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BUDESONIDE DR. FALK PHARMA is a brand name for Budesonide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Short-term treatment of mild to moderate acute ulcerative colitis limited to the rectum (ulcerative proctitis) in adult patients.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The recommended daily dose is 4 mg budesonide as one 4-mg-suppository. Method of administration For rectal administration only. Budesonide Dr. Falk Pharma suppositories should be administered at bedtime. If possible, the bowel should be emptied prior to administration of Budesonide Dr.
Falk Pharma suppositories in order to obtain the best results. Duration of treatment The duration of treatment is determined by the physician. An acute episode generally subsides after 6 to 8 weeks. Budesonide Dr. Falk Pharma suppositories should not be used after this period of time.
Special populations Renal impairment There are currently no data available for patients with renal impairment. Because budesonide is excreted via the kidneys only to a minor extent, patients with mild to moderate impairment may be treated with the same doses as patients without renal impairment.
Even though the pharmacokinetics of budesonide are not expected to be altered in patients with renal impairment, in the absence of further data, caution should be exercised in the administration of the product to patients with severe renal impairment.
Hepatic impairment Budesonide Dr. 2). Elderly (>65 years) No special dose adjustment is recommended. However, experience with the use of Budesonide Dr. Falk Pharma suppositories in the elderly is limited. Paediatric population The safety and efficacy of Budesonide Dr.
Falk Pharma suppositories in children and adolescents under the age of 18 years have not been established. No data are available.
Frequencies are defined as 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) or not known (cannot be estimated from the available data). The following adverse drug reactions have been observed in clinical studies with Budesonide Dr.
Falk Pharma suppositories:
MedDRA system organ class Very common Uncommon Endocrine disorders Adrenal insufficiency Nervous system disorders Headache Vascular disorders Flushing Gastrointestinal disorders Abdominal pain, flatulence, pancreatitis Skin and subcutaneous tissue disorders Rash Reproductive system and breast disorders Menstrual disorder, irregular menstruation Investigations Cortisol decreased The following known adverse reaction of the therapeutic class (corticosteroids, budesonide) can also occur under Budesonide Dr.
4) Vascular disorders Increased risk of thrombosis, vasculitis, hypertension Gastrointestinal disorders Dyspepsia, gastric and duodenal ulcers, constipation Skin and subcutaneous tissue disorders Allergic exanthema, petechiae, delayed wound healing, contact dermatitis, ecchymosis Musculoskeletal and connective tissue disorders Myalgia, arthralgia, muscle weakness, muscle twitching, osteoporosis, osteonecrosis General disorders Malaise, fatigue These adverse reactions are typical for systemic glucocorticosteroids.
Their occurrence depends on the dosage, the period of treatment, concomitant or previous treatment with other glucocorticosteroids and the individual sensitivity. Due to its local action, the risk of systemic adverse reactions of Budesonide Dr.
Falk Pharma suppositories is generally lower than when taking systemically acting glucocorticosteroids. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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.
Systemic effects of glucocorticosteroids may occur. 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 in 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 cholangitis (PBC) with hepatic cirrhosis an increased systemic availability of budesonide in all patients with severely impaired hepatic function is to be expected.
1 Hepatic cirrhosis
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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However, in patients with liver disease without hepatic cirrhosis budesonide in daily oral doses of 9 mg was safe and well tolerated. For Budesonide Dr. Falk Pharma suppositories, no specific dose adjustment for patients with non-cirrhotic liver diseases or only slightly impaired liver function is necessary.
Patients with renal disorders Even though the pharmacokinetics of budesonide are not expected to be altered in patients with renal impairment, in the absence of further data, caution should be exercised in the administration of the product to patients with severe renal impairment.
Visual disturbance Visual disturbance has been 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.
Interference with serological testing Because adrenal function may be suppressed by treatment with budesonide, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values). Elderly (>65 years) It should be considered that side effects may occur more frequently in elderly patients.
Therefore, elderly patients should be closely monitored for side effects. 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 and adrenal suppression is suspected, supplementary systemic glucocorticosteroid treatment is recommended.
Treatment with Budesonide Dr. Falk Pharma suppositories results in lower systemic steroid levels than conventional oral glucocorticosteroid therapy with systemically acting corticoids. Transfer from other glucocorticosteroid therapy may result in recurrence of symptoms relating to the change in systemic steroid levels.
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