PARACETAMOL EXTRA

Posology Children aged 12-15 years: 1 tablet every 4-6 hours Do not take more than 4 tablets in any 24-hour period Adults and children over 16 years of age: One to two tablets every four to six hours. Maximum of eight tablets daily.

Paediatric population Not recommended for children under 12 years of age.

Elderly:

One to two tablets every four to six hours. Maximum of eight tablets daily. Reduce dosage if renal or hepatic function is impaired. Method of administration For oral administration. Do not exceed the recommended dose. Do not take with any other paracetamol-containing products.

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. 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.

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 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 Thrombocytopenia Blood and lymphatic system disorders Agranulocytosis Anaphylaxis Immune system disorders Cutaneous hypersensitivity reactions including skin rashes, angioedema and Stevens Johnson syndrome/toxic epidermal necrolysis Respiratory, thoracic and mediastinal disorders Bronchospasm* Hepatobiliary disorders Hepatic dysfunction * There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDS Caffeine Nervousness Central Nervous System Dizziness At doses up to 520 mg per day undesirable effects are not normally observed in healthy individuals.

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. These include tremor, insomnia, nervousness, irritability, anxiety, headache, tinnitus, arrhythmia, and tachycardia, diuresis, gastrointestinal disturbances, elevated respiration, restlessness and palpitations.

Individuals who experience these effects must stop taking this medicine (and any others containing caffeine) and any other dietary caffeine. Following regular use of caffeine, cessation of intake may lead to withdrawal symptoms which may last for up to a week and which include headache, tiredness and decreased alertness.

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non- cirrhotic alcoholic liver disease. g. coffee, tea and some canned drinks) should be avoided while taking this product.

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 sight and reach of children. The pack label will state: • Contains paracetamol • Do not take more medicine than the label tells you to. If you do not get better talk to your doctor. • Do not take anything else containing paracetamol while taking this medicine.

• Talk to a doctor at once if you take too much of this medicine, even if you feel well. The patient information leaflet will state: • 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.

g. chronic alcoholism), as well as those using maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended. 5 Interaction with other medicinal products and other forms of interaction The speed of absorption of paracetamol may be increased by metoclopromide 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. Xanthine derivatives such as caffeine can weaken the vasodilating effect of substances used for myocardial imaging such as adenosine and dipyridamole.

Therefore, caffeine should be avoided for 24 hours before myocardial imaging. Caffeine, a CNS stimulant, has an antagonistic effect towards the action of sedatives and tranquilizers. Caffeine may enhance the tachycardic effect of phenylpropanolamine.

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.