Sinutab Sinus Pain Extra Strength 2 mg, 10 mg, 500 mg Tablets.

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, including the symptomatic relief of hay fever, influenza and the common cold.

Adults and children over 12 years: One to two tablets every four to six hours. Do not exceed eight tablets in 24 hours. Children aged less than 12 years: Not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine (see sections 4.3 and 4.4). DO NOT EXCEED THE RECOMMENDED DOSE.

• Hypersensitivity to chlorphenamine maleate, codeine phosphate, paracetamol, pseudoephedrine, or to any of the ingredients (see section 4.8).
• Contraindicated in persons receiving monoamine oxidase inhibitor treatment or within 14 days of ceasing such treatment.
• Chronic respiratory insufficiency.
• Kidney disease.
• Severe liver function impairment.
• Contraindicated in most forms of cardiovascular disease, including angina and hypertension, hyperthyroidism, hyperexcitability, phaeochromocytoma and closed angle glaucoma.
• Pseudoephedrine should be avoided in patients undergoing anaesthesia with halothane or other halogenated anaesthetic medicines.

Stop use and consult a doctor if pain or fever persists or gets worse at the recommended dosage, if new symptoms occur or if redness and swelling are present, as these could be signs of a more serious condition. Do not use SINUTAB u00ae SINUS PAIN EXTRA STRENGTH continuously without consulting a doctor: - for pain: for more than 5 days in adults and children over 12 years of age. - for fever: for more than 3 days. Dosages in excess of those recommended may provoke severe liver, kidney and cardiovascular repercussions. SINUTAB u00ae SINUS PAIN EXTRA STRENGTH may lead to drowsiness and impaired concentration which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant medicines. Do not use SINUTAB u00ae SINUS PAIN EXTRA STRENGTH with alcohol. Ask a doctor or pharmacist before use with benzodiazepines, sedatives, tranquilizers or other central nervous system depressants. SINUTAB u00ae SINUS PAIN EXTRA STRENGTH contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdosage and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or poison centre must be contacted immediately. Do not use SINUTAB u00ae SINUS PAIN EXTRA STRENGTH 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 or other cardiovascular conditions, particularly those with coronary heart disease (see section 4.5). Do not take concurrently with any other paracetamol - or sympathomimetic - containing medicines. Serious skin reactions such as acute generalised exanthematous pustulosis (AGEP), Stevens Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported very rarely in patients receiving paracetamol. Patients should be informed about the signs of serious skin reactions and use of SINUTAB u00ae SINUS PAIN EXTRA STRENGTH should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. Patients suffering from hepatitis or alcoholism, or recovering from any form of liver disease, should not take excessive quantities (more than 8 tablets in 24 hours) of SINUTAB u00ae SINUS PAIN EXTRA STRENGTH. Codeine is not recommended in patients with severe hepatic impairment because codeine is not converted to morphine leading to poor analgesia. Use with caution in renal disease. Patients with known renal disease should consult their healthcare provider for guidance relating to their dosage. Exceeding the prescribed dose, together with prolonged and continuous use of SINUTAB u00ae SINUS PAIN EXTRA STRENGTH, may lead to dependency and addiction. Codeine is not recommended in adolescents 12 to under 18 years of age for pain. Even at recommended dosages, ultra - rapid metabolisers of codeine may have life - threatening or fatal respiratory depression or experience signs of overdose (such as extreme sleepiness, confusion, or shallow breathing). Use of SINUTAB u00ae SINUS PAIN EXTRA STRENGTH should be discontinued, and quick medical attention should be sought at the earliest sign of codeine toxicity including symptoms such as extreme sleepiness, confusion, or shallow breathing which may be life threatening. Codeine should be used with caution in patients with convulsive disorders, head injuries, and in conditions in which intracranial pressure is raised. Hyperalgesia may occur with the use of opioids, particularly at high doses. An unexplained increase in pain, or increased levels of pain can occur with increasing opioid dosages. SINUTAB u00ae SINUS PAIN EXTRA STRENGTH may cause urinary retention in patients with prostatic hyperplasia. Tolerance with dependence may occur after continued use. The effects of pseudoephedrine hydrochloride are lessened by medicines containing guanethidine, reserpine, methyldopa and may be diminished or enhanced by tricyclic anti - depressants. SINUTAB u00ae SINUS PAIN EXTRA STRENGTH may increase blood pressure and therefore special care is advisable in patients receiving antihypertensive therapy. SINUTAB u00ae SINUS PAIN EXTRA STRENGTH should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop. Severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) have been reported with pseudoephedrine - containing medicines, such as SINUTAB u00ae SINUS PAIN EXTRA STRENGTH. This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non - follicular pustules arising on a widespread oedematous erythema and mainly localised on the skin folds, body, and upper extremities. Patients should be carefully monitored. If signs and symptoms such as formation of small pustules occur, with or without pyrexia or erythema, then treatment with pseudoephedrine should be discontinued and a doctor should be consulted. SINUTAB u00ae SINUS PAIN EXTRA STRENGTH should be given with caution to patients with persistent respiratory conditions such as emphysema, chronic bronchitis, bronchial asthma, or where cough is accompanied by excessive secretions, chronic pulmonary disease, hypothyroidism, diabetes, adrenocortical insufficiency, impaired kidney or liver function, obesity, obstructive sleep apnoea, prostatic hyperplasia and shock. It should be used with caution with patients with inflammatory or obstructive bowel disorders, or myasthenia gravis. 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 medicines containing the same or similar ingredients. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver or kidney damage.

