Paracetamol 500mg Caplets

Summary of Product Characteristics Updated 15-Jan-2020 | M & A Pharmachem Ltd

1. Name of the medicinal product

Paracetamol Tablets BP 500mg and

Mandanol Paracetamol 500

Paracetamol 500mg Caplets

Paravict 500mg Tablets

2. Qualitative and quantitative composition

Each tablet contains: Paracetamol BP 500mg.

3. Pharmaceutical form

Compressed tablet.

4. Clinical particulars
4.1 Therapeutic indications

Paracetamol is a mild analgesic and antipyretic.

It is indicated in the treatment of most painful and febrile conditions, for example, headache, toothache, colds, influenza, rheumatic pain, dysmenorrhoea, sore throat, migraine, muscular aches and pains and neuralgia.

4.2 Posology and method of administration

Posology

Adults, Elderly and Children over 16 years:

Two tablets every four hours as required. Not more than eight tablets in 24 hours. Do not take for more than 3 days without consulting your doctor.

These doses should not be repeated more frequently than every four hours nor should more than four doses be given in any 24 hour period.

Paediatric population

Children under 10 years:

Not recommended for children under 10 years of age.

Children aged 10 to 15 years:

One tablet every four to six hours when necessary to a maximum of four doses in 24 hours. Do not take for more than 3 days without consulting your doctor.

These doses should not be repeated more frequently than every four to six hours nor should more than four doses be given in any 24 hour period .

Method of administration

For oral administration

4.3 Contraindications

Hypersensitivity to paracetamol and/or other constituents.

4.4 Special warnings and precautions for use

Paediatric population Not recommended for children under 10 years of age

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

Keep out of the sight and reach of children.

Do not take paracetamol for more than 3 days without consulting a doctor.

Patients should be advised that paracetamol may cause severe skin reactions. If a skin reaction such as reddening, blisters, or rash occurs, they should stop use and seek medical assistance right away.

The Pack Label will state:

Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine, even if you feel well.

Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.

The Patient Information Leaflet will state:

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause 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. However, concurrent use need not be avoided.

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

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.

Imatinib - restriction or avoidance of concomitant regular paracetamol use should be taken with Imatinib.

Chloramphenicol: Increased plasma concentration of chloramphenicol.

4.6 Fertility, pregnancy and lactation

Pregnancy

A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.

Breastfeeding

Paracetamol is excreted in breast milk but not in clinically significant amount. Available published data do not contra-indicate breast feeding.

4.7 Effects on ability to drive and use machines

Paracetamol is unlikely to produce sedation or drowsiness.

4.8 Undesirable effects

The information below lists reported adverse reactions, ranked using the following frequency classification:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Immune system disorders

Hypersensitivity including skin rash may occur.

Not known: anaphylactic shock, angioedema

Blood and lymphatic system disorders

Not known: blood dyscrasias including thrombocytopenia and agranulocytosis

Skin and subcutaneous disorders

Very rare cases of serious skin reactions such as Toxic Epidermal Necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalised exanthematous pustulosis, fixed drug eruption have been reported.

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, gastrointestinal bleeding 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

ATC code: N02B E01, Other analgesics and antipyretics

Mechanisms of Action/Effect

Analgesic – the mechanism of analgesic action has not been fully determined. Paracetamol may act predominately 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 the 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 through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus. The drug has no effect on the cardiovascular and respiratory systems, and unlike salicylates it does not cause gastric irritation or bleeding.

Paracetamol has analgesic and antipyretic actions but it has no useful anti- inflammatory properties.

5.2 Pharmacokinetic properties

Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma levels occurring about 30 minutes to 2 hours after ingestion.

It is metabolised in the liver (90-95%) and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted unchanged.

The elimination half life of Paracetamol varies from about 1 to 4 hours. Plasma protein binding is negligible at usual therapeutic doses but increases with increasing concentrations.

A minor hydroxylated metabolite (N-acetyl-p-benzoquinoneimine) which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following paracetamol overdosage and cause liver damage.

The time to peak plasma concentration of paracetamol is 0.5 to 2 hours, the time to peak effect 1 to 3 hours and the duration of action 3 to 4 hours.

5.3 Preclinical safety data

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

Each tablet contains Maize Starch, Colloidal Anhydrous Silica, Magnesium Stearate and Potassium Sorbate.

6.2 Incompatibilities

This product is designed for oral administration.

Admixture with other medicines prior to ingestion is not intended or desirable.

6.3 Shelf life

The shelf life of the product is 3 years when stored in cartoned blister packs, 2 years in paper strips, and 5 years in all other packs, assuming the precautions stated below are taken.

In the case of tubs, provided the pack is re-sealed after each use there should be no reduction in shelf life.

Re-packing into any other pack may affect the shelf life and appropriate pharmaceutical judgement should be exercised.

6.4 Special precautions for storage

Keep well closed. Protect from light. For blister packs, store below 25°C in a dry place.

For all other packs, store in a cool dry place.

6.5 Nature and contents of container

Blister strips of 0.25mm PVC/0.02mm aluminium enclosed in a cardboard carton, containing 2, 4, 6, 8, 10, 12, 15, 16, 20, 24, 30, 32, 45, 48, 50, 56, 60, 75, 84, 96 or 100 tablets

HDPE or polypropylene tub or vial fitted with a plastic cap, child resistant and/or tamper-evident as appropriate, containing 16, 25, 32, 50, 56, 84, 100, 250, 500 or 1000 tablets

An amber glass bottle fitted with a child-resistant screw-cap, containing 16, 25, 32, 50, 56 or 100 tablets

HDPE bucket lined with a polythene bag and fitted with a HDPE lid, containing 5000, 20000, 25000 or 30000 tablets

A corrugated cardboard box lined with a polythene bag, containing 5000, 20000, 25000 or 30000 tablets

PVDC coated paper strips enclosed in a cardboard carton, containing 16, 24, 32 tablets

Amber polystyrene bottles fitted with a child-resistant screw-cap, containing 16, 25, 32, 50, 56 or 100 tablets

6.6 Special precautions for disposal and other handling

Not applicable.

7. Marketing authorisation holder

M & A Pharmachem Limited.

Allenby Laboratories,

Wigan Road,

Westhoughton,

Bolton BL5 2AL

8. Marketing authorisation number(s)

PL 4077/0001

9. Date of first authorisation/renewal of the authorisation

Authorisation granted 11.10.79.

Last renewal 25.09.98

10. Date of revision of the text

10/01/2020

Version: 04008

Company Contact Details
M & A Pharmachem Ltd
Address

Allenby Laboratories, Wigan Road, Westhoughton, Bolton, BL5 2AL

Telephone

+44 (0 ) 1942 852085

Medical Information Direct Line

+44 (0)1942 852 085

Customer Care direct line

+44 (0) 1942 816184

WWW

http://www.mapharmachem.co.uk

Fax

+44 (0)1942 813699

Medical Information e-mail
Medical Information Fax

+44(0) 1942 813699