DOZOL

Child’s Age How Much How often (in 24 hours) 6 – 8 years Two 5mL 3 times 8-10 years Three 5mL 3 times 10-12 years Four 5mL 3 times • Do not give more than 3 doses in any 24 hour period • Leave at least 4 hours between doses • Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist • Parents or carers should seek medical attention if the child’s condition deteriorates during treatment • Do not exceed the stated dose

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. Very rare cases of serious skin reactions have been reported. There have been a few reports of blood dyscrasias including thrombocytopoenia and agranulocytosis but these were not necessarily causally related to paracetamol.

Common side-effects:

CNS effects: Drowsiness (usually diminishes within a few days), paradoxical stimulation, headache, psychomotor impairment.

Antimuscarinic effects:

Urinary retention, dry mouth, blurred vision, gastrointestinal disturbances, thickened respiratory tract secretions.

Rare side-effects:

Hypotension, extrapyramidal effects, dizziness, confusion, depression, sleep disturbances, tremor, convulsions, palpitation, arrhythmia, hypersensitivity reactions, blood disorders and liver dysfunction. 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

1. Contains paracetamol 2. Do not exceed the stated dose. 3. Leave at least 4 hours between doses. 4. Do not give more than 3 doses in any 24 hour period. 5. Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist.

6. The product should be administered with caution to patients with known liver or renal impairment. The hazards of overdose are greater in those with alcoholic liver disease. 7. Keep out of the reach and sight of children. 8. This product may cause drowsiness.

Children receiving this medication should be kept under supervision. This product should not be used to sedate a child. 9. Do not give with any other paracetamol-containing products. 10. Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage.

11. Patients with rare hereditary problems of fructose intolerance should not take this medicine. 12. Sorbitol may have a mild laxative effect. 6 Kcal/g. 13. May cause alcohol like symptoms. 14. May cause allergic reactions (possibly delayed).

15. Do not take with any other cough and cold medicines. 16. As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this product. 17. Use with caution in prostatic hypertrophy, urinary retention, susceptibility to angle-closure, hepatic disease.

18. For oral use only. 19. Never give more medicine than shown in the table. 20. Always use the syringe supplied with the pack. 21. Do not store above 25ºC. Store in the original package. 22. Keep out of the reach and sight of children. 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.

Large doses of antihistamines may precipitate fits in epileptics. Hypersensitivity to the active substances or to any of the excipients. Not to be used in children under the age of six years. Monoamine inhibitors (MAOIs) or within 14 days of stopping treatment.