SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Paracetamol 500 mg capsules, soft

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each soft capsule contains 500 mg paracetamol.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Capsules, soft.

White, oblong soft gelatin capsule with a logo printed in black ink.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Paracetamol 500 mg capsules, soft is a mild analgesic and antipyretic, and is 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.

4.2 Posology and method of administration

Posology

Children aged 12 to 15 years:

Give one capsule every four to six hours as required, up to a maximum of six capsules in any 24-hour period.

Not suitable for children under twelve years of age. Children should not be given Paracetamol 500 mg capsules, soft for more than 3 days without consulting a doctor.

Adults and children aged 16 years and over:

Two capsules every four hours as required, up to a maximum of 8 capsules in any 24-hour period.

Method of administration

Paracetamol 500 mg capsules, soft is administered orally.

4.3 Contraindications

Hypersensitivity to paracetamol or to any of the excipients listed in section 6.1.

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 alcohol liver disease.

-    Do not exceed the stated dose.

-    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 out of reach and sight of children.

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, pregnancy and lactation

Pregnancy

A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Paracetamol can be used during pregnancy if clinically needed however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.

Breastfeeding

After oral administration, paracetamol is excreted into breast milk in small quantities. No undesirable effects on nursing infants have been reported. Consequently, Paracetamol 500 mg capsules, soft may be used in breast-feeding women.

Fertility

There are insufficient fertility data available to indicate paracetamol has any effect on fertility.

4.7 Effects on ability to drive and use machines

Paracetamol 500 mg capsules, soft has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Adverse events 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	Undesirable effect
Blood and lymphatic system disorders	Thrombocytopenia Agranulocytosis
Immune system disorders	Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angioedema and Stevens Johnson syndrome/toxic epidermal necrolysis
Respiratory, thoracic and mediastinal disorders	Bronchospasm*
Hepatobiliary disorders	Hepatic dysfunction
Skin and subcutaneous tissue disorders	Very rare cases of serious skin reactions have been reported

* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs

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:

-    Is on long term treatment with carbamazepine, phenobarbital, 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.

Treatment

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.

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.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Analgesics and antipyretics. Anilides, ATC code: N02BE01.

The mechanism of action of paracetamol 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. The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma halflife is 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 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.

6.1 List of excipients

Macrogol Purified water Propylene glycol Povidone

Silica, colloidal anhydrous

Capsule shell Gelatin

Sorbitol, liquid, partially dehydrated

Purified water

Glycerol

Titanium dioxide (E171)

Capsule printing

Black iron oxidePropylene glycol

Hypromellose

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

18 months

6.4 Special precautions for storage

Do not store above 25°C.

Store in the original package in order to protect from moisture.

6.5 Nature and contents of container

Blister formed of PVDC/PVC//Alu/PET, packed into carton.

Pack sizes of 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 or 32 capsules in blister.

Not all pack sizes may be marketed.