Reckitt Benckiser Ireland Limited

Lemsip Max Cough & Cold

Powder for Oral Solution

Powder for oral solution

Paracetamol 1000mg

Guaifenesin 200mg'.

For excipients see section 6.1. Also contains sucrose 1985mg and aspartame 61.5mg.

Pale yellow powder for oral solution with the odour and taste of lemons.

For the relief of symptoms of colds and influenza, including the relief of aches and pains, sore throat, headache, chesty coughs and lowering of temperature.

Oral administration after dissolution in water.

Adults and adolescents 12 years and over: One sachet dissolved by stirring in hot water and sweetened to taste.

Dose may be repeated in 4-6 hours. No more than four doses should be taken in 24 hours.

Not to be given to children under 12 without medical advice.

Hypersensitivity to any of the ingredients.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Use with caution in patients with diabetes. Each sachet contains approximately 2 g of carbohydrate. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Leaflet: 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 damage.

Do not exceed the stated dose. Do not take with any other paracetamol-containing products. If symptoms persist, consult your doctor. Keep out of the reach and sight of children. If you are pregnant or are being prescribed medicine by your doctor, seek his advice before taking this product. Contains paracetamol (panel). Total sugars 2 g. Contains aspartame. Immediate medical advice should be sought in the event of an overdose, even if you feel well.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Drugs, which induce hepatic microsomal enzymes, such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdosage.

Guaifenesin may increase the rate of absorption of paracetamol.

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data do not contraindicate breast-feeding.

Guaifenesin: Has been linked with an increased risk of neural tube defects in a small number of women with febrile illness in the first trimester of pregnancy although it was unclear whether the increased risk was due to the medication or the illness. The FDA class guaifenesin as 'C' in its register of pregnancy risk indications, and should only be given if the benefit outweighs the potential risk to the foetus. There is no information on use in lactation.

None known.

Adverse effects of paracetamol are rare, but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Guaifenesin has occasionally been reported to cause gastro-intestinal discomfort, nausea and vomiting, particularly in very high doses.

Paracetamol: Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of five or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors

If the patient:

(a) Is on long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes, or

(b) Regularly consumes ethanol in excess of recommended amounts, or

(c) Is likely to be glutathione deplete, e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.

Guaifenesin: Very large doses may cause nausea and vomiting. The drug is, however, rapidly metabolised and excreted in the urine. Patients should be kept under observation and treated symptomatically.

Paracetamol: Paracetamol has both analgesic and antipyretic activity, which is believed to be mediated principally through its inhibition of prostaglandin synthesis within the central nervous system.

Guaifenesin: Guaifenesin is an expectorant that reduces the viscosity of tenacious sputum.

Paracetamol: Paracetamol is absorbed rapidly and completely from the small intestine, producing peak plasma levels after 15-20 minutes following oral dosing. The systemic availability is subject to first-pass metabolism and varies with dose between 70% and 90%. The drug is rapidly and widely distributed throughout the body and is eliminated from plasma with a T½ of approximately 2 hours. The major metabolites are glucuronide and sulphate conjugates (>80%) which are excreted in urine.

Guaifenesin: Guaifenesin is absorbed from the gastrointestinal tract. It is metabolised and excreted in the urine.

None available specific to the product.

Ascorbic acid

Caster sugar

Pulverised sucrose

Citric acid

Sodium citrate

Lemon flavour no. 1

Aspartame (E951)

Saccharin sodium

Curcumin WD

None known.

Two years.

Do not store above 25°C.

Heat-sealed sachet of paper/polyethylene/aluminium foil/ polyethylene laminate in an outer cardboard carton.

Packs: 5 sachets.

No special precautions.

Reckitt Benckiser Ireland Limited,

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland.

PA 979/28/1.

22/06/2007

May 2008