Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Budesonide
Dr. Falk Pharma GmbH
A07EA06
budesonide
Antidiarrheals, intestinal antiinflammatory / antiinfective agents
Esophageal Diseases
Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).
Revision: 6
Authorised
2018-01-08
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT JORVEZA 0.5 MG ORODISPERSIBLE TABLETS JORVEZA 1 MG ORODISPERSIBLE TABLETS budesonide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Jorveza is and what it is used for 2. What you need to know before you take Jorveza 3. How to take Jorveza 4. Possible side effects 5. How to store Jorveza 6. Contents of the pack and other information 1. WHAT JORVEZA IS AND WHAT IT IS USED FOR Jorveza contains the active substance budesonide, a corticosteroid medicine that reduces inflammation. It is used in adults (older than 18 years of age) to treat eosinophilic oesophagitis, which is an inflammatory condition of the gullet (food pipe) that causes problems with swallowing food. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE JORVEZA DO NOT TAKE JORVEZA − if you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Jorveza if you have: − tuberculosis − high blood pressure − diabetes, or if somebody in your family has diabetes − weakening of the bones (osteoporosis) − ulcers in the stomach or first part of the small intestine (peptic ulcer) − increased pressure in your eye (which can cause glaucoma) or eye problems such as clouding of the lens (cataracts) or if somebody in your family has glaucoma − liver disease. If you have any of the conditions mentioned above you may be at increased risk of side effects. Your doctor Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Jorveza 0.5 mg orodispersible tablets Jorveza 1 mg orodispersible tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Jorveza 0.5 mg orodispersible tablets Each orodispersible tablet contains 0.5 mg of budesonide. _ _ _Excipient with known effect _ Each 0.5 mg orodispersible tablet contains 26 mg sodium. Jorveza 1 mg orodispersible tablets Each orodispersible tablet contains 1 mg of budesonide. _Excipient with known effect _ Each 1 mg orodispersible tablet contains 26 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible tablet Jorveza 0.5 mg orodispersible tablets White, round, biplane orodispersible tablets, with a diameter of 7.1 mm and height of 2.2 mm. They are debossed with “0.5” on one side. Jorveza 1 mg orodispersible tablets White, round, biplane orodispersible tablets, with a diameter of 7.1 mm and height of 2.2 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age). _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The treatment with this medicinal product should be initiated by a gastroenterologist or a physician experienced in the diagnosis and treatment of eosinophilic esophagitis. Posology _Induction of remission _ The recommended daily dose is 2 mg budesonide as one 1-mg-tablet in the morning and one 1-mg- tablet in the evening. 3 The usual duration of induction treatment is 6 weeks. For patients who are not appropriately responding during 6 weeks the treatment can be extended to up to 12 weeks. _Maintenance of remission _ _ _ The recommended daily dose is 1 mg budesonide as one 0.5-mg-tablet in the morning and one 0.5-mg- tablet in the evening or 2 mg budesonide as one 1-mg-tablet in the morning and one 1-mg-tablet in the evening, depending on the individual clinical requirement of the patient. A maintenance dose of 1 mg budesonide twice daily is recommended for Læs hele dokumentet