PANADOL ACTIFAST

For oral administration.

Adults, including the elderly and children 16 years and over:

Two tablets to be taken with half a tumbler of water (100 ml). To ensure fast onset of pain relief no less than two tablets must be taken with 100 ml of water. For maximum speed of action this should be on an empty stomach. Two tablets up to four times daily as required.

The dose should not be repeated more frequently than every four hours nor should more than four doses be taken in any 24 hour period.

Children aged 12-15 years:

One tablet to be taken with half a tumbler of water (100ml), up to four times daily as required. The dose should not be repeated more frequently than every four hours nor should more than 4 doses be given in any 24 hour period.

Children under 12 years of age:

Panadol ActiFast is not recommended for children under 12 years of age.

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 and frequency.

The following convention has been utilised for the classification of the undesirable effects: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000), not known (cannot be estimated from available data).

Adverse event frequencies have been estimated from spontaneous reports received through post-marketing data. 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, among others, skin rashes and angioedema.

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 or search for MHRA Yellow Card in the Google Play or Apple App store.

Contains paracetamol. Do not use with any other paracetamol-containing products. Underlying liver disease increases the risk or paracetamol related liver damage. Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication.

Do not exceed the stated dose. 6% of the WHO recommended maximum daily intake for sodium. 4% of the WHO recommended maximum daily intake for sodium. Panadol ActiFast is considered high in sodium. This should be particularly taken into account for those on a low salt diet.

Patients should be advised to consult their doctor if their headaches become persistent. Patients should be advised to consult a doctor if they suffer from non- serious arthritis and need to take painkillers every day. 9). Use with caution in patients with glutathione depletion due to metabolic deficiencies.

If symptoms persist consult your doctor. Contains no animal derived ingredients. Keep out of the sight and reach of children.

Pack Label:

Talk to a doctor at once if you take too much of this medicine even if you feel well. Do not take anything else containing paracetamol while taking this medicine.

Hypersensitivity to paracetamol or any of the other constituents.