Flusin S Effervescent 50 mg/ 4 mg/ 500 mg/ 330 mg Tablet

FLUSIN S EFFERVESCENT is indicated for:

• Symptomatic relief of minor aches and pains, and sinus and nasal congestion associated with colds and flu.

Posology

DO NOT EXCEED THE RECOMMENDED DOSE.

Adults and children over 12 years of age: One tablet every 6 hours if necessary. Consult a doctor if no relief is obtained from the recommended dosage. Do not use this product for more than 7 days without consulting a doctor.

Paediatric population

The safety and efficacy of FLUSIN S EFFERVESCENT in children under 12 years has not been established (see section 4.3).

Method of administration

For oral administration. Place one tablet in a glass of warm water and allow to dissolve. Drink the contents immediately once the whole tablet has dissolved.

FLUSIN S EFFERVESCENT is contraindicated in:

• Patients with hypersensitivity to chlorphenamine maleate, paracetamol, pseudoephedrine hydrochloride, vitamin C or to any of the excipients in FLUSIN S EFFERVESCENT (see section 2 and 6.1).
• Coronary disease and cardiovascular disease including angina, ischaemic heart disease, peripheral vascular disease, dysrhythmia or tachycardia.
• Children under the age of 12 years old.
• Patients sensitive to one antihistamine may be sensitive to others.
• Patients receiving monoamine oxidase inhibitor treatment (MAOI), or within 14 days of stopping such treatment should not take FLUSIN S EFFERVESCENT (see section 4.4).
• Severe liver function impairment.
• Paracetamol should not be used in patients with severe renal disease.
• FLUSIN S EFFERVESCENT should be avoided in patients undergoing anaesthesia with halothane or other halogenated anaesthetics as they may induce ventricular fibrillation.
• Safety in pregnancy and lactation has not been established (see section 4.6).
• Patients suffering from hypertension, hyperthyroidism, phaeochromocytoma, closed angle glaucoma or where intraocular pressure is raised and diabetes mellitus.
• Patients with hyperoxaluria.
• Patients taking beta-blockers (see section 4.5).

FLUSIN S EFFERVESCENT 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.

May lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressants e.g. sedatives and tranquilizers. Caution should be used when driving a motor vehicle or operating machinery or performing potentially dangerous tasks, where loss of concentration may lead to accidents.

Chlorphenamine maleate FLUSIN S EFFERVESCENT may lead to drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants. May enhance the sedative effects of CNS depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, tranquilisers and antipsychotics.

The anticholinergic properties of chlorphenamine maleate as contained in FLUSIN S EFFERVESCENT may cause drowsiness, dizziness, blurred vision and psychomotor impairment. Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents.

FLUSIN S EFFERVESCENT should be used with caution in patients with prostatic hypertrophy, emphysema or chronic bronchitis, porphyria, patients with bronchial asthma or where cough is accompanied by excessive secretions should be advised to consult a doctor before taking this medicine.

Paradoxical hyperexcitability, nervousness and insomnia may occur in children and in the elderly. Elderly patients are especially susceptible to dizziness, sedation, confusion, hypotension and anticholinergic effects such as dry mouth and urinary retention. The warning signs of damage caused by ototoxic medicines may be masked by chlorphenamine.

FLUSIN S EFFERVESCENT should be used with care in patients with pyloroduodenal obstruction and epilepsy.

Chlorphenamine may suppress positive skin test results and should be stopped several days before the test.

FLUSIN S EFFERVESCENT should not be taken concurrently with medicines that cause sedation such as anxiolytics and hypnotics as these may increase the sedative effects.

Other antihistamine containing medicines, including antihistamine containing cough and cold medicines should not be taken concurrently with FLUSIN S EFFERVESCENT.

Pseudoephedrine hydrochloride After 5 to 7 days tachyphylaxis may occur and the product loses effect. If symptoms do not improve, or are accompanied by a fever, consult a doctor.

Exceeding the recommended dosage may result in nervousness, dizziness, sleeplessness, tremulousness or cardiac dysrhythmia. This may also occur in sensitive individuals at small doses (see section 4.2).

Should be used with caution in patients with difficulty in urination, prostatic hypertrophy and aneurysms. Anginal pains may be precipitated in patients with angina pectoris (see section 4.3).

Acute Generalised exanthematous pustulosis (AGEP) Severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) have been reported with pseudoephedrine-containing medicines, such as FLUSIN S EFFERVESCENT. 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.

Ischaemic colitis FLUSIN S EFFERVESCENT should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.

