This information is intended for use by health professionals

1. Name of the medicinal product

Paediatric Paracetamol Elixir BP

2. Qualitative and quantitative composition

Each 5ml contains Paracetamol BP 120mg

3. Pharmaceutical form

Oral solution: Pale clear to slightly opalescent yellow, viscous liquid with an odour and taste of banana.

4. Clinical particulars
4.1 Therapeutic indications

For the treatment of mild to moderate pain, anti-pyretic and post immunisation pyrexia.

4.2 Posology and method of administration

Children aged 3 months – 6 years:

Child's Age

How Much

How often

(in 24 hours)

3 – 6 months

2.5 ml

4 times

6 – 24 months

5 ml

4 times

2 – 4 years

7.5 ml (5 ml + 2.5 ml)

4 times

4 –6 years

10 ml (5 ml + 5 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

Babies over 2 months in age

For the relief of fever after vaccination at 2, 3 and 4 months

2.5ml. This dose may be given up to 4 times a day at the time of vaccination. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist.

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

4.3 Contraindications

Hypersensitivity to paracetamol and/or other constituents.

4.4 Special warnings and precautions for use

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.

The label should contain the following statements:

• Contains paracetamol.

• Do not give this medicine with any other paracetamol-containing product.

• For oral use only.

• Never give more medicine than shown in the table.

• Do not overfill the spoon.

• Always use the spoon supplied with the pack.

• 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.

• If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist (leaflet).

• As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this product.

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

• Keep all medicines out of the sight and reach of children

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

• 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 (leaflet).

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

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.

4.6 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. A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.

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

No effects are known.

4.8 Undesirable effects

Very rare cases of serious skin reactions have been reported. Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these are not necessarily causally related to paracetamol.

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 or search for the MHRA Yellow Card in Google Play or Apple App store.

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 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 a beneficial effect up to at least 48 hours after the 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

Paracetamol has analgesic and anti-pyretic properties but no anti-inflammatory properties except at very high doses. Paracetamol inhibits prostaglandin synthesis, more centrally than peripherally.

5.2 Pharmacokinetic properties

Paracetamol is rapidly absorbed from the upper gastrointestinal tract after oral administration.

It is rapidly distributed throughout the body and is primarily metabolised in the liver. About 85% is conjugated with glucuronide and sulphate and about 10% is conjugated with glutathione.

Excretion of the biotransformation products is via the kidney. The elimination half life is approximately 2-3 hours.

In overdose glucuronide pathways become saturated and excess paracetamol is metabolised via the glutathione pathway. Hepatic glutathione is rapidly depleted and an intermediate hydroxylamine metabolite accumulates and binds to liver proteins causing irreversible damage.

5.3 Preclinical safety data

Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.

6. Pharmaceutical particulars
6.1 List of excipients

Ethanol 96%

Propylene Glycol

Glycerol (E422)

Sorbitol Solution 70%

Acesulfame K

Saccharin Sodium (E954)

Xanthan Gum

Quinoline yellow (E104)

Banana Liquid Flavour

Sodium Citrate

Citric Acid

Purified Water

6.2 Incompatibilities

None known

6.3 Shelf life

Amber glass bottles – 3 years

High density polyethylene bottles – 2 years

6.4 Special precautions for storage

Warning: Do not refrigerate. Do not store above 25°C. Store in the original container.

6.5 Nature and contents of container

Amber Glass bottles: 70 ml, 100 ml, 150 ml, 200 ml, 500 ml, 1L and 2L with pilfer proof screw cap.

Virgin HDPE bottles: 500 ml, 1L and 2L with tamper evident screw cap.

6.6 Special precautions for disposal and other handling

Do not refrigerate.

7. Marketing authorisation holder

Pinewood Laboratories Ltd., trading as Pinewood Healthcare



Co. Tipperary


8. Marketing authorisation number(s)

PL 04917/0008

9. Date of first authorisation/renewal of the authorisation

5th April 1991/28th May 2008

10. Date of revision of the text