Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
nintedanib
Boehringer Ingelheim International GmbH
L01XE
nintedanib
Antineoplastic agents
Idiopathic Pulmonary Fibrosis
Ofev is indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
Revision: 24
Authorised
2015-01-14
40 B. PACKAGE LEAFLET 41 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OFEV 100 MG SOFT CAPSULES nintedanib 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 Ofev is and what it is used for 2. What you need to know before you take Ofev 3. How to take Ofev 4. Possible side effects 5. How to store Ofev 6. Contents of the pack and other information 1. WHAT OFEV IS AND WHAT IT IS USED FOR Ofev contains the active substance nintedanib, a medicine belonging to the class of so-called tyrosine kinase inhibitors, and it is used for the treatment of idiopathic pulmonary fibrosis (IPF), other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype and systemic sclerosis associated interstitial lung disease (SSc-ILD) in adults. Idiopathic pulmonary fibrosis (IPF) IPF is a condition in which the tissue in your lungs becomes thickened, stiff and scarred over time. As a result, scarring reduces the ability to transfer oxygen from the lungs into the bloodstream and it becomes difficult to breathe deeply. Ofev helps to reduce further scarring and stiffening of the lungs. Other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype Besides IPF, there are other conditions in which the tissue in your lungs becomes thickened, stiff, and scarred over time (lung fibrosis) and keeps worsening (progressive phenotype). Examples of these conditions are hypersensitivity pneumonitis, autoimmune ILDs (e.g. rheumatoid arthritis associated ILD), idiopathic nonspecific interstitia Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ofev 100 mg soft capsules Ofev 150 mg soft capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ofev 100 mg soft capsules One soft capsule contains 100 mg nintedanib (as esilate) _Excipient with known effect_ Each 100 mg soft capsule contains 1.2 mg of soya lecithin. Ofev 150 mg soft capsules One soft capsule contains 150 mg nintedanib (as esilate) _Excipient with known effect_ Each 150 mg soft capsule contains 1.8 mg of soya lecithin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Soft capsule (capsule). Ofev 100 mg soft capsules Ofev 100 mg soft capsules are peach-coloured, opaque, oblong soft-gelatin capsules (approx. 16 x 6 mm) marked on one side with the Boehringer Ingelheim company symbol and “100”. Ofev 150 mg soft capsules Ofev 150 mg soft capsules are brown-coloured, opaque, oblong soft-gelatin capsules (approx. 18 x 7 mm) marked on one side with the Boehringer Ingelheim company symbol and “150”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ofev is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Ofev is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (see section 5.1). Ofev is indicated in adults for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated by physicians experienced in the management of diseases for which Ofev is approved. Posology _Adults_ The recommended dose is 150 mg nintedanib twice daily administered approximately 12 hours apart. The 100 mg twice daily dose is only recommended to be used in patients who do not tolerate the 150 mg twice daily dose. 3 If a dose is missed, administration should resume at the next scheduled time at the recommended dose. If a dose is missed the patient should not take an additional dose. The recommended maximum daily dose of Læs hele dokumentet