LEMSIP MAX ALL IN ONE

For short term use only. 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 (16 years and over):

Fill the measure cup with 10 - 20ml for each dose. Take one dose up to 4 times per day. Leave at least 4 hours between doses, and do not take more than 4 doses in any 24 hours. Wipe the neck of the bottle clean and replace the cap securely, without over- tightening it.

Rinse the measure cup after use. Do not exceed the stated dose. Do not give to children under 16 years of age.

Elderly Population:

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

Method of administration For oral administration. It is important to shake the bottle for at least 10 seconds before use.

Adverse events which have been associated rarely with paracetamol, phenylephrine, guaifenesin and cetylpyridinium chloride 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, leukopenia, pancytopenia, neutropenia and agranulocytosis1● Immune System Disorders Not known Hypersensitivity●■♦ Metabolism and Nutrition Disorders Not known High anion gap metabolic acidosis2 Nervous System Disorders Not known Headache♦ Cardiac Disorders Not known Palpitations♦ Vascular Disorders Not known Hypertension♦ 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, leukopenia, 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; ■ Guaifenesin; ♦ 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. Respiratory: 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 10 days, is recurrent, or is accompanied by fever, rash, or persistent headache, a physician should be consulted. 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. Patients should be advised not to take other paracetamol-containing products concurrently. 9). Use with caution in patients with porphyria. 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.

6). 6).

Excipients:

This medicine contains 2g Liquid Maltitol in each 20ml dose. Patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicine contains 3g sorbitol in each 20ml dose. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.

The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concurrently. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, patients with hereditary fructose intolerance should not take this medicinal product.

1. Due to the presence of phenylephrine, use of the product is contraindicated in: • Patients with severe coronary heart disease or cardiovascular disorders. • 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.