DISPRIN Dispersible tablet Ref.[49928] Active ingredients: Acetylsalicylic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Reckitt Benekiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom

4.3. Contraindications

Should not be given to patients suffering from a previous history of peptic ulceration or active peptic ulceration or haemophilia.

Dispirin contains soy protein. If you are allergic to peanut or soya do not use this medicinal product.

4.4. Special warnings and precautions for use

The product labelling will include:

Do not give to children under 16 years unless on the advice of a doctor.

Keep out of reach of children.

If you are receiving regular medical treatment, are asthmatic, allergic to aspirin or have or have had a stomach ulcer, seek your doctor’s advice before taking this product.

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. For this reason aspirin should not be given to children aged under 16 years unless specifically indicated (e.g. for Kawasaki’s disease).

This medicine contains less than 1mmol sodium (23 mg) per dose, that is to state essentially ‘sodium-free’.

4.5. Interaction with other medicinal products and other forms of interaction

Aspirin may enhance the effects of anticoagulants and inhibit the effects of uricosurics.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex-vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).

Metamizole may reduce the effect of acetylsalicylic acid on platelet aggregation when taken concomitantly. Therefore, this combination should be used with caution in patients taking low dose aspirin for cardioprotection.

4.6. Pregnancy and lactation

There is clinical and epidemiological evidence of the safety of aspirin in human pregnancy, but it may prolong labour and contribute to maternal and neonatal bleeding and is best avoided at term and during breastfeeding.

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

May precipitate bronchospasm and induce attacks of asthma or hypersensitivity in susceptible subjects. May also induce gastrointestinal haemorrhage, occasionally major.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

6.2. Incompatibilities

None known.

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