PARACETAMOL 500 MG CAPSULES SOFT - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Paracetamol 500 mg capsules, soft

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each soft capsule contains 500 mg paracetamol.

Excipients with known effect

Every capsule contains 58.2 mg of sorbitol, 6.0 mg of propylene glycol, and 66.4 mg of glycerol.

The capsules may contain trace amounts of soya lecithin.

For the full list of excipients, see section 6.1.

Capsules, soft.

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

4.1 Therapeutic indications

Paracetamol 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

Adults, elderly, and children aged 16 years and over:

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

Children

Aged 10 to 15 years:

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

Not suitable for children under ten years of age.

Children should not be given Paracetamol for more than 3 days without consulting a 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.

Method of administration

Paracetamol is administered orally.

4.3 Contraindications

Hypersensitivity to paracetamol, to peanut or soya, 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.

The capsules contain sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

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 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 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

* 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 or search for MHRA Yellow Card in the Google Play or Apple App Store

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 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Macrogol

Purified water

Propylene glycol

Povidone

Silica, colloidal anhydrous

Capsule shell

Gelatin

Sorbitol, liquid, partially dehydrated (E420)

Purified water

Glycerol

Titanium dioxide (E171)

Capsule printing

Black iron oxide (E172)

Propylene 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 or 16capsules in blister.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements

7 MARKETING AUTHORISATION HOLDER

Patheon Softgels B.V.

De Posthoornstraat 7

5048 AS Tilburg

The Netherlands

8 MARKETING AUTHORISATION NUMBER(S)

PL 14338/0011

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

27/12/2017