Boots Paracetamol 500mg Capsules (P)

1. Name Of The Medicinal Product

PARACETAMOL 500mg CAPSULES

Boots Paracetamol 500mg Capsules

2. Qualitative And Quantitative Composition

PARACETAMOL 500mg

For excipients see 6.1.

3. Pharmaceutical Form

HARD GELATIN CAPSULES

Red cap, white body, hard gelatin capsule, containing a white free flowing powder.

4. Clinical Particulars

4.1 Therapeutic Indications

For relief of mild to moderate pain including headaches, migraine, aches and pains, symptomatic relief of rheumatic aches and pains and of influenza, muscular and back pain, neuralgia, toothache, sore throat and period pain and to relieve the symptoms of feverishness and colds and flu.

4.2 Posology And Method Of Administration

For oral administration.

Unless otherwise directed by the doctor:

Adults, the elderly and children over 12

One or two capsules to be taken 3 or 4 times a day. The doses should not be repeated more frequently than every four hours and not more more than eight capsules should be taken in 24 hours.

Children under 12

Not recommended.

4.3 Contraindications

Hypersensitivity to paracetamol or to any of the other ingredients.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal or sever hepatic impairment. The hazards of overdose is greater in those with non-cirrhotic alcoholic liver disease.

The label will state:

Contains Paracetamol

Do not take with any other paracetamol-containing products.

Do not exceed the stated dose.

Immediate medical advice should be sought in the event of an overdose even if you feel well.

If symptoms persist for more than 3 days or get worse consult your doctor.

Keep out of the reach and sight of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Cholestyramine: The speed of absorption of paracetamol is reduced by cholestyramine. Therefore, the cholestyramine should not be taken within one hour if maximal analgesia id required.

Metoclopramide and Domperidone: The absorption of paracetamol is increased by metoclopramide and domperidone. However, concurrent use need not be avoided.

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.

Chloramphenicol: Increased plasma concentration of chloramphenicol.

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

No or negligible influence.

4.8 Undesirable Effects

Adverse effects are rare but hypersensitivity including skin rash may occur.

There have been reports of blood dyscrasias including thrombocytopenia purpura, methaemoglobenaemia 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

a, Is on long term treatment with carbamazepine, phenobarbitone, 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 24 hrs from ingestion should be discussed with the NPIS or a liver unit.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol is a peripherally acting analgesic with antipyretic activity.

ATC code: N02B E01

Mechanism of Action/ Effect

Analgesic – the mechanism of analgesic action has 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 thorough the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.

5.2 Pharmacokinetic Properties

Absorption and Fate

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. Paracetamol is distributed into most body tissues. It crosses the placenta and is present in breast milk. Plasma protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations. The elimination half-life varies from about 1-4 hours. Paracetamol is metabolised predominantly in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol.

A minor hydroxylated metabolite which is usually produced in very small amounts by mixed function oxidases in the liver and kidney which is usually detoxified by conjugation with glutathione, may accumulate following paracetamol overdosage and cause tissue damage.

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

Pregelatinised maize starch

Magnesium stearate

Sodium laurilsulfate

Capsule shell:

Titanium dioxide E171

Erythrosine E127

Quinoline yellow E104

Patent Blue V E131

Gelatin

Methyl parahydroxybenzoate E218

Propyl parahydroxybenzoate E216

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

Child resistant blister packs comprised of 20µm hard aluminium foil laminated to 15µm rigid PVC, and 250µm PVC. Pack sizes of 20, 24, 30, 32 capsules.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

Administrative Data

7. Marketing Authorisation Holder

Bristol Laboratories Ltd,

Unit 3, Canalside,

Northbridge Road,

Berkhamsted,

Hertfordshire

HP4 1EG

8. Marketing Authorisation Number(S)

PL 17907/0057

9. Date Of First Authorisation/Renewal Of The Authorisation

16/02/2006

10. Date Of Revision Of The Text

July 2009