Reckitt Benckiser Ireland Limited

Lemsip Max Sinus & Flu Hot Lemon.

Powder for Oral Solution

Each sachet contains Paracetamol 1000mg.

Pseudoephedrine hydrochloride 60mg.

This product contains 122mg sodium, 2.2g sucrose and 62.5mg aspartame per sachet.

For a full list of excipients, see Section 6.1.

Powder for oral solution.

A pale yellow powder with a lemon odour.

For the relief of symptoms of sinusitis, common cold and influenza, such as headache and nasal and sinus congestion.

Oral.

Adults only: The usual dose is one sachet up to three times daily. A maximum dose of three sachets per 24 hours should not be exceeded.

1. Use in patients hypersensitive to the active ingredient.

2. Use in patients who are receiving monoamine oxidase inhibitors or who have received these within the previous fourteen days.

3. Use in patients with severe hypertension or severe coronary artery disease.

The product should be used only with caution in patients with thyrotoxicosis, glaucoma or urinary retention.

Use with caution in diabetic patients as the product may cause an increase in blood sugar level.

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

This medicinal product contains 122mg 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.

Special labelling requirements:

If you are taking other medication consult your doctor or pharmacist.

If symptoms persist, consult your doctor.

Do not exceed the stated dose.

Do not use for more than three days without consulting a doctor.

Concomitant use with sympathomimetic agents such as decongestants, tricyclic antidepressants, appetite suppressants and amphetamine-like psychostimulants, or with monoamine oxidase inhibitors which interfere with the catabolism of sympathomimetic amines, may occasionally cause a rise in blood pressure.

The product should not be used in pregnancy unless considered essential by the physician.

None known.

Side-effects include symptoms of central nervous system excitation such as restlessness. Tachycardia, sleep disturbance and more rarely hallucinations, skin rash and urinary retention, have also been reported.

Overdosage with paracetamol should be treated promptly by gastric lavage followed by N-acetylcysteine infusion of oral methionine since liver damage following overdosage does not become apparent for one to six days after ingestion. Initial mild symptoms consist of nausea, vomiting and pallor. Measurement of the blood paracetamol level and the time elapsed since ingestion is important in order to determine whether further therapy with N-acetylcysteine is necessary.

Features of severe overdosage of pseudoephedrine may include irritability, palpitations, hypertension, convulsions, tremor, hyperactivity, hyperpyrexia, dryness of the skin and mucous membranes, and the possible effects given in "Undesirable effects". Treatment includes early gastric lavage and symptomatic and supportive measures. Elimination can be accelerated by acid diuresis or by dialysis. Hypertensive effects may be treated with an i.v. alpha-receptor blocking agent. Convulsions may be treated with an anticonvulsant.

Paracetamol

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.

Pseudoephedrine

Pseudoephedrine is an adrenergic agonist acting at both alpha- and beta-adrenoreceptors. It is reported to have less tachycardic and pressor activity and central nervous system effects than ephedrine. It is a recognised decongestant and acts by vasoconstriction to reduce oedema and nasal swelling.

Not applicable.

No preclinical findings of relevance have been reported.

Ascorbic acid

Sodium citrate

Citric acid anhydrous

Curcumin

Lemon flavour

Aspartame (E951)

Sucrose

Saccharin sodium

Not applicable

Three years.

Do not store above 25°C.

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

Pack size: ten sachets.

Oral administration after dissolution in water.

7. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Ireland Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

PA 979/20/1.

Date of first authorisation: 9th May, 1996

Date of last renewal: 9th May, 2006.

February 2009.