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

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

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 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.

Paediatric Population: Not to be used in children under 12 years of age.

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).

Elderly Population: No dosage adjustment is considered necessary in the elderly.

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

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 product. Take only when necessary. Prolonged use except under medical supervision can be harmful. Do not exceed the stated dose. Immediate medical advice should be sought in the event of an overdose, even if you feel well (see section 4.9).

If symptoms persist, the physician should be consulted.

Keep out of the sight and reach of children.

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

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

Contains a source of phenylalanine. May be harmful to people with phenylketonuria.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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.

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.

None.

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

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

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.”

ATC Code: N02BE01, other analgesics and antipyretics

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

lactose

polysorbate 80

silica

curcumin

None.

3 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.