|The following undesirable effects and frequencies of Budenofalk 3mg have been spontaneously reported:|
Very rare (< 1/10,000), including isolated reports: • Metabolism and nutritional disorders: oedema of legs, Cushing's syndrome• Nervous system disorders: Pseudotumor cerebri (including papilloedema) in adolescents• Gastrointestinal disorders: Constipation• Musculoskeletal, connective tissue and bone disorders: diffuse muscle pain and weakness, osteoporosis• General disorders: tiredness, malaiseSome of the undesired effects were reported after long-term use. Occasionally side effects may occur which are typical for systemic glucocorticosteroids. These side effects depend on the dosage, the period of treatment, concomitant or previous treatment with other glucocorticosteroids and the individual sensitivity.Clinical studies showed that the frequency of glucocorticosteroid associated side effects is lower with Budenofalk 3mg (approx. by half) than with oral treatment of equivalent dosages of prednisolone.
Immune system disorders:Interference with the immune response (e.g. increase in risk of infections).An exacerbation or the reappearance of extraintestinal manifestations (especially affecting skin and joints) can occur on switching a patient from the systemically acting glucocorticosteroids to the locally acting budesonide.
Metabolism and nutrition disorders:Cushing's syndrome: moon-face, truncal obesity, reduced glucose tolerance, diabetes mellitus, sodium retention with oedema formation, increased excretion of potassium, inactivity or atrophy of the adrenal cortex, growth retardation in children, disturbance of sex hormone secretion (e.g. amenorrhoea, hirsutism, impotence)
Psychiatric disorders: Depression, irritability, euphoriaIn addition very rarely a wide range of psychiatric/behavioural effects may occur.
Eyes disorders:Glaucoma, cataract
Vascular disorders:Hypertension , increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term therapy)Gastro intestinal disorders:Stomach complaints, gastroduodenal ulcer, pancreatitis
Skin and subcutaneous tissue disorders:Allergic exanthema, red striae, petechiae, ecchymosis, steroid acne, delayed wound healing, contact dermatitis
Musculoskeletal, connective tissue and bone disorders:Aseptic necrosis of bone (femur and head of the humerus)
Side effects in clinical studies with paediatric patients:
Crohn's disease:In clinical trials with Budenofalk 3mg capsules in 82 paediatric patients with Crohn's disease adrenal suppression and headache were the most frequent undesirable effects. Side effects which are typical for steroids were reported as well as other rare reactions such as dizziness, nausea, vomiting, and hyperacusis (see also section 5.1).
Autoimmune hepatitis:Safety data from the subset of a total of 42 paediatric patients in an autoimmune hepatitis clinical trial revealed that undesirable effects reported were not different and not more frequent compared to the adult population in this study (see also section 5.1).