LEMSIP MAX APPLE & CINNAMON FLAVOUR

Duration of treatment should be limited to a maximum of 5 days. Patients should consult a doctor or pharmacist if symptoms persist for more than 5 days, or worsen.

Posology Adults, the elderly and children 16 years and over:

One sachet dissolved by stirring in hot water and sweetened to taste. Dose may be repeated in 4-6 hours. Do no take more than 4 sachets in 24 hours. Do not give to children under 16 years of age.

Elderly population:

Experience has indicated that normal adult dose is usually appropriate. However, in frail, immobile, elderly subjects or in elderly patients with renal or hepatic impairment, a reduction in the amount of frequency of dosing may be appropriate.

Method of Administration:

Oral administration after dissolution in water.

Adverse events which have been associated with paracetamol and phenylephrine hydrochloride 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, leucopenia, pancytopenia, neutropenia, agranulocytosis1● Immune System Disorders Not known Hypersensitivity●■ Nervous System Disorders Not known Headache■ Cardiac Disorders Not known Palpitations■ Vascular Disorders Not known Hypertension■ Metabolism and Nutrition Disorders Not known High anion gap metabolic acidosis2 Gastrointestinal Disorders Not known Abdominal discomfort, nausea, vomiting Skin and Subcutaneous Tissue Disorders Very rare Not known Cases of serious skin reactions have been reported● Skin rash● Renal and Urinary Disorders Not known Urinary retention3■ Description of Selected Adverse Reactions 1 There have been reports of blood dyscrasias including thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. 3 Especially in males. ● Paracetamol; ■ Phenylephrine Hydrochloride 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Use with caution in patients with Raynaud's phenomenon. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. These patients should seek the advice of a doctor before taking this product.

The hazard of overdose is greater in those with non- cirrhotic alcoholic liver disease. Patients should be advised not to take other paracetamol-containing products concurrently. g. chronic alcoholism), who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.

If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring, is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as an underlying cause of HAGMA in patients with multiple risk factors.

9). 6). 6). 5 mg aspartame in each sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

2g sucrose per dose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. 45% of the WHO recommended maximum daily intake of 2g sodium for an adult.

7 % of the WHO recommended maximum daily intake for sodium. Lemsip Max Apple & Cinnamon Flavour Powder for Oral Solution is considered high in sodium. This should be particularly taken into account for those on a low salt diet. This medicine contains Sulphites, may rarely cause severe hypersensitivity reactions and bronchospasm.

Keep out of the sight and reach of children. Do not exceed the stated dose. If symptoms persist, consult your doctor.

1. Due to the presence of phenylephrine, use of this product is contraindicated in: • Patients with severe coronary heart disease or cardiovascular disorders. • Patients with hypertension. • Patients with hyperthyroidism. 5). • Patients using other sympathomimetic decongestants concomitantly.

• Patients with prostatic enlargement. • Patients with phaeochromocytoma. • Patients with closed-angle glaucoma. • Patients with diabetes mellitus.