PANADOL

This medicine is suitable for adults and children aged 10 years and older. Children should not be given this medicine, for more than 3 days without consulting a doctor. Posology For adults and children aged 16 years and older, the usual dosage is 1 to 2 capsules (500-1000 mg) at a time, up to four times daily as required, with a maximum of 8 capsules (4000 mg) every 24 hours.

Paediatric population A suitable dosage form should be used. See the table below for doses for children. Age (years) Number of capsules at a time Frequency of dosing Maximum number of capsules per day Maximum daily dosage (mg) 10-15 1 up to four times daily as required 4 whole capsules 2000 ≥16 1-2 up to four times daily as required 8 whole capsules 4000 These doses should not be repeated more frequently than every four hours nor should more than four doses be given in any 24 hour period.

Instructions for use: • The treatment should be kept as short as possible. • The administration interval must be at least 4 hours. 9). • Do not use in combination with other paracetamol-containing products. • Depending on the recurrence of symptoms (fever and pain), repeated administration is allowed.

• If pain lasts for longer than 5 days or fever lasts for longer than 3 days or these symptoms become worse or if other symptoms occur, the treatment must be stopped, and a doctor must be consulted.

Method of administration:

Capsule The capsules should be swallowed with enough water. The intake of paracetamol with food or drink doesn’t influence the efficacy of the medicine.

• The recommended dose should not be exceeded. • Long-term or frequent use is not advised. • Patients must be advised not to use any other paracetamol-containing products at the same time. • In the case of a high fever, symptoms of secondary infection or the persistence of symptoms, it will be necessary to reconsider the treatment.

• The taking of several daily doses at once can cause severe damage to the liver. In such cases, a loss of consciousness will not occur. 9). Long-term use can be harmful except under medical supervision. • Caution is required when administering paracetamol to patients with moderate to severe renal insufficiency, mild to moderate hepatic insufficiency (incl.

Gilbert’s syndrome), severe hepatic insufficiency (Child-Pugh > 9), acute hepatitis, the concomitant administration of medicinal products which have an influence on hepatic function, glucose-6-phosphate dehydrogenase deficiency, haemolytic anaemia, alcohol abuse, dehydration and chronic malnutrition.

• The risk of an overdose is greater in patients with non-cirrhotic alcoholic liver conditions. Caution is required in the case of chronic alcoholism. The daily dose may not exceed 2 grams in this case. No alcohol may be used during treatment with paracetamol.

• Caution is required in the case of asthmatic patients who are sensitive to acetylsalicylic acid as mild bronchospasms have been reported as a cross-reaction after the use of paracetamol. • For children a treatment of 60 mg/kg/day of paracetamol combined with another antipyretic is not allowed, unless due to a lack of efficacy.

• After the long-term use (> 3 months) of analgesics with intake every other day or more frequently, headache can occur or become worse. Headache which is caused by the excessive use of analgesics (drug-dependent headache) must not be treated by increasing the dose.

In these cases, the use of analgesics must be stopped in consultation with a doctor. • Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day. 9). Use with caution in patients with glutathione depletion due to metabolic deficiencies.

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