Prescribing Information Budenofalk Foam IE

Name of Medicinal Product: Budenofalk 2mg/dose rectal foam. Presentation: each dose of 1.2g foam contains 2mg budesonide plus 600.3mg propylene glycol, 8.4mg cetyl alcohol and 15.1mg cetostearyl alcohol. Indications: treatment of active ulcerative colitis limited to the rectum and the sigmoid colon. Dosage & Administration: adults aged over 18 years, one dose of 2mg budesonide daily, applied either in the morning or evening. Should not be used for longer than 6–8 weeks. Children, not recommended. Contra-indications: known hypersensitivity to budesonide or any of the ingredients, hepatic cirrhosis. Special Warnings & Precautions: Results in lower systemic steroid levels than oral therapy with systemically acting corticoids. Transfer from systemic corticoids may result in recurrence of symptoms. Systemic effects of glucocorticosteroids may occur, especially at high and/or prolonged doses. Caution in patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts, family history of diabetes, family history of glaucoma. 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. Clinical presentation of serious infections e.g. septicaemia and tuberculosis, may be atypical and masked. Chickenpox is of particular concern in immunosuppressed patients and those without a 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 those who have received within the previous 3 months) systemic corticosteroids, within 10 days of exposure to chickenpox. Urgent specialist care is required on confirmed chickenpox; corticosteroids should not be stopped and the dosage may need to be increased. Immunosuppressed patients in contact with measles should immediately receive normal immunoglobulin. Live vaccines should not be given to individuals with impaired immune responsiveness and antibody response to other vaccines may be diminished. Hepatic cirrhosis may increase systemic availability. Visual disturbances may require referral to ophthalmology. Corticosteroids may suppress the HPA axis and reduce the stress response. Supplementary systemic glucocorticoid treatment is recommended in patients subject to surgery or other stresses. Concomitant treatment with ketoconazole or other CYP3A4 inhibitors should be avoided. The cetyl alcohol and cetostearyl alcohol content may cause local skin reactions (e.g. contact dermatitis). The propylene glycol may cause skin irritation. Interactions: co-treatment with CYP3A inhibitors including cobicistat containing products may increase risk of systemic side effects. Concomitant administration of cardiac glycosides may potentiate the activity of the glycoside (due to increased excretion of potassium); simultaneous treatment with saluretics may also exacerbate the hypokalaemia. A void 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 relative affinities for this enzyme. Elevated plasma concentrations and enhanced effects of corticosteroids have been reported with oestrogens or oral contraceptives, although not with oral low dose contraceptives. 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. It is not known if budesonide passes into breastmilk. The risks and benefits of breastfeeding for the infant and therapy for the woman need to be considered. There are no data on the effects on fertility. Undesirable effects: the assessment of undesirable effects is based on the following frequencies. Common (≥1/100 to <1/10). Uncommon: (≥1/1000 to <1/100). Rare: (≥1/10,000 to <1/1000). Very rare: (<1/10,000). Common: headache, dyspepsia, burning in the rectum and pain, Cushing’s syndrome, increased risk of infection, muscle and joint pain, muscle weakness and twitching, osteoporosis, depression, irritability, euphoria, allergic exanthema, petechiae, delayed wound healing, contact dermatitis. Uncommon: duodenal or gastric ulcer, psychomotor hyperactivity, anxiety. Rare: glaucoma, cataract, blurred vision, pancreatitis, osteonecrosis, aggression, ecchymoses. Very rare: constipation, pseudotumor cerebri (including papilloedema) in adolescents, increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term therapy), fatigue and malaise, growth retardation in children. Seen in clinical studies with topical application of foam: uncommon: increased appetite, increase in erythrocyte sedimentation rate, leucocytosis, nausea, abdominal pain, flatulence, paraesthesias in the abdominal region, anal fissure, aphthous stomatitis, frequent urge to defecate, rectal bleeding, increase in transaminases (GOT, GPT), increase in parameters of cholestasis (GGT, AP), increase in amylase, change in cortisol, urinary tract infection, dizziness, disturbances of smell, insomnia, increased sweating, asthenia, increase in body weight. Occasionally side effects characteristic of systemic corticosteroid therapy may occur, these effects depend on the dosage, period of treatment, concomitant or previous treatment with other glucocorticosteroids and the individual sensitivity. Exacerbation or reappearance of extra intestinal manifestations can occur on switching from systemically to locally acting. Due to its local action, the risk of unwanted effects with Budenofalk rectal foam is generally lower than when taking systemically acting glucocorticoids. Price: packs containing 1 can of Budenofalk rectal foam sufficient for 14 doses €62.40 (PtW) Legal Category: POM. Product Licence number: PA573/2/2. Product Licence Holder: Dr Falk Pharma GmbH, Leinenweberstr. 5, 79108 Freiburg, Germany. Date of preparation: January 2023

Further information is available on request.

Adverse events should be reported. Reporting forms and information can be found at https://www.hpra.ie/homepage/about-us/report-an-issue/human-adverse-reaction-form

Adverse events should also be reported to Dr Falk Pharma UK Ltd at PV@drfalkpharma.co.uk