Levodopa/Carbidopa/Entacapone Sandoz 200 mg/50 mg/200 mg filmomhulde tabletten

מדינה: הולנד

שפה: הולנדית

מקור: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

מרכיב פעיל:

CARBIDOPA 1-WATER 54 mg/stuk SAMENSTELLING overeenkomend met ; CARBIDOPA 0-WATER 50 mg/stuk ; ENTACAPONE 200 mg/stuk ; LEVODOPA 200 mg/stuk

זמין מ:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

קוד ATC:

N04BA03

INN (שם בינלאומי):

CARBIDOPA 1-WATER 54 mg/stuk SAMENSTELLING overeenkomend met ; CARBIDOPA 0-WATER 50 mg/stuk ; ENTACAPONE 200 mg/stuk ; LEVODOPA 200 mg/stuk

טופס פרצבטיות:

Filmomhulde tablet

הרכב:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROL (E 422) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188 ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROL (E 422) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188 ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171),

מסלול נתינה (של תרופות):

Oraal gebruik

איזור תרפויטי:

Levodopa, Decarboxylase Inhibitor And Comt Inhibitor

leaflet_short:

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 ROOD (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); POLOXAMEER 188; POLYSORBAAT 80 (E 433); TITAANDIOXIDE (E 171);

תאריך אישור:

2016-04-05

עלון מידע

Sandoz B.V.
Page 1/11
Levodopa/Carbidopa/Entacapone Sandoz, filmomhulde tabletten
RVG 116852-58
1313-v2
1.3.1.3 Bijsluiter
september 2019 PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVODOPA/CARBIDOPA/ENTACAPONE SANDOZ 50 MG/12,5MG/200 MG FILMOMHULDE
TABLETTEN
LEVODOPA/CARBIDOPA/ENTACAPONE SANDOZ 75 MG/18,75 MG/200 MG FILMOMHULDE
TABLETTEN
LEVODOPA/CARBIDOPA/ENTACAPONE SANDOZ 100 MG/25 MG/200 MG FILMOMHULDE
TABLETTEN
LEVODOPA/CARBIDOPA/ENTACAPONE SANDOZ 125 MG/31,25 MG/200 MG
FILMOMHULDE TABLETTEN
LEVODOPA/CARBIDOPA/ENTACAPONE SANDOZ 150 MG/37,5 MG/200 MG FILMOMHULDE
TABLETTEN
LEVODOPA/CARBIDOPA/ENTACAPONE SANDOZ 175 MG/43,75 MG/200 MG
FILMOMHULDE TABLETTEN
LEVODOPA/CARBIDOPA/ENTACAPONE SANDOZ 200 MG/50 MG/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 r

מאפייני מוצר

Sandoz B.V.
Page 1/18
Levodopa/Carbidopa/Entacapone Sandoz,
filmomhulde tabletten
RVG 116852-58
1313-v4
SmPC
Mei 2020
1.
NAME OF THE MEDICINAL PRODUCT
Levodopa/Carbidopa/Entacapone Sandoz 50 mg/12,5mg/200 mg filmomhulde
tabletten
Levodopa/Carbidopa/Entacapone Sandoz 75 mg/18,75 mg/200 mg filmomhulde
tabletten
Levodopa/Carbidopa/Entacapone Sandoz 100 mg/25 mg/200 mg filmomhulde
tabletten
Levodopa/Carbidopa/Entacapone Sandoz 125 mg/31,25 mg/200 mg
filmomhulde tabletten
Levodopa/Carbidopa/Entacapone Sandoz 150 mg/37,5 mg/200 mg filmomhulde
tabletten
Levodopa/Carbidopa/Entacapone Sandoz 175 mg/43,75 mg/200 mg
filmomhulde tabletten
Levodopa/Carbidopa/Entacapone Sandoz 200 mg/50 mg/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.
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.
Each film-coated tablet contains 100 mg of levodopa, 25 mg of
carbidopa anhydrous (as 27 mg
Carbidopa monohydrate) and 200 mg of entacapone.
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.
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.
Each film-coated tablet contains 175 mg of levodopa, 43.75 mg of
carbidopa anhydrous (as 47.23
mg Carbidopa monohydrate) and 200 mg of entacapone.
Each film-coated tablet contains 200 mg of levodopa, 50 mg of
carbidopa anhydrous (as 54 mg
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
Each film-coated tablet of 75 mg/levodopa/18.75 mg of carbidopa
anhydrous/200 mg entacapone
contains 124 mg of lactose .
Each film-coat