Medine.co.uk

Paracetamol 500mg Tablets

Informations for option: Paracetamol 500mg Tablets, show other option
Document: spc-doc_PL 08977-0014 change

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Paracetamol 500mg Caplets Paracetamol 500mg Tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains: - Paracetamol Ph.Eur. 500mg.

For a full list of Excipients. See section 6.1

3    PHARMACEUTICAL FORM

Uncoated tablet

A white capsule shaped tablet with break line marked ap/500

4.1    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, toothache, 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 caplets to be administered orally only.

Adults:    Two caplets up to 4 times daily as required.

Children 6 -12 years: ^ to 1 caplet three or four times daily as required.

Children should not be given caplets 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 caplets 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 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.

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.

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

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.

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.

5.1    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 proteins 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.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Potato Starch Pregelatinised Starch Purified Talc Magnesium Stearate Providone Stearic Acid

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.

For polypropylene containers - Store in the original container

For blister packaging - Store in the original packaging. Keep in the outer carton to protect from light.

6.5 Nature and contents of container

Snap-safe vials (polypropylene 8, 16, 25, 32, 50, 100 container and cap)

Blister pack (aluminium foil and 8, 12, 16, 24, 32, 48, 50, 96, 100 PVC)

Paper strip

Securitainers (Polypropylene


2, 4, 8, 12, 16, 24, 32, 48, 96

8, 16, 32, 50, 100, 250, 500, 1000, 5000, 10000


container and polyethylene cap/wad)


All packs 16 and less are GSL.

All packs containing greater than 16 but not more than 32 are P. All packs over 32 are POM.

6.6 Special precautions for disposal

None

7    MARKETING AUTHORISATION HOLDER

ASPAR Pharmaceuticals Ltd 29-30 Capitol Way Capitol Way Industrial Park Colindale, London NW9 0EQ United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 08977/0014

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 19/04/2000 / 05/03/2009

10


DATE OF REVISION OF THE TEXT

22/05/2015