It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.

Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

Summary of Product Characteristics last updated on medicines.ie: 17/10/2012

Lemsip Cold + Flu Headcold

1. NAME OF THE MEDICINAL PRODUCT

Lemsip Cold & Flu Headcold 500mg Powder for Oral Solution.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient mg/Sachet
Paracetamol Ph Eur 500.0

Excipients: Contains 3g sucrose, 94mg sodium & 22.5mg aspartame per sachet

For full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Powder for oral solution.

Pale cream coloured homogenous powder with an odour of lemon and menthol and a taste of lemon and menthol intended for dissolution in water and oral administration to human beings.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

As an analgesic and antipyretic for the relief of the symptoms associated with the common cold and influenza.

4.2 Posology and method of administration

Adults and children aged 12 years and over: one sachet to be taken every 4 hours, if necessary, up to the maximum of six sachets in any period of 24 hours. Not to be given to children under 12 years of age.

Elderly: the normal adult dosage can be used.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

Hepatic or renal impairment.

4.4 Special warnings and precautions for use

Paracetamol-containing products should be given with caution to patients with impaired kidney and liver function, or if they are taking other drugs that affect their liver.

Use with caution in patients with diabetes. Each sachet contains approximately 3g 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 94mg 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.

4.5 Interaction with other medicinal products and other forms of interaction

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

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

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

4.6 Fertility, pregnancy and lactation

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

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

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

Skin rashes and other allergic reactions occur occasionally with paracetamol.

4.9 Overdose

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

Paracetamol overdosage initially causes nausea, vomiting and abdominal pain. Ingestion of 7.5-10 g of paracetamol (over twelve sachets) 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 paracetamol, haemo-perfusion may be necessary.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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.

5.2 Pharmacokinetic properties

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 at a T½ of approximately 2 hours. The major metabolites are glucuronide and sulphate conjugates (>80%) which is excreted in urine.

5.3 Preclinical safety data

No preclinical findings of relevance have been reported.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sucrose, citric acid anhydrous, sodium citrate, saccharin sodium, lemon flavour no. 1, menthol flavour, aspartame (E951), ascorbic acid and curcumin WD.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Three years.

6.4 Special precautions for storage

Store at a temperature not exceeding 25°C.

6.5 Nature and contents of container

A heat-sealed sachet of paper/polyethylene/aluminium foil/polyethylene laminate in an outer cardboard carton. Pack sizes: five or ten sachets.

6.6 Special precautions for disposal and other handling

The contents of each sachet are to be dissolved in hot water before administration.

7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Ireland Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

8. MARKETING AUTHORISATION NUMBER(S)

PA 979/14/1.

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

9th November, 1994/9th November, 2004.

10. DATE OF REVISION OF THE TEXT

October 2012

It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.