Paracetamol 500mg Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500.0 mg
This medicinal product contains 0.007 mmol of sodium per dose. To be taken into consideration by patients on a controlled sodium diet.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablets
White capsule shaped tablets marked with ‘PARA 500’ on one side and M+ on the other side.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Paracetamol is a mild analgesic and antipyretic. The tablets are recommended for headaches, including migraine and tension headaches, backache, rheumatic and muscle pain, period pains, nerve pains, toothache and for relieving the fever, aches and pains of colds and flu.
4.2 Posology and method of administration
Adults (including the elderly)
2 tablets up to 4 times a day.
Children
6-12 years: 'A - 1 tablet.
Paracetamol 500mg Tablets are not recommended for children under 6 years of age.
These doses should not be repeated more frequently than every 4 hours and not more than 4 doses should be given in any 24 hour period. Dosage should not be continued for longer than 3 days without consulting a doctor.
Paracetamol 500mg Tablets are for oral administration.
4.3 Contraindications
Hypersensitivity to paracetamol or any of the 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 hazard of overdose is greater in those with noncirrhotic alcoholic liver disease.
Do not exceed the stated dose.
Patients should be advised to consult their doctor if their headaches become persistent.
Patients should be advised not to take other paracetamol-containing products concurrently.
Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day.
If symptoms persist consult your doctor.
Keep out of the reach of children.
Pack Label:
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Do not take with any other paracetamol-containing products.
Patient. Information Leaflet:
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.
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 daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Chloramphenicol: increased plasma concentration of chloramphenicol.
Busulfan: paracetamol possibly inhibits metabolism of intravenous busulfan (manufacturer of intravenous busulfan advises caution within 72 hours of paracetamol).
Carbamazepine: Metabolism of paracetamol is possibly accelerated by carbamazepine.
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
None known.
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 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.
4.9 Overdose
Liver damage is possible in adults who have taken 10g or more of paracetamol in 24 hours. Ingestion of 5g or more of paracetamol in 24 hours 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, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
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. Persistence beyond this time, often associated with the onset of right subcostal pain and tenderness, usually indicates development of hepatic necrosis. Liver damage may become apparent 12 to 48 hours after ingestion. Liver damage is maximal 3-4 days 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
Paracetamol is an effective analgesic and antipyretic agent but has only weak anti-inflammatory properties. Its mechanism of action is not fully understood. It has been suggested that it may act predominantly by inhibiting prostaglandin synthesis in the 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.
Paracetamol probably produces an antipyretic action by a central effect 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.
Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion; the time to peak effect 1 to 3 hours and the duration of action 3 to 4 hours. The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma half-life is 1 - 4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids. It is metabolised in the liver (90 -95%) and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life varies from about 1 to 4 hours. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.
A minor hydroxylated metabolite (n-acetyl-p-benzoquinoneimine) 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
There are no pre-clinical 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 K 30 Docusate sodium Silica, colloidal anhydrous Magnesium stearate
Not applicable
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store below 25°C.
6.5 Nature and contents of container
The tablets are packed in 20 micron aluminium foils hard tempered bright side lacquered to a 15micron PVC Film. 0.25mm thick, opaque, white coloured, food grade, well thermoformable PVC film.
Pack sizes : 16 and 32 tablets (8 tablets per blister strip)& 100 tablets (10 tablets per blister strip).
6.6 Special precautions for disposal
No special requirements.
7. Marketing Authorisation Holder
Medreich Plc Warwick House
Plane Tree Crescent
Feltham
TW13 7HF
8 MARKETING AUTHORISATION NUMBER(S)
PL 21880/0014
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
04/02/2009
10 DATE OF REVISION OF THE TEXT
29/10/2014