BOOTS PARACETAMOL EXTRA

Route of administration:

Oral.

For all indications:

Adults, the elderly and children over 16 years of age: Two tablets every 4-6 hours when necessary to a maximum of 4 doses in 24 hours.

Children from 12 to 15 years:

One tablet every 4-6 hours when necessary to a maximum of 4 doses in 24 hours. Not recommended for children under 12 years of age. Dosage should not be continued for longer than 3 days without consulting a doctor. As caffeine is found naturally in tea, coffee and chocolate, and in some carbonated drinks there is the potential for users to take more than the recommended 520 mg/day of caffeine (8 tablets) per day.

Therefore users should take account of dietary and other medicinal sources of caffeine and ensure that they do not exceed the stated dose. Typical amounts of caffeine available from dietary sources are Brewed coffee; 50-100mg/ml* Instant coffee and tea: 20-73mg/100ml* Carbonated drinks (cola) 9-19mg/100ml* Chocolate 5-20mg/100ml (*100ml is equivalent to about 1 small cup of fluid)

Adverse events 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 listed 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 Paracetamol Body System Undesirable effect Blood and lymphatic system disorders Thrombocytopenia, agranulocytosis Agranulocytosis Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angioedema, Stevens Johnson syndrome / toxic epidermal necrolysis Respiratory, thoracic and mediastinal disorders Bronchospasm Hepatobiliary disorders Hepatic dysfunction Metabolism and nutrition disorders High anion gap metabolic acidosis** * There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

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. Caffeine Body System Undesirable effect Central nervous system Nervousness, Dizziness When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine- related adverse effects such as restlessness and palpitations.

Undesirable effects are not normally observed in healthy individuals taking caffeine at doses up to 520 mg per day. However some users who are caffeine naïve, have abstained from caffeine for a period or who are more sensitive to caffeine may experience effects more commonly seen at higher doses.

Patients should be advised to consult their doctor if their headaches become persistent. - Do not take anything else containing paracetamol while taking this medicine. - Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment.

The hazards of overdose are greater in those with non- cirrhotic alcoholic liver disease. g. coffee, tea and some canned drinks) should be avoided while taking this product. 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.

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. - Do not take more medicine than the label tells you to.

- Keep out of the sight and reach of children. Patient Information Leaflet - Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

- Keep this medicine out of the sight and reach of children.

Hypersensitivity to paracetamol, caffeine and/or other constituents. This medicine should not be used by people who have been diagnosed with hypertension or who are receiving antihypertensive medication, or who have a history of cardiac arrhythmia.

This medicine should not be used by patients recovering from chronic alcoholism who are taking disulfiram. This medicine should not be used if antidepressants (including lithium carbonate), anxiolytics (including clozapine) and sedatives are being used, or by persons with anxiety disorders.

5). Caffeine shares the same metabolic pathway as theophylline and therefore this medicine should not be used concurrently with theophylline.