ACTION:
SINUCLEAR PAEDIATRIC SYRUP/STROOP has decongestive, antipyretic, antihistamine and analgesic properties.

INDICATIONS:
For the relief of symptoms such as nasal decongestion, sniffing and headache associated with the common cold and influenza.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.
SINUCLEAR PAEDIATRIC SYRUP/STROOP should not be administered to patients suffering from cardiovacular disease (especially coronary insufficiency), hypertension, thyrotoxicosis, prostatism, bladder dysfunction, closed angle glaucoma, phaeochromocytoma and during an attack of asthma in asthmatic patients.
SINUCLEAR PAEDIATRIC SYRUP/STROOP is contra-indicated in patients being treated with monoamine oxidase inhibitors and within two weeks of stopping such treatment as a hypertensive response may result.
Premature infants or neonates.
Safety in pregnancy and lactation has not been established.

WARNINGS:
SINUCLEAR PAEDIATRIC SYRUP/STROOP contains paracetamol. Dosages of SINUCLEAR PAEDIATRIC SYRUP/STROOP in excess of those recommended, may cause severe liver damage.
Patients suffering from liver and kidney disease should take paracetamol under medical supervision.
SINUCLEAR PAEDIATRIC SYRUP/STROOP 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 be warned not to drive a motor vehicle, climb dangerous heights or operate dangerous machinery, as impaired mental alertness 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.
Consult your doctor if no relief is obtained with the recommended dosage.
Do not use continuously for longer than 10 days without consulting your doctor.

DOSAGE AND DIRECTIONS FOR USE:
Children 6-12 years: 5 mL - 10 mL
Children 2-6 years: 5 mL
May be given three times daily.
Children 6 months to 24 months: 2,5 mL three times daily on advice of a physician only.
Not recommended for children under 6 months 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 arrythmias; 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.
Paracetamol
Haematological reactions include thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis. Pancreatitis, skin rashes and other allergic reactions occur occasionally.

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.
Paracetamol
Give with care to patients with impaired kidney and liver function, and patients taking other drugs that affect the liver.

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.

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.
Paracetamol:
Symptoms of paractemol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 24 to 48 hours after ingestion.
Abnormalities of glucose metabolism and metabolic acidosis may occur.
Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported. Symptoms during the first 2 days of acute poisoning do not reflect the potential seriousness of the overdosage. Nausea, vomiting, anorexia and abdominal pain may persist for a week or more. Liver injury may become manifest on the second day (or later), initially by elevation of serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of prothrombin time. The liver damage may progress to encephalopathy, coma and death. Cerebral oedema and nonspecific myocardial depression have also occurred.
In the event of overdosage consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible. Any patient who has ingested about 7,5 g of paracetamol in the preceding 4 hours should undergo gastric lavage. Specialised therapy with an antidote such as acetylcysteine or methionine may be necessary. If decided upon, acetylcysteine should be administered IV as soon as possible.
Acetylcysteine:
Acetylcysteine should be administered as soon as possible, preferably within 8 hours of overdosage.
IV: An initial dose of 150 mg/kg in 200 mL glucose injection, given intravenously over 15 minutes, followed by an intravenous infusion of 50 mg/kg in 500 mL of glucose injection over the next 4 hours and then 100 mg/kg in 1000 mL over the next 16 hours. The volume of intravenous fluids should be modified for children.
Orally: 140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution every 4 hours for 17 doses. Acetylcysteine is effective if administered within 8 hours of overdosage.

IDENTIFICATION:
A pink, viscous syrup with a raspberry odour and flavour.

PRESENTATION:
Amber glass bottles containing 100 mL.

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

REGISTRATION NUMBER:
30/5.8/0053

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
GAREC (Pty) Ltd
Healthcare Park
Woodlands Drive
Woodmead
Sandton

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
13 November 1995

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

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