SOLPADEINE ONE

Posology This presentation is reserved for use in adults and in adolescents over 50kg of body weight aged 16 years and above. w. for total daily dose. Adults and adolescents (aged 16 years and above) > 50 kg of body weight Take one tablet (1000 mg) every four to six hours, upto a maximum of 3 tablets (3000 mg) in 24 hours.

Maximum daily dose: • The maximum daily dose of Paracetamol must not exceed 3000 mg. • Maximum single dose is 1000 mg (1 soluble tablet). Solpadeine One 1000 mg Soluble 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 Solpadeine One 1000 mg Soluble Tablets should not be given more frequently than every 6 hours, and not more than 3 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 500 mg every 6 hours < 10 ml/min 500 mg every 8 hours Paracetamol 1000 mg 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 60 mg/kg/day (upto maximum 2000 mg /day) in the following situations: • Adults weighing less than 50 kg • Mild to moderate hepatic insufficiency, Gilbert’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 medicinal product.

Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post- marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class and frequency.

The following convention has been utilised for the classification of the undesirable effects: 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).

Adverse event frequencies have been estimated from spontaneous reports received through post-marketing data. Body System Undesirable effect Frequency Immune system disorders Allergies (excluding angioedema) Rare Anaphylactic shock Hypersensitivity reaction (requiring discontinuation of treatment), Cutaneous hypersensitivity reactions including, among others, skin rashes and angiodema.

Very rare Respiratory, thoracic and mediastinal disorders Bronchospasm* Very rare edema of the larynx Unknown Erythema multiforme UnknownSkin and subcutaneous tissue disorders Pruritus rash sweating purpura urticaria Rare Leukopenia Pancytopenia Hemolytic anemia RareBlood and lymphatic system disorders Thrombocytopenia Agranulocytosis Very Rare Psychiatric disorders Depression NOS confusion hallucinations Rare Nervous system disorders Tremor NOS headache NOS Rare Eye disorders Abnormal vision Rare Cardiac disorders Oedema Rare Gastrointestinal disorders Haemorrhage NOS abdominal pain NOS diarrhoea NOS nausea vomiting Rare Hepatic failure hepatic necrosis jaundice RareHepatobiliary disorders Hepatotoxicity Hepatic dysfunction Very rare General disorders and administration site conditions Dizziness (excluding vertigo) malaise pyrexia sedation drug interaction NOS Rare Injury, poisoning and procedural complications Overdose and poisoning Rare Hypoglycaemia very rareMetabolism and nutrition disorders High anion gap metabolic acidosis Not known Renal and urinary disorders Sterile pyuria (cloudy urine) and renal side effects (Severe renal impairment, Haematuria, Anuria, Tubulointerstitial nephritis) very rare * There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

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). 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.

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. 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. Solpadeine One Tablets should not be administered in children and adolescents below 16 years of age and under 50 kg body weight.

76 % of the WHO recommended maximum daily intake for sodium. 28 % of the WHO recommended maximum daily intake for sodium. Solpadeine One Tablets is considered high in sodium. This should be particularly taken into account for those on a low salt diet.

• Hypersensitivity to Paracetamol, or any of the excipients.