Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Budesonide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Budenofalk Rectal Foam contains the active substance budesonide, a type of locally acting steroid used to treat inflammatory bowel disease. Budenofalk Rectal Foam is used for the treatment of: •
Inflammation of the rectum (back passage) and the lower part of the colon (sigmoid colon), known by doctors as ulcerative colitis.
e Budenofalk Rectal Foam Do not use Budenofalk Rectal Foam
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Warnings and precautions Talk to your doctor before using Budenofalk Rectal Foam if you have:
cardiac glycosides such as digoxin (medicines used to treat heart conditions) diuretics (to remove excess fluid from the body) ketoconazole or itraconazole (to treat fungal infections) antibiotic drugs used to treat infections (such as clarithromycin) carbamazepine (used in the treatment of epilepsy) rifampicin (for treating tuberculosis) oestrogens or oral contraceptives
Some medicines may increase the effects of Budenofalk Rectal Foam and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat). Budenofalk Rectal Foam could affect the results of tests performed by your doctor or in hospital. Tell your doctor that you are using Budenofalk Rectal Foam before any tests are carried out.
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Budenofalk Rectal Foam with food and drink You should not drink grapefruit juice whilst you are using this medicine as this can alter its effects. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. You should only use Budenofalk Rectal Foam during pregnancy if your doctor tells you to. Budesonide passes in small amounts into the breast milk. If you are breast-feeding you should only use Budenofalk Rectal Foam if your doctor tells you to. Driving and using machines Budenofalk Rectal Foam is not expected to affect your ability to drive or operate machinery. Budenofalk Rectal Foam contains propylene glycol, cetyl alcohol and cetostearyl alcohol This medicinal product contains 600.3 mg propylene glycol in each actuation of Budenofalk Rectal Foam. Propylene glycol may cause skin irritation. Cetyl alcohol and cetostearyl alcohol (component of emulsifying wax) may cause local skin reactions (e.g. contact dermatitis).
Budenofalk Rectal Foam Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is Dose for adults over 18 years of age The usual dose is 1 spray actuation per day, either in the morning or to be used at bedtime. Emptying your bowels before using Budenofalk Rectal Foam produces the best results. Use in children and adolescents Budenofalk Rectal Foam should not be used in children under 18 years of age, because there is very limited experience with Budenofalk Rectal Foam in this age group. Method of administration This medicine may only be used rectally, so it has to be inserted through the anus. It is not intended to be taken by mouth. Do not swallow. Picture of the spray can
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The applicators are in a special rail. Please hold the rail firmly and pull the applicator out sharply. Preparing to use the foam Push applicator firmly onto the spout of the spray can. Shake the spray can for about 15 seconds to mix the contents.
Before the first use, remove the safety lock (plastic flap) from under the pump dome.
Twist the dome on the top of the spray can until the semi-circular gap underneath is in line with the applicator. The spray can is now ready for use.
Using the foam Place your index finger on the top of pump dome and turn the can upside down. Note that the spray can will only work properly when held with the pump dome pointing down as vertically as possible. Stand with one foot on a stool or chair or lie on your side with the lower leg stretched out and the upper leg bent for balance. Insert the applicator into your rectum as far as possible. Push the pump dome down fully once and then slowly release it – the foam comes out of the spray can when you release the dome. Keep the applicator in place for 10 – 15 seconds before taking it out. This ensures the full dose is delivered into the rectum and no foam is spilt.
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After administering the foam, remove the applicator and dispose of it with your household waste in the plastic bag provided. Use a new applicator for the next administration. In order to prevent the inadvertent loss of foam from the spray can between applications turn the pump dome around so that the semicircular gap faces the opposite direction to the spout. • •
Wash your hands and try not to empty your bowels until the next morning. If you go to hospital or see another doctor or dentist tell them you are using this medicine.
