Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Ciclosporin
PCO Manufacturing Ltd.
L04AD; L04AD01
Ciclosporin
100 milligram(s)
Capsule, soft
Product subject to prescription which may be renewed (B)
Calcineurin inhibitors; ciclosporin
Authorised
2005-03-11
_ _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NEORAL ® 25MG SOFT CAPSULES NEORAL ® 50MG SOFT CAPSULES NEORAL ® 100MG SOFT CAPSULES ciclosporin 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 onto 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. WHAT IS IN THIS LEAFLET 1. What Neoral is and what it is used for 2. What you need to know before you take Neoral 3. How to take Neoral 4. Possible side effects 5. How to store Neoral 6. Contents of the pack and other information 1. WHAT NEORAL IS AND WHAT IT IS USED FOR What Neoral is The name of your medicine is Neoral. 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 NEORAL IS USED FOR AND HOW NEORAL WORKS If you have had an organ transplant, bone marrow and stem cell transplantation, the function of Neoral is to control your body's immune system. Neoral 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, Neoral stops this immune reaction. Such diseases include eye problems which threaten your vision (endogenous uveitis, including Behcet's uveitis), severe cases of certain skin diseases (atopic dermatitis, or eczema and psoriasis), severe rheumatoid arthritis and a kidney disease called nephrotic syndrome. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEORAL If you are taking Neoral following a transplant it will Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Neoral 100 mg Soft Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100mg ciclosporin. Excipients: Ethenol Polyoxyl 40 hydrogenated castor oil For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Soft Capsules. _Product imported from Greece & Poland_ Oval, blue-grey capsules, imprinted with the ‘NVR’ and ‘100mg’ in red printing ink _Product imported from the UK:_ Oval, blue-grey capsules, imprinted with the Sandoz triangle and ‘100mg’ in red printing ink 4 CLINICAL PARTICULARS As per PA0013/054/003. 5 PHARMACOLOGICAL PROPERTIES As per PA0013/054/003. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS DL- -tocopherol Absolute ethanol Propylene glycol Corn-oil-mono-di-triglycerides Polyoxyl 40 hydrogenated castor oil Black iron oxide (E172) Titanium dioxide (E171) Glycerol 85% Gelatin _Product imported from Greece also contains (in red printing ink):_ Carminic acid Aluminium chloride Sodium hydroxide Hypromellose H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _9_ _/_ _0_ _2_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _7_ _3_ _2_ _6_ _8_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. Store Διαβάστε το πλήρες έγγραφο