Alcohol and medicines that induce liver enzymes can increase the toxicity of SINUTAB u00ae SINUS PAIN EXTRA STRENGTH. Concurrent use of SINUTAB u00ae SINUS PAIN EXTRA STRENGTH and hepatotoxic medicines may increase the risk of hepatotoxicity. Concurrent use with enzyme - inducing medicines may also increase the risk of hepatotoxicity. The absorption of SINUTAB u00ae SINUS PAIN EXTRA STRENGTH may be accelerated when used with metoclopramide. Absorption of SINUTAB u00ae SINUS PAIN EXTRA STRENGTH is reduced if given within one hour of cholestyramine. Prolonged use of SINUTAB u00ae SINUS PAIN EXTRA STRENGTH with salicylates increases the risk of adverse renal effects. SINUTAB u00ae SINUS PAIN EXTRA STRENGTH may enhance the sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and antipsychotics, and other medicines with anticholinergic properties such as tricyclic antidepressants. SINUTAB u00ae SINUS PAIN EXTRA STRENGTH may reverse the action of certain cardiovascular medications and therefore special care is advisable in patients receiving such therapy. Concomitant use with other sympathomimetic medicines, such as decongestants, tricyclic antidepressants and appetite suppressants or with monoamine oxidase inhibitors, which interfere with the catabolism of sympathomimetic amines, may cause a rise in blood pressure. An increased risk of arrhythmias may also occur if given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants. There is an increased risk of vasoconstrictor or pressor effect in patients receiving ergot alkaloids, oxytocin or other vasoconstrictors. Interactions are possible with guanethidine, reserpine, tricyclic antidepressants, digoxin and alpha methyldopa. Should be used with caution in patients undergoing anaesthesia with halothane or other halogenated anaesthetics as they may induce ventricular fibrillation. Aluminium hydroxide - containing medicines may increase the absorption rate of SINUTAB u00ae SINUS PAIN EXTRA STRENGTH. The depressant effects of SINUTAB u00ae SINUS PAIN EXTRA STRENGTH is enhanced by medicines which depress the action of the central nervous system, such as alcohol, anaesthetics, hypnotics and sedatives, phenothiazines and tricyclic antidepressants. Patients should be instructed to ask a doctor or pharmacist before use if they are taking warfarin or other coumarin derivatives.

Safety in pregnancy and lactation has not been established.

Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery, or performing hazardous tasks where loss of concentration could lead to accidents.

