CALPOL SIX PLUS SUSPENSION

CALPOL SIX PLUS SUSPENSION contains

Paracetamol Ph Eur 250 mg per 5 ml.

Suspension for oral use.

Calpol Six Plus 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, sore throat, colds and influenza, aches and pains and post-immunisation fever.

Repeat every 4 hours if necessary up to a maximum of 4 doses per 24 hours.

Use in 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 is contra-indicated in patients with known hypersensitivity to paracetamol and/or any other constituents.

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.

CALPOL SIX PLUS suspension should not be diluted, where a dilution of CALPOL SIX PLUS suspension is prescribed, Calpol Infant suspension should be recommended.

Sorbitol may have a mild laxative effect. Each 5ml spoonful of this product contains 1.895g of sorbitol. It has a calorific value of 2.6kcal/g sorbitol.

The label shall contain 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 if necessary.

Do not give more than 4 doses in 24 hours.

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

Leave at least 4 hours between doses.

If your child is currently taking any other medicine consult your doctor or pharmacist before using this product.

Do not store above 25°C.

Store in the original package.

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.

None known

Adverse effects of paracetamol are rare. Very rarely hypersensitivity and anaphylactic reactions including skin rash may occur. There have been reports of blood dyscreasis including thrombocytopenia and agranulocystosis but these were not necessarily causality related to paracetamol.

Most reports of adverse reactions to paracetamol relate to overdosage 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.

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 had ingested around 7.5 g or more of paracetamol in the preceding 4 hours should undergo gastric lavage.

Administration of oral methionine or intravenous N-acetylcysteine which may have beneficial effect up to at least 48 hours after overdose, may be required. General supportive measures must be available

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, 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 10 g or more of paracetamol.

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.

Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal 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 overdosage 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.

Sucrose

Sorbitol Solution (E420)

Glycerol

Dispersible Cellulose

Polysorbate 80

Flavour, white sugar DA 13780

Flavour, Orange 510652E

Methyl Parahydroxybenzoate (E218)

F,D and C Yellow No. 6 Soluble/Sunset Yellow FCF (E110)

Purified Water

None known

36 months unopened

Do not store above 25°C

Store in the original package.

100 ml, 140 ml, 200 ml, 500 ml and 1000 ml amber glass bottle with plastic screw cap fitted with a polyethylene or polyvinylidene (PVDC) laminate faced wad,

or

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

and

10 x 5 ml Paper /aluminium foil/surlyn sachets

A spoon with a 5 ml measure is supplied with all packs of this product.

No special requirements.

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

UK

15513/0002

28 April 1997 / 04 Mar 2009

05 October 2009