Aerosol-Service AG, Italy
For adults on prescription
1 dose contains foam:
2 mg budesonide;
propylene glycol 600.3 mg,
water 550.93 mg,
wax emulsion * 16.8 mg,
macrogol stearyl ether 16.8 mg,
cetyl alcohol, 8.4 mg,
citric acid monohydrate 3.67 mg,
Disodium edetate dihydrate 1.1 mg
propellants (pressure about 2.5 bar: 7.24% propane, n-butane 6.66% isobutane, 86.01%) 83 mg.
* Wax emulsion comprises cetostearyl alcohol and polysorbate 60.
Aggravation of the distal form of ulcerative colitis (affecting rectum and sigmoid).
Hypersensitivity to budesonide or other ingredients, infectious bowel disease (bacterial, fungal, amoebic, viral infection), cirrhosis with signs of portal hypertension (e.g., at the terminal stage of primary biliary cirrhosis), child (under 18 years), pregnancy, breastfeeding.
Tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer and duodenal ulcer, glaucoma, cataracts, family history of diabetes or glaucoma.
The following adverse events reported during the application of the drug divided by the frequency of occurrence according to the following gradation: frequent (from ≥ 1/100 to < 1/10), infrequently (from ≥ 1/1000 to < 1/100), rarely (from ≥ 1/10000 to < 1/1000), very rare (< 1/10000).
Infectious and parasitic diseases
Uncommon: urinary tract infection.
Blood disorders and lymphatic system
Uncommon: anemia, accelerated erythrocyte sedimentation rate, leukocytosis.
Violations by the metabolism and nutrition
Uncommon: increased appetite.
Violations by the psyche
Disorders of the nervous system
Uncommon: headache, dizziness, impaired sense of smell.
Violations by vessels
Uncommon: increased blood pressure.
Disorders of the gastrointestinal tract
Uncommon: nausea, abdominal pain, dyspepsia, flatulence, paraesthesias in the abdominal region, anal fissure, frequent urge to act of defecation, rectal bleeding, hemorrhoids, aphthous stomatitis.
Disorders of the liver and biliary tract
Uncommon: increase in liver enzymes (ACT and ALT), cholestasis.
Violations of the skin and subcutaneous tissue
Uncommon: inflammation of the sebaceous glands (acne), increased sweating.
Laboratory and instrumental data
Uncommon: increase in amylase (pancreatic enzymes), changing the content of cortisol (a hormone produced by the adrenal cortex).
General disorders and injection site
Common: burning sensation and pain in the rectum.
Uncommon: asthenia, increase in body weight.
In applying Budenofalk preparation may also be side effects that are typical for all glucocorticosteroids due both local and systemic effect of the drug on the human body. Such side effects depend on the dose, duration of therapy, concomitant or prior treatment with other glucocorticoid drugs, as well as on the individual sensitivity.
Violations by the immune system: the weakening of the body’s systems and, consequently, increased risk of infection.
Violations by the Metabolism and nutrition: Cushing’s syndrome.
Mental disorders: Depression, irritability, euphoria.
Violations by the organ of vision: glaucoma, cataract.
Disorders of the nervous system: papilledema.
Violations by vessels: increased blood pressure, increased risk of thrombosis, vasculitis (on the background of a sharp withdrawal of the drug after long-term treatment).
Disorders of the gastrointestinal tract: the complaints of discomfort in the stomach, duodenal ulcer, pancreatitis, constipation.
Disorders of the skin and subcutaneous tissue disorders: allergic exanthema, striae, and ekhimatoznye petechial hemorrhage, delayed wound healing, contact dermatitis.
Violations by musculoskeletal and connective tissue disorders: aseptic necrosis of the femoral head and shoulder bones, diffuse muscle pain, weakness, osteoporosis.
General disorders: fatigue, discomfort.
Some of these side effects were observed in clinical trials only after prolonged oral budesonide. The risk of side effects caused by the use Budenofalk foam rectal dosage of 2 mg / dose, significantly lower than in systemic administration of glucocorticoids.
If any of these instructions side effects are compounded or you notice other effects not listed in the instructions, tell your doctor.
How to accept, acceptance rate and dosage
The drug is administered rectally.
If your doctor prescribed otherwise, adults – once daily (morning or evening). recommended drug administration after a bowel movement (defecation) To achieve the best result.
At the time of introduction Budenofalk preparation should be at room temperature (20-25 ° C).
1. Fit the applicator cylinder head.
2. Shake the bottle for 15 seconds to mix the contents.
3. At first use: remove the protective tab from the base of the dispensing head.
4. Turn the cap to a semicircular notch on the ferrule was in line with the nozzle.
5. Place the index finger on the cap and turn the bottle upside down.
6. Enter the applicator into the rectum as far as possible. It is best to put a foot on a chair or stool. In order to administer a dose of the drug, it is necessary to press the cap up to the stop and release slowly. Wait 10-15 seconds, then slowly remove the applicator from the rectum.
7. After the introduction of the foam, remove the applicator and throw it away, packed in a plastic bag. For each new dose of the drug should use a new applicator.
8. After the procedure, wash your hands. Try not to defecate until the next morning.
The duration of treatment is chosen individually by the physician, but no more than 6-8 weeks.
The action of cardiac glycosides can be enhanced due to potassium deficiency.
Hypokalemia may increase.
Inhibitors of cytochrome CYP3A (P450), for example, ketoconazole, ritonavir, troleandomycin, erythromycin, cyclosporine, grapefruit juice effect may enhance glucocorticosteroids.
Inductors cytochrome CYP3A (P450), for example, carbamazepine and rifampicin, can reduce systemic, as well as local effects of budesonide on the intestinal mucosa. In this case, the necessary dose adjustment of budesonide.
Strengthening corticosteroid effects associated with an increase in their concentration in blood plasma was observed in women taking estrogens or large doses of combined oral contraceptives. This fact was not observed when using low-dose combined oral contraceptives.
Simultaneous with the appointment of cimetidine and budesonide may result in clinically insignificant increase in budesonide plasma levels.
Theoretically, we can not exclude interaction with ion exchange resins, capable of binding steroids (e.g., cholestyramine), and antacids. When co-administration with Budenofalk the interaction may decrease the therapeutic effect of budesonide.
Budenofalk does not affect the function of the hypothalamic-pituitary-adrenal system, but due to the fact that part of the budesonide in rectal absorbed into the blood, can not completely eliminate the lack of influence on the system.
In treating drug Budenofalk observed lower concentration of budesonide in the blood as compared to its systemic application, however patient transfer with oral or parenteral administration of budesonide may lead to the development of symptoms associated with the change in system level steroids.
Cetyl alcohol and propylene glycol may cause local allergic reaction (contact dermatitis).
The preparation does not contain preservatives.
The cylinder is under high pressure. The container should not be exposed to sunlight and heated to a temperature above 50 ° C. Open or puncture the balloon, as well as burn empty used bottles is unacceptable. Do not use near open flames or hot objects.
Cases of overdose have been identified.
If overdose symptomatic treatment.