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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

CALPOL Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

CALPOL Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension contains 120 mg Paracetamol in each 5 ml.

Excipients: maltitol liquid (E965), sorbitol liquid (E420), methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214) and propyl parahydroxybenzoate (E216). See section 4.4 for further information.

For full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Oral Suspension.

An off-white strawberry flavoured suspension.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

CALPOL Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension is indicated for the treatment of mild to moderate pain and as an antipyretic. It can be used in many conditions including headache, toothache, earache, teething, sore throat, colds and influenza, aches and pains and post-immunisation fever.

4.2    Posology and method of administration

Age : 2 - 3 months	Dose
1. Post-vaccination fever	2.5 ml If necessary, after 4-6 hours,
2. Other causes of Pain and Fever - if

Children aged 3 months - 6 years:

Child’s Age	How Much	How often (in 24 hours)
3 - 6 months	2.5 ml	4 times
6 - 24 months	5 ml	4 times
2 - 4 years	7.5 ml (5 ml + 2.5 ml)	4 times
4 - 6 years	10 ml (5 ml + 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 halflife is longer and paracetamol clearance is lower than in young adults.

4.3 Contraindications

CALPOL Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension is contraindicated in patients with known hypersensitivity to paracetamol, or any of the other components.

4.4 Special warnings and precautions for use

CALPOL Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension should be used with caution in severe renal impairment or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Concomitant use of other paracetamol-containing products should be avoided.

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).

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 reach and sight of children.

Do not store above 25°C. Keep bottle in outer carton.

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.

Talk to your doctor: If your child has an inherited intolerance to fructose or been diagnosed with an intolerance to some other sugars.

The sorbitol liquid (E420) and maltitol liquid (E965) content of this product means that this product is unsuitable for people with inherited intolerance to fructose.

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.

4.5 Interaction with other medicinal products and other forms of interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Chronic alcohol intake can increase the hepatotoxicity of paracetamol overdose and may have contributed to the acute pancreatitis reported in one patient who had taken an overdose of paracetamol. Acute alcohol intake may diminish an individual’s ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.

The use of drugs that induce hepatic microsomal enzymes, such as anticonvulsants and oral contraceptives, may increase the extent of metabolism of paracetamol, resulting in reduced plasma concentrations of the drug and a faster elimination rate.

4.6 Fertility, pregnancy and lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of the doctor regarding its use.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

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

Most reports of adverse reactions to paracetamol relate to overdose with the drug.

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.

Nephrotoxicity following therapeutic doses of paracetamol is uncommon, but papillary necrosis has been reported after prolonged administration.

Low level transaminase elevations may occur in some patients taking therapeutic doses of paracetamol; these are not accompanied with liver failure and usually resolve with continued therapy or discontinuation of paracetamol.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9 Overdose

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below)

Risk Factors:

If the patient

a)    Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes

OR

b)    Regularly consumes ethanol in excess of recommended amounts OR

c)    Is likely to be glutathione deplete e.g, eating disorders, cystic fibrosis, HIV infection, starvation, cachexia

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, hyperhidrosis, malaise, vomiting, anorexia, and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. This may include hepatomegaly, liver tenderness, jaundice, acute hepatic failure and hepatic necrosis. Abnormalities of glucose metabolism and metabolic acidosis may occur. Blood bilirubin, hepatic enzymes, INR, prothrombin time, blood phosphate and blood lactate may be increased. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentrations should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patient who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Paracetamol has analgesic and antipyretic effects similar to those of aspirin and is useful in the treatment of mild to moderate pain. It has only weak anti-inflammatory effects.

ATC Code: NO2 BE01 - Other analgesics and antipyretics.

5.2 Pharmacokinetic properties

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached 30-90 minutes post dose and the plasma halflife is in the range of 1 to 3 hours after therapeutic doses. Drug is widely distributed throughout most body fluids. Following therapeutic doses 90-100% of the drug is recovered in the urine within 24 hours almost entirely following hepatic conjugation with glucuronic acid (about 60%), sulphuric acid (about 35%) or cysteine (about 3%). Small amounts of hydroxylated and deacetylated metabolites have also been detected. Children have less capacity for glucuronidation of the drug than do adults. In overdosage there is increased N-hydroxylation followed by glutathione conjugation.

When the latter is exhausted, reaction with hepatic proteins is increased leading to necrosis.

5.3 Preclinical safety data

Mutagenicity

There are no studies relating to the mutagenic potential of CALPOL Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension.

In vivo mutagenicity tests of paracetamol in mammals are limited and show conflicting results. Therefore, there is insufficient information to determine whether paracetamol poses a mutagenic risk to man.

Paracetamol has been found to be non-mutagenic in bacterial mutagenicity assays, although a clear clastogenic effect has been observed in mammalian cells in vitro following exposure to paracetamol (3 and 10 mM for 2h).

Carcinogenicity

There are no studies to the carcinogenic potential of CALPOL Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension.

There is inadequate evidence to determine the carcinogenic potential of paracetamol in humans. A positive association between the use of paracetamol and cancer of the ureter (but not of other sites in the urinary tract) was observed in a case-control study in which approximate lifetime consumption of paracetamol (whether acute or chronic) was estimated. However, other similar studies have failed to demonstrate a statistically significant association between paracetamol and cancer of the urinary tract, or paracetamol and renal cell carcinoma.

There is limited evidence for the carcinogenicity of paracetamol in experimental animals. Liver cell tumours can be detected in rats following chronic feeding of 500 mg/kg/day paracetamol.

Teratogenicity

There is no information relating to the teratogenic potential of CALPOL Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension. In humans, paracetamol crosses the placenta and attains concentrations in the foetal circulation similar to those in the maternal circulation. Intermittent maternal ingestion of therapeutic doses of paracetamol are not associated with teratogenic effects in humans.

Paracetamol has been found to be foetotoxic to cultured rat embryo.

Fertility

There is no information relating to the effects of CALPOL Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension on fertility. A significant decrease in testicular weight was observed when male Sprague-Dawley rats were given daily high doses of paracetamol (500 mg/kg/body weight/day) orally for 70 days.

6.1 List of excipients

Maltitol liquid (E965)

Sorbitol liquid (non crystallising) (E420) Glycerol

Dispersible cellulose Xanthan gum

Ethyl parahydroxybenzoate (E214) Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Polysorbate 80 Strawberry Flavour 500286E Purified water

6.2 Incompatibilities

None known

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25°C. Keep bottle in the outer carton.

6.5 Nature and contents of container

Amber glass bottle with a two-piece white plastic child-resistant external cap, fitted with an inner plastic cap, including a tamper evident ring fitted with a polyethylene or polyvinylidene chloride (PVDC) polyethylene laminate faced wad.

Or

Amber glass bottle with a two-piece white plastic child-resistant external cap, fitted with an inner plastic cap, including a tamper evident ring, in high density polyethylene. The cap contains a plug made of Low Density Polyethylene (LDPE).