Budenofalk is a gastric acid-resistant capsule (capsule with gastric acid-resistant pellets).
Budenofalk also contains the following excipients: Povidon K25, lactose monohydrate, saccharose, talcum, maize starch, poly(ethylacrylate-co-methacryl acid) (1:1), poly(methacryl acid-co-methyl-methacrylate)(1:2), poly[ethylacrylate-co-methyl methacrylate-co-(2-trimethylammonioethyl)methacrylatechloride] (1:2:0,1), poly[ethylacrylate-co-methylmethacrylate-co-(2-trimethylammonioethyl)methacrylatechloride] (1:2:0,2) (=Eudragit L, S, RS and RL), dibutylphthalate, titanium dioxide (E171), water, gelatin, erythrosine (E127), ferrum oxide (E172), sodium dodecylsulfate.
Induction of remission in patients with mild to moderate Crohn's disease with involvement of the ileum and/or ascending colon. Note: Treatment of Budenofalk does not appear useful in patient with crohn's disease affecting the upper gastro-intestinal track. Extraintestinal symptoms eg involving the skin, eyes, or joints, are unlikely to respond to budenofalk because of its local action.
The recommended daily dosage is one capsule (containing 3 mg Budesonide) three times daily (morning, midday, and evening). The capsules should be taken about 30 minutes before meals, swallowed whole with plenty of fluid (e.g. a glass of water). The capsules must not be chewed. The duration of administration takes generally 8 weeks. Budenofalk should not be stopped abruptly but withdrawn gradually (tapering doses).
Hypersensitivity to budesonide or to one of the other ingredients of Budenofalk. Local intestinal infection (bacteria, fungi, amoebae, viruses).
As with other glucocorticoids, treatment with Budenofalk in patients with severely impaired liver function is associated with a reduced elimination rate and an increase in systemic availability. At the moment, these patients are excluded from budesonide treatment.
Budenofalk may reduce the responsiveness of the hypothalamo-pituitary-adrenocortical axis to stress. Therefore, a systemically acting glucocorticoid should be co-administered in the event eg, of operations or similar stress situations.
Use in children: Because there is no adequate experience, Budenofalk should not be used in children.
Caution is necessary if patient is suffering from 1 or several of the following diseases: Tuberculosis, hypertension, diabetes mellitus, softening of the bones (osteoporosis), stomach ulcer or duodenal ulcer (peptic ulcer), glaucoma, cataract, or diabetes or familial glaucoma.
Chicken pox and measles may worsen under treatment with Budenofalk. If a patient who has not had these diseases became infected, treatment with relevant immunoglobulins may be indicated. If chicken pox occurs, treatment with a virostatic agent should be taken into consideration.
Use in pregnancy & lactation: Budenofalk may be used during pregnancy, especially in the 1st 3 months, only on express instruction from the physician. Women of childbearing age should exclude a pregnancy before starting treatment with Budenofalk and should take suitable measures to prevent pregnancy during treatment. Since it is not known whether Budenofalk passes into breast milk, mothers should not breastfeed during treatment with Budenofalk.
Side effects typical of systemically acting glucocorticoids (cushingoid features) may occur occasionally. These side effects are dependent on the dose, the treatment period, a simultaneous or previous therapy with other glucocorticoids and the individual sensitivity.
Clinical studies have shown that during administration of Budenofalk, the frequency of glucocorticoid-related side effects is lower (approximately halved) than during oral administration of equivalent doses of prednisolone. However, the occurrence of side effects typical of glucocorticoids cannot be excluded.
Skin: Exanthema due to hypersensitivity reactions (allergic exanthema), striae and bleeding of the skin, acne, delayed wound healing, contact eczema.
Muscle and Skeleton: Myopathy, bone fragility, osteochondroses (aseptic osteonecroses).
Eyes: Glaucoma, cataract.
Central Nervous System: Psyche: Depression, nervousness, euphoria.
Gastrointestinal Tract: Gastric complaints, gastric ulcer, pancreatitis.
Metabolism: Cushing's syndrome: Moon face, stern obesity, diabetes, increased blood sugar, edema, increased potassium excretion, inactivity of the adrenal cortex or adrenocortical atrophy, retardation of growth in children, disturbance of excretion of sex hormones (eg, amenorrhea, hirsutism, disturbance of potency).
Vascular System: Increased risk of thrombosis, vascular diseases (withdrawal syndrome following long-term therapy.
Immunologic System: Decrease of natural body defense (eg, increased risk of infection). For juveniles, papilledema and/or pseudotumor cerebri in single cases.
When changing from systemically-acting glucocorticoids to the topically acting budesonide, an increase of recurrence of disease symptoms may occur which appear outside the intestine, especially at skin and joints (extraintestinal manifestations).
Cardiac glycosides: Hypokalemia may increase the effect of glycosides.
Diuretics: The potassium excretion may be increased.
Cytochrome P-450 inhibitors (eg, ketoconazole, troleandomycin, ethinylestradiol, erythromycin, cyclosporine): The corticoid effect may be increased.
The simultaneous administration of cimetidine and budesonide may lead to a slight increase of the budesonide plasma level, which is of no clinical relevance. The simultaneous administration of omeprazole does not change the pharmacokinetics of budesonide.
Possible interactions with steroid-binding synthetic resins eg, cholestyramine and antacids cannot be excluded. Therefore, during simultaneous intake of Budenofalk, the effect of budesonide may be decreased. Therefore, these drugs should be administered with at least 2 hrs interval.
A07EA06 - budesonide ; Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation.