Sinutab Sinus Allergy Congestion &Amp, Pain 30 mg/2 mg/500 mg

For the symptomatic relief of sinus pain, including maxillary, frontal or facial pain and the relief of associated malaise, fever and congestion of the nasal, sinus and Eustachian tube mucosa. For the symptomatic relief of allergic rhinitis (hay fever), vasomotor rhinitis, influenza and the common cold.

Posology: Adults and children over 12 years: Two tablets every six to eight hours. Do not exceed eight tablets in 24 hours. Not to be used in children below the age of 12 years. DO NOT EXCEED THE RECOMMENDED DOSE.

• Hypersensitivity to chlorphenamine maleate, paracetamol, pseudoephedrine, or to any of the ingredients (see section 4.8).
• Contraindicated in children under 12 years of age.
• Paracetamol should not be used in patients with severe liver and renal disease.
• Pseudoephedrine should be avoided in patients undergoing inhalation anaesthesia.
• SINUTAB Sinus Allergy Congestion & Pain should not be given concurrently with any monoamine oxidase inhibitor (MAOI) for depression or within 14 days of stopping such treatment. The concomitant use of these medicines may cause a rise in blood pressure and/or hypertensive crisis.
• Contraindicated in most types of cardiovascular disease, including angina and hypertension, and in hyperthyroidism, phaeochromocytoma, closed angle glaucoma and diabetes mellitus.

SINUTAB Sinus Allergy Congestion & Pain 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 with any other medicines containing paracetamol. Do not use continuously for more than seven days. If symptoms persist or get worse, or if new symptoms occur, irrespective of therapy used, patients should stop use and consult your doctor. Dosages in excess of those recommended may cause severe liver, or kidney damage. Consult your doctor if no relief is obtained with the recommended dosage. Patients with a persistent respiratory condition such as emphysema, chronic bronchitis, bronchial asthma, or where cough is accompanied by excessive secretions should be advised to consult a doctor before using SINUTAB Sinus Allergy Congestion & Pain. While taking SINUTAB Sinus Allergy Congestion & Pain, avoid alcoholic beverages and consult a doctor prior to taking with central nervous system depressants (see section 4.5).

Paracetamol 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 Sinus Allergy Congestion & Pain should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Chlorphenamine maleate: Chlorphenamine should be given with care to patients with glaucoma, urinary retention, prostatic hypertrophy or pyloroduodenal obstruction. Caution is advised in patients with epilepsy and severe cardiovascular disorders. Elderly patients are more susceptible to the central nervous system depressant and lowering of blood pressure effects even at dose quantities effective for treatment. The warning signs of damage caused by ototoxic medicines may be masked by chlorphenamine. Chlorphenamine may cause drowsiness. Chlorphenamine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, analgesics, sedatives and tranquillisers. Care should be taken when taking medicines containing tricyclic anti-depressants or atropine together.

Pseudoephedrine hydrochloride: SINUTAB Sinus Allergy Congestion & Pain should not be used by patients with cardiovascular disease in particular those with coronary heart disease and hypertension, hyperthyroidism, liver disease, renal disease, difficulty in urination and/or enlargement of the prostate, glaucoma or diabetes. (See section 4.3) SINUTAB Sinus Allergy Congestion & Pain 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 Sinus Allergy Congestion & Pain. 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 possibly convulsions or cardiac dysrhythmias. 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.

Combinations containing any of the following medicines, depending on the amount, may also interact with SINUTAB Sinus Allergy Congestion & Pain. Chlorphenamine may enhance the effects of central nervous system depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and antipsychotics, and other medicines with anti-cholinergic properties such as tricyclic anti-depressants. Cardiac dysrhythmias 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. Anticholinergic effects may be potentiated when SINUTAB Sinus Allergy Congestion & Pain is used concurrently with anticholinergics or other medicines with anticholinergic activity. Concurrent use with SINUTAB Sinus Allergy Congestion & Pain may also potentiate the cardiovascular effects of sympathomimetic amines. Pseudoephedrine may reverse the action of cardiovascular medicines and therefore special care is advisable in patients receiving such therapy. Antihypertensive effects may be reduced when these medicines are used concurrently with sympathomimetic amines. 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 safety in pregnancy and lactation has not been established. Doxapram used concurrently with SINUTAB Sinus Allergy Congestion & Pain may increase the pressor effects of either doxapram or sympathomimetic amines. Monoamine oxidase inhibitors used concurrently with antihistamines may prolong and intensify the anticholinergic and CNS depressant effects of SINUTAB Sinus Allergy Congestion & Pain. Concurrent use of MAOIs 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. 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 hepatotoxic 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.

Safety in pregnancy and lactation has not been established.

SINUTAB Sinus Allergy Congestion & Pain may cause drowsiness and impaired concentration which may be aggravated by the 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.

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.

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.

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, 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.

Chlorphenamine/Pseudoephedrine/Paracetamol combination: Nervous system disorders: Frequent: Dizziness, somnolence. Gastrointestinal disorders: Frequent: Dry mouth. General disorders and administration site conditions: Frequent: Asthenia.

Post-marketing experience: The following adverse drug reactions were identified during post-marketing experience with chlorpheniramine, 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 section 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 lactic dehydrogenase activity, increased serum bilirubin concentration.

The plasma paracetamol level can be plotted against time since ingestion in the nomogram below. 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: Chlorphenamine overdosage may be fatal especially in infants and children. The main symptoms being central nervous system stimulation and anti-muscarinic 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. The usual symptoms in adults 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 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. 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.