SUMMARY OF PRODUCT CHARACTERISTICS

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

Age	Dose
For post-vaccination fever for babies aged between 2 - 3 months	One 2.5 ml spoonful (small end) If necessary, after 4-6 hours, give a second 2.5 ml dose
•    Do not give to babies less than 2 months of age •    Do not give more than 2 doses •    Leave at least 4 hours between doses •    If further doses are needed, talk to your doctor or pharmacist

Child’s Age	How Much	How often (in 24 hours)
3 - 6 months	One 2.5 ml spoonful (small end)	4 times
6 - 24 months	One 5 ml spoonful (large end)	4 times
2 - 4 years	One 5.0 ml spoonful (large end) and one 2.5 ml spoonful (small end)	4 times
4 - 8 years	Two 5 ml spoonfuls (large end)	4 times
8 - 10 years	Three 5 ml spoonfuls (large end)	4 times
10 - 12 years	Four 5 ml spoonfuls (large end)	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

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 noncirrhotic 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 to babies less than 2 months of age.

•    For infants 2-3 months no more than 2 doses should be given.

•    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 taking this product.

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

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

•    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).

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.

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 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 attention and any patient who has ingested around 7.5g 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 10g 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

Not stated

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

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

6.6    Special precautions for disposal

Do not refrigerate

7    MARKETING AUTHORISATION HOLDER

Pinewood Laboratories Ltd

Trading as Pinewood Healthcare

Ballymacarbry

Clonmel

Co. Tipperary

Ireland

8    MARKETING AUTHORISATION NUMBER

PL 04917/0008

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

05/04/1991 /    16/10/2003

10 DATE OF REVISION OF THE TEXT

25/07/2014