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PURE HEALTH PARACETAMOL 500 MG CAPLETS, PARACETAMOL 500 MG CAPLETS, PARACETAMOL 500 MG TABLETS - summary of medicine characteristics

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Summary of medicine characteristics - PURE HEALTH PARACETAMOL 500 MG CAPLETS, PARACETAMOL 500 MG CAPLETS, PARACETAMOL 500 MG TABLETS

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 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, 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. CLINICAL PARTICULARS

4.2 Posology and method of administration

Posology:

Adults and children over 16: One or two caplets to be taken every four to six hours when necessary to a maximum of four doses in 24 hours.

Children 10 –15 years: One caplet to be taken every four to six hours when necessary to a maximum of four doses in 24 hours.

Not suitable for children under 10 years of age.

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 to six hours nor

should more than 4 doses be given in any 24 hour period.

Method of administration:

The tablets to be administered orally only.

4.3 Contraindications

Hypersensitivity to Paracetamol or any of the other constituents.

5. CLINICAL PARTICULARS

4.4 Special Warnings and Special 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 take more medicine than the label tells you to. If you do not get better, talk to your doctor.

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 medicines out of the sight and reach of children.

Pack Label:

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, 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. Fertility,Pregnancyandlactation

4.7    Effects on ability to drive and use machines

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.

ManagementManagement

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 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. Preclinicalsafetydata

5.3. Preclini­calsafetydata

Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.

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 container and cap)

Blister pack (aluminium foil and PVC)

Paper strip

Securitainers (Polypropylene container and polyethylene cap/wad)

8, 16, 25, 32, 50, 100

8, 12, 16, 24, 32, 48, 50, 96, 100

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

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

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