Reckitt Benckiser Ireland Limited

Lemsip Max Cold & Flu Hot Lemon 1000mg Powder for Oral Solution.

Excipients: Contains 2.2g Sucrose, 129mg sodium & 61.5mg aspartame per sachet

For full list of excipients, see section 6.1.

Powder for oral solution.

A pale yellow unit-dose powder for oral solution with the odour and flavour of lemons.

For the relief of the symptoms associated with the common cold or influenza, including fever, headache, sore throat, body aches and pains.

Oral administration.

Adults and children 12 years and over: The usual dose is one sachet up to four times daily. The dose may be repeated in 4 hours with a maximum of four doses in a 24 hour period.

Hypersensitivity to any of the ingredients.

Use with caution in patients with severe renal or severe hepatic impairment.

Use with caution in patients with diabetes. Each sachet contains approximately 2.2 g of carbohydrate.

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

This medicinal product contains 129mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

Sweetened with aspartame (E951), a source of phenylalanine. May be harmful for people with phenylketonuria.

Label warnings: Do not exceed the stated dose. Keep out of the reach of children. Contains paracetamol (panel). If symptoms persist, consult your doctor. Do not take any other paracetamol-containing products. Total sugars 2.2 g. Contains aspartame. Immediate medical advice should be sought in the event of overdosage even if you feel well. Please read the enclosed leaflet carefully.

Leaflet: Immediate medical advice should be sought in the event of overdosage, because of the risk of irreversible liver damage.

1. Paracetamol is reported to increase the half-life of chloramphenicol.

2. Large doses of paracetamol may potentiate the effects of coumarin anticoagulants.

3. The hepatotoxicity of paracetamol may be potentiated by other drugs that affect the liver.

There is epidemiological evidence of safety in human pregnancy. However, as with all medicines, caution should be exercised during pregnancy and lactation.

None.

Side-effects are rare when the product is used correctly.

Skin rashes and other allergic reactions occur occasionally with paracetamol.

The main cause for concern in overdosage with this product is paracetamol intake.

Paracetamol overdosage initially causes nausea, vomiting and abdominal pain. Ingestion of 7.5-10 g of paracetamol can cause liver damage, though symptoms may not appear for two to three days. Treatment is by gastric lavage and using a specific antidote such as acetylcysteine or methionine if treatment can be started within 10 hours of ingestion. If more than 10 hours have elapsed since ingestion of the paracetamol, haemoperfusion may be necessary.

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.

Paracetamol is absorbed rapidly and completely mainly 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.

No preclinical findings of relevance have been reported.

Sucrose

citric acid anhydrous

sodium citrate

lemon flavour no. 1

aspartame E951,

saccharin sodium

ascorbic acid

curcumin.

None.

Three years.

Do not store above 25°C.

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

Contents of one sachet dissolved by stirring in hot, not boiling water, and sweetened to taste.

Reckitt Benckiser Ireland Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

PA 979/21/1.

Date of first authorisation: 1st October, 1999

Date of last renewal: 1st October, 2009.

February 2010