Salofalk Side Effects

Like all medicines, Salofalk can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are very rare. Patients should seek medical attention immediately in any case of: Allergic skin rash; Fever; Breathing difficulties.
Salofalk should be stopped in any case of a marked reduction of general state of health, especially if accompanied by fever and/or a sore throat and mouth. Urgent medical advice or treatment may be needed.
These symptoms can, very rarely, be due to a fall in the number of white cells in the blood (a condition called agranulocytosis), which may make the patient more prone to developing a serious infection. A blood test can confirm whether the symptoms are due to an effect of this medicine on the blood.
Gastro-resistant tab 500 mg/Supp: Stop using mesalazine and seek medical attention immediately if the patient notices any of the following symptoms: 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, widespread rash (Gastro-resistant tab 500 mg), fever (Gastro-resistant tab 500 mg) and enlarged lymph nodes (Gastro-resistant tab 500 mg). These serious skin rashes can be preceded by fever and flu-like symptoms.
Gastro-resistant PR granules: If a patient gets any of the following symptoms after taking this medicine, the patient should contact a doctor and stop the intake of Salofalk granules immediately: General allergic reactions such as skin rash, fever, joint pain and/or breathing difficulties or a general inflammation of the large bowel (causing severe diarrhoea and abdominal pain). These reactions are very rare.
A marked reduction of general health, especially if accompanied by fever, and/or a sore throat and mouth. These symptoms can, very rarely, be due to a fall in the number of white cells in the blood, which may make the patient more prone to developing a serious infection (agranulocytosis). Other cells of the blood may also be affected (e.g. platelets or red cells causing aplastic anaemia or thrombocytopenia) and cause symptoms which may include unexplained bleeding, purple spots or patches under the skin, anaemia (feeling tired, weak and looking pale, especially on lips and nails). A blood test can confirm whether the symptoms are due to an effect of this medicine on the blood. These reactions are very rare.
Serious skin rashes with 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, widespread rash, fever and enlarged lymph nodes. These can be preceded by fever and flu-like symptoms. These reactions occur in an unknown number of patients (frequency not known).
Shortness of breath, chest pain or irregular heartbeat, or swollen limbs which may be indicative of cardiac hypersensitivity reactions. These reactions are rare.
Problems with the kidney function (can occur very rarely), e.g. a change in the colour or amount of urine produced and swollen limbs or a sudden flank pain (caused by a kidney stone) (occur in an unknown number of patients (frequency not known)).
The following side effects have also been reported in patients using medicines containing mesalazine: Common (may affect up to 1 in 10 patients): Gastro-resistant tab 500 mg/PR granules: Headache.
Gastro-resistant PR granules: Rash, itching.
Uncommon (may affect up to 1 in 100 patients): Gastro-resistant tab 500 mg/PR granules: Abdominal pain, diarrhoea, dyspepsia, wind (flatulence), nausea and vomiting; Severe abdominal pain because of acute inflammation of the pancreas; Changes in liver function parameters, changes in pancreatic enzymes.
Gastro-resistant tab 500 mg: Changes in the number of white blood cells.
Rare side effects (may affect up to 1 in 1,000 patients): Dizziness; Chest pain, breathlessness or swollen limbs because of an effect on the heart.
Gastro-resistant tab 250 mg/PR granules/Enema/Supp: Abdominal pain, diarrhoea, wind (flatulence), nausea and vomiting; Headache.
Gastro-resistant tab/PR granules/Supp: Increased sensitivity of the skin to sun and ultraviolet light (photosensitivity).
Gastro-resistant tab 500 mg/PR granules: Jaundice or abdominal pain because of liver and bile flow disorders; Joint pain; Feeling weak or tired.
Very rare side effects (may affect up to 1 in 10,000 patients): Changes in kidney function, sometimes with swollen limbs or flank pain; Fever, sore throat or malaise, because of blood count changes; Shortness of breath, cough, wheezing, lung shadow on X-ray due to allergic and/or inflammatory lung conditions; Severe diarrhoea and abdominal pain because of an allergic reaction to this medicine within the bowel; Hair loss and the development of baldness; Numbness and tingling in the hands and feet (peripheral neuropathy); Reversible decrease in semen production.
Gastro-resistant tab 250 mg/PR granules/Enema/Supp: Severe abdominal pain because of acute inflammation of the pancreas; Skin rash or inflammation; Muscle and joint pain; Jaundice or abdominal pain because of liver and bile flow disorders.
Gastro-resistant tab 500 mg: Skin rash or inflammation, allergic condition which causes joint pain, skin rashes and fever; Muscle pain.
Not known (frequency cannot be estimated from the available data): Gastro-resistant tab 500 mg/Supp: Kidney stones and associated kidney pain (see Precautions).
Reporting of side effects: Side effects should be reported. This includes any possible side effects not previously listed.