Paracetamol 500mg Tablets Bp
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Tablets BP.
PocketPak Paracetamol 500 mg Caplets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol 500mg.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, capsule shaped tablet with a break-line on one face.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pain, aches and pains.
Symptomatic relief of rheumatic aches and pains.
Symptomatic relief of influenza, feverishness, feverish colds.
4.2 Posology and method of administration
For oral administration.
Adults, the elderly and children over 12 years: One or two tablets to be taken up to four times daily. Maximum dose of 8 tablets in 24 hours.
Children 6 to 12 years of age: Half to one tablet to be taken up to four times a day.
Children under 6 years of age: Not recommended.
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.
Dosage should not be continued for more than 3 days without consulting a doctor.
4.3 Contraindications
Hypersensitivity to paracetamol or any of the other ingredients.
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 non-cirrhotic alcoholic liver disease.
Patients should be advised to consult their doctor if their headaches become persistent.
Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day.
Do not exceed the recommended dose.
If symptoms persist, consult your doctor.
Keep out of the sight and reach of children.
May rarely cause severe hypersensitivity reactions and bronchospasm as this medicine contains sodium metabisulphite.
The label will state the following warnings:
Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.
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.
The leaflet will state the following warnings:
Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.
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. This is because too much paracetamol can cause delayed, serious liver damage.
4.5 Interaction with other medicinal products and other forms of interaction
Alcohol reduces liver capacity to deal with paracetamol.
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.
Colestyramine reduces absorption of paracetamol; and Metoclopramide and Domperidone accelerate absorption of paracetamol. May interact with chloramphenicol causing increased plasma levels.
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 literature 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 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:
Blood and lymphatic system disorders: Thrombocytopenia, agranulocytosis.
Immune system disorders: Anaphylaxis. Cutaneous hypersensitivity reactions including skin rashes, angioedema and Stevens Johnson syndrome/toxic epidermal necrolysis.
Respiratory, thoracic and mediastinal disorders: Bronchospasm*.
*There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
Hepatobiliary disorders: Hepatic dysfunction.
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
• Is on long term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
• Regularly consumes ethanol in excess of recommended amounts.
• 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
Paracetamol is an effective analgesic and antipyretic agent but has only weak anti-inflammatory properties. Its mechanism of action is not fully understood, as it is only a weak inhibitor of prostaglandin bio-synthesis, but it has been suggested that it is more effective against enzymes in the CNS than those in the periphery. The drug has no effect on the cardiovascular and respiratory systems, and it does not cause gastric irritation or bleeding like salicylates.
5.2 Pharmacokinetic properties
Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring 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 as 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 concentration.
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
No data of relevance which is additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Pregelatinised Maize Starch
Sodium Metabisulphite Magnesium Stearate
6.2 Incompatibilities
Not Applicable.
6.3 Shelf life
5 years.
6.4 Special precautions for storage
Blister strips: Do not store above 25°C. Store in the original package.
Tablet containers: Do not store above 25°C. Keep the container tightly closed. Store in the original container.
6.5 Nature and contents of container
Al/PVC blister strips (child resistant) enclosed in an outer carton containing 24 or 32
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
None applicable.
7 MARKETING AUTHORISATION HOLDER
Special Concept Development (UK) Ltd
Units 1-7 Colonial Way
Watford
Hertfordshire
WD24 4YR
8 MARKETING AUTHORISATION NUMBER(S)
PL 36722/0016
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18/05/2009
10 DATE OF REVISION OF THE TEXT
23/12/2013