Nazione: Unione Europea
Lingua: inglese
Fonte: EMA (European Medicines Agency)
budesonide, micronised
Stada Arzneimittel AG
A07EA06
budesonide
Antidiarrheals, intestinal antiinflammatory / antiinfective agents
Glomerulonephritis, IGA
Kinpeygo is indicated for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.
Revision: 5
Authorised
2022-07-15
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT KINPEYGO 4 MG MODIFIED-RELEASE HARD CAPSULES budesonide This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 Kinpeygo is and what it is used for 2. What you need to know before you take Kinpeygo 3. How to take Kinpeygo 4. Possible side effects 5. How to store Kinpeygo 6. Contents of the pack and other information 1. WHAT KINPEYGO IS AND WHAT IT IS USED FOR Kinpeygo contains the active substance budesonide, a corticosteroid medicine which mainly acts locally in the intestine to reduce the inflammation associated with primary immunoglobulin A (IgA) nephropathy. Kinpeygo is used to treat primary IgA nephropathy in adults 18 years of age or older. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KINPEYGO _ _ DO NOT TAKE KINPEYGO: - If you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6). - If you have loss of function of your liver that your doctor has told you is “severe”. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Kinpeygo: • If you are going to have surgery. • If you have liver problems. • If you are taking or have recently taken corticosteroids. • If you have recently had an infection. • If you have active or quiescent tuber Leggi il documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Kinpeygo 4 mg modified-release hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified-release hard capsule contains budesonide 4 mg. Excipient(s) with known effect Each capsule contains 230 mg of sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified-release hard capsule. 19 mm white coated opaque capsules printed with “CAL10 4MG” in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kinpeygo is indicated for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 16 mg once daily in the morning, at least one hour before a meal, for 9 months. When treatment is to be discontinued, the dose should be reduced to 8 mg once daily for 2 weeks of therapy; the dose may be reduced to 4 mg once daily for an additional 2 weeks, at the discretion of the treating physician. Re-treatment may be considered at the discretion of the treating physician. Safety and efficacy of treatment with subsequent courses of Kinpeygo have not been established. If the patient forgets to take Kinpeygo, the patient should take Kinpeygo the next day, in the morning as usual. The patient should not double the daily dose to make up for a missed dose. _ _ _ _ _Special populations _ _Elderly _ 3 Experience of the use of Kinpeygo in the elderly is limited. However, from the clinical data available, the efficacy and safety of Kinpeygo are expected to be similar to that of other age groups studied. _Hepatic impairment _ The safety and efficacy of Kinpeygo capsules i Leggi il documento completo