Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Abrocitinib
Pfizer Europe MA EEIG
D11AH08
abrocitinib
Other dermatological preparations
Dermatitis, Atopic
Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.
Revision: 5
Authorised
2021-12-09
44 B. PACKAGE LEAFLET 45 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CIBINQO 50 MG FILM-COATED TABLETS CIBINQO 100 MG FILM-COATED TABLETS CIBINQO 200 MG FILM-COATED TABLETS abrocitinib 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. In addition to this leaflet, your doctor will give you a patient card, which contains important safety information that you need to be aware of. Keep this patient card with you. WHAT IS IN THIS LEAFLET 1. What Cibinqo is and what it is used for 2. What you need to know before you take Cibinqo 3. How to take Cibinqo 4. Possible side effects 5. How to store Cibinqo 6. Contents of the pack and other information 1. WHAT CIBINQO IS AND WHAT IT IS USED FOR Cibinqo contains the active substance abrocitinib. It belongs to a group of medicines called Janus kinase inhibitors, which help to reduce inflammation. It works by reducing the activity of an enzyme in the body called ‘Janus kinase’, which is involved in inflammation. Cibinqo is used to treat adults and adolescents 12 years and older with moderate-to-severe atopic dermatitis, also known as atopic eczema. By reducing the activity of Janus kinase enzymes, Cibinqo lessens itching and inflammation of the skin. This in turn can reduce sleep disturbances and other consequences of atopic eczema such as anxiety or depression and i Læs hele dokumentet
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 Cibinqo 50 mg film-coated tablets Cibinqo 100 mg film-coated tablets Cibinqo 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cibinqo 50 mg film-coated tablets Each film-coated tablet contains 50 mg of abrocitinib. _Excipient with known effect _ Each film-coated tablet contains 1.37 mg of lactose monohydrate. Cibinqo 100 mg film-coated tablets Each film-coated tablet contains 100 mg of abrocitinib. _ _ _Excipient with known effect _ Each film-coated tablet contains 2.73 mg of lactose monohydrate. Cibinqo 200 mg film-coated tablets Each film-coated tablet contains 200 mg of abrocitinib. _Excipient with known effect _ Each film-coated tablet contains 5.46 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Cibinqo 50 mg film-coated tablets _ _ Pink, approximately 11 mm long and 5 mm wide oval tablet debossed with “PFE” on one side and “ABR 50” on the other. Cibinqo 100 mg film-coated tablets _ _ Pink, approximately 9 mm in diameter round tablet debossed with “PFE” on one side and “ABR 100” on the other. 3 Cibinqo 200 mg film-coated tablets _ _ Pink, approximately 18 mm long and 8 mm wide oval tablet debossed with “PFE” on one side and “ABR 200” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of atopic dermatitis. Posology The recom Læs hele dokumentet