Rogin-E Adverse Reactions

The following adverse reactions have been identifed during post-approval use of the medicinal product. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
Gastrointestinal disorders: Gastrointestinal and abdominal pain, vomiting, nausea, diarrhea, constipation, faeces discolored.
Immune system disorders: Allergic reaction, anaphylactic reaction, anaphylactic shock. Symptoms may include urticaria, allergic asthma, allergic edema and angioedema, erythema, rash, blisters, pruritus and may affect the respiratory tract, gastrointestinal tract, cardiovascular system. Severe reactions, including anaphylactic reactions, have been reported and may lead to cardio-respiratory distress according to the literature. If an allergic reaction occurs, treatment must be stopped and a healthcare professional consulted.
Nervous system disorders: Headache, dizziness, insomnia, nervousness.
Renal and urinary disorders: Chromaturia (slight yellow discoloration of urine). This effect is harmless and is due to the vitamin B2 contained in the preparation.