Χώρα: Ολλανδία
Γλώσσα: Ολλανδικά
Πηγή: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
METHYLPREDNISOLON 4 mg/stuk
Eurogenerics N.V. Heizel Esplanade b22 1020 BRUSSEL (BELGIË)
H02AB04
METHYLPREDNISOLON 4 mg/stuk
Tablet
LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; SACCHAROSE ; SILICIUMDIOXIDE (E 551), LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551),
Oraal gebruik
Methylprednisolone
Hulpstoffen: LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); SACCHAROSE; SILICIUMDIOXIDE (E 551);
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER METHYLPREDNISOLON EUROGENERICS 4 MG TABLETTEN METHYLPREDNISOLON EUROGENERICS 16 MG TABLETTEN Methylprednisolone 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 Methylprednisolon Eurogenerics is and what it is used for 2. What you need to know before you take Methylprednisolon Eurogenerics 3. How to take Methylprednisolon Eurogenerics 4. Possible side effects 5. How to store Methylprednisolon Eurogenerics 6. Contents of the pack and other information 1. WHAT METHYLPREDNISOLON EUROGENERICS IS AND WHAT IT IS USED FOR Methylprednisolon Eurogenerics contains methylprednisolone. Methylprednisolone belongs to a group of medicines called corticosteroids. Methylprednisolone inhibits local signs of inflammation (fever, swelling, pain, redness) and hypersensitivity reactions. It also acts on several organs and metabolic processes. Therefore, it is used to treat a wide range of conditions, including: - rheumatic conditions of a variety of origins; - allergic conditions: including hay fever, asthma, drug allergies; - skin conditions; - eye conditions of allergic or inflammatory origin; - certain types of inflammation of the digestive tract; - certain disorders of the airways; - certain severe blood diseases; - abnormal adrenal function; - organ transplantation. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METHYLPREDNISOLON EUROGENERICS DO NOT TAKE METHYLPREDNISOLON EUROGENERICS: - if you are allergic to methylprednisolone or any of the other ingredients of this medicin Διαβάστε το πλήρες έγγραφο
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT _ _ Methylprednisolon Eurogenerics 4 mg tabletten Methylprednisolon Eurogenerics 16 mg tabletten _ _ _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Methylprednisolon Eurogenerics 4 mg tablets: Each tablet contains 4 mg methylprednisolone Methylprednisolon Eurogenerics 16 mg tablets: Each tablet contains 16 mg methylprednisolone Excipients with known effect: Methylprednisolon Eurogenerics 4 mg tablets: Each tablet contains 36.625 mg of lactose monohydrate and 5.625 mg of sucrose. Methylprednisolon Eurogenerics 16 mg tablets: Each tablet contains 146.5 mg of lactose monohydrate and 22.5 mg of sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Methylprednisolon Eurogenerics 4 mg tablets: White to off white, round, 4 mm in diameter, biconvex tablets, plain on both sides. Methylprednisolon Eurogenerics 16 mg tablets: White to off white, oval, with a length of 10,10 mm and a height of 7,30 mm, biconvex tablets, breakline on one side and embossed ‘16’ on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Glucocorticoids should be considered as a purely symptomatic treatment, unless in case of certain endocrine disorders, where they are applied as substitution treatment. Methylprednisolon Eurogenerics is indicated in the following cases: NONENDOCRINE DISORDERS 1. RHEUMATIC DISORDERS As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: - Psoriatic arthritis - Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) - Ankylosing spondylitis - Abarticular inflammations (such as acute and subacute bursitis, acute nonspecific tenosynovitis and epicondylitis) - Acute arthritis (gouty, post-traumatic) 2/18 - Synovitis of osteoarthritis 2. COLLAGEN DISEASES During an exacerbation or as maintenance therapy in selected cases of: - S Διαβάστε το πλήρες έγγραφο