Paracetamol Elixir Bp 120mg/5ml
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol Elixir B.P. 120mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains:
Paracetamol Elixir B.P. 120mg
3 PHARMACEUTICAL FORM
Elixir
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of mild to moderate pain, including headache, migraine, neuralgia, toothache, pain in teething, sore throat, aches and pains Symptomatic relief of influenza, feverishness, feverish colds.
4.2 Posology and method of administration
Children 3-12 months: 2.5ml to 5.0ml every four hours.
Children 1 year - under 6 years: 5.0 ml to 10.0ml every four hours Children 6 years - 12 years: 10.0ml to 20.0ml every four hours Dosage for children under 3 months is at Physicians discretion.
Not more than 4 doses should be administered in any 24-hour period.
Contraindications
4.3
Hypersensitivity to Paracetamol.
4.4 Special warnings and precautions for use
Renal Dysfunction or Diabetes. to patients asking other drugs that
more sensitive to the toxic effects
Use with caution in patients with Hepatic or Paracetamol should also be given with care effect the liver.
Occasionally malnourished patients may be of Paracetamol.
4.5 Interaction with other medicinal products and other forms of interaction
Drugs, which induce hepatic microsmal enzymes such as Alcohol, Barbiturates and Tricyclic Antidepressants, may increase the hepatotoxicity of Paracetamol particularly after overdosage.
Where Paracetamol is taken regularly or in high doses and Oral Anticoagulants such as Warfarin are administered concurrently, potentiation of the oral Anticoagulant may occur.
4.6 Pregnancy and lactation
There is an epidemiological evidence of the safety of Paracetamol in pregnancy. Smaller effective doses should be used.
There is no evidence of harm where Paracetamol is or has been taken during breastfeeding. However, in cases where Paracetamol has been taken by nursing mothers, significant amounts have been found in breast milk.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Side effects from Paracetamol administered n normal dose are rare. There have been isolated reports of Agranulocytosis, Methaemoglobinaemia and Thrombocytopenic Purpura, and after overdosage or prolonged administration isolated cases of Chronic Hepatic Necrosis, Acute Pancreatitis and Hephrotoxicity. Skin rashes and other allergic reactions occur occasionally.
4.9 Overdose
Overdosage should be treated promptly by gastric lavage followed by I.V.N-Acetylcysteine or oral Methionine since liver Damage following overdosagedose not become apparent for 1 t 6 days after ingestion. Initial mild symptoms consist of Nausea, Vomiting and Pallor. Measurements of the blood Paracetamol level and the time lapsed since ingestion is important in order to determine whether further therapy with N-Acetylcysteine is necessary.
The hepatic changes produced by overdosage of Parcetamol result from the accumulation of highly reactive intermediated metabolites and hepatocytes.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Analgesic and Antipyretic ATC code: N02BE01
Paracetamol has analgesic and antipyretic effects but has only weak antiinflammatory effects.
These actions are considered to be due to inhibition of the Biosynthesis of Prostaglandins.
5.2 Pharmacokinetic properties
Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 30minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged Parcetamol. The elimination half-life varies from 1-4 hours. Plasma protein binding is negligible at usual therapeutic concentrations but increase with increasing concentrations. A minor hyroxylated metabolite, which is usually produced in very small amounts by mixed function, oxidises in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following Paracetamol overdosage and cause liver damage.
Particularly no Paracetamol is excreted unchanged, and the bulk is excreted after hepatic conjugation with glucuronic acid (about 60%) sulphuric acid (about 35%) or cysteine (about 3%)
Children have less capacity for glucuronidation of the dugs than do adults. When high doses are ingested Paracetamol undergoes N-Hydroxylation t form (for further details see product licence file).
5.3 Preclinical safety data
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Alcohol 96%, Propylene Glycol, Potassium Sorbate, Sorbital, Glycerol, Saccharin Sodium, Raspberry Flavour (IFF 17.40.0478), Citric Acid Hydrated, Amaranth Ariavit 311801, Purified Water.
6.2 Incompatibilities
None stated.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 25°C. Keep the bottle tightly closed. Store in the original container.
6.5 Nature and contents of container
Amber glass bottles with ROPP cap, 60ml, 100ml, and 200ml.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
GlobeGen Laboratories Ltd,
1406 Coventry Road,
South Yardley,
Birmingham,
B25 8AE United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 41318/0038
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30 September 1996
10 DATE OF REVISION OF THE TEXT
21/10/2016