Sinutab Sinus Pain Non-Drowsy 30 mg. 500 mg Tablet.

For the relief of symptoms of nasal, sinus and Eustachian tube mucosal congestion and associated pain and fever due to colds and influenza.

Adults and children over 12 years: Two tablets every four to six hours. Do not exceed eight tablets in 24 hours. Not be used in children below the age of 12 years. The Elderly: There have been no specific studies of SINUTAB u00ae SINUS PAIN NON - DROWSY in the elderly. Experience has indicated that normal adult dosage is appropriate. In the elderly the rate and extent of paracetamol absorption is normal but plasma half life is longer and paracetamol clearance is lower than in young adults. Hepatic dysfunction: Caution should be exercised when administering SINUTAB u00ae SINUS PAIN NON - DROWSY to patients with severe hepatic impairment. Renal dysfunction: Caution should be exercised when administering SINUTAB u00ae SINUS PAIN NON - DROWSY to patients with moderate to severe renal impairment. Method of administration: For oral use. DO NOT EXCEED THE RECOMMENDED DOSE.

• Hypersensitivity to paracetamol, pseudoephedrine, or to any of the ingredients (see section 4.8).
• SINUTAB u00ae SINUS PAIN NON - DROWSY is contraindicated in persons receiving monoamine oxidase inhibitor (MAOI) treatment or within 14 days of ceasing such treatment.
• Contraindicated in most forms of cardiovascular disease, including angina and hypertension, and also in hyperthyroidism, phaeochromocytoma and closed angle glaucoma.
• Severe liver disease.
• Should be avoided in patients undergoing inhalation anaesthesia.

SINUTAB u00ae SINUS PAIN NON - DROWSY contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or poison centre must be contacted immediately. Do not use continuously for more than ten days; if symptoms persist, irrespective of therapy used, consult your doctor. Dosages in excess of those recommended may provoke severe liver, kidney, and cardiovascular repercussions. 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 or other cardiovascular conditions (see section 4.3). Do not take concurrently with any other paracetamol - or sympathomimetic - containing medicines. Chronic alcohol users should ask their physician whether they should take paracetamol or other pain relievers or fever reducers. Patients with impaired kidney or liver function should take paracetamol under medical supervision only. 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 NON - DROWSY should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. SINUTAB u00ae SINUS PAIN NON - DROWSY should not be used by patients with cardiovascular disease, hyperthyroidism, liver disease, renal disease, difficulty in urination and/or enlargement of the prostate, glaucoma or diabetes (see section 4.3). There have been reports of ischaemic colitis with pseudoephedrine. SINUTAB u00ae SINUS PAIN NON - DROWSY should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop (see section 4.8). Severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) have been reported with pseudoephedrine - containing medicines, such as SINUTAB u00ae SINUS PAIN NON - DROWSY. 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. If symptoms persist or get worse, or if new symptoms occur, patients should stop use and consult a doctor.

