Calpol Six Plus Sugar Free Suspension

Calpol Six Plus Sugar Free Suspension contains 250 mg Paracetamol Ph Eur in each 5 ml.

Suspension.

Calpol Six Plus Sugar Free 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.

4.2.1 Posology

Adults and children 12 years and over:

Oral. The optimal dosage range is 500 mg to 1 g paracetamol , ie. 10 to 20 ml Calpol Six Plus Sugar Free Suspension (maximum 1 g), which may be repeated every 4 hours to a maximum of 4 g paracetamol/day (80 ml Calpol Six Plus Sugar Free Suspension) .

Children aged 6 to 12 years:

Oral. 5 to 10 ml (250 mg to 500 mg paracetamol). Repeat every 4 hours, if necessary, up to a maximum of 4 doses per 24 hours.

Children under 6 years:

Not recommended.

Shake well before use.

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 Six Plus Sugar Free Suspension is contra-indicated 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 impairment or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Sorbitol and maltitol may have a mild laxative effect. Each 5 ml spoonful of this product contains 1.935 g sorbitol and 2.04g of maltitol.

Calorific values: 2.6 kcal/g sorbitol and 2.3 kcal/g maltitol.

The label contains the following statements:

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.

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

As with all medicines, if you are currently taking any medicine consult your doctor or pharmacist before taking 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 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.

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 dyscrasias including thrombocytopenia and agranulocystosis but these were not necessarily casually related to paracetamol.

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

Maltitol Liquid (E965)

Sorbitol Liquid (70% non crystallising) (E420)

Glycerol

Dispersible cellulose

Xanthan gum

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Acesulfame potassium

Polysorbate 80

Saccharin Sodium

Strawberry flavour 500286E

Strawberry Cream 11407-33

Purified water

None known

36 months for the bottles.

36 months for the sachets.

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

12 x 5 ml aluminium foil/polyethylene laminate sachets.

70 ml, 100 ml, 140 ml, 200 ml, 500 ml and 1000 ml amber glassbottle closed with a two-piece plastic child resistant, tamper evident closure fitted with a polyethylene or polvinylidine 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

or

Amber glass bottle closed with a plastic screw closure or metal roll-on pilfer proof closure fitted with a polyethylene or polyvinylidene chloride (PVDC) laminate faced wad.

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

No special requirements.

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

UK

PL 15513/0003

28.04.97 / 05/March/2009

05 October 2009