GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Hedex 500mg Film-coated tablets

Each tablet contains paracetamol 500 mg.

For a full list of excipients, see section 6.1

Film-coated tablet

White film coated capsule-shaped tablet with flat edges marked 'Hedex' on both sides and a breakline on one side. The breakline is for ease of swallowing only.

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

Hedex is for oral administration.

Adults (including the elderly):

2 tablets repeated if necessary 3-4 times a day to a maximum of 8 tablets in any 24 hour period.

Children 6-12 years:

The usual dose is 1 tablet repeated if necessary 3-4 times a day to maximum of 4 tablets in any 24 hour period.

Hedex tablets are not suitable for children under 6 years of age.

These doses should not be repeated more frequently than every 4 hours and not more than 4 doses should be given in any 24 hour period.

Maximum duration of continued use without medical advice: 3 days.

Hypersensitivity to paracetamol or any of the other constituents.

Use in children under 6 years of age.

Underlying liver disease increases the risk of paracetamol-related liver damage. Patients with renal or hepatic impairment should seek medical advice prior to treatment with paracetamol. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Do not exceed the stated dose.

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.

Consult your doctor if you are taking warfarin or have been diagnosed with liver or kidney disease.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. 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.

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.

None.

Adverse events associated with paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labeled dose and considered attributable are tabulated below by System Organ Class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000) and very rare (<1/10,000) including isolated reports.

Immune system disorders

Very rare (< 1/10,000) Cutaneous hypersensitivity reactions, including skin rashes, angioedema and Stevens Johnson syndrome. Anaphylaxis.

Haematological system disorders

Very rare (<1/10,000) thrombocytopaenia.

Respiratory system disorders

Very rare (<1/10,000) aggravation of bronchospasm has been reported in asthmatic patients known to be sensitive to aspirin and other non-steroidal anti-inflammatory drugs.

Hepatobiliary disorders

Very rare (<1/10,000) Liver dysfunction

Symptoms of paracetamol overdose 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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

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 and any patient who has ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

ATC Code: NO2BE01

Paracetamol is an analgesic and antipyretic. Its mechanism of action is believed to include inhibition of prostaglandin synthesis, primarily within the central nervous system.

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal 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.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Maize starch

Potassium sorbate

Talc

Stearic acid

Povidone

Pre-gelatinised starch

Hypromellose

Triacetin

Brilliant blue (E133)

Silicone antifoam emulsion

Shellac

Sodium lactate

Not applicable

4 years.

This medicinal product does not require any special storage conditions.

Opaque PVC/aluminium foil blister strips packed into cardboard boxes containing 12, 16, 24 or 40 tablets.

Not all pack sizes may be marketed.

No special requirements.

GlaxoSmithkline Consumer Healthcare (Ireland) Limited

Stonemasons Way

Rathfarnham

Dublin 16

PA 678/28/1

Date of first authorisation: 20 August 1992

Date of last renewal: 20 August 2007

November 2009