McNeil Healthcare (Ireland) Ltd

CALPOL Six Plus Fastmelts 250 mg Paracetamol OrodispersibleTablets

Each tablet contains -

Paracetamol Ph Eur 250 mg

Excipients:

Aspartame (E951) 8mg

For full list of excipients, see section 6.1.

Orodispersible tablet (Tablet)

White, round, bi-convex tablets with central concave depression and a characteristic strawberry odour.

Calpol Six Plus Fastmelts are indicated for the treatment of mild to moderate pain such as headache, teething pain and sore throat, and as an antipyretic (e.g. fever associated with colds and flu).

Oral:

Tablets should be placed in the mouth where they melt on the tongue. The tablet will rapidly disperse to a pleasant tasting paste that can be easily ingested. Alternatively the tablet can be dispersed in a teaspoonful of water or milk.

Adults and children

Use in the Elderly

Normal adult dosage is appropriate. However, a reduction in dosing may be necessary in frail, elderly subjects (see Section 5.2).

Calpol Six Plus Fastmelts are contra-indicated in patients with known hypersensitivity to paracetamol and in subjects with phenylketonuria.

Calpol Six Plus Fastmelts should be used with caution in the presence of severe hepatic or renal dysfunction.

Patients should be advised not to exceed the recommended dose.

Patients should be advised not to take other paracetamol-containing products concurrently.

If symptoms persist, patients should consult a doctor.

The label shall contain the following statements:

Keep out of reach of children.

Dose up to 4 times a day if necessary.

Do not exceed the recommended dose.

Do not give more than 4 doses in 24 hours.

Do not repeat doses more frequently than 4 hourly.

Do not give for more than 3 days without consulting a doctor.

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

If symptoms persist consult your doctor.

Contains paracetamol.

Do not take with any other paracetamol containing products.

Immediate medical advice should be sought in the event of overdosage, even if the child seems well. Please read the enclosed Leaflet carefully.(label)

Immediate medical advice should be sought in the event of overdosage, because of the risk of irreversible liver damage (leaflet).

Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.

Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic paracetamol levels by increasing first pass metabolism or clearance.

Alcohol 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.

There is epidemiological evidence of safety of paracetamol in human pregnancy. Consequently, under normal conditions of use, paracetamol can be used during pregnancy.

A pharmacokinetic study in 12 nursing mothers revealed that less than 1% of the dose ingested by a nursing mother appears in human milk. Available data do not contraindicate breast-feeding.

None known

Paracetamol has been widely used for many years and when taken at the usual recommended dosage side effects are mild and infrequent and reports of adverse reactions are rare. Skin rashes and other allergic reactions occur rarely.

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

Isolated cases of thrombocytopenic purpura, haemolytic anaemia and agranulocytosis have been recorded.

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

Symptoms of paracetamol overdose 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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue.

Treatment

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 and any patient who has ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous n-acetylcysteine, which can have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

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 gastro-intestinal tract. Peak plasma concentrations are reached 30-90 minutes post dose.

Paracetamol is distributed rapidly throughout all tissues. Protein binding is low.

The plasma half-life is in the range of 1 to 3 hours after therapeutic doses.

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.

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.

Paracetamol is a well known constituent of medicinal products and its safety profile is well documented. The results of pre-clinical studies do not add anything of relevance for therapeutic purposes.

Not applicable

3 Years

This medicinal product does not require any special storage conditions.

Store in the original packaging.

Blister containing 12 tablets or 24 tablets (Polyamide/PVC/Aluminium).

No special requirements

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

PA 823/10/8

23^rd February 2001 / 23^rd February 2006

December 2011