SOLPAONE

Posology Paediatric population • Dose depends on body weight and age. A single dose ranges from 10 to 15 mg/kg bodyweight. The maximum total daily dose is 60 mg/kg body weight. • Children and adolescents below 16 years of age: this product is not recommended in patients aged less than 16 years.

• Adolescents of 16 to 18 years and weighing more than 50 kg: as adults. Adults For adults and adolescents weighing more than 50 kg (aged 16 years and older) the usual single dose is 1 tablet at a time, to be repeated every 6 hours as needed, the maximum being 4 tablets per day (paracetamol 4000 mg per 24 hours).

Paracetamol 1000mg tablets are not suitable for patients weighing less than 50 kg. e. 500 mg tablets) are available on the market for use. Renal impairment It is recommended, when giving paracetamol to patients with renal impairment, to reduce the dose and to increase the minimum interval between each administration to at least 6 hours unless directed otherwise by a physician.

See Table below.

Adults:

Glomerular filtration rate Dose 10-50 ml/min 500 mg every 6 hours < 10 ml/min 500 mg every 8 hours Paracetamol 1000 mg tablets are not suitable for patients with renal insufficiency when reduced dose is required. e. 500 mg tablets) are available in the market for use.

Hepatic impairment In patients with hepatic impairment or Gilbert´s Syndrome, the dose should be reduced or the dosing interval prolonged. Paracetamol 1000 mg tablets are not suitable for patients with hepatic insufficiency when reduced dose is required.

e. 500 mg tablets) are available in the market for use. daily dose should not exceed 2g/day unless directed by a physician. The Elderly 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.

The maximum daily dose should not exceed 60mg/kg/day (up to a maximum of 2g per day) in the following situations, unless directed by a physician: • Weight less than 50kg • Chronic alcoholism • Dehydration • Chronic malnutrition Method of administration Oral use.

Place the tablets in a full tumbler of water and allow to dissolve completely before swallowing. After dissolving the tablets, a slightly opalescent solution will be produced.

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 anaemia, pancytopenia, methaemoglobenaemia Immune system disorders Allergies (excluding angioedema).

Psychiatric disorders Depression NOS, confusion, hallucinations. Nervous system disorders Tremor NOS, headache NOS. Eye disorders Abnormal vision. Rare >1/10000 - < 1/1000 Cardiac disorders Oedema. Gastrointestinal disorders Haemorrhage NOS, abdominal pain NOS, diarrhoea NOS, nausea, vomiting.

Hepato-biliary disorders Abnormal 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.

Injury, poisoning and procedural complications Overdose and poisoning Frequency System Symptoms Very Rare (< 10,000) Respiratory, thoracic and mediastinal disorders Bronchospasm Hepato-biliary disorders hepatotoxicity General disorders and administration site conditions hypersensitivity reaction (requiring discontinuation of treatment) Metabolism and nutrition disorders Hypoglycemia Renal and urinary disorders Sterile pyuria (cloudy urine) and renal side effects Skin and subcutaneous disorders Very rare cases of serious skin reactions have been reported.

Not known (cannot be estimated from the available data) Metabolism and nutrition disorders High anion gap metabolic acidosis 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.

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.

2). Alcohol usage 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 (acetylsalicylic acid), because light reaction bronchospasm with paracetamol (cross reaction) has been reported in less than 5% of the patients tested" Other medications and withdrawal: 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. Cases of paracetamol induced hepatotoxicity, including fatal cases, have been reported in patients taking paracetamol at doses within the therapeutic range.

These cases were reported in patients with one or more risk factors for hepatotoxicity including low body weight (<50 Kg), renal and hepatic impairment, chronic alcoholism, concomitant intake of hepatotoxic drugs, sepsis and in acute and chronic malnutrition (low reserves of hepatic glutathione).

Paracetamol should be administered with caution to patients with these risk factors. g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.

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