This information is intended for use by health professionals

1. Name of the medicinal product

Hedex or Paracetamol Tablets

2. Qualitative and quantitative composition

Each tablet contains Paracetamol Ph Eur 500.0 mg

3. Pharmaceutical form

White capsule-shaped tablet with a break line on one side.

The break line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

4. Clinical particulars
4.1 Therapeutic indications

Hedex is a mild analgesic and antipyretic. The tablets are recommended for headaches, including migraine and tension headaches, backache, rheumatic and muscle pain, period pains, nerve pains, toothache and for relieving the fever, aches and pains of colds and flu.

4.2 Posology and method of administration

Age

How much

How often

Adults and children over 16 years

1 or 2 tablets

Every 4-6 hours, as required. Don't take more than 8 tablets (4 doses) in any 24 hours

Children 12 - 15 years

1 to 1½ tablets

Every 4-6 hours, as required. Don't take more than 6 tablets (4 doses) in any 24 hours

Children 10 – 12 years

1 tablet

Every 4-6 hours, as required. Don't take more than 4 tablets (4 doses) in any 24 hours

Children 6 – 10 years

½ tablet

Every 4-6 hours, as required. Don't take more than 2 tablets (4 doses) in any 24 hours

Not suitable for children under 6.

Children should not be given Hedex tablets for more than 3 days without consulting a doctor.

These doses should not be repeated more frequently than every 4 hours.

Hedex is for oral administration.

4.3 Contraindications

Hypersensitivity to paracetamol or any of the other constituents.

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 alcoholic 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. If symptoms persist consult your doctor.

Keep out of the reach and sight 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 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

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 post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. The following convention has been utilised for the classification of undesirable effects: Very common (≥1/10), common (≥1/100 to, <1/10), uncommon (≥1/1,000, to <1/100), rare (≥1/10,000 to, <1/1000), very rare (<1/10,000), not known (cannot be estimated from available data).Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

Post marketing data

Body System

Undesirable effect

Frequency

Blood and lymphatic system disorders

Thrombocytopenia

Agranulocytosis

Very rare

Immune system disorders

Anaphylaxis

Cutaneous hypersensitivity reactions including skin rashes and angiodema

Very rare

Skin and subcutaneous tissue disorders

Serious skin reactions

Very rare

Respiratory, thoracic and mediastinal disorders

Bronchospasm*

Very rare

Hepatobiliary disorders

Hepatic dysfunction

Very rare

* 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

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 24h from ingestion should be discussed with the NPIS or a liver unit.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Paracetamol is a well established analgesic.

5.2 Pharmacokinetic properties

Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. Concentration in plasma reaches a peak in 30 - 60 minutes

Plasma half-life is 1 - 4 hours.

Paracetamol is relatively uniformly distributed throughout most body fluids. Plasma protein binding is variable.

Excretion is almost exclusively renal, in the form of conjugated metabolites.

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

Maize starch, potassium sorbate, purified talc, stearic acid, polyvidone, soluble starch, hydroxypropylmethylcellulose and triacetin.

6.2 Incompatibilities

None.

6.3 Shelf life

48 months.

6.4 Special precautions for storage

None.

6.5 Nature and contents of container

Opaque PVC 250 µm/aluminium foil 30 µm blister strips packed into cardboard cartons containing 8, 12, 16, 24, 30, or 32 tablets; or opaque PVC 250µm/aluminium foil 30µm blisters in a round, wallet style pack containing 12 tablets.

Clear PVC 250 µm /30 µm aluminium foil blister strips packed into cardboard cartons containing 8, 12, 16, 24, 30, or 32 tablets.

6.6 Special precautions for disposal and other handling

None.

7. Marketing authorisation holder

Omega Pharma Ltd.

1st Floor, 32 Vauxhall Bridge Road,

LONDON, SW1V 2SA

United Kingdom

8. Marketing authorisation number(s)

PL 02855/0067

9. Date of first authorisation/renewal of the authorisation

21.07.81

10. Date of revision of the text

13/04/18