CALPOL INFANT ORIGINAL

5ml. This dose may be given up to 4 times a day starting at the time of vaccination. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist.

Age : 2 – 3 months Dose Pain and other causes of fever - if your baby weighs over 4 kg and was born after 37 weeks • Do not give to babies less than 2 months of age. • Leave at least 4 hours between doses. • Do not give more than 2 doses.

This is to ensure that fever that may be due to a serious infection is quickly diagnosed. If your child is still feverish after two doses, talk to your doctor or pharmacist. 5 ml) 4 times 4 – 6 years 10 ml (5ml + 5 ml) 4 times • Do not give more than 4 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 It is important to shake the bottle for at least 10 seconds before use.

The Elderly:

In the elderly, the rate and extent of paracetamol absorption is normal but plasma half-life is longer and paracetamol clearance is lower than in young adults.

Adverse drug reactions (ADRs) identified during clinical trials and post- marketing experience with paracetamol are listed below by System Organ Class (SOC).

The frequencies are defined according to the following convention:

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 available data). ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available or 2) when incidence is unavailable, frequency category is listed as Not known.

System Organ Class (SOC) Frequency Adverse Drug Reaction (Preferred Term) Blood and lymphatic system disorders Not known Blood disorder (including thrombocytopenia and agranulocytosis) 1 Immune System Disorders Very rare Very rare Anaphylactic reaction Hypersensitivity Hepatobiliary disorders Not known Liver injury2 Skin and Subcutaneous Tissue disorders Very rare Not known Not known Not known Rash Fixed eruption Rash pruritic Urticaria Renal and urinary disorders Uncommon Not known Nephropathy toxic Renal papillary necrosis3 Investigations Not known Transaminases increased4 Metabolism and nutrition disorders Not known High anion gap metabolic acidosis 1 Reported following paracetamol use, but not necessarily causally related to the drug 2 Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year 3 Reported after prolonged administration 4 Low level transaminase elevations may occur in some patients taking therapeutic doses of paracetamol; these elevations are not accompanied with liver failure and usually resolve with continued therapy or discontinuation of paracetamol.

Very rare cases of serious skin reactions have been reported. Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods.

Do not exceed the recommended dose. Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help straight away. Quick medical attention is critical for adults as well as children even if signs and symptoms are not noticed.

Taking this product with other paracetamol-containing medicines could lead to overdose and should therefore be avoided. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment.

The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Chronic alcohol users should consult a doctor before use. 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.

Sorbitol may cause gastrointestinal discomfort and have a mild laxative effect. 45 g sorbitol liquid. 6 kcal/g sorbitol. Due to the presence of sucrose and sorbitol liquid (E420), patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Ethyl (E214), Propyl (E216) and Methyl (E218) parahydroxybenzoate may cause allergic reactions (possibly delayed). Carmoisine (E122) may cause allergic reactions. This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially ‘sodium-free’.

73 mg/ml. Caution in babies less than 4 weeks old. Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates. Patients should be informed about the signs of serious skin reactions and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

1.