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: 10/6/2016

Lemsip Cold & Flu Headcold 500mg Powder for Oral Solution

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 and approximately 10mg lactose 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

Duration of treatment is dependent on indications. A healthcare professional should be consulted for indications where treatment duration exceeds short term use.

Posology

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.

Method of administration

For oral administration after dissolution in water. For instructions on reconstitution of the medicinal product before administration, see section 6.6.

Hepatic Impairment: Patients with hepatic impairment should seek the advice of a doctor before taking this product (see section 4.4).

Renal Impairment: Patients with renal impairment should seek the advice of a doctor before taking this product (see section 4.4).

4.3 Contraindications

Hypersensitivity to paracetamol or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Serious skin reactions, including Stevens-Johnson Syndrome, toxic epidermal necrolysis, and acute generalised exanthematous pustulosis, have been reported very rarely in association with paracetamol. These severe hypersensitivity reactions are potentially life threatening. The product should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Patients with hepatitis, non-cirrhotic alcoholic liver disease, hepatic insufficiency or renal insufficiency are at an increased risk of adverse reactions associated with paracetamol use. These patients should seek the advice of a doctor before taking this product or other drugs that affect the liver.

Do not take with any other Paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well (see section 4.9).

Do not exceed the recommended dose.

Keep out of the sight and reach of children.

If symptoms persist, consult your doctor.

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

Antiemetics: The speed of absorption of Paracetamol may be increased by metoclopramide or domperidone.

Anticoagulants: Large doses or prolonged regular daily use of paracetamol may potentiate anticoagulant the effects of warfarin and other coumarin anticoagulants with increased risk of bleeding.

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

4.6 Fertility, pregnancy and lactation

Pregnancy

A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Paracetamol can be used during pregnancy if clinically needed however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.

Breast-feeding

Paracetamol is excreted in breast milk, but not in a clinically significant amount. Product use is compatible with breast-feeding.

Fertility

No known effects.

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.

Adverse events which have been associated with paracetamol are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

System Organ Class

Frequency

Adverse Events

Blood and Lymphatic System Disorders

Not known

Thrombocytopenia, agranulocytosis

Skin and Subcutaneous Tissue Disorders

Not known

Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis1

Skin rash

Description of Selected Adverse Reactions

1 Very rare cases of serious skin reactions have been reported (see section 4.4).

Reporting of Suspected Adverse Reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E- mail:medsafety@hpra.ie

4.9 Overdose

There is a risk of poisoning, particularly in elderly subjects, in young children, in patients with liver disease, in cases of chronic alcoholism, in patients with chronic malnutrition. Overdosing may be fatal in these cases.

Symptoms generally appear within the first 24 hours and comprise: nausea, vomiting, anorexia, pallor, and abdominal pain.

Overdose of paracetamol in a single administration in adults or in children causes liver cell necrosis likely to induce complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy which may lead to coma and death. Simultaneously, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed together with increased prothrombin levels that may appear 12 to 48 hours after administration.

Liver damage is likely in adults who have taken more than the recommended amounts of paracetamol. It is considered that excess quantities of toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

Some patients may be at increased risk of liver damage from paracetamol toxicity.

Risk Factors include:

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 depleted e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia

Emergency Procedure:

Immediate transfer to hospital

Blood sampling to determine initial paracetamol plasma concentration

Gastric lavage

IV (or oral if possible) administration of the antidote N-acetylcysteine as soon as possible and before the 10th hour of the overdose in accordance with National guidelines.

Symptomatic treatment should be implemented.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Analgesics, Anilides;

ATC Code: N02BE01

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 (constituents of curcumin WD include; curcumin, lactose, polysorbate and silica).

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

May 2016

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.