Combinations containing any of the following medicines, depending on the amount present, may also interact with SINUTAB u00ae SINUS PAIN NON - DROWSY. Cardiac arrythmias may occur when pseudoephedrine is used prior to anaesthesia with inhalation anaesthetics such as chloroform, cyclopropane, enflurane, halothane, isoflurane, methoxyflurane, and trichloroethylene or concurrently with digitalis glycosides. Concurrent use of tricyclic antidepressants with SINUTAB u00ae SINUS PAIN NON - DROWSY may potentiate the cardiovascular effects of sympathomimetic amines. When diuretics or antihypertensives are used concurrently with sympathomimetic amines the antihypertensive effects may be reduced. Concurrent use of beta - adrenergic blocking agents with sympathomimetic amines may result in significant hypertension and excessive bradycardia with possible heart block. CNS stimulants used concurrently with pseudoephedrine may result in additive CNS stimulation to excessive levels, which may cause unwanted effects, such as nervousness, irritability, insomnia, or possibly convulsions or cardiac arrythmias. Doxapram used concurrently with SINUTAB u00ae SINUS PAIN NON - DROWSY may increase the pressor effects of either doxapram or sympathomimetic amines. Monoamine oxidase (MAO) inhibitors used concurrently with sympathomimetic amines may prolong and intensify the cardiac stimulant and vasopressor effects of pseudoephedrine. These medicines should not be administered during or within 14 days following the administration of a MAO inhibitor (see section 4.3). Concurrent use with rauwolfia alkaloids may inhibit the indirect - acting sympathomimetic action of pseudoephedrine. The risk of hepatotoxicity with single toxic doses or prolonged use of high doses of paracetamol may be increased in alcoholics or in patients regularly taking other hepatoxic medicines or hepatic enzyme inducers. Prolonged concurrent use of paracetamol with other NSAIDs may also increase the risk of adverse renal effects. Paracetamol may competitively inhibit the hepatic glucuronidation and decrease the clearance of zidovudine; zidovudine may also inhibit the hepatic glucuronidation of paracetamol. Aluminium hydroxide containing preparations may increase the absorption rate of pseudoephedrine hydrochloride. Warfarin - like compounds: For most patients, occasional use of paracetamol generally has little or no effect on the International Normalised Ratio (INR) in patients on chronic warfarin therapy; however, there has been controversy regarding the possibility of paracetamol potentiating the anticoagulant effects of warfarin and other coumarin derivatives. Patients should consult a doctor or pharmacist before use if they are taking warfarin or other coumarin derivatives.

There are no adequate and well - controlled clinical studies in pregnant or breast - feeding women for the combination of paracetamol and pseudoephedrine. This product should not be used during pregnancy or lactation. Pregnancy: The safety of pseudoephedrine in pregnancy has not been established. Breastfeeding: Pseudoephedrine is excreted in breast milk in small amounts. Paracetamol is excreted in breast milk but not in a clinically significant amount. Fertility: No studies have been conducted in animals to determine whether pseudoephedrine has the potential to impair fertility. There is no information of the effect of SINUTAB u00ae SINUS PAIN NON - DROWSY on fertility.

It is not known if SINUTAB u00ae SINUS PAIN NON - DROWSY has an effect on the ability to drive or operate machinery. As dizziness can occur patients are advised not to drive or operate machinery until they know how SINUTAB u00ae SINUS PAIN NON - DROWSY affects them.

Paracetamol: Blood and lymphatic system disorders: Less frequent: neutropenia, pancytopenia, leucopenia, thrombocytopenia. Immune system disorders: Less frequent: sensitivity/allergic reactions resulting in skin rash, laryngeal oedema, angioedema and anaphylaxis. Skin and subcutaneous tissue disorders: Less frequent: erythematous rash, urticarial rash. Gastrointestinal disorders: Less frequent: mucosal lesions, pancreatitis. General disorders and administration site conditions: Less frequent: fever. 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 dysrhythmias, anginal pain, palpitations, and cardiac arrest. Vascular disorders: Less frequent: hypertension, reflex bradycardia, tachycardia, hypotension, flushing, 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. Pseudoephedrine/Paracetamol combination: Psychiatric disorders: Frequent: nervousness. Post - marketing experience: The following adverse drug reactions were identified during post - marketing experience with 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. Gastrointestinal disorders: Frequency unknown: Abdominal pain, colitis ischaemic, diarrhoea, vomiting. Skin and subcutaneous tissue disorders: Frequency unknown: Acute generalised exanthematous pustulosis, angioedema, fixed eruption, pruritus, rash, pruritic rash, urticaria. Renal and urinary disorders: Frequency unknown: Dysuria, urinary retention. Investigations: Frequency unknown: Increased blood pressure, increased transaminases.

See sections 4.4 and 4.8. 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 - 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 lactate 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 stuperose 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 1000 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, unless high, may be misleading. Patients at risk of liver damage, and hence requiring continued treatment with N - acetylcysteine, can be identified according to their plasma paracetamol level. The plasma paracetamol level can be plotted against time since ingestion in the nomogram below. Those whose plasma paracetamol levels are above the u201cnormal treatment lineu201d, 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. 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 and gastric lavage 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.