Prescribing Information Budenofalk Granules 9mg IE

Prescribing Information (Please refer to full SPC before prescribing)

Presentation: Budenofalk® 9 mg gastro-resistant granules, each sachet contains 9 mg budesonide. Also containing 828mg sucrose, 36mg lactose monohydrate and 900mg sorbitol. Indications: Induction of remission in patients with mild to moderate active Crohn’s disease affecting the ileum and/or the ascending colon. Induction of remission in patients with active microscopic colitis in adults aged ≥ 18 years. Dosage: Adults: One sachet daily, in the morning, half an hour before breakfast. Children: Budenofalk 9mg granules should not be taken by children and adolescents due to insufficient experience in this age group. No specific dose recommendations in renal/hepatic impairment. 8 weeks maximum treatment. Do not stop treatment abruptly. Contra-indications: Known hypersensitivity to budesonide or any of the ingredients. Hepatic cirrhosis. Warnings/Precautions: Transfer of patients from other steroid therapy may result in symptoms relating to the lowering of systemic steroid levels. Use with caution in patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts or family history of glaucoma or diabetes, or any other condition in which glucocorticoids may have undesirable effects. Not appropriate for use in upper GI Crohn’s disease or for extraintestinal symptoms e.g., of the eyes, skin, joints. Long term, high dose use may result in systemic effects of glucocorticosteroids such as Cushing’s syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma, psychiatric/behavioural effects. Infection: suppression of the inflammatory response and immune function increases susceptibility to infections and their severity, with risk of deterioration of bacterial, fungal, amoebic and viral infections. The clinical presentation of infections may be atypical and the presentation of serious infections e.g. septicaemia and tuberculosis, may be masked. Chickenpox is of particular concern in immunosuppressed patients and those without definite medical history of this infection should avoid close personal contact with chickenpox or herpes zoster. Passive immunisation is needed by exposed non-immune patients receiving (or who have received within the previous 3 months) systemic glucocorticosteroids, within 10 days of exposure to chickenpox. Urgent specialist care is required if chickenpox is confirmed; glucocorticosteroids should not be stopped and dosage may need to be increased. Measles: Immunosuppressed patients who come into contact with measles should receive normal immunoglobulin as soon as possible after exposure. Live vaccines should not be given to patients with chronic glucocorticosteroid use. Antibody response to other vaccines may be diminished. Patients with liver function disorders: patients suffering with late stage PBC with hepatic cirrhosis should expect an increased systemic bioavailability of budesonide. In patients without hepatic cirrhosis 9mg budesonide was well tolerated. Visual disturbances may require referral to ophthalmology. Other: Glucocorticosteroids may suppress the HPA axis and reduce the stress response. Supplementary systemic glucocorticosteroid treatment is recommended in patients subject to surgery or other stress. Concomitant treatment with ketoconazole or other CYP3A4 inhibitors should be avoided. Patients with rare hereditary problems of galactose or fructose intolerance, glucose – galactose malabsorption, sucrase – isomaltase insufficiency or Lapp lactase deficiency or congenital lactase deficiency should not take this medicine. Interactions: Co-treatment with CYP3A inhibitors, including cobicistat-containing products, may increase the risk of systemic side-effects and should be avoided. Concomitant administration of cardiac glycosides may potentiate the activity of the glycoside (due to increased excretion of potassium); simultaneous treatment with saluretics may exacerbate the hypokalaemia. Avoid concomitant administration with ketoconazole, grapefruit juice or other CYP3A4 inhibitors (e.g. ritonavir, itraconazole and clarithromycin) because they may markedly increase the plasma concentrations of budesonide. CYP3A4 inducers (e.g. carbamazepine and rifampicin) may reduce systemic and local (gut mucosa) exposure, necessitating dose adjustment of budesonide. CYP3A4 substrates may compete with budesonide leading to possible increases in plasma concentrations of either budesonide or substrate, depending on their relative affinities for this enzyme. Elevated plasma concentrations and enhanced effects of glucocorticosteroids have been reported with oestrogens or oral contraceptives, although not with oral low dose contraceptives. Cimetidine has a small (non-significant) effect on the kinetic effects of budesonide. Steroid-binding compounds (e.g. cholestyramine) and antacids may reduce the efficacy of budesonide, therefore they should be given at least 2 hours apart. Because adrenal function may be suppressed, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values). Use in pregnancy and lactation: Budenofalk should be avoided during pregnancy unless essential. Lactating mothers should not breast feed infants during Budenofalk treatment. Undesirable effects: Occasionally adverse events characteristic of systemic glucocorticosteroid therapy may occur depending on user, dose, period of use and prior use. Clinical studies show that the frequency of these events is lower with Budenofalk than with oral equivalent doses of prednisolone. Exacerbation or reappearance of extraintestinal manifestations when switching treatment from systemically acting glucocorticosteroids may occur. Other adverse effects include: Cushing’s syndrome, headache, muscle and joint pain and weakness and twitching, osteoporosis. increase in risk of infections, depression, irritability and euphoria, allergic exanthema, petechiae, ecchymosis, contact dermatitis, delayed wound healing. Psychomotor hyperactivity, anxiety, aggression, fatigue, malaise, growth retardation in children, glaucoma, cataracts, blurred vision, dyspepsia, abdominal pain, increased risk of thrombosis, vasculitis (after withdrawal from long-term treatment), constipation, gastric or duodenal ulcers, pancreatitis, osteonecrosis, pseudotumor cerebri including papilloedema in adolescents. Legal category: POM. UK NHS Cost: Packs of 60 sachets £135. Ireland cost: Packs of 60 sachets: €145.84 (PtW). Product licence holder: Dr Falk Pharma GmbH, Leinenweberstr.5, D-79108 Freiburg, Germany. Product licence number: PL08637/0020 (UK) PA573/2/3 (IE). Date of preparation: January 2023

Further information is available on request.

Adverse events should be reported. Reporting forms and information can be found at (UK residents) or at (residents in Ireland). Adverse events should also be reported to Dr Falk Pharma UK Ltd at