PHARMACOLOGICAL CLASSIFICATION: A: 5.8 Preparations for the common cold including nasal decongestants and antihistaminics.
PHARMACOLOGICAL ACTION: Sinutab with Codeine has analgesic, antipyretic, decongestant and antihistaminic properties.
INDICATIONS: Sinutab with Codeine is indicated for the symptomatic relief of severe 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 hayfever, 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 followedphenylpropanolamine 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 with Codeine (see Contra-indications). In addition, Sinutab with Codeine 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 with Codeine (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.
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. 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. Codeine Phosphate: The most common side-effects are nausea, vomiting, constipation, drowsiness and confusion. Dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood, miosis and raised intracranial pressure also occur. Micturition may be difficult and there may be ureteric or biliary spasm.
Due to the histamine-releasing effect allergic reactions such as urticaria, pruritus and itching of the nose occur in some individuals. 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 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.
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. Codeine Phosphate: Codeine should be given with caution to patients with bronchial asthma, chronic pulmonary disease, hypothyroidism, adrenocortical insufficiency, impaired liver function, prostatic hypertrophy or shock. It should be used with caution in patients with inflammatory or obstructive bowel disorders. The dosage should be reduced in elderly and debilitated patients.
The prolonged use of high doses of codeine has produced dependence of the morphine type.
Avoid concurrent use of preparations containing the same or similar ingredients. 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 with Codeine.
The anticholinergic effects of atropine and tricyclic antidepressants may be enhanced by Sinutab with Codeine.
The concurrent use of CNS stimulant drugs may potentiate the stimulatory effect of Sinutab with Codeine.
Sinutab with Codeine 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 with Codeine with beta-blocking agents, may result in significant hypertension and bradycardia and possible heartblock.
Sinutab with Codeine used concurrently with Rauwolfia containing preparations may produce unpredictable cardiovascular repercussions.
Sinutab with Codeine 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 guanethedine, reserpine and methyldopa may diminish the effects of Sinutab with Codeine.
Safety during pregnancy and lactation has not been shown.
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. Codeine phosphate: Produces central stimulation with excitation and, in children, convulsions, followed by vomiting, drowsiness, respiratory depression and cyanosis, and coma. Treatment: Symptomatic and supportive. Further gastro-intestinal absorption can be limited by gastric lavage, and the subsequent administration of repeated doses of activated charcoal.
Naloxone hydrochloride is used to counteract the respiratory depression and coma produced by excessive doses of codeine. A dose of 0,4 to 2 mg is given intravenously, repeated at intervals of 2 to 3 minutes. In children, a dose of 0,01 to 0,1 mg per kg body weight may be given similarly.
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 double layer, biconvex tablet with mottled pink bottom layer and white upper layer, debossed with a CL monogram.
PRESENTATION: Packs containing 20, 50 and 100 tablets.
STORAGE INSTRUCTIONS: Keep tightly sealed in a cool (below 25°C), dry place. KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: F/5.8/279
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:
75/22.2.5/526 PID
Updated on this site: aaMay 2003 Source: Pharmaceutical Industry
SINUTAB WITH CODEINE