LEMSIP MAX DAYTIME COLD AND FLU RELIEF

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. The product is particularly appropriate for day-time use.

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

Take two capsules every 4-6 hours as required to a maximum of four doses in any 24 hours, or up to a maximum of three doses in any 24 hours if a night-time paracetamol-containing product is taken before bedtime. Do not take more than 8 capsules (4 doses) in any 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 For oral administration. Swallow whole with water. Do not chew.

Adverse effects of paracetamol are rare. The most commonly reported adverse events following dosing with caffeine are GI irritation and CNS stimulation.

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●■♦ Metabolism and Nutrition Disorders Not known High anion gap metabolic acidosis2 Psychiatric Disorders Not known Insomnia♦ , restlessness♦ , anxiety♦ , agitation♦ , nervousness, delirium Nervous System Disorders Not known Headache■ , Dizziness♦ Cardiac Disorders Not known Palpitations■ Vascular Disorders Not known Hypertension■ Gastrointestinal Disorders Not known Epigastric discomfort♦ , gastric ulcer♦ , 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; ♦ Caffeine Reporting of Suspected Adverse Reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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. 9). 6). 6). Due to the presence of caffeine, the product should be taken with care in patients with a history of peptic ulcers.

g. coffee, tea and some soft drinks) should be avoided while taking this product due to the risk of adverse effects, such as, palpitations. 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.

140mmol) sodium per dose, that is to say essentially ‘sodium-free’. 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 the product is contraindicated in: - Patients with severe coronary heart disease or cardiovascular disorder. - Patients with hypertension. - Patients with hyperthyroidism. - Patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors (MAOIs).

- Patients using other sympathomimetic decongestants concomitantly. - Patients with prostatic enlargement. - Patients with phaeochromocytoma. - Patients with closed-angle glaucoma. - Patients with diabetes mellitus.