PARACETAMOL 500 MG TABLETS, RELIMOL 500 MG TABLETS - Summary of medicine characteristics

Summary of medicine characteristics - PARACETAMOL 500 MG TABLETS, RELIMOL 500 MG TABLETS

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Relimol 500 mg Tablets (Paracetamol 500mg)

Paracetamol 500 mg Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains Paracetamol Ph.Eur. 500 mg

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablet

White to off-white capsule shaped biconvex tablets with P 500 embossing on one side and a break line on the other side.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Relimol 500 mg Tablets are 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

For all indications:

Adults and adolescents above the age of 16:

One or two tablets up to four times a day, as required.

Maximum daily dose is 4 g in divided doses

Children aged 12 to 15 years:

One to one and a half tablets up to four times a day, as required,

Children ages 10 to 11 years:

One tablet up to four times a day, as required,

Children 6 to 9 years:

Half a tablet up to four times a day, as required.

Children under 6 years:

Do not give to children under 6.

The dose should not be repeated more frequently than every four hours, and not more than four doses should be taken in any 24-hour period.

Dosage should not be continued for longer than 3 days without consulting a doctor.

The maximum daily dose of paracetamol should not exceed 2g in the following situations unless directed by physician:

– Adults or adolescents weighing less than 50 kg

– Mild to moderate hepatic insufficiency, Gilbert’s syndrome (familial non-haemolytic

jaundice)

– Chronic alcoholism

– Dehydration

– Chronic malnutrition

Method of administration

Oral administration only.

4.3 Contraindications

Hypersensitivity to paracetamol or any of the other excipients.

4.4 Special warnings and precautions for use

Paracetamol should be administered with caution under the following circumstances (see section 4.2 where relevant):

Hepatic impairment

Chronic alcoholism

Renal impairment (GFR<50ml/min)

Gilbert’s Syndrome (familial non-haemolytic jaundice)

Concomitant treatment with medicinal products affecting hepatic function

Glucose-6-phosphate dehydrogenase deficiency

Haemolytic anaemia

Glutathione deficiency

Dehydration

Chronic malnutrition

Weight less than 50kg

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 the sight and reach of children.

Pack Label:

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

Do not take with any other paracetamol-containing products.

Patient Information Leaflet:

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 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 (more than 1000 pregnancy outcomes) 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.

Breast Feeding

Paracetamol is excreted in breast milk but not in clinically significant amounts. No undesirable effects on nursing infants have been reported. Consequently, Paracetamol may be used in breast feeding women.

Fertility

There is insufficient information available on the effects of Paracetamol on human fertility. Animal reproduction studies with Paracetamol have not revealed any adverse effects on fertility.

4.7 Effects on ability to drive and use machines None.

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	Thrombocytop enia Agranulocytosis
Immune system disorders	Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis
Respiratory, thoracic and mediastinal disorders	Bronchospasm*
Hepatobiliary disorders	Hepatic dysfunction

* 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

Paracetamol overdose can result in liver damage which may be fatal.

Symptoms generally appear within the first 24 hours and may comprise: nausea, vomiting, anorexia, pallor, and abdominal pain, or patients may be asymptomatic.

Overdose of paracetamol can cause liver cell necrosis likely to induce complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy which may lead to coma and death. Simultaneously, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed together with increased prothrombin levels that may appear 12 to 48 hours after administration.

Liver damage is likely in patients who have taken more than the recommended amounts of paracetamol. It is considered that excess quantities of toxic metabolite become irreversibly bound to liver tissue.

Some patients may be at increased risk of liver damage from paracetamol toxicity:

Risk factors include;

Patients with liver disease

Elderly patients

Young children

Patients receiving long-term treatment with carbamazepine, phenobarbitone,

phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver

enzymes.

Patients who regularly consume ethanol in excess of recommended amounts

Patients with glutathione depletion e.g. eating disorders, cystic fibrosis, HIV

infection, starvation, cachexia

Acute renal failure with acute tubular necrosis may also develop.

Cardiac arrhythmias and pancreatitis have also been reported.

Emergency Procedure:

Immediate transfer to hospital.

Blood sampling to determine initial paracetamol plasma concentration. In the case of a single acute overdose, paracetamol plasma concentration should be measured 4 hours post

ingestion. Administration of activated charcoal should be considered if the overdose of paracetamol has been ingested within the previous hour.

The antidote N-acetylcysteine, should be administered as soon as possible in accordance with national treatment guidelines.

Symptomatic treatment should be implemented.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

Relimol (paracetamol) is an antipyretic analgesic. The mechanism of action 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

Pregelatinized starch

Povidone (K-30)

Stearic Acid

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions

6.5 Nature and contents of container

White opaque PVC/CR aluminium foil blister packs of 16 tablets.

6.6 Special precautions for disposal