Duration of treatment How long you will use the medicine depends upon your condition. Your doctor will decide how long you are to continue the medication. Acute episodes of inflammatory bowel disease (ulcerative colitis) generally subside after 6 – 8 weeks. If you think that the effect of Budenofalk Rectal Foam is too strong or too weak, talk to your doctor. If you use more Budenofalk Rectal Foam than you should If you have used too much medicine on one occasion, use your next dose as prescribed. Do not use a smaller amount. Contact a doctor if you are in doubt, so he or she can decide what to do; take the carton and this leaflet with you if possible. If you forget to use Budenofalk Rectal Foam If you miss a dose, just continue your treatment at the prescribed dosage. Do not use a double dose to make up for a forgotten dose. If you stop using Budenofalk Rectal Foam Speak to your doctor if you want to interrupt or end your treatment early. It is important that you do not stop using your medicine abruptly as it could make you ill. Keep using your medicine until your doctor tells you to stop, even if you start to feel better. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any of the following symptoms after using this medicine, you should contact your doctor immediately:
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•
changes in behaviour such as depression, irritability, euphoria, restlessness, anxiety or aggression
The following side effects have also been reported: Common: may affect up to 1 in 10 people
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–
tiredness, general feeling of being ill
These side effects are typical of steroid medication and most of them can also be expected for treatments with other steroids. They may occur depending on your dose, duration of treatment, whether you have had or are having treatment with other cortisone preparations, and your individual susceptibility. Some of these unwanted effects were only reported after long-term use of oral budesonide. In general, the risk of side effects with Budenofalk Rectal Foam is lower than with systemically acting (affecting the whole body) cortisone preparations due to its local action. If you have been treated with a stronger cortisone preparation before starting treatment with Budenofalk Rectal Foam, your symptoms may reappear when the medicine is changed. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any
not listed in this leaflet. You can also report side effects directly as follows. Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store By reporting side effects you can help provide more information on the safety of this medicine. 5.
Budenofalk Rectal Foam
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and on the pressurised container. The expiry date refers to the last day of that month. The contents of the container must be used within 4 weeks after first opening. Do not store above 25 °C. Do not refrigerate or freeze! The container is pressurised and contains flammable propellant. Do not expose to temperature higher than 50°C, protect from direct sunlight. Do not pierce or burn, even when empty.
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Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment. 6.
What Budenofalk Rectal Foam contains The active substance is budesonide. Each dose of foam contains 2 mg budesonide. The other ingredients are cetyl alcohol, emulsifying wax, purified water, disodium edetate, macrogol stearyl ether, propylene glycol, citric acid monohydrate and nbutane, isobutane and propane as propellants. What Budenofalk Rectal Foam looks like and contents of the pack Budenofalk Rectal Foam is a white to pale white, creamy, firm foam and is presented in a pressurised container. Budenofalk Rectal Foam is available in packs containing 1 pressurised container, 14 applicators and 14 plastic bags or in packs containing 2 pressurised containers, 28 applicators and 28 plastic bags, for the hygienic disposal of the applicators. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Dr. Falk Pharma GmbH Leinenweberstr. 5 79108 Freiburg Germany Tel. +49 (0) 761/1514-0 E-mail: [email protected] This medicinal product is authorised in the Member States of the EEA under the following names: Denmark, Finland, Greece, Ireland, Romania, Sweden, United Kingdom: Budenofalk Austria: Budo-San Italy: Intesticort Spain: Intestifalk This leaflet was last revised in 10/2023.
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The active substance in Budenofalk 2mg/dose rectal foam is budesonide.
This leaflet reproduces the patient information leaflet approved for Budenofalk 2mg/dose rectal foam, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For the treatment of active ulcerative colitis that is limited to the rectum and the sigmoid colon.
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.
Budenofalk 2mg rectal foam must not be used in patients with:
- hypersensitivity to the active substance or to any of the excipients listed in section 6.1
- hepatic cirrhosis
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. Such effects may include Cushing's syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma and a wide range of psychiatric/behavioural effects (see section 4.8).
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 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.
Concomitant treatment with ketoconazole or other CYP3A4 inhibitors should be avoided (see section 4.5).
This medicinal product contains 600.3 mg propylene glycol in each actuation of Budenofalk rectal foam. Propylene glycol may cause skin irritation.
Cetyl alcohol and cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Pharmacodynamic interactions
Cardiac glycosides
The action of the glycoside can be potentiated by potassium deficiency.
Saluretics
Potassium excretion can be enhanced.