Ischaemic optic neuropathy Cases of ischaemic optic neuropathy have been reported with pseudoephedrine hydrochloride as contained in FLUSIN S EFFERVESCENT. FLUSIN S EFFERVESCENT should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs.

Posterior reversible encephalopathy syndrome (PRES) and Reversible cerebral vasoconstriction syndrome (RCVS) FLUSIN S EFFERVESCENT should not be used in patients with severe or uncontrolled high blood pressure, or with severe acute or chronic kidney disease/failure. Patients should be advised to stop using these medicines immediately and seek treatment if they develop symptoms of PRES or RCVS which may include visual disturbance, seizure, headaches, and altered mentation.

Paracetamol FLUSIN S EFFERVESCENT should be stopped if fever persists or pain worsens. Dosages in excess of those recommended may cause severe liver or kidney damage. Patients with impaired kidney or liver function should take paracetamol under medical supervision only. Patients suffering from hepatitis or alcoholism, or recovering from any form of liver disease, should not take paracetamol (see section 4.3).

Severe Cutaneous Adverse Reactions (SCARS) Severe Cutaneous Adverse Reactions (SCARS) such as toxic epidermal necrolysis (TEN), Steven-Johnson syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), eosinophilia and systemic (DRESS)/Drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE) have been reported in patients treated with paracetamol containing medicines. If a patient develops SCAR, treatment with FLUSIN S EFFERVESCENT must immediately be discontinued and appropriate treatment instituted. Patients should be informed about the signs of serious skin reactions and the use of FLUSIN S EFFERVESCENT should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. Consult your doctor if pain or fever persists or gets worse, if new symptoms occur or if redness and swelling is present, as these could be signs of a serious condition. Do not use FLUSIN S EFFERVESCENT with any other medicines containing paracetamol.

High Anion gap metabolic acidosis (HAGMA) Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as those using maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.

Ascorbic acid Tolerance may be induced in patients taking high doses of ascorbic acid, as contained in FLUSIN S EFFERVESCENT. Increased intake of ascorbic acid over a prolonged period may result in increased renal clearance of ascorbic acid, and deficiency may result if the intake is reduced or withdrawn rapidly (see section 4.8).

Interference with serological testing Ascorbic acid may interfere with tests and assays for urinary glucose, giving false-negative results with methods utilising glucose oxidase with indicator (e.g. Labstix, Testape) and false-positive results with neocuproin methods. Estimation of uric acid by phosphotungstate or uricase with copper reduction and measurement of creatinine in non-deproteinised serum may also be affected. High doses of ascorbic acid may give false-negative readings in faecal occult blood tests.

Excipients FLUSIN S EFFERVESCENT contains aspartame. Aspartame should be avoided, or its intake restricted in patients with phenylketonuria.

Patients sensitive to another antihistamine may be sensitive to FLUSIN S EFFERVESCENT (see section 4.3).

FLUSIN S EFFERVESCENT may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressants e.g. sedatives and tranquilizers (see section 4.4).

Combinations containing any of the following medicines, depending on the amount, may also interact with FLUSIN S EFFERVESCENT.

Chlorphenamine Phenytoin: Chlorphenamine may increase the risk of phenytoin toxicity. Belladonna: There may be an excessive anticholinergic effect caused by the combination of belladonna and chlorphenamine. Sedatives: All sedatives (barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, antipsychotics), including alcohol will potentiate depressant effects on the central nervous system if taken with antihistamines. Medications tending to cause extrapyramidal reactions and those with anticholinergic effects may be potentiated. These include tricyclic antidepressants, maprotiline and monoamine oxidase inhibitors.

Pseudoephedrine MAOIs: Pseudoephedrine may cause a hypertensive crisis and prolong and intensify the cardiac stimulant and vasopressor effects in patients receiving a monoamine oxidase inhibitor (MAOI) (see section 4.3). FLUSIN S EFFERVESCENT should not be administered during or within 14 days following the administration of a MAOI.

Anaesthetics: FLUSIN S EFFERVESCENT should be avoided in patients undergoing anaesthesia with halothane or other halogenated anaesthetics as they may induce ventricular fibrillation (see section 4.3).

