Tablet: Gastrointestinal tract side effects: Abdominal pain, diarrhea, flatulence, nausea, vomiting.
Central nervous system side effects: Headache, dizziness, peripheral neuropathy.
Side effects on the kidney: Impairment of renal function including acute and chronic interstitial.
nephritis and renal insufficiency.
Hypersensitivity reactions: Allergic skin rash (exanthema), drug fever, spasmodic contraction of the airways (bronchospasm), inflammation of the heart sac and heart muscle (peri- and myocarditis), acute inflammation of the pancreas (pancreatitis), allergic and fibrotic lung reactions (including dispnoea, cough, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis), butterfly rash (lupus erythematosus syndrome), inflammation of the entire large bowel (pancolitis).
Musculoskeletal disorders: Muscle and joint pain (myalgia, arthralgia).
Blood and lymphatic system disorders: Changes in the blood counts (aplastic anaemia, agranulocytosis, pancytopenia, neutropenia, leucopenia, thrombocytopenia).
Disorders of the liver and gall bladder: Changes in liver function tests (raised transaminase and parameters of cholestasis), inflammation of the liver (hepatitis), inflammation of the liver associated with cholestasis (cholestatic hepatitis).
Disorders of the skin and appendages: Hair loss (alopecia) and the development of baldness.
Disorders of the reproductive system: Oligospermia (reversible).
Note: Salofalk 500 mg gastro-resistant tablets should be taken under medical supervision. Blood tests (differential blood count; liver function parameters such as transaminases; serum creatinine)
and urine status (dip sticks / sediments) should be checked before and during treatment, at the discretion of your doctor. As a guideline, controls are recommended 14 days after starting treatment, then a further two to three times at intervals of 4 weeks.
If the findings are normal, follow-up tests are required every three months. If additional symptoms develop, tests must be performed immediately. The recommended kidney function tests are serum
urea (BUN) and creatinine assay as well as urine sediment test.
Caution is recommended in patients with impaired hepatic function.
Salofalk 500 mg gastro-resistant tablets should not be used in patients with impaired renal function.
Mesalazine-induced renal toxicity should be considered, if renal function deteriorates during treatment.
In patients with pulmonary function disturbances, in particular asthma, close medical supervision is necessary during treatment with drugs containing mesalazine.
Treatment with Salofalk 500 mg gastro-resistant tablets should only be started under medical supervision in patients with known hypersensitivity to preparations containing sulphasalazine. If acute signs of intolerability e.g. cramps, acute abdominal pain, fever, severe headache and skin rash occur, treatment must be withdrawn immediately.
In rare cases, in patients who have undergone bowel resection/bowel surgery in the ileocoecal region with removal of the ileocoecal valve, it has been observed that Salofalk 500 mg gastroresistant tablets were excreted undissolved in the stool, due to an excessively rapid intestinal passage.
1 Salofalk 500 gastro-resistant tablet contains 2.1 mmol (49 mg) sodium. This must be taken into consideration in patients on a sodium-controlled (low-sodium/low-salt) diet.
Enema/Suppository: Gastrointestinal: Abdominal discomfort, diarrhea, flatulence, nausea and vomiting have been reported rarely.
Central Nervous System: In isolated cases under treatment with mesalazine, central nervous phenomena eg, headache, dizziness and peripheral neuropathy have been observed.
Hypersensitivity Reactions: Hypersensitivity reactions that are not dose-dependent and are common to salicylic acid and its derivatives eg, allergic rash, drug fever, bronchospasm, peri- and myocarditis, acute pancreatitis and intestinal nephritis are possible in rare cases.
Sporadic cases of allergic alveolitis have been observed during treatment with mesalazine. In isolated cases, pancolitis may occur.
Under certain conditions, some drugs with a similar chemical structure to mesalazine may cause a lupus erythematosus-like syndrome (butterfly rash). Thus, the onset of this syndrome cannot be ruled out under treatment with Salofalk tablets.
Others: Myalgia and arthralgia have been observed rarely.
Elevated methemoglobin levels cannot be excluded on account of the chemical structure of the active constituent.
In isolated cases, changes in the blood count (neutropenia, thrombocytopenia) have been reported after the use of drugs containing mesalazine.
There have been occasional reports of changes in liver function parameters (elevated transaminase levels).
Granules: Side effects for granules are defined through system organ class with the following frequency convention: Rare (≥1/10,000, <1/1,000) and very rare (<1/10,000).
Blood and Lymphatic System Disorders: Very Rare: Altered blood counts (aplastic anemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia).
Nervous System Disorders: Rare: Headache, dizziness. Very Rare: Peripheral neuropathy.
Cardiac Disorders: Rare: Myocarditis, pericarditis.
Respiratory, Thoracic and Mediastinal Disorders: Very Rare: Allergic and fibrotic lung reactions (including dyspnea, cough, bronchospasm, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis).
Gastrointestinal Disorders: Rare: Abdominal pain, diarrhea, flatulence, nausea, vomiting. Very Rare: Acute pancreatitis.
Renal and Urinary Disorders: Very Rare: Impairment of renal function including acute and chronic interstitial nephritis and renal insufficiency.
Skin and Subcutaneous Tissue Disorders: Very Rare: Alopecia.
Musculoskeletal and Connective Tissue Disorders: Very Rare: Myalgia, arthralgia.
Immune System Disorders: Very Rare: Hypersensitivity reactions eg, allergic exanthema, drug fever, lupus erythematosus syndrome, pancolitis.
Hepatobiliary Disorders: Very Rare: Changes in liver function parameters (increase in transaminases and parameters of cholestasis), hepatitis, cholestatic hepatitis.
Reproductive System Disorders: Very Rare: Oligospermia (reversible).