- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
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
|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|
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 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.
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
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
6.3 Shelf life
Amber glass bottles 3 yearsHigh 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 HealthcareBallymacarbryClonmelCo. TipperaryIreland
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
5th April 1991/28th May 2008
10. Date of revision of the text
Ballymacarby, Clonmel, Co. Tipperary, Co. Tipperary, Ireland
+ 353 52 6136311
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