LEMSIP MAX FLU LEMON

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 aged 16 years and over:

Content of one sachet dissolved by stirring in hot water and sweetened to taste. Dose may be repeated every 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. 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 Oral administration after dissolution in water.

Adverse events which have been associated with paracetamol and pseudoephedrine 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.

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.

System Organ Class Frequency Adverse Events Blood and Lymphatic System Disorders Not known Haemopoietic disorders1 Immune System Disorders Not known Hypersensitivity Metabolism and Nutrition Disorders Not known High anion gap metabolic acidosis2 Psychiatric Disorders Not known Anorexia nervosa, insomnia, agitation, hallucination, anxiety, restlessness Nervous System Disorders Not known Headache, tremor, Posterior reversible encephalopathy syndrome (PRES)3, reversible cerebral vasoconstriction syndrome (RCVS)3, Haemorrhagic stroke, Ischaemic stroke, Transient ischaemic attack (TIA) Eye Disorders Not known Ischaemic optic neuropathy Cardiac Disorders Not known Tachycardia, arrhythmia, palpitations, myocardial infarction Vascular Disorders Not known Hypertension Gastrointestinal Disorders Not known Nausea, vomiting, dry mouth, ischaemic colitis, pancreatitis acute Skin and Subcutaneous Tissue Disorders Very rare Not known Cases of serious skin reactions have been reported Skin rash, hyperhidorosis Renal and Urinary Disorders Not known Urinary retention4 General and Administration Site Conditions Not known Irritability Description of selected adverse reactions 1 There have been a few reports of blood dyscrasias including thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Use with caution in patients with hyperexcitability. If hallucinations, restlessness, or sleep disturbances are experienced whilst taking the product, use of the product should be discontinued. 1 g of carbohydrate. 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.

Label warnings:

Warning - Do not exceed the stated dose (panel). Keep out of the reach of children. Contains paracetamol (panel). If symptoms persist, consult your doctor. If you are pregnant or are being prescribed medicine by your doctor, seek his advice before taking this product.

1 g. Contains aspartame. Do not take with any other paracetamol- containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Leaflet:

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Ischaemic colitis Some cases of ischaemic colitis have been reported with pseudoephedrine.

Pseudoephedrine should be discontinued, and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop. Ischaemic optic neuropathy Cases of ischaemic optic neuropathy have been reported with pseudoephedrine.

Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs. 8). 3). Pseudoephedrine should be discontinued and immediate medical assistance sought if the following symptoms occur: sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances.

1. • Patients with severe coronary heart disease and cardiovascular disorders. • Patients with severe hypertension or uncontrolled hypertension. • Patients with hyperthyroidism. • Patients with severe acute or chronic kidney disease/renal failure.

• Patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors (MAOIs). • Patients with prostatic enlargement. • Patients with phaeochromocytoma. • Patients with diabetes mellitus. • Patients with closed-angle glaucoma.

5). The effects of a single dose on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment. 5).