Calpol | Calpol fastmelts | mild to moderate pain

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

Child's Age	How Much	How often (in 24 hours)
Under 6 years	Not recommended	N/A
6 - 9 years	1 tablet	4 times
9 - 12 years	2 tablets	4 times
12 – 16 years	2 to 3 tablets	4 times
Adults and children over 16 years	2 to 4 tablets	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

Use in the Elderly

Normal adult dosage is appropriate. However, a reduction in dosing may be necessary in frail, elderly subjects

Calpol Six Plus Fastmelts are contraindicated in patients with known hypersensitivity to paracetamol or any other ingredient and in subjects with phenylketonuria. Care is advised in the administration of paracetamol to patients with severe hepatic or severe renal impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Calpol Six Plus Fastmelts contain aspartame which is a source of phenylalanine equivalent to 0.04 mg/250 mg tablet. The phenylalanine in the tablets may be harmful to people with phenylketonuria. Calpol Six Plus Fastmelts contain mannitol which may have a mild laxative effect. The label should contain the following statements: Contains paracetamol. Do not give this medicine with any other paracetamol containing products. For oral use only Never give more medicine than shown in the table. 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 exceed the stated dose. If symptoms persist consult your doctor. 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). 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. Adverse effects of paracetamol are rare. Very rarelyhypersensitivity and anaphylactic reactions including skin rash may occur. 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. Nephrotoxicity following therapeutic doses of paracetamol is uncommon, but papillary necrosis has been reported after prolonged administration. Pharmacodynamic properties Paracetamol has analgesic and antipyretic effects similar to those of aspirin and is useful in the treatment of mild to moderate pain Pharmacokinetic properties 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 4 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.

Calpol Six Plus Fastmelts (pack of 12)