Paracetamol 500mg Tablets
Summary of Product Characteristics
1 Name of the medicinal product
Paracetamol 500 mg Caplets Paracetamol 500 mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500.00 mg of Paracetamol BP
3 PHARMACEUTICAL FORM
White, capsule shaped tablets, plain on one side and with a breakline on the other side.
The tablet or caplet can be divided into equal doses.
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
Unless otherwise directed by the doctor:
Posology
Adults, the elderly and children 16 years and over: One or two tablets every 4 - 6 hours when necessary to a maximum of 4 doses in 24 hours.
Paediatric population
Children 12 to15 years: One to one and a half tablets every 4 - 6 hours when necessary to a maximum of 4 doses in 24 hours.
Children 10 to 12 years: One tablet every 4 - 6 hours when necessary to a maximum of 4 doses in 24 hours.
Children 6 to 10 years: Half a tablet every 4 - 6 hours when necessary to a maximum of 4 doses in 24 hours.
Not recommended for children under 6 years.
Method of administration
For oral use. To be swallowed with some water.
4.3. Contra-Indications
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.
Do not exceed the recommended dose.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
Immediate medical advice should be sought in the event of an overdose even if you feel well, because of the risk of delayed serious liver damage.
Do not take with any other paracetamol-containing products.
4.5
Interaction with other medicinal products and other forms of interactions
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 Use during 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
None reported.
4.8 Undesirable effects
Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive postmarketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but postmarketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.
|
Body System |
Undesirable effect |
|
Blood and lymphatic system disorders |
Thrombocytopenia Agranulocytosis |
|
Immune system disorders |
Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema |
|
Respiratory, thoracic and mediastinal |
Bronchospasm* |
|
disorders | |
|
Hepatobiliary disorders |
Hepatic dysfunction |
|
Skin and subcutaneous tissue disorders |
Very rare cases of serious skin reactions have been reported |
* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
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 symptoms, emergency procedures, antidotes
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 h from ingestion should be discussed with the NPIS or a liver unit.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Paracetamol is an analgesic with antipyretic properties. The mechanism of analgesic action has not been fully determined. It acts by inhibiting prostaglandin synthesis 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 of 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 involved inhibition of prostaglandin synthesis in the hypothalamus.
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 Povidone
Pregelatinised maize starch Sodium starch glycollate Magnesium stearate
6.2. Incompatibilities
None reported.
6.3.
Shelf Life
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 20 pm hard aluminium foil laminated to 15 pm rigid PVC film, and 250 pm white opaque PVC.
Contents: 25, 100, 250, 500, 1000 tablets.
6.6. Instruction for Use/Handling
No special instructions for use/handling.
7. MARKETING AUTHORISATION HOLDER
Cresent Pharma Limited
Units 3 & 4, Quidhampton Business Units
Polhampton Lane
Overton
Hants, RG25 3ED United Kingdom
PL 20416/0123
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10
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
03/03/2009
DATE OF REVISION OF THE TEXT
05/11/2016