SUPERDRUG HOT LEMON COLD RELIEF

Adults and Children over 12 years Contents of one sachet (with hot water). Dosage should not be repeated more frequently than 4 times in any 24 hour period. The dosage should not be continued for more than 3 days without consulting a doctor.

Adverse events of paracetamol from historical clinical trial sate 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 Blood an lymphatic system disorders Thrombocytopenia Agranulocytosis Neutropenia Pancytopenia Leukopenia Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angioedema and Stevens Johnson syndrome/toxic epidermal necrolysis Respiratory, thoracic and mediastinal disorders Bronchospasm* Hepatobiliary disorders Hepatic dysfunction General disorders and administration site conditions Drug fever * 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. 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. Patients, who are receiving a course of medicinal treatment, consult your doctor before taking this product.

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 your 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. If you are pregnant or being prescribed medicine by your doctor, seek your doctor’s advice before taking this product.

3. Contra-indications Should be given with care to patients with impaired kidney or liver function and to alcoholics. Hypersensitivity to paracetamol or any of the other constituents.