FLU STRENGTH HOT LEMON

Posology Adults and children 16 years and over:

The contents of one sachet dissolved in hot water every 4 hours. The dose should not be repeated more than four times in any 24 hour period. Maximum Daily dose • The maximum daily dose of Paracetamol must not exceed 4g (four sachets) • Maximum single dose is 1g (one sachet) The dosage should not be continued for more than 3 days without consulting a doctor.

Paediatric Population Children below 16years of age:

Flu Strength Hot Lemon Powder is not recommended in children aged less than 16 years Method of administration Flu Strength Hot Lemon Powder sachets are for oral administration ONLY. The contents of one sachet should be placed in hot water and allowed to dissolve completely before swallowing.

The frequency using the following convention: very common (> 1/10); common (>1/100 to < 1/10); uncommon (>1/1000 to < 1/100); rare (>1/10000 to < 1/1000); very rare (< 1/10000), including isolated reports; not known: frequency cannot be estimated from the available data.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequency System Symptoms Blood and lymphatic system disorders Platelet disorders, stem cell disorders. Immune system disorders Allergies (excluding angioedema).

Psychiatric disorders Depression NOS, confusion, hallucinations. Nervous system disorders Tremor NOS, headache NOS. Eye disorders Abnormal vision. Cardiac disorders Oedema. Gastrointestinal disorders Haemorrhage NOS, abdominal pain NOS, diarrhoea NOS, nausea, vomiting.

Hepato-biliary disorders Hepatic function abnormal, hepatic failure, hepatic necrosis, jaundice. Rare >1/10000- <1/100 Skin and subcutaneous Pruritus, rash, sweating, purpura, tissue disorders angioedema, urticaria General disorders and administration site conditions Dizziness (excluding vertigo), malaise, pyrexia, sedation, drug interaction NOS.

Injury, poisoning and procedural complications Overdose and poisoning Hepato-biliary disorders hepatotoxicity General disorders and administration site conditions hypersensitivity reaction (requiring discontinuation of treatment) Blood and lymphatic system disorders thrombocytopenia leukopenia neutropenia hemolytic anemia agranulocytosis Metabolism and nutrition disorders Hypoglycaemia Renal and urinary disorders Sterile pyuria (cloudy urine) and renal side effects Very Rare (< 10 000) Skin and subcutaneous disorders Serious skin reactions have been reported.

Not known Metabolism and nutrition disorders High anion gap metabolic acidosis Not known: Edema of the larynx, anaphylactic shock, anaemia, bronchospasm*, liver alteration and hepatitis, renal alteration (severe renal impairment, nephrite interstitial, haematuria, anuresis), gastrointestinal effects and vertigo have been reported.

* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs. At the recommended dosage drowsiness, impaired mental functions and methaemoglobinaemia may occur.

Allergic reactions and sensitivity are rare and may include skin rash, drug fever, mucosal lesions, neutropaenia, pancytopaenia and leukopaenia. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.

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.

2 Pharmacokinetic properties Absorption Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring 30 minutes to 2 hours after ingestion. Biotransformation It is metabolised in the liver and excreted in the urine mainly as a glucuronide and sulphate conjugates.

Less than 5 % is excreted as unchanged paracetamol.. A minor hydroxylated metabolite which is usually produced in very small amounts by mixed function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following paracetamol overdose and can cause liver damage.

EliminationElimination is essentially through the urine. 90% of the ingested dose is eliminated via the kidneys within 24 hours, principally as glucuronide (60 to 80%) and sulphate conjugates (20 to 30%). Less than 5% is eliminated in unchanged form.

Elimination half life is about 2 hours.

Renal Function Renal Insufficiency:

In cases of severe renal insufficiency (creatinine clearance lower than 10 ml/min) the elimination of paracetamol and its metabolites is delayed. Elderly Subjects The capacity for conjugation is not modified. 1 Pharmacodynamic properties Pharmacotherapeutic group: Analgesics, ATC code: N02BE01 Paracetamol: useful anti- has analgesic and antipyretic actions similar to Aspirin.

It has no inflammatory properties. 2 Pharmacokinetic properties Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as a glucuronide and sulphate conjugates.

Less than 5 % is excreted as unchanged paracetamol. The elimination half-life varies from about 1-4 hours. Plasma protein binding is negligible at usual therapeutic concentrations, but increases with increased concentration. A minor hydroxylated metabolite which is usually produced in very small amounts by mixed function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following paracetamol overdose and can cause liver damage.

Elimination is essentially through the urine. 90% of the ingested dose is eliminated via the kidneys within 24 hours, principally as glucuronide (60 to 80%) and sulphate conjugates (20 to 30%). Less than 5% is eliminated in unchanged form.

Elimination half life is about 2 hours.

Renal Insufficiency:

In cases of severe renal insufficiency (creatinine clearance lower than 10 ml/min) the elimination of paracetamol and its metabolites is delayed. Elderly Subjects. The capacity for conjugation is not modified. 3 Preclinical safety data In animal studies investigating the acute, sub chronic and chronic toxicity of paracetamol in the rat and mouse, […]

i. Do not exceed the stated dose. ii. If you are receiving a course of medicinal treatment, consult your doctor or pharmacist. iii. Contains paracetamol. iv. Do not take with any other paracetamol containing-products v. 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.

vi. The hazards of overdose are greater in those with non- cirrhotic alcoholic liver disease. Caution should be exercised in cases of chronic alcoholism. The daily dose should not exceed 2 grams in such case. Alcohol should not be used during the treatment with Paracetamol.

vii. Prolonged or frequent use is discouraged viii. Caution is advised in the administration of Paracetamol to patients with moderate and severe renal insufficiency, mild to moderate hepatic insufficiency (including Gilbert’s syndrome), severe hepatic insufficiency (child-pugh>9), acute hepatitis, concomitant treatment with medicinal products affecting hepatic functions, glucose- 6-phosphatedehydrogenase deficiency, hemolytic anemia, alcohol abuse dehydration and chronic malnutrition ix.

In the case of high fever, or signs of secondary infection or persistence of symptoms a doctor should be consulted. x. 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 underlying cause of HAGMA in patients with multiple risk factors.

Important information regarding the ingredients of this medicineSucrose:

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase- isomaltase insufficiency should not take this medicine. 04 % of the WHO recommended maximum daily intake of 2g sodium for an adult.

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