Pharmacokinetic interactions
Cytochrome P450
- CYP3A4 inhibitors
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
Ketoconazole 200 mg once daily p.o. increased the plasma concentrations of budesonide (3 mg single dose) approximately 6 - fold during concomitant administration. When ketoconazole was administered 12 hours after budesonide, the concentrations increased approximately 3 - fold. As there are not enough data to give dose recommendations, the combination should be avoided.
Other potent inhibitors of CYP3A4 such as ritonavir, itraconazole, clarithromycin and grapefruit juice are also likely to cause a marked increase of the plasma concentrations of budesonide. Therefore concomitant administration of budesonide should be avoided.
- CYP3A4 inducers
Compounds or drugs such as carbamazepine and rifampicin, which induce CYP3A4, might reduce the systemic but also the local exposure of budesonide at the gut mucosa. An adjustment of the budesonide dose might be necessary.
- CYP3A4 substrates
Compounds or drugs which are metabolized by CYP3A4 might be in competition with budesonide. This might lead to an increased budesonide plasma concentration if the competing substance has a stronger affinity to CYP3A4, or - if budesonide binds stronger to CYP3A4 - the competing substance might be increased in plasma and a dose adaption/reduction of this drug might be required.
Elevated plasma concentrations and enhanced effects of glucocorticosteroids have been reported in women also receiving oestrogens or oral contraceptives, but this has not been observed with oral low dose combination contraceptives.
Because adrenal function may be suppressed by treatment with budesonide, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values).
Pregnancy
Administration during pregnancy should be avoided unless there are compelling reasons for therapy with Budenofalk 2mg rectal foam. There are few data of pregnancy outcomes after oral administration of budesonide in humans. Although data on the use of inhaled budesonide in a large number of exposed pregnancies indicate no adverse effect, the maximal concentration of budesonide in plasma has to be expected to be higher in the treatment with Budenofalk 2mg rectal foam compared to inhaled budesonide. In pregnant animals, budesonide, like other glucocorticosteroids, has been shown to cause abnormalities of fetal development (see section 5.3). The relevance of this to man has not been established.
Breast-feeding
Budesonide is excreted in human milk (data on excretion after inhalative use is available). However, only minor effects on the breast-fed child are anticipated after application of Budenofalk 2mg rectal foam within the therapeutic range. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from budesonide therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility
There are no data on the effect of budesonide on human fertility. Fertility was unaffected following budesonide treatment in animal studies (see section 5.3).
No studies on the effects on the ability to drive and use machines have been performed.
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).
System organ class
Frequency according to MedDRA convention
Adverse reaction
Metabolism and nutrition disorders
Common
Cushing's syndrome: e.g. with moon face, truncal obesity, reduced glucose tolerance, diabetes mellitus, hypertension, sodium retention with oedema, increased potassium excretion, inactivity or atrophy of the adrenal cortex, red striae, steroid acne, disturbance of sex hormone secretion (e.g. amenorrhoea, hirsutism, impotence)
Very rare
Growth retardation in children
Eye disorders
Rare
Glaucoma; cataract; vision, blurred (see also section 4.4)
Gastrointestinal disorders
Common
Dyspepsia
Uncommon
Duodenal or gastric ulcer
Rare
Pancreatitis
Very rare
Constipation
Immune system disorders
Common
Increased risk of infection
Musculoskeletal and connective tissue disorders
Common
Muscle and joint pain, muscle weakness and twitching, osteoporosis
Rare
Osteonecrosis
Nervous system disorders
Common
Headache
Very rare
Pseudotumor cerebri including papilloedema in adolescents
Psychiatric disorders
Common
Depression, irritability, euphoria
Uncommon
Psychomotor hyperactivity, anxiety
Rare
Aggression
Skin and subcutaneous tissue disorders
Common
Allergic exanthema, petechiae, delayed wound healing, contact dermatitis
Rare
Ecchymosis
Vascular disorders
Very rare
Increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term therapy)
General disorders and administration site conditions
Common
Burning in the rectum and pain
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.
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. Healthcare professionals are asked to report any suspected adverse reactions via: United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
To date, no cases of overdose with budesonide are known.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Budenofalk 2mg/dose rectal foam. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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