Land: Holland
Tungumál: hollenska
Heimild: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CARBIDOPA 1-WATER SAMENSTELLING overeenkomend met ; CARBIDOPA 0-WATER ; ENTACAPONE ; LEVODOPA
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
N04BA03
CARBIDOPA 1-WATER COMPOSITION corresponding to ; CARBIDOPA 0-WATER ; ENTACAPONE ; LEVODOPA
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROL (E 422) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188 ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Levodopa, Decarboxylase Inhibitor And Comt Inhibitor
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); GLYCEROL (E 422); HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); POLOXAMEER 188; POLYSORBAAT 80 (E 433); TITAANDIOXIDE (E 171);
2016-04-05
Sandoz B.V. Page 1/10 Dazonay filmomhulde tabletten RVG 116845-51 1313-v3 1.3.1.3 Bijsluiter Oktober 2019 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DAZONAY 50/12,5/200 MG, FILMOMHULDE TABLETTEN DAZONAY 75/18,75/200 MG, FILMOMHULDE TABLETTEN DAZONAY 100/25/200 MG, FILMOMHULDE TABLETTEN DAZONAY 125/31,25/200 MG, FILMOMHULDE TABLETTEN DAZONAY 150/37,5/200 MG, FILMOMHULDE TABLETTEN DAZONAY 175/43,75/200 MG, FILMOMHULDE TABLETTEN DAZONAY 200/50/200 MG, FILMOMHULDE TABLETTEN levodopa/carbidopa/entacapone 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 symptoms 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 [nationally completed name] is and what it is used for 2. What you need to know before you take [nationally completed name] 3. How to take [nationally completed name] 4. Possible side effects 5. How to store [nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [Nationally completed name] contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet. [nationally completed name] is used for the treatment of Parkinson’s disease. Parkinson’s disease is caused by low levels of a substance called dopamine in the brain. Levodopa increases the amount of dopamine and hence reduces the symptoms of Parkinson’s disease. Carbidopa and entacapone improve the antiparkinson effects of levodopa. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] DO NOT TAKE [NATIONALLY COMPLETED NAME] IF YOU - are allergic to levodopa, carb Lestu allt skjalið
Sandoz B.V. Page 1/16 Dazonay filmomhulde tabletten RVG 116845-51 1311-v3 1.3.1.1 Samenvatting van de Productkenmerken Mei 2020 SUMMARY OF PRODUCT CHARACERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dazonay 50/12,5/200 mg, filmomhulde tabletten Dazonay 75/18,75/200 mg, filmomhulde tabletten Dazonay 100/25/200 mg, filmomhulde tabletten Dazonay 125/31,25/200 mg, filmomhulde tabletten Dazonay 150/37,5/200 mg, filmomhulde tabletten Dazonay 175/43,75/200 mg, filmomhulde tabletten Dazonay 200/50/200 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of levodopa, 12.5 mg of carbidopa anhydrous (as 13.5mg carbidopa monohydrate) and 200 mg of entacapone. Excipient with known effect Each film-coated tablet of 50 mg levodopa/12.5 mg carbidopa anhydrous/200 mg entacapone contains 112 mg of lactose (as monohydrate). Each film-coated tablet contains 75 mg of levodopa, 18.75 mg of carbidopa anhydrous (as 20.24 mg carbidopa monohydrate) and 200 mg of entacapone. Excipient with known effect Each film-coated tablet of 75 mg levodopa/18.75 mg carbidopa anhydrous/200 mg entacapone contains 124 mg of lactose (as monohydrate). Each film-coated tablet contains 100 mg of levodopa, 25 mg of carbidopa anhydrous (as 27 mg carbidopa monohydrate) and 200 mg of entacapone. Excipient with known effect Each film-coated tablet of 100 mg levodopa/25 mg carbidopa anhydrous/200 mg entacapone contains 139 mg of lactose (as monohydrate). Each film-coated tablet contains 125 mg of levodopa, 31.25 mg of carbidopa anhydrous(as 33.74 mg carbidopa monohydrate) and 200 mg of entacapone. Excipient with known effect Each film-coated tablet of 125 mg levodopa/31.25 mg carbidopa anhydrous/200 mg entacapone contains 152 mg of lactose (as monohydrate). Each film-coated tablet contains 150 mg of levodopa, 37.5 mg of carbidopa anhydrous(as 40.48 mg carbidopa monohydrate) and 200 mg of entacapone. Sandoz B.V. Page 2/16 Dazonay filmomhulde tabletten RVG 116845-51 1311-v3 1.3.1.1 Samenvatting van de Productkenmerk Lestu allt skjalið