BUDENOFALK

Generic Name/API: budesonide

Manufacturer: DR. FALK PHARMA GmbH

Dosage Forms & Strength & Pack Size:
Budenofalk 3mg capsules are available in pack sizes of 10, 50, 90, 100 or 120 – not all may be marketed.

Storage:
How to store Budenofalk 3mg capsules
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and blister pack. The expiry date refers to the last day of that month.
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 protect the environment.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

What Budenofalk 3mg capsules are and what they are used for
Budenofalk 3mg capsules contain the active substance budesonide, a type of locally acting steroid used to treat chronic inflammatory diseases of the intestine and the liver.
Budenofalk 3mg capsules are used in the treatment of:
– Crohn’s disease: mild to moderate acute attacks of chronic inflammation of the intestine affecting the lower part of the small bowel (ileum) and/or upper part of the large bowel (the ascending colon).
– Microscopic colitis: a disease with the subtypes collagenous and lymphocytic colitis, characterised by chronic inflammation of the large bowel typically accompanied by chronic watery diarrhoea.
– Autoimmune hepatitis: a disease with chronic inflammation of the liver.

Warnings and precautions
Talk to your doctor before taking Budenofalk 3mg capsules if you have:
– tuberculosis
– high blood pressure
– diabetes, or if diabetes has been diagnosed in your family
– brittle bones (osteoporosis)
– ulcers in the stomach or first part of the small intestine (peptic ulcer)
– increased pressure in your eye (glaucoma) or eye problems such as clouding of the lens (cataracts) or if glaucoma has been diagnosed in your family
– severe liver problems
Budenofalk 3mg capsules are not suitable for patients with Crohn’s disease affecting the upper gastrointestinal tract.
Sometimes this disease may cause symptoms outside the intestine (e.g. affecting the skin, eyes and joints) which are unlikely to respond to this medicine.
Typical effects of cortisone preparations may occur which may affect all parts of the body, particularly when you take Budenofalk 3mg capsules at high doses and
for prolonged periods (see section 4. Possible side effects).
Further precautions during treatment with Budenofalk 3mg capsules
– Tell your doctor if you have an infection. The symptoms of some infections can be unusual or less pronounced.
– Keep away from people who have chickenpox or herpes zoster (shingles), if you have never had them. They could affect you severely. If you do come into contact with chickenpox or shingles, see your doctor straight away.
– Tell your doctor if you have not yet had measles.
– If you know that you need to be vaccinated please speak to your doctor first.
– If you know that you are due to have an operation please tell your doctor that you are using Budenofalk 3mg capsules.
– If you have been treated with a stronger cortisone preparation before starting treatment with Budenofalk 3mg capsules, your symptoms may reappear when the medicine is changed. If this happens, contact your doctor.
– Contact your doctor if you experience blurred vision or other visual disturbances.
– If you have autoimmune hepatitis, your doctor will carry out liver function tests regularly and will adjust the dosage of this medicine periodically.
Other medicines and Budenofalk 3mg capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular:
– 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
– cimetidine (used to inhibit the production of acid in the stomach)
Some medicines may increase the effects of Budenofalk 3mg capsules and your doctor may wish to monitor you carefully if you are taking these medicines
(including some medicines for HIV: ritonavir, cobicistat).
If you take cholestyramine (for hypercholesterolemia and also used to treat diarrhoea) or antacids (for indigestion) in addition to Budenofalk 3mg capsules, take these medicines at least 2 hours apart.
Budenofalk 3mg capsules could affect the results of tests performed by your doctor or in hospital. Tell your doctor that you are taking Budenofalk 3mg capsules before
any tests are carried out.

Budenofalk 3mg capsules with food and drink
You should not drink grapefruit juice whilst you are taking 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 taking this medicine.
You should only take Budenofalk 3mg capsules 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 take Budenofalk 3mg capsules if your doctor tells you to.
Driving and using machines
Budenofalk 3mg capsules are not expected to affect your ability to drive or operate machinery.
Budenofalk 3mg capsules contain sucrose and lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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