Paracetamol: Blood and lymphatic system disorders: Less frequent: Agranulocytosis, thrombocytopenia, leucopenia, pancytopenia, neutropenia, anaemia. Gastrointestinal disorders: Less frequent: Pancreatitis. Hepato - biliary disorders: Less frequent: Hepatitis. Skin and subcutaneous tissue disorders: Less frequent: Dermatitis, skin rashes and other allergic reactions. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by fever and mucosal lesions. Renal and urinary disorders: Less frequent: Renal colic, renal failure and sterile pyuria. Chlorphenamine maleate: Blood and lymphatic system disorders Less frequent: agranulocytosis, leucopenia, haemolytic anaemia and thrombocytopenia. Immune system disorders Less frequent: hypersensitivity reactions such as pruritus or rash. Psychiatric disorders Less frequent: nervousness, euphoria, irritability, nightmares, hallucinations. Nervous system disorders Frequent: sedation, varying from slight drowsiness to deep sleep, including lassitude, dizziness and incoordination. Less frequent: insomnia, tremors, convulsions, headache, blurred vision, paraesthesias extrapyramidal effects. Ear and labyrinth disorders Less frequent: tinnitus. Vascular disorders Less frequent: hypertension, hypotension. Respiratory, thoracic and mediastinal disorders Less frequent: thickened respiratory - tract secretions and tightness of the chest. Gastrointestinal disorders Less frequent: nausea, vomiting, dry mouth, constipation, gastric reflux, diarrhoea, epigastric pain. Musculoskeletal and connective tissue disorders Less frequent: myalgia. Renal and urinary disorders Less frequent: urinary difficulty and retention. General disorders and administration site conditions Less frequent: Sweating, hair loss. Pseudoephedrine hydrochloride: Metabolism and nutrition disorders Less frequent: decreased appetite, hypokalaemia, altered metabolism. Psychiatric disorders Frequent: fear, anxiety, insomnia, confusion, irritability, psychotic states. Nervous system disorders Frequent: restlessness, tremor, dizziness. Less frequent: cerebral haemorrhage, headache. Cardiac disorders Less frequent: pulmonary oedema, cardiac arrhythmias, anginal pain, palpitations, and cardiac arrest. Vascular disorders Less frequent: hypertension, reflex bradycardia, tachycardia, hypotension, fainting. Respiratory, thoracic and mediastinal disorders Less frequent: dyspnoea. Gastrointestinal disorders Less frequent: nausea, vomiting, hypersalivation. Renal and urinary disorders Less frequent: difficulty in micturition, urinary retention. General disorders and administration site conditions Frequent: weakness, sweating, tolerance with dependence. Investigations Less frequent: changes in blood sugar levels. Codeine phosphate: The following side - effects have been reported but frequencies are unknown. Psychiatric disorders Restlessness, changes of mood, hallucinations. Nervous system disorders Drowsiness and confusion. Dry mouth, dizziness, sweating, facial flushing, headache, vertigo. Raised intracranial pressure. Eye disorders Miosis. Cardiac disorders Bradycardia, tachycardia, palpitations. Vascular disorders Orthostatic hypotension. Gastrointestinal disorders The most common side effects are nausea, vomiting, constipation. Skin and subcutaneous tissue disorders Due to the histamine - releasing effect, reactions such as urticaria, pruritus and itching of the nose may occur. Renal and urinary disorders Micturition may be difficult and there may be ureteric or biliary spasm. Reproductive system and breast disorders Decreased libido or impotence. General disorders and administration site conditions Hypothermia. Post - marketing experience: The following adverse drug reactions were identified during post - marketing experience with chlorpheniramine, codeine, paracetamol, pseudoephedrine by frequency category estimated from clinical trials or epidemiology studies: Immune system disorders: Frequency unknown: Anaphylactic reaction, hypersensitivity. Psychiatric disorders: Frequency unknown: Anxiety, euphoric mood, hallucination, visual hallucination, restlessness. Nervous system disorders: Frequency unknown: Cerebrovascular accident, headache, paraesthesia, psychomotor hyperactivity, tremor. Cardiac disorders: Frequency unknown: Dysrhythmia, myocardial infarction, palpitations, tachycardia. Respiratory, thoracic and mediastinal Disorders Frequency unknown: Respiratory depression. Gastrointestinal disorders: Frequency unknown: Abdominal pain, ischaemic colitis, diarrhoea, vomiting. Skin and subcutaneous tissue disorders: Frequency unknown: Acute generalised exanthematous pustulosis, angioedema, dermatitis, fixed eruption, pruritus, rash, pruritic rash, urticaria. Renal and urinary disorders: Frequency unknown: Dysuria, urinary retention. Investigations: Frequency unknown: Increased blood pressure, increased transaminases. Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of SINUTAB u00ae SINUS PAIN EXTRA STRENGTH is important. It allows continued monitoring of the benefit/risk balance of SINUTAB u00ae SINUS PAIN EXTRA STRENGTH. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8 For further information, please contact the Johnson and Johnson call centre on 0860 410032 (landline).

