Paracetamol 500mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500.00 mg of Paracetamol BP
3 PHARMACEUTICAL FORM
Tablet
White, capsule-shaped tablets, plain on one side and with a breakline on the other side.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Paracetamol is indicated for the relief of headaches, migraine, neuralgia, rheumatic aches and pains.
For the relief of colds and influenza.
4.2 Posology and method of administration
Adults, the elderly and children 16 years and over: Take one or two tablets up to 4 times a day.
Children 10 to 15 years of age: Take one tablet up to 4 times a day.
Not recommended for children under 10 years of age
The dose should not be repeated more frequently than every 4 hours and not more than 4 doses should be taken in any 24 hour period.
Route of administration: Oral
4.3 Contraindications
Hypersensitivity to paracetamol and/or other constituents.
4.4 Special warnings and precautions for use
Not recommended for children under 6 years of age.
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.
Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.
Keep out of the reach and sight of children.
Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.
Do not take anything else containing paracetamol while taking 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 colestyramine.
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
4.8 Undesirable effects
The information below lists reported adverse reactions, ranked using the following frequency classification:
Very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Immune system disorders
Hypersensitivity including skin rash may occur.
Not known: anaphylactic shock, angioedema Blood and lymphatic system disorders
Not known: blood dyscrasias including thrombocytopenia and agranulocytosis Skin and subcutaneous disorders
Very rare cases of serious skin reactions such as Toxic Epidermal Necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalised exanthematous pustulosis, fixed drug eruption have been reported.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk factors:
If the patient:
a, is on long term treatment with carbamazepine, Phenobarbital, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
Or
b, regularly consumes ethanol in excess of recommended amounts.
Or
c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
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, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
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 medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage.
Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital.
Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC code: N02B E01, Other analgesics and antipyretics
Paracetamol is an analgesic with antipyretic properties, but has only weak antiinflammatory properties. The mechanism of analgesic action has not been fully determined. It acts by inhibiting prostaglandin syntheses in the central nervous system (CNS) and through a peripheral action by blocking pain-impulse generation. The peripheral action may also be due to inhibition of the synthesis of prostaglandins or to inhibition of the synthesis or actions of other substances, which sensitise pain receptors to mechanical or chemical stimulation.
Paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat-regulating centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus. The drug has no effect on the cardiovascular and respiratory systems, and unlike salicylates it does not cause gastric irritation or bleeding.
5.2 Pharmacokinetic properties
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract following oral administration. Peak plasma concentrations are attained within 30-60 minutes and the half-life in plasma is about 2 hours following therapeutic doses. The duration of action is 3-4 hours. Protein binding of paracetamol is variable; 20-50% may be bound at concentrations encountered during acute intoxication. It is relatively uniformly distributed throughout the body fluids. Approximately 90-95% of the drug is metabolised in the liver primarily by conjugation with glucuronic acid, sulphuric acid and cysteine. When high doses are ingested, paracetamol undergoes N-hydroxylation to form N-acetyl-benzo-quinonethine, a highly reactive intermediate. This metabolite reacts with sulphydryl groups in proteins and glutathione. When hepatic glutathione is depleted (following overdosage) reaction with hepatic proteins is increased and hepatic necrosis results. Paracetamol is excreted by the kidneys primarily as conjugates, about 3% of the dose is excreted unchanged.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Maize starch BP Povidone BP
Pregelatinised maize starch BP Potable water
Sodium starch glycollate BP Magnesium stearate BP
6.2 Incompatibilities
Shelf life
6.3
5 years
6.4 Special precautions for storage
Keep out of the reach and sight of children Protect from heat, light and moisture
6.5 Nature and contents of container
1) Opaque plastic containers with tamper-evident or tamper-evident child-resistant closures.
2) Blister packs of 20pm hard aluminium foil laminated to 15 pm rigid PVC film, and 250pm white opaque PVC.
Contents: 10, 12, 14 and 16 tablets.
6.6 Special precautions for disposal
No special instructions for use/handling.
7 MARKETING AUTHORISATION HOLDER
Bell Sons & Co (Druggists) Ltd
Gifford House
Slaidburn Crescent
Southport
Merseyside
PR9 9AL
8 MARKETING AUTHORISATION NUMBER(S)
PL 03105/0087
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/04/2010
10 DATE OF REVISION OF THE TEXT
21/11/2016