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What you need to know before you use Budenofalk Rectal Foam

Do not use Budenofalk Rectal Foam • if you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6) • if you have a severe liver disease (liver cirrhosis). Warnings and precautions Talk to your doctor before using Budenofalk Rectal Foam 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 Typical effects of cortisone preparations may occur which may affect all parts of the body, particularly when you use Budenofalk Rectal Foam at high doses and for prolonged periods (see section 4. Possible side effects). Further precautions during treatment with Budenofalk Rectal Foam – 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 Rectal Foam. – If you have been treated with a stronger cortisone preparation before starting treatment with Budenofalk Rectal Foam, 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 Rectal Foam 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 Some medicines may increase the effects of Budenofalk Rectal Foam and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat). Budenofalk Rectal Foam could affect the results of tests performed by your doctor or in hospital. Tell your doctor that you are using Budenofalk Rectal Foam before any tests are carried out. Budenofalk Rectal Foam with food and drink You should not drink grapefruit juice whilst you are using 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 using this medicine. You should only use Budenofalk Rectal Foam 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 use Budenofalk Rectal Foam if your doctor tells you to. Driving and using machines Budenofalk Rectal Foam is not expected to affect your ability to drive or operate machinery. Budenofalk Rectal Foam contains propylene glycol, cetyl alcohol and cetostearyl alcohol This medicinal product contains 600.3 mg propylene glycol in each actuation of Budenofalk Rectal Foam. Propylene glycol may cause skin irritation. Cetyl alcohol and cetostearyl alcohol (component of emulsifying wax) may cause local skin reactions (e.g. contact dermatitis).