Levodopa/Carbidopa/Entacapone Sandoz 125 mg/31,25 mg/200 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

CARBIDOPA 1-WATER 33,7 mg/stuk SAMENSTELLING overeenkomend met ; CARBIDOPA 0-WATER 31,3 mg/stuk ; ENTACAPONE 200 mg/stuk ; LEVODOPA 125 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

N04BA03

INN (Algemene Internationale Benaming):

CARBIDOPA 1-WATER 33,7 mg/stuk SAMENSTELLING overeenkomend met ; CARBIDOPA 0-WATER 31,3 mg/stuk ; ENTACAPONE 200 mg/stuk ; LEVODOPA 125 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Levodopa, Decarboxylase Inhibitor And Comt Inhibitor

Product samenvatting:

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);

Autorisatie datum:

2016-04-05

Bijsluiter

Sandoz B.V.
Page 1/10
Levodopa/Carbidopa/Entacapone Sandoz, filmomhulde tabletten
RVG 116852-58
1313-v3
1.3.1.3 Bijsluiter
Mei 2020 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 redu

Productkenmerken

Sandoz B.V.
Page 1/16
Levodopa/Carbidopa/Entacapone Sandoz, filmomhulde tabletten
RVG 116852-58
1313-v3
1.3.1.1 Bijsluiter
Mei 2020
SUMMARY OF PRODUCT CHARACERISTICS
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.
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