HEDEX

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. 9). Hedex is for oral administration. Paediatric patients Not suitable for children under 6. Elderly patients Elderly patients, especially those who are frail or immobile, may require a reduced dose or frequency of dosing.

Renal impairment Patients who have been diagnosed with kidney impairment must seek medical advice before taking this medication. 4). 4). If pain or fever persist for more than 3 days or get worse, or if any other symptoms occur, treatment should be discontinued, and a physician consulted.

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

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.

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 Allergies (not including angioedema) Not Known Immune system disorders Anaphylaxis Not Known Metabolism and nutrition disorders High anion gap metabolic acidosis Not Known Cutaneous hypersensitivity reactions including skin rashes, pruritus, sweating, purpura, urticaria and angioedema.

Very rare Skin and subcutaneous tissue disorders Very rare cases of serious skin reactions have been reported. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. * 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. uk/yellowcard.

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. Due to the risk of hepatotoxicity at therapeutic doses, paracetamol should be administered only with particular caution in patients who are underweight (adults or adolescents less than 50kg) or of low body mass index, malnourished, dehydrated, those with chronic alcoholism, co- existing renal or hepatic impairment, concomitantly taking hepatotoxic drugs, those with conditions that may predispose to glutathione deficiency or depletion.

2). Precaution should be observed in patients with asthma who are sensitive to acetylsalicylic acid, since mild bronchospasms are reported in association with paracetamol (cross reaction). g. chronic alcoholism), who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.

If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.

Do not exceed the stated dose. 9). Patients should be advised to consult their doctor if their headaches become persistent. Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued.

The diagnosis of medication overuse headache should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications. 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.

Hypersensitivity to paracetamol or any of the other constituents.