CALPOL SUGAR FREE INFANT

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 (5 ml + 5ml) 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 Anaphylactic reaction Very rare Hypersensitivity Hepatobiliary disorders Not known Liver injury2 Skin and Subcutaneous Very rare Rash Tissue disorders Not known Fixed eruption Not known Rash pruritic Not known Urticaria Uncommon Nephropathy toxicRenal and urinary disorders Not known 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.

A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of their disease improved after paracetamol withdrawal.

High anion gap metabolic acidosis. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 or 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 and maltitol may cause gastrointestinal discomfort and have a mild laxative effect. 72 g of maltitol liquid. 3 kcal/g maltitol. Due to the presence of maltitol liquid (E965) and sorbitol liquid (E420), patients with rare hereditary problems of fructose intolerance 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’.

86 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. 03 mg/ml. Benzyl alcohol may cause allergic reactions. Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (“gasping syndrome”) in young children.

Caution in newborn babies (up to 4 weeks old). Caution in children under 3 years old; do not use for more than 1 week due to increased risk due to accumulation. Ask your doctor or pharmacist for advice if you are pregnant or breastfeeding, or if you have a liver or kidney disease.

This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called "metabolic acidosis") 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.

The label contains the following statements:

Contains paracetamol. Do not give anything else containing paracetamol while giving this medicine. Do not give more medicine than the label tells you to. If your child does not get better, talk to your doctor. For oral use only. Always use the syringe supplied with the pack.

Do not give to babies less than 2 months of age. For infants 2-3 months no more than 2 doses should be given. 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.

As with all medicines, if your child is currently taking any other medicine consult your doctor or pharmacist before using this product. Keep out of the sight and reach of children. Do not store above 25°C. Keep bottle in the outer carton.

It is important to shake the bottle for at least 10 seconds before use. Talk to a doctor at once if your child takes too much of this medicine, even if they seem well.

The leaflet contains the following statements:

Talk to a doctor at once if your child takes too much of this medicine, even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage. Very rare cases of serious skin reactions have been reported.

Symptoms may include: - Skin reddening - Blisters - Rash If skin reactions occur or existing skin symptoms worsen, stop use and seek medical help right away.

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