Benylin Four Flu Liquid

For the relief of symptoms associated with colds and flu; including coughing, fever, headache, minor aches and pains and nasal congestion.

DO NOT EXCEED THE RECOMMENDED DOSE. For oral use only. Shake the bottle before use.

Adults, the elderly and children over 12 years: 20 mL (four 5 mL medicine measurements) four times daily as required. Do not take more frequently than every four hours. Maximum daily dose: Do not exceed four doses in 24 hours.

Children under 12 years of age: Not recommended.

• Known hypersensitivity to diphenhydramine hydrochloride, pseudoephedrine hydrochloride, paracetamol or any of the other ingredients (see section 6.1).
• Most types of cardiovascular disease, including angina and hypertension and also in hyperthyroidism, hyperexcitability, phaeochromocytoma and closed angle glaucoma.
• Concomitant use of monoamine oxidase inhibitors, or within 14 days of stopping treatment with this class of medicine. Concomitant use may cause a rise in blood pressure and/or hypertensive crisis.
• Severe liver disease.
• Should be avoided in patients undergoing anaesthesia with cyclopropane, halothane, or other halogenated anaesthetics.
• Not recommended for children under the age of 12 years.

BENYLIN u00ae FOUR FLU LIQUID 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.

BENYLIN u00ae FOUR FLU LIQUID should not be used continuously for more than ten days; if symptoms persist, irrespective of therapy used, a medical practitioner should be consulted.

Dosages in excess of those recommended may cause severe liver or kidney damage (see section 4.9).

BENYLIN u00ae FOUR FLU LIQUID may lead to drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol, sedatives, tranquilisers or other central nervous system depressants. The use of alcohol while using BENYLIN u00ae FOUR FLU LIQUID should be avoided.

BENYLIN u00ae FOUR FLU LIQUID should not be used without consulting a doctor or pharmacist if the patient is presently taking monoamine oxidase inhibitors (see section 4.3) or other medicines for depression, psychiatric or emotional conditions or hypertension (see section 4.5).

A medical practitioner should be consulted if there is a pre-existing respiratory disease such as emphysema, chronic bronchitis, acute or chronic bronchial asthma or glaucoma.

Patients should not use BENYLIN u00ae FOUR FLU LIQUID for persistent or chronic cough, such as occur with asthma, or where cough is accompanied by excessive secretions, unless directed by a medical practitioner.

BENYLIN u00ae FOUR FLU LIQUID should not be taken with any other pseudoephedrine, paracetamol-containing products, or with any other product containing diphenhydramine hydrochloride, even if used on skin.

As both diphenhydramine hydrochloride and pseudoephedrine hydrochloride have been associated with central nervous system adverse events, there is a possibility that the risk of experiencing such adverse events may be increased by use of the combination. If hallucinations, restlessness and sleep disturbances occur, stop using BENYLIN u00ae FOUR FLU LIQUID.

Patients with difficulty in urination due to enlargement of the prostate gland, should be advised to consult their medical practitioner before using diphenhydramine or pseudoephedrine containing medicines.

Chronic alcohol abusers should ask their medical practitioners whether they should take paracetamol or other pain relievers or fever reducing medication.

Patients with hepatic disease should consult a medical practitioner before using BENYLIN u00ae FOUR FLU LIQUID (see section 4.3).

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 BENYLIN u00ae FOUR FLU LIQUID should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Use with care in patients with pre-existing cardiovascular disease in particular those with coronary heart disease and hypertension (see section 4.3).

Patients with thyroid disease, diabetes mellitus or decreased kidney function should not use pseudoephedrine hydrochloride unless advised by a medical practitioner.

There have been reports of ischaemic colitis with pseudoephedrine. BENYLIN u00ae FOUR FLU LIQUID 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 very rarely with pseudoephedrine containing products. 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, trunk, 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 BENYLIN u00ae FOUR FLU LIQUID should be discontinued and a doctor should be consulted.

If symptoms persists or gets worse, or if new symptoms occur, a doctor should be consulted.

BENYLIN u00ae FOUR FLU LIQUID contains sodium benzoate. An increase in bilirubinaemia following its displacement from albumin may increase neonatal jaundice which may develop into kernicterus (non-conjugated bilirubin deposits in the brain tissue).

Central nervous system depressants: Diphenhydramine hydrochloride may enhance the sedative effects of central nervous system depressants, including alcohol, tranquilisers, neuroleptic medicines, barbiturates and sedatives.

Antimuscarinic medicines (having anti-cholinergic properties): Diphenhydramine hydrochloride may have an additive effect with medicines such as atropine, tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs) (see section 4.3).

Antibacterial medicines: Diphenhydramine hydrochloride may mask the damage caused by ototoxic medicines such as aminoglycosides.

Cough and cold preparations: Avoid concurrent use as other preparations could have similar acting components which will result in a potentiation of the effect of both products.

Laboratory tests: Diphenhydramine hydrochloride may suppress cutaneous histamine response to allergen.

Antihypertensive medicines: Pseudoephedrine hydrochloride may reverse the effect of antihypertensive medicines which modify sympathetic activity.

Sympathomimetic medicines: Concomitant use with other sympathomimetic medicines such as decongestants, tricyclic anti-depressants and appetite suppressants or with monoamine oxidase inhibitors, including linezolid which interfere with the catabolism of sympathomimetic amines may cause a rise in blood pressure. An increased risk of dysrhythmias may also occur if sympathomimetic medicines are given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.

Anticoagulant medicines: Paracetamol may potentiate the anticoagulant effects of warfarin and other coumarin derivatives.

Hepatotoxic medicines: The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic medicines or medicines that induce liver microsomal enzymes.

