BUDENOFALK

Posology Crohn’s disease and microscopic colitis Adults aged > 18 years The recommended daily dose is one sachet (containing gastro-resistant granules with 9 mg budesonide) once daily in the morning about half an hour before breakfast.

Paediatric population Budenofalk Uno 9mg gastro-resistant granules should not be taken by children and adolescents due to insufficient experience in this age group. 2). 2). Method of administration Oral use The content of one sachet should be taken before breakfast.

g. a glass of water). The granules should not be chewed or crushed to avoid destruction of the gastro-resistant coating of the granules. Premature disintegration will affect drug disposition in an unpredictable fashion. Duration of treatment The duration of treatment should be limited to 8 weeks.

Termination of treatment The treatment with Budenofalk Uno 9mg gastro-resistant granules should not be stopped abruptly. e. every other day for up to two weeks. Afterwards treatment can be stopped.

The following frequency conventions are used in the evaluation of undesirable effects: very common: (≥ 1/10) common: (≥ 1/100 to < 1/10) uncommon: (≥ 1/1,000 to < 1/100) rare: (≥ 1/10,000 to < 1/1,000) very rare: (<1/10,000), not known (cannot be estimated from the available data).

g. g. 4) Common Dyspepsia, abdominal pain Uncommon Duodenal or gastric ulcer Rare Pancreatitis Gastrointestinal disorders Very rare Constipation Immune system disorders Common Increased risk of infection Common Muscle and joint pain, muscle weakness and twitching, osteoporosis Musculoskeletal and connective tissue disorders Rare Osteonecrosis Common HeadacheNervous system disorders Very rare Pseudotumor cerebri including papilloedema in adolescents Common Depression, irritability, euphoria Uncommon Psychomotor hyperactivity, anxiety Psychiatric disorders Rare Aggression System organ class Frequency according to MedDRA convention Adverse reaction Common Allergic exanthema, petechiae, delayed wound healing, contact dermatitis Skin and subcutaneous tissue disorders Rare Ecchymosis Vascular disorders Very rare Increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term therapy) General disorders and administration site conditions Very rare Fatigue, malaise Most of the adverse events mentioned in this SmPC can also be expected for treatments with other glucocorticosteroids.

Occasionally, adverse events may occur which are typical for systemic glucocorticosteroids. These adverse events 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 adverse events is lower with oral Budenofalk than with oral treatment of equivalent dosages of prednisolone. An exacerbation or the reappearance of extra-intestinal manifestations (especially affecting skin and joints) can occur on switching a patient from systemically acting glucocorticosteroids to the locally acting budesonide.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Treatment with Budenofalk 9mg gastro-resistant granules results in lower systemic steroid levels than conventional oral glucocorticosteroid therapy. Transfer from other glucocorticosteroid therapy may result in symptoms relating to the change in systemic steroid levels.

Caution is required in patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts, family history of diabetes, family history of glaucoma, or any other condition in which glucocorticosteroids may have undesirable effects.

This medicine is not appropriate for patients suffering from Crohn’s disease of the upper gastrointestinal tract. g. of the eyes, skin, joints) cannot be expected. Systemic effects of glucocorticosteroids may occur, particularly when prescribed at high doses and for prolonged periods.

8). Infection Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The risk of deterioration of bacterial, fungal, amoebic and viral infections during glucocorticosteroid treatment should be carefully considered.

The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculosis may be masked, and therefore may reach an advanced stage before being recognised. Chickenpox Chickenpox is of particular concern since this normally minor illness may be fatal in immunosuppressed patients.

Patients without a definite history of chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster and if exposed they should seek urgent medical attention. If the patient is a child, parents must be given the above advice.

Passive immunisation with varicella zoster immunoglobulin (VZIG) is needed by exposed non-immune patients who are receiving systemic glucocorticosteroids or who have used them within the previous 3 months; this should be given within 10 days of exposure to chickenpox.

If a diagnosis of chickenpox is confirmed, the illness warrants specialist care and urgent treatment. Glucocorticosteroids should not be stopped and the dose may need to be increased. Measles Patients with compromised immunity who have come into contact with measles should, wherever possible, receive normal immunoglobulin as soon as possible after exposure.

Vaccines Live vaccines should not be given to individuals with chronic glucocorticosteroid use. The antibody response to other vaccines may be diminished. Patients with liver function disorders Based on the experience with patients suffering from late stage primary biliary cirrhosis (PBC) with hepatic cirrhosis an increased systemic availability of budesonide in all patients with severely impaired hepatic function is to be expected.

However, in patients with liver disease without hepatic cirrhosis budesonide in daily doses of 9 mg was safe and well tolerated. There is no evidence that a specific dose recommendation for patients with non-cirrhotic liver diseases or only slightly impaired liver function is necessary.

Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Others Glucocorticosteroids may cause suppression of the hypothalamic-pituitary- adrenal (HPA) axis and reduce the stress response. When patients are subject to surgery or other stresses, supplementary systemic glucocorticosteroid treatment is recommended.

5). Budenofalk 9mg gastro-resistant granules contain lactose, sucrose and sorbitol. Patients with rare hereditary problems of galactose or fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase insufficiency, total lactase deficiency or the congenital lactase deficiency should not take this medicine.

1 – hepatic cirrhosis.