Paracetamol: Nausea, vomiting and anorexia. Liver damage, which may be fatal, may only appear after a few days. Acute intoxication may cause kidney failure. Prompt treatment is essential. In the event of an overdosage, consult a doctor immediately, or take the person to a hospital directly. A delay in starting treatment may mean that antidote is given too late to be effective. Evidence of liver damage is often delayed until after the time for effective treatment has lapsed. Susceptibility to paracetamol toxicity is increased in patients who have taken repeated high doses (greater than 5 u2013 10 g/day) of paracetamol for several days, in chronic alcoholism, chronic liver disease, AIDS, malnutrition, and with the use of medicines that induce liver microsomal oxidation such as barbiturates, isoniazid, rifampicin, phenytoin and carbamazepine. Symptoms of paracetamol overdosage in the first 24 hours include pallor, nausea, vomiting, anorexia and possibly abdominal pain. Mild symptoms during the first two days of acute poisoning, do not reflect the potential seriousness of the overdosage. Liver damage may become apparent 12 to 48 hours, or later, after ingestion, initially by elevation of the serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of the prothrombin time. Liver damage may lead to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Abnormalities of glucose metabolism and metabolic acidosis may occur. Cardiac arrhythmias have been reported. Treatment for paracetamol overdosage: Although evidence is limited it is recommended that any adult person who has ingested 5 u2013 10 grams or more of paracetamol (or a child who has had more than 140 mg/kg) within the preceding four hours, should have the stomach emptied by lavage (emesis may be adequate for children) and a single dose of 50 g activated charcoal given via the lavage tube. Ingestion of amounts of paracetamol smaller than this may require treatment in patients susceptible to paracetamol poisoning (see above). In patients who are stuporous or comatose endotracheal intubation should precede gastric lavage in order to avoid aspiration. N - acetylcysteine should be administered to all cases of suspected overdose as soon as possible, preferably within eight hours of overdosage, although treatment up to 36 hours after ingestion may still be of benefit, especially if more than 150 mg/kg of paracetamol was taken. An initial dose of 150 mg/kg N - acetylcysteine in 200 ml dextrose injection given intravenously over 15 minutes, followed by an infusion of 50 mg/kg in 500 ml dextrose injection over the next four hours, and then 100 mg/kg in 1 000 ml dextrose injection over the next sixteen hours. The volume of intravenous fluid should be modified for children. Although the oral formulation is not the treatment of choice, 140 mg/kg dissolved in water may be administered initially, followed by 70 mg/kg every four hours for seventeen doses. A plasma paracetamol level should be determined four hours after ingestion in all cases of suspected overdosage. Levels done before four hours may be misleading. Patients at risk of liver damage, and hence requiring continued treatment with N - acetylcysteine, can be identified according to their 4 - hour plasma paracetamol level. The plasma paracetamol level can be plotted against time after ingestion in the nomogram below. The nomogram should be used only in relation to a single acute ingestion. Those whose plasma paracetamol levels are above the u2018normal treatment lineu2019, should continue N - acetylcysteine treatment with 100 mg/kg IV over sixteen hours repeatedly until recovery. Patients with increased susceptibility to liver damage as identified above should continue treatment if concentrations are above the u2018high risk treatment lineu2019. Prothrombin index correlates best with survival. Monitor all patients with significant ingestions for at least ninety - six hours. Chlorphenamine maleate: Plasma Paracetamol Concentration Overdosage with chlorphenamine may be fatal, especially in infants and children, in whom the main symptoms are central nervous system stimulation and antimuscarinic effects, including ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia. Deepening coma, cardiorespiratory collapse, and death may occur within 18 hours. In adults the usual symptoms are central nervous system depression with drowsiness, coma and convulsions. Hypotension may also occur. Pseudoephedrine hydrochloride: Convulsions and hyperpyrexia in children due to cerebral stimulation. In adults, symptoms of stimulation include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions. Severe cardiovascular repercussions include hypertension, angina, arrhythmias, myocardial infarction and cerebral haemorrhage. Treatment of overdose: To decrease absorption: Because pseudoephedrine is rapidly absorbed from the gut, emetics should be instituted within 4 hours of overdosage in order to be effective. Charcoal is useful only if administered within 1 hour. To enhance elimination: Forced diuresis will increase elimination of pseudoephedrine provided renal function is adequate; however, diuresis is not recommended for severe overdosage. Specific treatment: For delirium or convulsions, intravenous diazepam may be administered. The cardiac state should be monitored and serum electrolytes measured. If there are signs of cardiac toxicity, intravenous propranolol may be indicated. Hypokalaemia may be treated, if necessary, with a slow infusion of a dilute potassium chloride solution; serum potassium concentration should be monitored during and for several hours after administration of potassium chloride. 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. Future gastrointestinal absorption can be limited by 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.