Metoclopramide: May accelerate the absorption of paracetamol.

Probenecid: Paracetamol excretion may be affected and plasma concentrations altered when given together with probenecid.

Cholestyramine: Reduces the absorption of paracetamol if given within 1 hour of paracetamol.

The safety of BENYLIN u00ae FOUR FLU LIQUID in pregnancy and lactation has not been established (see section 4.3).

BENYLIN u00ae FOUR FLU LIQUID may lead to prolonged drowsiness 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.

Diphenhydramine hydrochloride

Blood and the lymphatic system disorders: Less frequent: blood dyscrasias (including agranulocytosis, leucopenia and haemolytic anaemia), thrombocytopenia

Immune system disorders: Less frequent: allergic reactions, anaphylaxis

Psychiatric disorders: Frequency unknown: euphoria.

Nervous system disorders: Frequent: sedation (varying from slight drowsiness to deep sleep), lassitude, dizziness, inco-ordination. Less frequent: deepening coma, extrapyramidal effects. Frequency unknown: headache

Elderly patients are more susceptible to the central nervous system depressant effects. In infants and children it may act as a cerebral stimulant. Symptoms of stimulation include insomnia, nervousness, tachycardia, tremors and convulsions. Large doses may precipitate fits in epileptics.

Eye disorders: Frequency unknown: blurred vision

Ear and labyrinth disorders: Frequency unknown: tinnitus

Vascular disorders: Less frequent: hypotension. Elderly patients are more susceptible to the hypotensive effects.

Respiratory, thoracic and mediastinal disorders: Frequency unknown: tightness of the chest

Gastrointestinal disorders: Less frequent: nausea, vomiting, diarrhoea, constipation, anorexia or increased appetite, epigastric pain. Frequency unknown: dryness of the mouth

Skin and subcutaneous tissue disorders: Less frequent: photosensitisation of the skin

Musculoskeletal, connective tissue and bone disorders: Frequency unknown: muscular weakness

Renal and urinary disorders: Frequency unknown: difficulty in micturition, dysuria

Investigations: Less frequent: The positive results of skin tests may be suppressed

Paracetamol

Blood and the lymphatic system disorders: Less frequent: neutropenia, pancytopenia, leucopenia, thrombocytopenia

Immune system disorders: Less frequent: sensitivity reactions resulting in skin rash, laryngeal oedema, angioedema and anaphylaxis (the rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by fever and mucosal lesions)

Endocrine disorders: Frequency unknown: pancreatitis

Pseudoephedrine hydrochloride

Metabolism and nutrition disorders: Less frequent: hypokalaemia. Frequency unknown: altered metabolism (including changes in blood sugar levels)

Psychiatric disorders: Less frequent: fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, psychotic states

Nervous system disorders: Less frequent: headache

Cardiac disorders: Less frequent: pulmonary oedema, reflex bradycardia, tachycardia, cardiac dysrhythmias, anginal pain, palpitations, cardiac arrest

Vascular disorders: Less frequent: hypertension, cerebral haemorrhage, hypotension (with dizziness), fainting, flushing

Respiratory, thoracic and mediastinal disorders: Less frequent: dyspnoea

Gastrointestinal disorders: Less frequent: reduced appetite, hypersalivation, nausea and vomiting

Skin and subcutaneous tissue disorders: Less frequent: sweating

Renal and urinary disorders: Less frequent: difficulty in micturition and urinary retention (in patients with prostatic hypertrophy)

General disorders and administrative site conditions: Less frequent: weakness

Post-marketing data

The side effects reported are: Psychiatric disorders Hallucinations (including visual hallucinations), depression, excitability and paranoid delusions. Nervous system disorders Paradoxical stimulation, agitation, paraesthesia, psychomotor hyperactivity, cerebrovascular accident. Cardiac disorders Myocardial infarction. Respiratory, thoracic and mediastinal disorders Dry throat, nasal dryness, thickened respiratory tract secretions. Gastrointestinal disorders Abdominal pain, dyspepsia, ischaemic colitis. Skin and subcutaneous tissue disorders Pruritus, pruritic rash, acute generalised exanthematous pustulosis, fixed eruption. General disorders and administrative site conditions Jittery feeling.

Investigations Increased transaminases.

Diphenhydramine hydrochloride: Mild to moderate symptoms are: Somnolence, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, decreased bowel sounds, tachycardia, mild hypertension, nausea and vomiting are common after overdose. Agitation, confusion and hallucinations may develop with moderate poisoning. Severe symptoms: Effects may include delirium, psychosis, seizures, coma, convulsions, hypotension, QRS widening, and ventricular dysrhythmias, including torsades de pointes, but are generally reported in adults after large ingestions. Rhabdomyolysis and renal failure may rarely develop in patients with prolonged agitation, coma or seizures. Death may occur as a result of respiratory failure or circulatory collapse.

Paracetamol: 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 dysrhythmias 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, 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 4-hour plasma paracetamol level. The plasma paracetamol level can be plotted against time since ingestion in the nomogram below. The nomogram should be used only in relation to a single acute ingestion.

Pseudoephedrine hydrochloride: Overdosage may result in nausea, vomiting, sympathomimetic symptoms including central nervous system stimulation, insomnia, tremor, mydriasis, anxiety, agitation, hallucinations, seizures, palpitations, tachycardia, hypertension, and reflex bradycardia. Other effects may include dysrhythmias, hypertensive crisis, intracerebral haemorrhage, myocardial infarction, psychoses, rhabdomyolysis, hypokalaemia, and ischemic bowel infarction. Drowsiness has been reported with overdose in children. Treatment: Symptomatic and supportive.