SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Boots Paracetamol 6 Years Plus 250mg/5ml Oral Suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients    Per 5 ml

Paracetamol    250 mg

Excipients:

Sorbitol solution (E420)    1.5    ml

Methyl hydroxybenzoate (E218)    7.5 mg

See section 4.4 for further information.

For a full list of excipients, see Section 6.1

3    PHARMACEUTICAL FORM

Oral Suspension

An off-white, strawberry-flavoured, syrupy suspension.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

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    Posology and method of administration

For oral use only.

It is important to shake the bottle for at least 10 seconds before use.

Children aged 6 to 12 years:

Child’s Age	How Much	How Often (in 24 hours)
6-8 years	5 ml	4 times
8-10 years	7.5 ml	4 times
10-12 years	10 ml	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. Do not give to children under the age of 6 years.

Children aged 12-16 years: 10-15 ml up to 4 times a day.

Adults and children over 16 years: 10-20 ml up to 4 times a day.

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.

4.3 Contraindications

Hypersensitivity to paracetamol or any of the other ingredients.

4.4 Special warnings and precautions for use

Caution in patients with severe renal impairment or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Sorbitol may have a mild laxative effect. Each 5 ml spoonful of this product contains 1.1 g sorbitol.

Calorific values: 3kcal/g sorbitol.

The label will state:

Do not give anything else containing paracetamol while giving this medicine.

Do not give more medicine than the label tells you to.

If your child does not get better, talk to their doctor.

Talk to a doctor at once if your child takes too much of this medicine, even if they seem well

Keep out of the reach and sight of children.

The label should convey the following information:

For oral use only.

Never give more medicine than shown in the table.

Always use the syringe supplied with the pack.

Do not give to children under 6 years of age.

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 medicine consult your doctor or pharmacist before giving this product.

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

Shake the bottle for at least 10 seconds before use.

The leaflet will state:

Talk to a doctor at once if your child takes too much of this medicine even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage

This product contains sorbitol, patients with rare hereditary problems of fructose intolerance should not take this medicine.

Methyl hydroxybenzoate (E218) may cause allergic reactions (possibly delayed).

4.5 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 cholestyramine.

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.

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 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.

4.6 Fertility, Pregnancy and Lactation

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.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Adverse effects of paracetamol are rare. Very rarely hypersensitivity and anaphylactic reactions including skin rash may occur.

Very rare cases of serious skin reactions have been reported.

There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally 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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

4.9 Overdose

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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC code: N02BE01

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.

5.2 Pharmacokinetic properties

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached 30-90 minutes post dose and the plasma halflife 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.

5.3 Preclinical safety data

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

6.1 List of excipients

Sorbitol solution (E420)

Glycerol

Dispersible cellulose (containing microcrystalline cellulose and sodium carboxymethylcellulose)

Hydroxyethylcellulose

Acesulfame potassium

Methyl hydroxybenzoate (E218)

Strawberry flavour ABJH9 (containing benzyl alcohol, ethyl benzoate, propylene glycol)

Cream flavour ACP3P (containing propylene glycol)

Purified water

6.2 Incompatibilities

None known.

6.3    Shelf life

24 months

6.4    Special precautions for storage

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

6.5    Nature and contents of container

70ml or 80ml amber PET bottle with polypropylene child resistant closure with expanded polyethylene liner or polyethylene plug.

Syringe composed of a natural polypropylene barrel and a polyethylene pigmented white plunger.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA

Trading as BCM

8    MARKETING AUTHORISATION NUMBER(S)

PL00014/0860

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

05/11/2012

10    DATE OF REVISION OF THE TEXT

14/10/2015