Budosan 3 mg gastro-resistant capsules – budesonide for Crohn's disease, microscopic colitis and autoimmune hepatitis

Budosan contains budesonide, a corticosteroid that acts mainly locally in the bowel. The capsules are gastro-resistant – the pellets do not dissolve in the stomach but release budesonide in the lower small intestine and the first part of the large intestine, where the inflammation is.

The medicine is used for acute flares of mild to moderate Crohn's disease, microscopic colitis and autoimmune hepatitis. It is a prescription-only medicine and treatment is managed by a specialist.

What is Budosan 3 mg used for and how should it be taken?

Key facts about the medicine

What is Budosan used for?

• acute flares of mild to moderate Crohn's disease affecting the lower small intestine (ileum) and/or the ascending colon
• microscopic colitis (collagenous and lymphocytic colitis) – chronic inflammation of the large intestine, usually with chronic watery diarrhoea
• autoimmune hepatitis – a chronic inflammatory liver disease

The medicine is not suitable for Crohn's disease of the upper digestive tract and is not expected to act on symptoms outside the bowel (skin, eyes, joints).

How is it taken and dosed?

• Swallow the capsules whole, without chewing, with plenty of liquid (e.g. a glass of water), about half an hour before a meal.
• If you have difficulty swallowing, the capsule can be opened and the pellets swallowed whole, without chewing, with plenty of liquid – this does not affect efficacy.
• Treatment is ended by gradually reducing the dose over about 2 weeks.

This is the general dosage from the leaflet – your doctor decides on the dose and duration of treatment.

Special patient groups

• Children under 12 years: the capsules are not used; experience in children over 12 is limited.
• Liver impairment: contraindicated in cirrhosis; in autoimmune hepatitis the doctor regularly monitors liver enzymes and adjusts the dose.
• Patients previously treated with stronger corticosteroids: symptoms may return during the switch – contact your doctor.

Contraindications – when the medicine must not be used

• hypersensitivity to budesonide or the excipients
• severe liver disease (liver cirrhosis)

Warnings and precautions

• Talk to your doctor if you have tuberculosis, high blood pressure, diabetes (or a family history of diabetes), osteoporosis, a stomach or duodenal ulcer, glaucoma or cataract (or a family history of glaucoma) or serious liver problems.
• Typical corticosteroid effects may occur, especially with high doses and long-term treatment.
• Infections may have unusual or milder symptoms – tell your doctor about any infection.
• If you have never had chickenpox or shingles, avoid contact with infected people; also tell your doctor if you have never had measles.
• Tell your doctor that you are using Budosan before any vaccination or surgery.
• Report blurred vision or other visual disturbances to your doctor.
• The medicine may give a positive result in doping tests and affect laboratory test results.
• Contains lactose and sucrose.

Interactions with other medicines, food and drink

• cardiac glycosides (digoxin) and diuretics
• ketoconazole, itraconazole, clarithromycin, ritonavir and cobicistat – may increase the effect of budesonide
• carbamazepine and rifampicin
• oestrogens and oral contraceptives, cimetidine
• colestyramine and antacids – take at least 2 hours apart from Budosan
• Grapefruit juice should be avoided during treatment.

Pregnancy and breast-feeding

During pregnancy Budosan may only be taken if your doctor has advised it. Budesonide passes into breast milk in small amounts – during breast-feeding the medicine is taken only on your doctor's recommendation.

Driving and using machines

Budosan is not expected to affect the ability to drive or use machines.

Possible side effects

• Contact your doctor immediately with: infection, headache or behavioural changes (depression, irritability, euphoria, restlessness, anxiety, aggression).
• Common: Cushing's syndrome (round face, weight gain, raised blood sugar, high blood pressure, swelling, low potassium, irregular periods, unwanted body hair in women, impotence, reduced adrenal function, stretch marks, acne), indigestion and abdominal pain, increased risk of infection, muscle and joint pain, muscle weakness, osteoporosis, headache, mood changes, rash, red spots from bleeding under the skin, slow wound healing, contact dermatitis.
• Uncommon: stomach and small intestine ulcers, restlessness with increased activity, anxiety.
• Rare: blurred vision, inflammation of the pancreas, osteonecrosis, aggression, bruising.
• Very rare: growth retardation in children, constipation, raised intracranial pressure in adolescents, increased risk of blood clots and vasculitis (after stopping long-term treatment), tiredness and malaise.

Report suspected side effects to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• If you once took too much, take the next dose as prescribed (do not reduce it); if unsure, contact your doctor and bring the carton and leaflet.
• Missed dose: continue treatment with the prescribed dose; do not take a double dose.
• Do not stop taking it suddenly – continue until your doctor tells you otherwise, even if you feel better.

Related information

For additional care and support with digestive and bowel complaints, see also the Digestive system category – products in this category do not replace the medicine you have been prescribed.

Composition, pack and manufacturer

• Active substance: budesonide 3 mg per capsule.
• Excipients (capsule content): talc, triethyl citrate, two ammonio methacrylate copolymers (Eudragit RS 12.5), Eudragit S 100 and L 100 (methacrylic acid–methyl methacrylate copolymers), povidone K25, lactose monohydrate, sugar spheres (sucrose, maize starch); capsule shell: gelatin, erythrosine (E127), titanium dioxide (E171), red and black iron oxide (E172), sodium dodecyl sulfate.
• Pack: Al/PVC/PVDC blisters of 10 capsules; carton with 100 capsules and package leaflet.
• Marketing authorisation holder: EWOPHARMA D.O.O. BEOGRAD, Borisavljevićeva 78, Belgrade. Manufacturer: Dr. Falk Pharma GmbH, Leinenweberstrasse 5, Freiburg, Germany.

Storage

• This medicine does not require any special storage conditions.
• Shelf life: 3 years.
• Keep out of the sight and reach of children. Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

How is Budosan different from other corticosteroid tablets?

The budesonide in Budosan acts mainly locally in the bowel, where it is released from gastro-resistant pellets. However, typical corticosteroid effects can still occur, especially with high doses and longer use.

How long does Budosan treatment for Crohn's disease last?

According to the leaflet, treatment of an acute flare lasts about 8 weeks and ends with a gradual dose reduction over about 2 weeks.

Can I open the capsule if I cannot swallow it?

Yes – the pellets from the capsule can be swallowed whole, without chewing, with plenty of liquid. This does not affect the efficacy of the medicine.

Why should I not drink grapefruit juice?

Grapefruit juice can change the effect of budesonide, so the leaflet advises avoiding it throughout treatment.

Sources

• ALIMS – Summary of Product Characteristics Budosan®, 3 mg, gastro-resistant capsules, hard (Serbian)
• ALIMS – Package leaflet Budosan®, 3 mg, gastro-resistant capsules, hard (August 2022, Serbian)

Sources checked on: 24 October 2026.