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What you need to know before you take Budenofalk granules

DO NOT take Budenofalk granules − if you are allergic to budesonide or any of the other ingredients in this medicine (listed in section 6) − if you have a severe liver disease (liver cirrhosis). Warnings and precautions Talk to your doctor before taking Budenofalk granules 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 granules 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 granules at high doses and for prolonged periods (see section 4. Possible side effects). Further precautions during treatment with Budenofalk granules – Tell your doctor if you have an infection. The symptoms of some infections can be atypical 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 granules. − If you have been treated with a stronger cortisone preparation before starting treatment with Budenofalk granules, 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. Other medicines and Budenofalk granules 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 granules 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 hypercholesterolaemia and also used to treat diarrhoea) or antacids (for indigestion) in addition to Budenofalk granules, take these medicines at least 2 hours apart. Budenofalk granules could affect the results of tests performed by your doctor or in hospital. Tell your doctor that you are taking Budenofalk granules before any tests are carried out. Budenofalk granules 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 granules during pregnancy if your doctor tells you to. Budesonide passes in small amounts into the breast milk. If you are breastfeeding you should only take Budenofalk granules if your doctor tells you to. Driving and using machines Budenofalk granules are not expected to affect your ability to drive or operate machinery. Budenofalk granules contain sucrose, lactose and sorbitol If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine contains 900 mg sorbitol in each sachet. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take or receive this medicine.