Loading…
BUDENOFALK is a brand name for Budesonide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the treatment of active ulcerative colitis that is limited to the rectum and the sigmoid colon.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults aged > 18 years One actuation of 2 mg budesonide daily. Paediatric population Budenofalk 2mg rectal foam should not be used in children due to insufficient experience in this age group. Method of administration Budenofalk 2mg rectal foam can be applied in the morning or evening.
The canister is first fitted with an applicator and then shaken for about 15 seconds before the applicator is inserted into the rectum as far as comfortable. Note that the dose is only sufficiently accurate when the pump dome is held downwards as vertically as possible.
To administer a dose of Budenofalk 2mg rectal foam, the pump dome is fully pushed down and very slowly released. Following the activation the applicator should be held in position for 10 - 15 seconds before being withdrawn from the rectum.
The best results are obtained when the intestine is evacuated prior to administration of Budenofalk 2mg rectal foam. Duration of treatment The attending physician determines the duration of use. An acute episode generally subsides after 6 to 8 weeks.
Budenofalk 2mg rectal foam should not be used after this period of time.
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 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 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) Common Burning in the rectum and painGeneral disorders and administration site conditions Very rare Fatigue, malaise The following adverse reactions were additionally reported in clinical studies with Budenofalk 2mg rectal foam (frequency: 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.
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.
Treatment with Budenofalk 2mg rectal foam results in lower systemic steroid levels than conventional oral glucocorticosteroid therapy with systemically acting corticoids. Transfer from other glucocorticosteroid therapy may result in reappearance or recurrence of 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.
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.
1 − hepatic cirrhosis
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Budesonide in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Some of the adverse events were reported after long-term use of orally administered budesonide. Due to its local action, the risk of adverse reactions of Budenofalk 2mg rectal foam is generally lower than when taking systemically acting glucocorticosteroids.
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
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.
However, in patients with liver disease without hepatic cirrhosis budesonide in daily oral 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). 3 mg propylene glycol in each actuation of Budenofalk rectal foam. Propylene glycol may cause skin irritation. g. contact dermatitis).