TOPTABS

Posology Adults and children aged 16 years and over: 1 or 2 tablets with a drink of water and preferably after a little food. The dose can be repeated every 4 to 6 hours, up to a maximum of 8 tablets in any 24 hour period. If symptoms persist consult your doctor.

Elderly Use with particular caution in elderly patients who are more prone to adverse events. g. for Kawasaki’s disease). Product should be discontinued if pain gets worse or lasts more than 10 days (or lasts more than 3 days for fever).

Do not exceed the stated dose. Method of administration Oral administration.

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by MedDRA System Organ Class.

Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data). Aspirin Tabulated list of adverse reactions Body System Undesirable effect Gastrointestinal disorders Nausea, vomiting, dyspepsia.

Gastrointestinal ulceration, gastrointestinal haemorrhage and gastritis. Renal and urinary disorders Renal dysfunction, increased blood uric acid levels. Hepatobiliary disorders Elevation in aminotransferase levels. Blood and lymphatic system disorders Prolonged bleeding time.

Thrombocytopenia. Ecchymosis Metabolism and Nutrition disorders Sodium and fluid retention. g. rhinitis, angioedema, urticaria, bronchospasm, skin reactions and anaphylaxis. Respiratory, thoracic and mediastinal disorders Bronchospasm in patients sensitive to aspirin and other NSAIDs Ear and labyrinth disorders Tinnitus, temporary hearing loss.

Caffeine Tabulated list of adverse reactions Body System Undesirable effect Central nervous system Nervousness and dizziness. When the recommended aspirin-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 insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization 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.

4 Special Warnings and Special Precautions for Use − Aspirin should be used with caution in patients with hypertension, mild to moderate renal or hepatic impairment, or in patients who are dehydrated. − Aspirin decreases platelet adhesiveness and increases bleeding time.

Haematological and haemorrhagic effects can occur, and may be severe. Patients should report any unusual bleeding symptoms to their physician. Due to its inhibitory effect on platelet aggregation aspirin may cause increased bleeding during and after surgery.

− Aspirin may precipitate acute haemolytic anaemia in patients with G6PDH deficiency. g. coffee, tea and some canned drinks) should be avoided while taking this product. − If you suffer from asthma, allergic disease, kidney or liver problems consult your doctor before taking this product.

Paediatric population:

There is a possible association between aspirin and Reye's syndrome when given to children. Reye's syndrome is a very rare disease which affects the brain and liver, and can be fatal. g. for Kawasaki's disease).

Warnings for the label:

If you do not get better talk to your doctor. Contains aspirin. Do not give to children under 16 years of age unless your doctor tells you to.

Warnings for the leaflet:

Aspirin can cause Reye’s syndrome when it is given to children. This is a very rare disease but it can be fatal. Do not give aspirin to children under 16 of age unless your doctor tells you to.

Important information regarding excipients in this medicine:

Lactose: Toptabs contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactase malabsorption should not take this medicine.

1. g. asthma, bronchospasm, rhinitis, urticaria, nasal polyps) in response to aspirin or non-steroidal anti- inflammatory drugs. • Patients with severe hepatic or renal failure. Aspirin is known to cause sodium and water retention which may exacerbate hypertension, congestive heart failure and renal impairment.

• Aspirin is contraindicated in patients with active peptic ulceration or a history of peptic ulceration. History of gastrointestinal bleeding or perforation after treatment with aspirin or other NSAIDS. • It should not be used if suffering from haemophilia, hypothrombinaemia or other clotting disorders, or gout.

• Doses > 100 mg/day during the third trimester of pregnancy.