Cardiovascular medicines: Pseudoephedrine as contained in FLUSIN S EFFERVESCENT may reverse the action of cardiovascular medicines and therefore special care is advisable in patients receiving such therapy. Antihypertensives: Reversal of the action of antihypertensive medicines may occur. Interactions with alpha- and beta-blockers may be complex and can produce hypertensive crisis. An increased risk of dysrhythmias may occur given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants. Interactions are possible with tricyclic antidepressants, guanethidine, reserpine, alpha-methyldopa and digoxin. Aluminium hydroxide mixtures: May enhance the absorption rate of pseudoephedrine. CNS stimulants: May result in additive CNS stimulation to excessive levels, which may cause unwanted effects, such as nervousness, irritability, insomnia, or possibly convulsions or cardiac dysrhythmias. Doxapram: Used concurrently with FLUSIN S EFFERVESCENT may increase the pressor effects of either doxapram or sympathomimetic amines.

Ergot alkaloids (ergotamine & methysergide): May lead to an increased risk of ergotism. Appetite suppressants and amphetamine-like psychostimulants: May lead to an increased risk of hypertension. Oxytocin: May lead to an increased risk of hypertension.

Paracetamol Isoniazid: The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic medicines such as isoniazid or medicines that induce liver microsomal enzymes. Metoclopramide: The absorption of paracetamol may be accelerated by medicines such as metoclopramide. Probenecid: Excretion may be affected and plasma concentrations altered when given with probenecid. Colestyramine: Reduces the absorption of paracetamol if given within 1 hour of paracetamol. NSAIDs: Prolonged concurrent use of paracetamol with other NSAIDs may also increase the risk of adverse renal effects. Zidovudine: Paracetamol may competitively inhibit the hepatic glucuronidation and decrease the clearance of zidovudine; zidovudine may also inhibit the hepatic glucuronidation of paracetamol.

Warfarin: Paracetamol can potentiate 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.

Flucloxacillin: Caution should be taken when FLUSIN S EFFERVESCENT is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis, especially in patients with risk factors (see section 4.4).

Anticonvulsants and oral contraceptive steroids: May increase the rate at which paracetamol is metabolised, leading to a reduced plasma concentrations.

Ascorbic acid May interact with fluphenazine and warfarin. Amphetamine: Ascorbic acid increases the renal excretion of amphetamine. Smoking and Oral contraceptives: The plasma concentration of ascorbate is decreased by smoking and oral contraceptives. Iron: Ascorbic acid increases the absorption of iron. Aspirin: Concomitant administration of aspirin and ascorbic acid may interfere with absorption of ascorbic acid. Renal excretion of salicylate is not affected and does not lead to reduced anti-inflammatory effects of aspirin.

Antacids: Concomitant administration of aluminium-containing antacids may increase urinary aluminium elimination. Concurrent administration of antacids and ascorbic acid is not recommended, especially in patients with renal insufficiency. Amygdalin: Co-administration with amygdalin (a complementary medicine) can cause cyanide toxicity. Desferrioxamine: Concurrent administration of ascorbic acid with desferrioxamine enhances urinary iron excretion. Cases of cardiomyopathy and congestive heart failure have been reported in patients with idiopathic haemochromatosis and thalassaemias receiving desferrioxamine who were subsequently given ascorbic acid. Ascorbic acid should be used with caution in these patients and cardiac function monitored. Ascorbic acid may interfere with biochemical determinations of creatinine, uric acid and glucose in samples of blood and urine.

The use of FLUSIN S EFFERVESCENT is contraindicated in pregnancy and lactation (see section 4.3).

Pregnancy

The safety of FLUSIN S EFFERVESCENT during pregnancy has not been established.

Breastfeeding

The safety of FLUSIN S EFFERVESCENT during breastfeeding has not been established.

Fertility

No data available.

FLUSIN S EFFERVESCENT may lead to drowsiness, dizziness, blurred vision and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents (see section 4.4).

a) Tabulated list of adverse reactions

Paracetamol

System organ class Less frequent Frequency unknown (cannot be estimated from the available data)

Blood and the lymphatic system disorders Agranulocytosis, thrombocytopenia, neutropenia, pancytopenia, leucopenia, anaemia

Immune system disorders Sensitivity/allergic reactions resulting in skin rash, laryngeal oedema, angioedema and anaphylaxis

Metabolism and nutrition disorders Pyroglutamic aciduria (5- oxoprolinuria) and high-anion gap metabolic acidosis

Gastrointestinal disorders Mucosal lesions, pancreatitis

Hepatobiliary disorders Hepatitis

Skin and subcutaneous tissue disorders Skin rashes, other allergic reactions, erythematous*, urticarial rash* Dermatitis, Severe Cutaneous Adverse Reactions (SCARS) such as toxic epidermal necrolysis (TEN), Steven-Johnson syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), eosinophilia and systemic (DRESS)/Drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE), dermatitis

