Paracetamol 500mg Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Tablets Paracetamol 500mg Caplets Boots Paracetamol 500mg Caplets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500 mg.
Also contains 0.56mg of Sodium metabisulphite.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, capsule shaped tablet with a break-line on one face.
The break line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of most painful and febrile conditions for example headache including migraine and tension headaches neuralgia, toothache, sore throat, period pains, aches and pains. .Also recommended for symptomatic relief of rheumatic aches and pains and the fever, aches and pains of cold and flu.
4.2 Posology and method of administration
For oral administration.
Adults, the elderly and children over 12 years:
2 tablets up to four times daily as required
Children 6 to 12 years of age:
Half to one tablet three or four times daily as required..
Children under 6 years of age:
Do not give to children aged under 6 years of age.
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.
Children should not be given Paracetamol for more than 3 days without consulting a doctor.
4.3. Contra-indications
Hypersensitivity to paracetamol or any of the other ingredients.
4.4 Special warnings and special 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 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:
These words must appear in a prominent position.
“Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor”. This must appear adjacent to either the directions for use or the recommended dosage.
“Talk to a doctor at once if you take too much of this medicine, even if you feel well”;
“Do not take anything else containing paracetamol while taking this medicine”.
Patient Information Leaflet:
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”.
Important information regarding the ingredients of this medicine
This medicinal product contains sodium metabisulphite which may rarely cause severe hypersensitivity reactions and bronchospasm.
4.5
Interaction with other medicinal products and other forms of interaction
Colestyramine: The speed of absorption of paracetamol is reduced by colestyramine..
Metoclopramide and Domperidone: The speed of absorption of paracetamol is increased by metoclopramide and domperidone
Warfarin: 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 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 the 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.
Effects on Ability to Drive and Use Machines
4.7.
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
|
Body System |
Undesirable effect |
|
Blood and lymphatic system disorders |
Thrombocytopenia, Agranulocytosis |
|
Immune system disorders |
Anaphylaxis, |
|
Angioedema | |
|
Respiratory, thoracic and mediastinal disorders |
Bronchospasm* |
|
Hepatobiliary disorders |
Hepatic dysfunction |
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
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 phenytoin, primidone, liver enzymes.
Or
term treatment with carbamazepine, phenobarbitone, rifampicin, St. John’s Wort or other drugs that induce
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 hrs 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 hr. 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 hrs after ingestion of paracetamol however, the maximum protective effect is obtained upto 8 hours post ingestion.
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
ATC Code: N02B E01
Pharmacotherapeutic Group: Antipyretic analgesic
Mechanism of Action/ Effect
Analgesic - the mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly 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 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.
5.2. Pharmacokinetic Properties
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma halflife is 1 - 4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids.. . 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. Following therapeutic doses 90 - 100% of the drug may be recovered in the urine within the first day. Plasma protein binding is negligible at usual therapeutic concentrations but increases with increasing concentration.
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
Do not store above 25°C. Store in the original package in order to protect from moisture.
Blisters:
Containers: Do not store above 25°C. Keep the container tightly closed in order
to protect from moisture.
6.5 Nature and contents of container
Al/PVC child resistant blisters enclosed in an outer carton.
Pack sizes: 8, 12, 16, 24, 30, 32, 100 tablets HDPE tablet containers.
OR
Child resistant and adult accessible PP container with HDPE lid
Pack sizes: 16, 1000 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal No special requirements.
7. MARKETING AUTHORISATION HOLDER
Bristol Laboratories Ltd Unit 3, Canalside,
Northbridge Road,
Berkhamsted,
Hertfordshire HP4 1EG United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 17907/0001
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 02/12/2008
10
DATE OF REVISION OF THE TEXT
22/05/2015