Stop taking the medicine and seek urgent medical advice immediately if you experience any of the following:

• reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms
• Unexplained bruising (without injury), bleeding under your skin, purple spots or patches under your skin, anaemia (feeling tired, weak and looking pale, especially on lips, nails and inside of eyelids), fever (high temperature), sore throat or unusual bleeding (e.g. nose bleeds).
• Lung disease (scarring of lung tissue, allergic reaction) resulting in difficulty in breathing, cough, wheezing and collection of fluid in the lungs, pneumonia
• Abnormal liver function tests, hepatitis (inflammation of the liver giving rise to flu-like symptoms and jaundice)
• Inflammation of the heart with signs like chest pains or palpitations
• Disorder of the immune system (lupus-like syndrome) which can cause inflammation of the heart sac or membranes around the lungs and heart, rash and /or joint pain
• Kidney problems (associated with blood in urine and/or swelling in feet and ankles), kidney failure, which may be reversible if treatment is stopped early

The following side effects have been reported at the approximate frequencies shown:

Common (may affect up to 1 in 10 people)

• rash
• indigestion

Uncommon (may affect up to 1 in 100 people)

• fever
• high number of white blood cells called eosinophil granulocytes
• sensation of tingling, pricking and numbness
• hives, itching skin
• chest pain

Rare (may affect up to 1 in 1000 people)

• headache
• dizziness
• diarrhoea, stomach pain, wind (flatulence), feeling of unease and discomfort in the stomach with an urge to vomit and vomiting
• increased sensitivity of your skin to sun and ultraviolet light (photosensitivity).

Very rare (may affect up to 1 in 10000 people)

• severe reduction in blood cells which can cause weakness, bruising or make infections more likely, low blood cell counts; reduction in blood platelets which increases the risk of bleeding
• allergic reactions such as rash or skin eruption
• fever that occurs while taking the medicine and which disappears when the medicine is stopped (drug fever)
• immune system disease that can involve organs and joints
• ulcerative colitis involving the entire large intestine
• abnormal or damaged nerves giving a sensation of numbness or tingling
• inflamed pancreas (associated with pain in upper abdomen and back and feeling sick)
• abnormal liver function tests, hepatitis (inflammation of the liver giving rise to flu-like symptoms and jaundice)
• muscle or joint pain
• hair loss
• reversible decrease in sperm production

Not known (frequency cannot be estimated from available data)

• inflammation of the membranes of the pleural cavity surrounding the lungs (pleurisy)
• intolerance to mesalazine sometimes with worsening symptoms of underlying disease
• kidney stones and associated kidney pain (see also section 2)
• weight loss
• laboratory test results out of normal range

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report any side effects directly via the Yellow Card Scheme online at yellowcard.mhra.gov.uk or via the free Yellow Card app.

By reporting side effects you can help provide more information on the safety of this medicine.