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

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

SINUTAB ORIGINAL
(tablets)

COMPOSITION:
Each tablet contains:

	Paracetamol	300 mg
	Phenylpropanolamine Hydrochloride	25 mg
	Phenyltoloxamine Citrate	22 mg

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

PHARMACOLOGICAL ACTION:
Sinutab Original has analgesic, anti-pyretic, decongestant and antihistaminic properties.

INDICATIONS:
Sinutab Original is indicated for the symptomatic relief of sinus pain, including maxillary, frontal or facial pain. Also for associated malaise, fever and congestion of the nasal, sinus and Eustachian tube mucosa; also for the symptomatic relief of allergic rhinitis (hayfever), vasomotor rhinitis, influenza and the common cold.

CONTRA-INDICATIONS:
Contra-indicated in patients hypersensitive to any of the ingredients. Contra-indicated in most types of cardiovascular disease, including angina and hypertension, and also in hyperthyroidism, hyperexcitability, phaeochromocytoma and closed angle glaucoma.
Not to be given concurrently with any MAO inhibitor for depression (e.g. tranylcypromine), or within 14 days of stopping such treatment.
Contra-indicated in children under 6 months of age.
Safety in pregnancy and lactation has not been established.

WARNINGS:
Do not use continuously for more than seven days; if symptoms persist, irrespective of therapy used, consult your doctor. Dosages in excess of those recommended may cause severe liver or kidney damage.
This medicine 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, operate dangerous machinery, or climb dangerous heights, as impaired decision making could lead to accidents.
Severe hypertensive episodes leading to intracranial haemorrhage have followed phenylpropanolamine ingestion. Patients should be informed of the dangers of exceeding the recommended dose; in particular the increased risk of serious adverse effects such as hypertensive crisis and haemorrhagic stroke. Patients with cardiovascular disease, hypertension or hyperthyroidism should not use Sinutab Original (see Contra-indications). In addition, Sinutab Original may aggravate conditions such as diabetes, glaucoma or prostatic enlargement. Patients presently taking mono-amine oxidase inhibitors for depression (e.g. tranylcypromine), or other medicines for depression, psychiatric or emotional conditions, should not use Sinutab Original (see Contra-indications).

DOSAGE AND DIRECTIONS FOR USE:

Adults and Children over 12 years:	One tablet every four hours. Do not exceed 4 tablets per day.
Children 6 to 12 years:	Half the adult dose.
Children under 6 years:	Not recommended.

Do not exceed the recommended dose.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Paracetamol:
Sensitivity reactions resulting in skin rash, laryngeal oedema, angioedema and anaphylaxis have been reported rarely. Blood disorders such as neutropenia and thrombocytopenia have also been reported rarely.
Phenylpropanolamine Hydrochloride:
Phenylpropanolamine hydrochloride may cause giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tremors, anxiety, restlessness, insomnia, fear, confusion, irritability, weakness and psychotic states. Hypertension and ventricular arrhythmias may occur. Appetite may be reduced.
Vasoconstriction with resultant hypertension. This rise in blood pressure may produce cerebral haemorrhage and pulmonary oedema. There may also be a reflex bradycardia, but stimulation of beta-1 adrenergic receptors of the heart may produce tachycardia and cardiac arrhythmias, anginal pain, palpitations and cardiac arrest. Hypotension with dizziness and fainting and flushing may occur.
Urinary retention, dyspnoea, altered metabolism, including disturbances of glucose metabolism, sweating and hypersalivation.
Phenyltoloxamine Citrate:
The most common side-effects are sedation, varying from slight drowsiness to deep sleep, and includes the 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, 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 may occur.
Allergy may occur. Blood dyscrasias, including agranulocytosis and haemolytic anaemia may occur.
Large doses may precipitate fits in epileptics.

Special Precautions:
Paracetamol:
Patients with impaired kidney or liver function should take paracetamol under medical supervision only.
Phenylpropanolamine Hydrochloride:
Should be used with caution in patients with hyperthyroidism, cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia; occlusive vascular disorders, including arteriosclerosis, hypertension or aneurysms; diabetes mellitus and closed angle glaucoma.
Anginal pain may be precipitated in patients with angina pectoris.
Should be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics as they may induce ventricular fibrillation.
Severe hypertensive episodes have followed phenylpropanolamine ingestion.
Prolonged use may lead to rebound congestion.
Haemorrhagic stroke may occur, particularly at high doses and in high risk patients (see Warnings and Contra-indications).
Phenyltoloxamine Citrate:
Phenyltoloxamine citrate has anticholinergic properties and should be used with care in conditions such as glaucoma and prostatic hypertrophy.
In infants and children it may act as a cerebral stimulant. Symptoms of stimulation in adults include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions.
Avoid concurrent use of preparations containing the same or similar ingredients.
Safety during pregnancy and lactation has not been shown.
Drug Interactions:
Concurrent use of CNS depressants including alcohol, hypnotics and sedatives, narcotic analgesics, phenothiazines and general anaesthetics, such as chloroform, cyclopropane, halothane and other halogenated anaesthetics, may enhance the CNS depressant effect of Sinutab Original.
The anticholinergic effects of atropine and tricyclic antidepressants may be enhanced by Sinutab Original.
The concurrent use of CNS stimulant drugs may potentiate the stimulatory effect of Sinutab Original.
Sinutab Original used concurrently with cardiac glycosides, tricyclic antidepressants, cyclopropane, halothane or other halogenated anaesthetics may induce arrhythmias.
Reversal of the action of antihypertensive agents may occur and therefore special care is advisable in patients receiving antihypertensive therapy.
Interactions with alpha-and beta-blocking drugs may be complex.
Concurrent use of Sinutab Original with beta-blocking agents, may result in significant hypertension and bradycardia and possible heartblock.
Sinutab Original used concurrently with Rauwolfia-containing preparations may produce unpredictable cardiovascular repercussions.
Sinutab Original may mask the warning symptoms of damage caused by ototoxic medicines and may enhance the likelihood of hepatotoxicity if used concurrently with other potentially hepatotoxic medicines.
Concurrent use with guanethidine, reserpine and methyldopa may diminish the effects of Sinutab Original.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Paracetamol: Nausea, vomiting and anorexia. Liver damage which may be fatal, may only appear after a few days. Acute intoxication may cause kidney failure.
Phenylpropanolamine hydrochloride: Rapid pulse and respiration, disorientation, elevated blood pressure, tachycardia, mydriasis, headache, excitation of the central nervous system, nausea, vomiting and anorexia.
Phenyltoloxamine citrate: Convulsions and hyperpyrexia in children due to cerebral stimulation. In adults symptoms of stimulation include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions.
Treatment: Symptomatic and supportive. Further gastrointestinal absorption can be limited by gastric lavage, and the subsequent administration of repeated doses of activated charcoal.
Consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible. The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre.

IDENTIFICATION:
A mottled, pink, round, biconvex, odourless tablet bearing a score on one side.

PRESENTATION:
Blister packs containing 20 and 50 tablets.

STORAGE INSTRUCTIONS:
Store in a cool (below 25°C) dry place. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
F/5.8/275

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pfizer Consumer Healthcare, division of
Warner-Lambert S.A. (Pty) Ltd.
241 Main Road
RETREAT
7945

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
8 May 2001.

Zimbabwe Details: 75/22.2.5/527        P

Updated on this site: May 2003
Source: Pharmaceutical Industry
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