Land: Nederland
Språk: nederlandsk
Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ETORICOXIB
Mylan B.V. Dieselweg 25 3752 LB BUNSCHOTEN
M01AH05
ETORICOXIB
Filmomhulde tablet
CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CARNAUBAWAS (E 903) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Etoricoxib
Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341); CARNAUBAWAS (E 903); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
2015-09-14
1 Bijsluiter Etoricoxib Mylan 30, 60, 90 en 120 mg, filmomhulde tabletten RVG 115518, 9, 20, 21 Versie: november 2021 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Etoricoxib Mylan 30 mg, filmomhulde tabletten Etoricoxib Mylan 60 mg, filmomhulde tabletten Etoricoxib Mylan 90 mg, filmomhulde tabletten Etoricoxib Mylan 120 mg, filmomhulde tabletten etoricoxib 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 Etoricoxib Mylan is and what it is used for 2. What you need to know before you take Etoricoxib Mylan 3. How to take Etoricoxib Mylan 4. Possible side effects 5. How to store Etoricoxib Mylan 6. Contents of the pack and other information 1. WHAT ETORICOXIB MYLAN IS AND WHAT IT IS USED FOR Etoricoxib Mylan is one of a group of medicines called selective cyclooxygenase-2 (COX-2) inhibitors. These belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). - Etoricoxib helps to reduce the pain and swelling (inflammation) in the joints and muscles of people 16 years of age and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout. - Etoricoxib is also used for the short term treatment of moderate pain after dental surgery in people 16 years of age and older. WHAT IS OSTEOARTHRITIS? Osteoarthritis is a disease of the joints. It results from the gradual breakdown of cartilage that cushions the ends of the bones. This causes swelling (inflammation), pain, tenderness, stiffness and disability. WHAT IS RHEUMATOID ARTHRITIS? Rheumatoid arthritis is a lo Les hele dokumentet
1 Samenvatting van de Productkenmerken Etoricoxib Mylan 30, 60, 90 en 120 mg, filmomhulde tabletten RVG 115518, 9, 20, 21 Versie: September 2020 1. NAME OF THE MEDICINAL PRODUCT Etoricoxib Mylan 30 mg, filmomhulde tabletten Etoricoxib Mylan 60 mg, filmomhulde tabletten Etoricoxib Mylan 90 mg, filmomhulde tabletten Etoricoxib Mylan 120 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 30 mg of etoricoxib. Each film-coated tablet contains 60 mg of etoricoxib. Each film-coated tablet contains 90 mg of etoricoxib. Each film-coated tablet contains 120 mg of etoricoxib. Excipients with known effect: Each film-coated tablet contains 0.80 mg lactose (as monohydrate). Each film-coated tablet contains 1.60 mg lactose (as monohydrate). Each film-coated tablet contains 2.39 mg lactose (as monohydrate). Each film-coated tablet contains 3.19 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Blue green, film-coated, round, biconvex, bevelled edge tablet debossed with ‘E’ on one side and ‘30’ on the other side, approximately 6.5 mm in diameter. Green, film-coated, round, biconvex, bevelled edge tablet debossed with ‘E’ on one side and ‘60’ on the other side , approximately 8 mm in diameter . White, film-coated, round, biconvex, bevelled edge tablet debossed with ‘E’ on one side and ‘90’ on the other side , approximately 9 mm in diameter . Pale green, film-coated, round, biconvex, bevelled edge tablet debossed with ‘E’ on one side and ‘120’ on the other side, approximately 10 mm in diameter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Etoricoxib is indicated in adults and adolescents 16 years of age and older for the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis. Etoricoxib is indicated in adults and adolescents 16 years of age and older for the Les hele dokumentet