LEMSIP MAX ALL IN ONE BREATHE EASY

Patients should consult a doctor or pharmacist if symptoms persist for more than 5 days, or worsen.

Posology:

Adults and children 16 years and over: Content of one sachet dissolved by stirring in hot water and sweetened to taste. Dose may be repeated in 4-6 hours as required. Do not take more than 4 sachets in 24 hours. Do not give to children under 16 years of age.

Elderly Population:

No dosage adjustment is considered necessary in the elderly.

Method of administration:

Oral administration after dissolution in water.

Adverse events which have been associated with paracetamol, guaifenesin and phenylephrine 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 Metabolism and Nutrition Disorders Not known High anion gap metabolic acidosis2 Gastrointestinal Disorders Not known Abdominal discomfort, nausea, vomiting, diarrhoea 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. 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

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non- cirrhotic alcoholic liver disease. 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.

Patients should be advised not to take other paracetamol -containing products concurrently. This product should not be used for persistent or chronic cough such as that occurring with smoking, asthma, chronic bronchitis or emphysema, or for cough associated with excessive phlegm.

A persistent cough may be indicative of a serious condition. If cough persists for more than 5 days, is recurrent, or is accompanied by fever, rash, or persistent headache, a physician should be consulted. Use with caution in patients suffering from porphyria.

9). 6). 6). Use with care in patients with Raynaud’s Phenomenon. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 3mg sucrose per dose (total sugars 2g).

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. 6mmol) sodium per dose - to be taken into consideration for patients on a controlled sodium diet.

Contains a source of phenylalanine. May be harmful for people with phenylketonuria. Contains sulphite; may rarely cause severe hypersensitivity reactions and bronchospasm. If you are pregnant or are being prescribed medicine by your doctor, seek his advice before taking this product.

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 and cardiovascular disorders • Patients with hypertension • Patients with hyperthyroidism • Patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors (MAOIs) • Concomitant use of other sympathomimetic decongestants • Patients with prostatic enlargement • Patients with phaeochromocytoma • Patients with diabetes mellitus • Patients with closed-angle glaucoma