2. Qualitative & Quantitative composition - To add full list of excipients.
4.4 Special warnings and special precautions for use - To add the following text;
In case of acute symptoms of intolerance, i.e. cramps, abdominal pain, fever, severe headache and rash, the treatment should be discontinued immediately.
Blood tests (differential blood count, liver function parameters like ALT or AST) should be assessed prior to and during treatment, at the discretion of the treating physician.
4.5 Interaction with other medicinal products and other forms of interaction - To add the following text;
No specific interaction studies have been performed. Concomitant treatment with mesalazine can increase the risk of blood dyscrasia in patients receiving azathioprine or 6-mercaptopurine.
4.8 Undesirable effects - Tp update the side effects table
5.1 Pharmacodynamic prop. - To add Pharmacotherapeutic group - Intestinal anti-inflammatory agents.
6.4 Special precautions for storage - re-phrased the none storage condition sentence.
6.5 Nature & content of container - To add "Not all pack sizes may be marketed".
6.6 Special precautions for disposal - To replace the text to "Any unused product or waste material should be disposed of in accordance with local requirements.
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