CALPOL Paediatric Suspension Sugar Free

CALPOL Paediatric Suspension Sugar Free contains 120 mg Paracetamol in each 5 ml.

Suspension.

CALPOL Paediatric Suspension Sugar Free is indicated for the treatment of pain (including teething pain), and as an antipyretic (including post immunisation fever).

Children aged 1 to under 6 years:

Oral. 5 to 10 ml (120 mg to 240 mg paracetamol). Repeat every 4 hours, if necessary, up to a maximum of 4 doses per 24 hours.

Infants 3 months to under 1 year:

Oral. 2.5 to 5 ml (60 mg to 120 mg paracetamol). Repeat every 4 hours, if necessary, up to a maximum of 4 doses per 24 hours.

Infants aged 2 -3 months:

Oral. A 2.5 ml (60 mg paracetamol) dose is suitable for babies who develop post- vaccination fever at 2 months followed, if necessary, by a second dose 4 to 6 hours later. The same 2 doses may be given for other causes of fever or mild to moderate pain provided the infant weighs over 4 kg and was not born before 37 weeks gestation. Medical advice should be sought promptly if further doses are required or if the cause of the infant's fever or pain is not known.

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.

CALPOL Paediatric Suspension Sugar Free is contraindicated in patients with known hypersensitivity to paracetamol, or any of the other components.

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.

Concomitant use of other paracetamol-containing products with CALPOL Infant Suspension Sugar/Colour Free could lead to paracetamol overdose and therefore should be avoided.

The label contains the following statements:

Shake the bottle thoroughly.

Do not exceed the stated dose.

If symptoms persist consult your doctor.

Keep out of the reach and sight of children.

Do not give with any other paracetamol containing products.

Dose: up to 4 times a day as necessary.

Do not give more than 2 doses. If further doses required consult your doctor (age: 2 months).

Do not give more than 4 doses in 24 hours. Do not give for more than 3 days without consulting a doctor (aged 3 months to 6 years). Leave at least 4 hours between doses.

As with all medicines, if your child is currently taking any other medicine consult your doctor or pharmacist before using this product.

Contains paracetamol.

Immediate medical advice should be sought in the event of an overdose, even if the child seems well. (label)

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. (leaflet)

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.

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 their 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.

No special comment - unlikely to produce an effect.

Adverse effects of paracetamol are rare, but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causality 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 the disease improved after paracetamol withdrawal.

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

Liver damage is possible in adults who have taken 10 g 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, phenobarbital, 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, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. 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 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 concentration 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 patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

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

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached 30-90 minutes post dose and the plasma half-life 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 overdose there is increased N-hydroxylation followed by glutathione conjugation. When the latter is exhausted, reaction with hepatic proteins is increased leading to necrosis.

The active ingredient of this product is a well known constituent of medicinal products and its safety profile is well documented.

Maltitol Liquid

Sorbitol solution (70% non crystallising)

Glycerol

Dispersible cellulose

Xanthan gum

Ethyl parahydroxybenzoate (E214)

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Polysorbate 80

Strawberry flavour

Carmoisine (E122)

Purified water

None known

36 months bottles, 24 months sachets

Do not store above 25°C. Store in the original container.

5 ml paper/PE/foil/surlyn sachets.

Amber glass bottle with a plastic screw cap, a polyethylene or polyvinylidene chloride (PVDC) laminate faced wad.

or

Amber glassed bottle with a two-piece plastic child resistant, tamper evident closure fitted with a polyethylene or polyvinylidene chloride (PVDC) laminate faced wad.

or

Amber glass bottle with a three piece plastic child resistant, tamper evident closure fitted with a polyethylene or polyvinylidene chloride (PVDC) laminate faced wad.

Pack sizes

100 ml and 1000 ml

1000 ml amber glass bottle with an aluminium cap fitted with a polyethylene wad.

None applicable.

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

UK

PL 15513/0008

28 April 1997 / 31^st March 2003

October 2007