Paracetamol 500mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: - Paracetamol Ph.Eur. 500mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Uncoated tablet.
A white capsule shaped tablet with break line marked ap/500.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A mild analgesic and antipyretic, recommended for the treatment of most painful and febrile conditions, for example, headache including migraine and tension headaches, tooth ache, backache, rheumatic and muscle pains, dysmenorrhoea, sore throat and for relieving the fever, aches and pains of colds and flu.
Also recommended for the symptomatic relief of pain due to non- serious arthritis.
4.2 Posology and method of administration
Paracetamol tablets to be administered orally only.
Adults: Two tablets up to 4 times daily as required.
Children 6 -12 years: ^ to 1 tablet three or four times daily as required.
Children should not be given tablets for more than 3 days without consulting a doctor.
These doses should not be repeated more frequently than every four hours nor should more than four doses be administrated in any 24 hour period.
The tablets should not be given to children under 6 years of age.
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 renal or 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 and sight 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 interaction
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption may be 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 does have no significant effect
4.6 Fertility, 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.
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 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 |
Thrombocytop enia Agranulocytosis |
|
Immune system disorders |
Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes and angiodema |
|
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.
Very rare cases of serious skin reactions 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 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.
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 24h from ingestion should be discussed with the NPIS or a liver unit.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Paracetamol is an antipyretic analgesic. The mechanism of action is probably similar to that of aspirin and dependant on the inhibition of prostaglandin synthesis. This inhibition appears, however to be on a selective basis.
5.2 Pharmacokinetic properties
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract with peak plasma concentrations occurring 30 to 60 minutes and plasma half-life 1-4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma protein is variable; 20 to 30% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90 - 100% of the drug may be recovered in the urine within the first day. However, practically no paracetamol is excreted unchanged and the bulk is excreted after hepatic conjugation.
5.3 Preclinical safety data
There are no clinically relevant preclinical safety data
List of excipients
Potato Starch Pregelatinised starch
6 PHARMACEUTICAL PARTICULARS
6.1
Magnesium Stearate Povidone Stearic Acid Talc
6.2 Incompatibilities
None
6.3 Shelf life
5 years from date of manufacture (60 months)
6.4 Special precautions for storage
Do not store above 25°C.
Store in original packaging
6.5 Nature and contents of container
Blister pack (aluminium foil and PVC) 16 pack
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
Aspar Pharmaceuticals Ltd
29-30 Capitol Way
Colindale
London
NW9 0EQ
8 MARKETING AUTHORISATION NUMBER(S)
PL 08977/0047
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 12/07/2016
10 DATE OF REVISION OF THE TEXT
12/07/2016