Paracetamol 500mg Soluble Tablets / Soluble Paracetamol Tablets 500mg

1. Name Of The Medicinal Product

Paracetamol 500mg Soluble Tablets / Soluble Paracetamol Tablets 500mg

2. Qualitative And Quantitative Composition

Paracetamol 500mg Ph Eur.

3. Pharmaceutical Form

Effervescent tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

Paracetamol Soluble is a mild analgesic and antipyretic. The tablets are recommended for the treatment of most painful conditions for example, headache, including migraine, toothache, sore throat, dysmenorrhoea, rheumatic pains and the symptomatic relief of colds and influenza.

4.2 Posology And Method Of Administration

Adults and children over 12 years:

1-2 tablets in at least half a tumbler full of water, up to 4 times daily as required. Do not take for more than 3 days without consulting your doctor.

These doses should not be given more frequently than every 4 hours, and not more than 4 doses should be given in any 24 hour period.

Children under 12 years:

Not recommended for children under the age of 12 years.

Route of administration: the tablets should be dissolved in water and are for oral administration only.

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 severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Do not exceed the recommended dose.

Do not take with any other paracetamol-containing products.

If symptoms persist consult your doctor.

Keep out of the reach of children.

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 cholestyramine. 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 are rare but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.

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, phenobarbitone, phenytoin, primidone, rifampicin, St. John's Wort or other drugs that induce liver enzymes, or

• regularly consumes ethanol in excess of recommended amounts, or

• 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. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol is a well established analgesic.

5.2 Pharmacokinetic Properties

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Concentration of the drug in plasma reaches a peak in 30-60 minutes and the plasma half-life is 1-4 hours.

Paracetamol is relatively uniformly distributed throughout most body fluids and exhibits variable protein binding.

Excretion is almost exclusively renal, in the form of conjugated metabolites.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium bicarbonate,

Sorbitol powder

Saccharin sodium

Sodium lauryl sulphate

Citric acid (anhydrous)

Sodium carbonate (anhydrous)

Polyvidone

Dimeticone

Purified water

6.2 Incompatibilities

None

6.3 Shelf Life

48 months.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

The tablets will be individually packed into PPFP laminate strips in cardboard cartons.

Pack size: 32, 48, 60, 100.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Sterwin Medicines Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

United Kingdom

Trading as: Sterwin Medicines, PO Box 611, Guildford, Surrey, GU1 4YS

8. Marketing Authorisation Number(S)

PL 17780/0162

9. Date Of First Authorisation/Renewal Of The Authorisation

17 November 2002

10. Date Of Revision Of The Text

18 August 2008