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: 12/1/2015

Lemsip Max Cold & Flu Blackcurrant 1000mg Powder for Oral Solution

1. NAME OF THE MEDICINAL PRODUCT

Lemsip Max Cold & Flu Blackcurrant 1000mg Powder for Oral Solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Constituents

mg/Sachet

Paracetamol

1000.0

Excipient(s) with known effect:

Also contains sucrose (2.1g), aspartame (E951) 61.5mg and sodium (119mg) per sachet.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Powder for oral solution.

A lilac unit-dose powder for oral solution with the odour and flavour blackcurrants.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

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

4.2 Posology and method of administration

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.

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

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

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 sugar

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

This product contains 119 mg of sodium per dose. This should be taken into consideration by patients on a sodium controlled diet.

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 (E951) which contains a source of phenylalanine. May be harmful to people with phenylketonuria. 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.

4.5 Interaction with other medicinal products and other forms of interaction

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.

4.6. 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

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.

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 with a T½ of approximately 2 hours. The major metabolites are glucuronide and sulphate conjugates (>80%) which are 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 (pulverised).

Sucrose (caster),

Citric acid anhydrous

Sodium citrate

Blackcurrant flavour

Aspartame (E951)

Saccharin sodium

Ascorbic acid

Enocyanine

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Heat-sealed sachet of paper/polyethylene/aluminium foil/polyethylene laminate in an outer cardboard carton containing 5 or 10 sachets.

6.6 Special precautions for disposal and other handling

No special precautions

7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Ireland Limited, 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.

8. MARKETING AUTHORISATION NUMBER(S)

PA 979/21/3.

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of First Authorisation: 23rd November, 2007, 23rd November 2012

10. DATE OF REVISION OF THE TEXT

July 2014

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.