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BOOTS PARACETAMOL 6 YEARS PLUS 250MG/5ML ORAL SUSPENSION

Active substance(s): PARACETAMOL / PARACETAMOL / PARACETAMOL

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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.
Ingestion of lower doses equivalent to 5 g or more of paracetamol may lead to liver
damage if the patient has risk factors. These include if:


They are undergoing long-term treatment with drugs that induce liver
enzymes



They regularly consume ethanol in excess of advised amounts



They are likely to be glutathione deplete e.g. as in cystic fibrosis, eating
disorders, HIV infection, starvation, cachexia

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

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sorbitol solution (E420)
Glycerol
Dispersible cellulose (containing
carboxymethylcellulose)

microcrystalline

cellulose

and

sodium

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 25ºC. 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
11/01/2017

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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