Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nintedanib esilate
Boehringer Ingelheim Ltd
L01XE31
Nintedanib esilate
150mg
Capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500; GTIN: 5012816099241
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OFEV 150 MG SOFT CAPSULES Nintedanib 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 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 and it is used for the treatment of 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 scarring and stiffening of the lungs. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OFEV _ _ DO NOT TAKE OFEV: - if you are allergic to nintedanib, peanut or soya, or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Ofev, - if you have or ever had liver problems, - if you have or ever had bleeding problems, - if you take blood-thinning medicines (such as warfarin, phenprocoumon or heparin) to prevent blood clotting, - if you have or ever had problems with Lees het volledige document
OBJECT 1 OFEV 100 MG SOFT CAPSULES Summary of Product Characteristics Updated 01-Jun-2018 | Boehringer Ingelheim Limited 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 Ofev 100 mg soft capsules Ofev 150 mg soft capsules 2. Qualitative and quantitative composition One capsule contains 100 mg nintedanib (as esilate) One capsule contains 150 mg nintedanib (as esilate) Excipient(s) with known effect: Each capsule contains 1.2 mg of soya lecithin. Each 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 are peach-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and 100. Ofev 150 mg soft capsules are brown-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black 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). 4.2 Posology and method of administration Treatment with Ofev should be initiated by physicians experienced in the diagnosis and treatment of IPF. Posology 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. 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 300 mg should not be exceeded. _Dose adjustments_ In addition to symptomatic treatment if applicable, the management of adverse reactions to Ofev (see se Lees het volledige document