Renal and urinary disorders Renal colic, renal failure, sterile pyuria

General disorders and administrative site conditions Fever

* The rash is usually erythematous or urticarial but sometimes more serious and accompanied by fever and mucosal lesions

Pseudoephedrine hydrochloride

System organ class Frequent Less frequent Frequency unknown (cannot be estimated from the available data)

Immune system disorders Hypersensitivity reactions, including cross-sensitivity that may occur with other sympathomimetics

Metabolism and nutrition disorders Decreased appetite, hypokalaemia, altered metabolism Disturbances of glucose metabolism

Psychiatric disorders Anxiety, restlessness, insomnia, fear, confusion, irritability, psychotic states

Nervous system disorders Tremor, dizziness, Headache, cerebral haemorrhage, Excitability, hallucinations, paranoid delusions, posterior reversible encephalopathy syndrome (PRES), reversible cerebral vasoconstriction syndrome (RCVS)

Eye disorders Ischaemic optic neuropathy

Cardiac disorders Pulmonary oedema, cardiac dysrhythmias, anginal pain, palpitations, and cardiac arrest Vasoconstriction with resultant hypertension

Vascular disorders Hypertension, reflex bradycardia, tachycardia, hypotension, fainting

Respiratory, thoracic and mediastinal disorders Dyspnoea

Gastrointestinal disorders Nausea, vomiting, hypersalivation Reduced appetite, ischaemic colitis

Skin and subcutaneous tissue disorders Skin reactions including rash, severe skin reactions, including acute generalized exanthematous pustulosis (AGEP)

Renal and urinary disorders Difficulty in micturition, urinary retention

General disorders and administrative site conditions Weakness, sweating, tolerance with dependence

Investigations Changes in blood sugar levels

Chlorphenamine maleate

System organ class Frequent Less frequent Frequency unknown (cannot be estimated from the available data)

Blood and the lymphatic system disorders Blood dyscrasias, including agranulocytosis, leucopenia, haemolytic anaemia, thrombocytopenia

Immune system disorders Hypersensitivity reactions such as pruritus or rash, Allergic dermatitis, drug fever bronchospasm, angioedema, anaphylaxis

Metabolism and nutrition disorders Anorexia

Psychiatric disorders Nervousness, euphoria, irritability*, nightmares*, hallucinations Depression, excitation*

Nervous system disorders Sedation, varying from slight drowsiness to deep sleep (somnolence), including lassitude, dizziness and incoordination CNS reactions including fatigue, tremors Confusion, tinnitus, ataxia, insomnia, convulsions, headache, paraesthesias tingling, heaviness and weakness of the hands

Eye disorders Blurred vision

Ear and labyrinth disorders Tinnitus

Cardiac disorders Palpitation and dysrhythmias, tachycardia

Vascular disorders Hypertension, hypotension

Respiratory, thoracic and mediastinal disorders Thickening of mucous, Dryness of the respiratory passages tightness of the chest

Gastrointestinal disorders Nausea, dry mouth Loss of appetite, reduction in tone and motility of the gastrointestinal tract resulting in constipation, Dry throat gastric reflux, diarrhoea, epigastric pain, vomiting, dyspepsia

Hepatobiliary disorders Hepatitis, including jaundice

Skin and subcutaneous tissue disorders Skin rash Photosensitivity, hair loss, sweating, urticaria, exfoliative dermatitis, Musculoskeletal and connective tissue disorders Myalgia Extrapyramidal effects with muscle spasms, dystonia, muscle weakness

Renal and urinary disorders Urinary retention, dysuria, urinary difficulty Urinary frequency

General disorders and administrative site conditions Fatigue

* Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (e.g. increased energy, restlessness, nervousness).

Ascorbic acid

System organ class Less frequent Frequency unknown (cannot be estimated from the available data)

Blood and the lymphatic system disorders Haemolysis (in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency)

Nervous system disorders Headache

Vascular disorders Flushing

Gastrointestinal disorders Diarrhoea, gastrointestinal disturbances Nausea, vomiting, stomach cramps

Skin and subcutaneous tissue disorders Redness of skin

Renal and urinary disorders Formation of renal calcium oxalate calculi

General disorders and administrative site conditions Tolerance

Chlorphenamine/Pseudoephedrine/Paracetamol combination

System organ class Frequent

Nervous system disorders Dizziness, somnolence

Gastrointestinal disorders Dry mouth

General disorders and administrative site conditions Asthenia

Post-marketing:

