ALTRIDEXAMOL

This presentation is reserved for use in adults and in adolescents aged 16 years and above. Maximum daily dose: • The maximum daily dose of Paracetamol must not exceed 4000mg. • Maximum single dose is 1000mg (1 effervescent tablet). Paracetamol 1000mg Effervescent Tablets are for oral administration.

The tablets should be placed in a full tumbler of water immediately before use and allowed to dissolve completely before swallowing.

Frequency of administration:

Doses of Paracetamol 1000mg Effervescent Tablets should not be given more frequently than every 6 hours, and not more than 4 doses should be given in any 24 hour period.

Renal insufficiency:

In case of renal insufficiency the dose should be reduced: Glomerular filtration rate Dose 10 - 50 ml/min 500mg every 6 hours <10 ml/min 500mg every 8 hours Paracetamol 1000mg Tablets are not suitable for patients with renal and hepatic insufficiency when reduced dose is required.

More appropriate pharmaceutical forms are available in the market for use.

Hepatic insufficiency:

In patients with impaired hepatic or Gilbert’s syndrome, the dose must be reduced or the dosing interval prolonged. The daily effective dose should not exceed 60mg/kg/day (up to maximum 2000mg/day) in the following situations: • Adults weighing less than 50 kg • Mild to moderate hepatic insufficiency, Gilbel1's syndrome (familial non- haemolytic jaundice) • Dehydration • Chronic malnutrition • Chronic alcoholism Intake of paracetamol with food and drink does not affect the efficacy of the medical product.

The frequency using the following convention should be: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (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, agranulocytosis, leucopenia, thrombocytopenia, haemolytic, naemia, pancytopenia 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. Rare >1/10000 - < 1/1000 Gastrointestinal disorders Haemorrhage NOS, abdominal pain NOS, dianhoea NOS, nausea, vomiting.

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

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Interstitial nephritis has been reported incidentally after prolonged use of high doses. Some cases of epidermal necrolysis, Stevens Johnson syndrome, erythema multiforme, edema of the larynx, anaphylactic shock.

anemia. liver alteration and hepatitis, renal alteration (severe renal impairment, haematuria, anuresis), gastro intestinal effects and vertigo have been reported. 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.

Prolonged or frequent use is discouraged. Patients should be advised not to take other Paracetamol containing products concurrently. Taking multiple daily doses in one administration can severely damage the liver; in such case unconsciousness does not occur.

However, medical assistance should be sought immediately. Prolonged use except under medical supervision may be harmful. In children treated with 60mg/kg daily of Paracetamol, the combination with another antipyretic is not justified except in the case of ineffectiveness.

Caution is advised in the administration of Paracetamol to patients with moderate and severe renal insufficiency, mild to moderate hepatocellular insufficiency (including Gilbelt's syndrome), severe hepatic insufficiency (Child-Pugh >9), acute hepatitis, concomitant treatment with medicinal products affecting hepatic functions, glucose-6-phosphatedehydrogenase deficiency, haemolytic anaemia, dehydration.

2). 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 2000 mg in such case. Alcohol should not be used during the treatment with Paracetamol.

"Caution is advised in asthmatic patients sensitive to aspirin, because light reaction bronchospasm with paracetamol (cross-reaction) has been reported in less than 5% of the patients tested" Abrupt discontinuation of long term use of high-dosed analgesics, taken not as directed, may cause headache, tiredness, muscular pain, nervousness and vegetative symptoms.

The withdrawal symptoms subside within a few days. Patients should be advised to consult their doctor if headaches become persistent. Paracetamol Effervescent Tablets should not be administered in children and adolescents below 16 years of age and under 50 kg body weight.

This medicinal product contains 438 mg of sodium per tablet. To be taken into consideration by patients on a controlled sodium diet. Do not exceed the stated dose. If symptoms persist consult a doctor. Treatment with an antidote is advised if an overdose is suspected.

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.

• Hypersensitivity to Paracetamol, or any of the excipients.