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

Logo SINUTAB ND
SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

SINUTAB ND
tablets

COMPOSITION:
Each tablet contains:
  Paracetamol                        325 mg
  Phenylpropanolamine hydrochloride         18 mg

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

PHARMACOLOGICAL ACTION:
Sinutab ND has antipyretic, analgesic and sympathomimetic properties.

INDICATIONS:
For the symptomatic relief of congestion of the nasal, sinus and Eustachian tube mucosa and associated pain and fever due to colds and influenza.

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.
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 ND (see Contra-indications). In addition, Sinutab ND 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 ND (see Contra-indications).

DOSAGE AND DIRECTIONS FOR USE:
Adults and Children over 12 years: One tablet every four to six hours. Do not exceed five tablets perday.
Children 6 - 12 years: Half the adult dose.
Children under six 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. The 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.
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 hyperthroidism, 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 pains 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.
Use with caution in persons with diabetes.
Avoid concurrent use of preparations containing the same or similar ingredients.
Safety during pregnancy and lactation has not been shown.
Haemorrhagic stroke may occur, particularly at high doses and in high risk patients (see Warnings and Contra-indications).
Drug Interactions:
The concurrent use of CNS stimulant drugs may potentiate the stimulatory effect of Sinutab ND.
Sinutab ND 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 ND with beta-blocking agents may result in significant hypertension and bradycardia and possible heartblock.
Sinutab ND used concurrently with Rauwolfia containing preparations may produce unpredictable cardiovascular repercussions.
Concurrent use with guanethidine, reserpine and methyldopa may diminish the effects of Sinutab ND.

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.
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.
Treatment: Symptomatic and supportive. Further gastrointestinal absorption can be limited by gastric lavage, and the subsequent administration of repeated doses of activated charcoal.

IDENTIFICATION:
White, round, biconvex tablet, scored on one side.

PRESENTATION:
Packs of 20's.

STORAGE INSTRUCTIONS:
Protect from light and store in a cool (below 25°C) dry place. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
V/5.8/138

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:
95/22.2.5/3005         P

Updated on this site: May 2003
Source: Pharmaceutical Industry

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