Paracetamol Tablets Bp 500mg
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1. NAME OF THE MEDICINAL PRODUCT
Paracetamol Tablets BP 500mg, and Mandanol Paracetamol 500.
Paracetamol 500mg Caplets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: Paracetamol BP 500mg.
3. PHARMACEUTICAL FORM
Compressed tablet.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Paracetamol is a mild analgesic and antipyretic.
It is indicated in the treatment of most painful and febrile conditions, for example, headache, toothache, colds, influenza, rheumatic pain, dysmenorrhoea, sore throat, migraine, muscular aches and pains and neuralgia.
4.2 Posology and method of administration
This preparation is intended for oral administration.
Adults and children over 12 years:
One or two tablets to be taken every four to six hours as required. Children 6 to 12 years
Half to one tablet to be taken three or four times daily.
Children should not be given this medicine for more than 3 days without consulting a doctor.
Not suitable for children under 6.
Elderly patients:
As the adult dose - but see warnings.
Dosage warnings:
Four hours must elapse between each dose and not more than 4 doses should be taken in 24 hours.
4.3 Contraindications
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 alcoholic liver disease.
Keep out of the sight and reach of children.
Patients should be advised that paracetamol may cause severe skin reactions. If a skin reaction such as reddening, blisters, or rash occurs, they should stop use and seek medical assistance right away.
The Pack Label will state:
Do not take anything else containing paracetamol while taking this medicine.
Talk to a doctor at once if you take too much of this medicine, even if you feel well.
Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.
The Patient Information Leaflet will state:
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.
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. However, concurrent use need not be avoided.
The speed of absorption of paracetamol is reduced by colestyramine. Therefore, the colestyramine should not be taken within one hour if maximal analgesia is required.
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.
Imatinib - restriction or avoidance of concomitant regular paracetamol use should be taken with Imatinib.
Chloramphenicol: Increased plasma concentration of chloramphenicol.
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 clinically significant amount. Available published data do not contra-indicate breast feeding.
4.7 Effects on ability to drive and use machines
Paracetamol is unlikely to produce sedation or drowsiness.
4.8 Undesirable effects
Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. Very rare cases of serious skin reactions have been reported. There have been reports of blood dyscrasias including thrombocytopenia purpura, methaemoglobenaemia and agranulocytosis, but these were not necessarily causally related to paracetamol.
Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing 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 post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.
Post marketing data
|
Body System |
Undesirable effect |
|
Blood and lymphatic system disorders |
Thrombocytopenia purpura Agranulocytosis Methaemoglobenaemia |
|
Immune system disorders |
Anaphylaxis |
|
Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis | |
|
Respiratory, thoracic and mediastinal disorders |
Bronchospasm* |
|
Hepatobiliary disorders |
Hepatic dysfunction |
* 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
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.
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 24h from ingestion should be discussed with the NPIS or a liver unit.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Mechanisms of Action/Effect
Analgesic - the mechanism of analgesic action has not been fully determined. Paracetamol may act predominately by inhibiting prostaglandin synthesis in the central nervous system (CNS) and to a lesser extent, through a peripheral action by blocking pain-impulse generation.
The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation.
Antipyretic - Paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat-regulation 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.
Paracetamol has analgesic and antipyretic actions but it has no useful antiinflammatory properties.
5.2 Pharmacokinetic properties
Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma levels occurring about 30 minutes 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 unchanged.
The elimination half life of Paracetamol varies from about 1 to 4 hours. Plasma protein binding is negligible at usual therapeutic doses but increases with increasing concentrations.
A minor hydroxylated metabolite which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following paracetamol overdosage and cause liver damage.
5.3 Preclinical safety data
Paracetamol has been in clinical use separately and in combination products for many years. Preclinical data has therefore been superseded by clinical data.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Each tablet contains Maize Starch, Colloidal Anhydrous Silica, Magnesium Stearate and Potassium Sorbate
6.2 Incompatibilities
This product is designed for oral administration.
Admixture with other medicines prior to ingestion is not intended or desirable.
6.3 Shelf life
The shelf life of the product is 3 years when stored in cartoned blister packs, 2 years in paper strips, and 5 years in all other packs, assuming the precautions stated below are taken.
In the case of tubs, provided the pack is re-sealed after each use there should be no reduction in shelf life.
Re-packing into any other pack may affect the shelf life and appropriate pharmaceutical judgement should be exercised.
6.4 Special precautions for storage
Keep well closed. Protect from light. For blister packs, store below 25°C in a dry place. For all other packs, store in a cool dry place.
6.5 Nature and contents of container
Blister strips of 0.25mm PVC/0.02mm aluminium enclosed in a cardboard carton containing 2, 4, 6, 8, 10, 12, 15, 16, 20, 24, 30, 32, 45, 48, 50, 56, 60, 75, 84, 96 or 100 tablets.
HDPE or polypropylene tub or vial fitted with a plastic cap, child resistant and/or tamper-evident as appropriate, containing 16, 25, 32, 50, 56, 84, 100, 250, 500 or 1000 tablets.
An amber glass bottle fitted with a child-resistant screw-cap, containing 16, 25, 32, 50, 56 or 100 tablets.
HDPE bucket lined with a polythene bag and fitted with a HDPE lid, containing 5000, 20000, 25000 or 30000 tablets.
A corrugated cardboard box lined with a polythene bag, containing 5000, 20000, 25000 or 30000 tablets.
PVDC coated paper strips enclosed in a cardboard carton, containing 16, 24, 32, tablets.
Amber Polystyrene bottles fitted with a child-resistant screw-cap, containing 16, 25, 32, 50, 56 or 100 tablets.
6.6 Instruction for use and handling
Not applicable.
Administrative Data
7. MARKETING AUTHORISATION HOLDER
M & A Pharmachem Limited
Allenby Laboratories
Wigan Road
Westhoughton
Bolton
BL5 2AL
8. MARKETING AUTHORISATION NUMBER
PL 04077/0001
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Authorisation granted 11th October 1979
Last renewal 25th September 1998
10 DATE OF REVISION OF THE TEXT
09/07/2015