System organ class Frequency unknown (cannot be estimated from the available data)

Immune system disorders Anaphylactic reaction, hypersensitivity

Psychiatric disorders Anxiety, euphoric mood, hallucination, visual hallucination, restlessness

Nervous system disorders Cerebrovascular accident, headache, paraesthesia, psychomotor hyperactivity, tremor

Cardiac disorders Dysrhythmia, myocardial infarction, palpitations, tachycardia

Gastrointestinal disorders Abdominal pain, colitis ischaemic, diarrhoea, vomiting

Skin and subcutaneous tissue disorders Acute generalised exanthematous pustulosis, angioedema, fixed eruption, pruritus, rash, pruritic rash, urticaria

Renal and urinary disorders Dysuria, urinary retention

Patients known to be at risk of hyperoxaluria should not ingest ascorbic acid doses exceeding 1 g daily as there may be increased urinary oxalate excretion. However, such risk has not been demonstrated in normal, non-hyper oxaluric individuals. Increased intake of ascorbic acid over a prolonged period may result in increased renal clearance of ascorbic acid, and deficiency may result if the intake is reduced or withdrawn rapidly. Doses of more than 600mg daily have a diuretic effect. Ascorbic acid has been implicated in precipitating haemolytic anaemia in certain individuals deficient of glucose-6-phosphate dehydrogenase.

Paracetamol

Symptoms

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 the 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 to10 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 carbamazapine.

Symptoms of paracetamol overdosage in the first 24 hours are 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/INR. 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 dysrhythmias have been reported.

Treatment

Treatment of paracetamol overdosage: N-acetylcysteine should be administered to all cases of suspected overdose as soon as possible, preferably within 8 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.

IV: An initial dose of 150 mg/kg N-acetylcysteine in 200 ml dextrose injection given intravenously over 15 minutes, followed by an intravenous infusion of 50 mg/kg in 500 ml of 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 fluids should be modified for children.

Orally (not the treatment of choice): 140 mg/kg as a 5 % solution initially, followed by a 70 mg/kg solution every four hours for seventeen doses. N-acetylcysteine is more likely to be effective if administered within 8 hours of overdosage.

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 of N-acetylcysteine, can be identified according to their plasma paracetamol level. The plasma paracetamol level can be plotted against the 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 over sixteen hours repeatedly until recovery. Patients with increased susceptibility to liver damage as identified above, should continue treatment if concentrations are above the u201cHigh - risk treatment lineu201d. Prothrombin time/INR correlates best with survival. Monitor all patients with significant ingestions for at least ninety six hours.

Chlorphenamine maleate

Symptoms

Chlorphenamine overdosage may be fatal especially in infants and children. Central excitatory effects constitute the greatest danger in overdose. Symptoms include drowsiness or paradoxical excitement, hallucinations, ataxia, incoordination, athetosis and convulsions. Fixed dilated pupils with a flushed face, sinus tachycardia, dyspnoea, urinary retention, dry mouth and fever. Terminally deepening coma and cardio-respiratory collapse and death may occur within 18 hours.

Children and the elderly are more likely to exhibit anticholinergic and central nervous system stimulant effects. The elderly are prone to hypotension.

Treatment

There is no specific antidote and treatment is symptomatic and supportive. It may be necessary to treat extrapyramidal reactions with diphenhydramine. The patient must be taken to a doctor or hospital immediately as specialised treatment may be necessary.

Pseudoephedrine hydrochloride

Symptoms

Pseudoephedrine overdosage produces central nervous system stimulation with excitement, restlessness, rapid speech, hallucinations, hypertonicity and hyperflexia with dilated pupils. Convulsions 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, dysrhythmias, myocardial infarction and cerebral haemorrhage.

Treatment

Potassium supplements may be required. Tachycardia. Beta-blockers may be administered for tachycardia. 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.

Ascorbic acid

Symptoms

At doses of over 3 g per day unabsorbed ascorbic acid is mainly excreted unmetabolised in the faeces. Absorbed ascorbic acid additional to the body's needs is rapidly eliminated. Large doses of ascorbic acid may cause diarrhoea and the formation of renal oxalate calculi. Symptomatic treatment may be required. Ascorbic acid may cause acidosis or haemolytic anaemia in certain individuals with a deficiency of glucose 6-phosphate dyhydrogenase. Renal failure can occur with massive ascorbic acid overdosage.

Treatment

General supportive measures should be employed as required.