Paracetamol Tablets Bp 500mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol Tablets BP 500 mg.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol Tablets BP 500 mg contain:
Paracetamol BP 500 mg.
3 PHARMACEUTICAL FORM
Tablets.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of pain in headache and menstruation and symptomatic relief of colds, flu and feverishness.
4.2 Posology and method of administration
Take every three to four hours when needed.
Adults: One to two tablets Maximum: Eight daily
Children 6-12 years Half to one tablet Maximum: Four daily
Children under six: On medical advice only.
4.3 Contraindications
Impaired kidney or liver function.
4.4 Special warnings and precautions for use
Do not exceed the stated dose. If you are taking any other medication or are under the care of your doctor you should consult him before using paracetamol. If symptoms persist, consult your doctor. Keep out of the reach of children.
Label: Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Leaflet: Immediate medical advice should be sought in the event of an overdose, even of you feel well, because of the risk of delayed, serious liver damage.
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 daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Alcohol, barbiturates, anticonvulsants and tricyclic anti-depressants may increase the hepatotoxicity of paracetamol, particularly after an overdose. Chloramphenicol -paracetamol may increase the half life.
4.6 Pregnancy and lactation
There is epidemiological evidence of the safety of Paracetamol in human pregnancy. It may, therefore be taken during human pregnancy. It may also be taken during lactation.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
If given in therapeutic doses, side effects are rare. Haematological reaction has been reported. Skin rashes and other allergic responses may occur occasionally. Most reports of adverse reaction to Paracetamol relate to overdose.
4.9 Overdose
An overdose should be treated as soon as possible (within 12 hours) as liver damage from an overdose does not become apparent for one to six days after ingestion. Initial symptoms include pallor, nausea, vomiting, anorexia and abdominal pain. After gastric lavage, a suitable antidote such as acetylcysteine or methionine should be given. Acetylcysteine is given by intravenous infusion in an initial dose of 150 mg/kg body weight over 15 minutes, followed by 50 mg/kg over four hours, and then by 100 mg/kg over the next 16 hours. Alternatively, Methionine 2.5G may be given by mouth every four hours to a total of four doses. The blood Paracetamol levels should be monitored to determine whether further therapy is necessary.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Analgesic and antipyretic.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber additional to that covered in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Starch, Maize BP
Sodium Starch Glycollate BP Magnesium Stearate BP Potassium Sorbate BP Pregelatinized Maize Starch BP
6.2 Incompatibilities
None stated.
6.3 Shelf life
Five years
6.4 Special precautions for storage
None stated.
6.5 Nature and contents of container
Round white polypropylene container that is child resistant and tamper evident containing 50 tablets in 50 ml size and 100 tablets in 100 ml. size.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Ayrton Saunders Limited Ayrton House,
Commerce Way,
Parliament Business Park,
Liverpool,
L8 7BA
8 MARKETING AUTHORISATION NUMBER(S)
PL 16431/0172
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of First Authorisation: 14-Dec-1981
10 DATE OF REVISION OF THE TEXT