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When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Section 4.4 “Special warnings and precautions for use”: conditions and treatments associated with an increased risk of muscle disorders are added. Section 4.5 “Interaction with other medicinal products and other forms of interaction”: addition of interaction with macrolides. Section 4.8 “Undesirable effects”: addition of tendonitis and 3 AE in the SOC “Skin and subcutaneous disorders”, namely angioedema, photosensitivity reaction and dermatomyositis.
Section 4.5 “Interaction with other medicinal products and other forms of interaction”: addition of interaction with macrolides. Section 4.8 “Undesirable effects”: addition of tendonitis and 3 AE in the SOC “Skin and subcutaneous disorders”, namely angioedema, photosensitivity reaction and dermatomyositis.
Section 4.8 “Undesirable effects”: addition of tendonitis and 3 AE in the SOC “Skin and subcutaneous disorders”, namely angioedema, photosensitivity reaction and dermatomyositis.