Pajjiż: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ciclosporin
Viatris UK Healthcare Ltd
L04AD01
Ciclosporin
50mg
Oral capsule
Oral
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 08020200; GTIN: 5016695002781
December 2015 Page 1 of 11 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CAPIMUNE 25 MG SOFT CAPSULES CAPIMUNE 50 MG SOFT CAPSULES CAPIMUNE 100 MG, SOFT CAPSULES CICLOSPORIN READ ALL OF THIS LEAFLET CAREFULLY, BEFORE YOU START TAKING THE MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. 1. Keep this leaflet. You may need to read it again. 2. If you have any further questions, ask your doctor or pharmacist. 3. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their sign of illness are the same as yours. 4. 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 Capimune soft gel capsules are and what they are used for 2. What you need to know before you take Capimune soft gel capsules 3. How to take Capimune soft gel capsules 4. Possible side effects 5. How to store Capimune soft gel capsules 6. Contents of the pack and other information 1. WHAT CAPIMUNE SOFT GEL CAPSULES ARE AND WHAT THEY ARE USED FOR WHAT CAPIMUNE SOFT GEL CAPSULES ARE The name of your medicine is Capimune soft gel capsules. It contains the active substance ciclosporin. This belongs to a group of medicines known as immunosuppressive agents. These medicines are used to lower the body’s immune reactions. What Capimune soft gel capsules are used for and how Capimune soft gel capsules work • If you have had an organ transplant, bone marrow and stem cell transplantation, the function of Capimune soft gel capsules is to control your body’s immune system. Capimune soft capsules prevents rejection of transplanted organs by blocking the development of certain cells which would normally attack the transplanted tissue. • If you have an autoimmune disease, in which your body’s immune response attacks your body’s own cells, Capimune soft gel capsules stops this immune reaction. Such diseases include eye problems which threaten your vision (endogenous uveitis, inclu Aqra d-dokument sħiħ
OBJECT 1 CAPIMUNE 50 MG SOFT CAPSULES Summary of Product Characteristics Updated 14-Jul-2017 | Generics UK T/A Mylan 1. Name of the medicinal product Capimune 50 mg, Soft capsules 2. Qualitative and quantitative composition Each soft capsule contains 50 mg of Ciclosporin Excipient with known effect Each soft capsule 50mg contains 50.00mg ethanol and 190.00 mg macrogolglycerol hydroxystearate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Soft Capsules. 50 mg: White gelatin capsules 4. Clinical particulars 4.1 Therapeutic indications Transplantation indications _Solid organ transplantation_ Prevention of graft rejection following solid organ transplantation. Treatment of transplant cellular rejection in patients previously receiving other immunosuppressive agents. _Bone marrow transplantation _ Prevention of graft rejection following allogeneic bone marrow and stem cell transplantation. Prevention or treatment of graft-versus-host disease (GVHD). Non-transplantation indications _Endogenous uveitis _ Treatment of sight-threatening intermediate or posterior uveitis of non-infectious aetiology in patients in whom conventional therapy has failed or caused unacceptable side effects. Treatment of Behçet uveitis with repeated inflammatory attacks involving the retina in patients without neurological manifestations. _Nephrotic syndrome _ Steroid-dependent and steroid-resistant nephrotic syndrome, due to primary glomerular diseases such as minimal change nephropathy, focal and segmental glomerulosclerosis, or membranous glomerulonephritis. Capimune can be used to induce and maintain remissions. It can also be used to maintain steroid-induced remission, allowing withdrawal of steroids. _Rheumatoid arthritis _ Treatment of severe, active rheumatoid arthritis. _Psoriasis _ Treatment of severe psoriasis in patients in whom conventional therapy is inappropriate or ineffective. _Atopic dermatitis _ Capimune is indicated in patients with severe atopic dermatitis when systemic therapy is required. 4.2 P Aqra d-dokument sħiħ