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PANADOL 1000MG TABLETS

Active substance(s): PARACETAMOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Panadol OA 1000 mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains paracetamol 1000 mg For full list of excipients, see section 6.1.

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PHARMACEUTICAL FORM
Film-coated tablet. White, capsule-shaped tablets having flat edges, debossed with PAN 1G on one side with a break-line on both sides. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

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4.1

CLINICAL PARTICULARS
Therapeutic indications For the management of mild to moderate pain, including osteoarthritis and for pyrexia.

4.2

Posology and method of administration
Panadol OA 1000 mg Tablets are for oral administration. Adults (including the elderly): One tablet up to 4 times daily as required. Not to be given to children under 12 years.

The minimum dosing interval is 4 hours and the maximum daily dose is 4000 mg (4 tablets).

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 non-cirrhotic alcoholic liver disease. Do not exceed the stated dose. Patients should be advised not to take other paracetamol-containing products concurrently. This product should only be used by the person for whom it is prescribed when clearly necessary. If symptoms persist, medical advice must be sought. 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 effects 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. Post marketing data Body System Blood and lymphatic system disorders Immune system disorders Undesirable effect Thrombocytopenia Agranulocytosis Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis Bronchospasm*

Respiratory, thoracic and mediastinal disorders 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 Paracetamol

Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g 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, phenobarbitone, phenytoin, primidone, rifampicin, St Johns Wort or other drugs that induce liver enzymes.

Or Or Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia. Regularly consumes ethanol in excess of recommended amounts.

Symptoms Symptoms of paracetamol overdose 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 Nacetylcysteine, 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.

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5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Paracetamol is an antipyretic analgesic. The mechanism of action is probably similar to that of aspirin and dependent 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. Concentration in plasma reaches a peak in 30 to 60 minutes. Plasma half-life is 1 - 4 hours 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. Excretion is almost exclusively renal, in the form of conjugated metabolites.

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.

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6.1

PHARMACEUTICAL PARTICULARS
List of excipients Maize starch Pregelatinised starch Potassium sorbate Talc Stearic acid Povidone Film coat: Hypromellose Triacetin.

6.2

Incompatibilities Not applicable.

6.3

Shelf life 5 years.

6.4

Special precautions for storage Do not store above 25C.

6.5

Nature and contents of container Opaque high density, polyethylene (HDPE) bottles with a polypropylene screw closure and induction seal liner, containing 100 tablets.

6.6

Special precautions for disposal No special requirements.

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MARKETING AUTHORISATION HOLDER
SmithKline Beecham (SWG) Limited 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom

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MARKETING AUTHORISATION NUMBER(S)
PL 00071/0456

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24/08/2009

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DATE OF REVISION OF THE TEXT
24/01/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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