Dazonay 100/25/200 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

CARBIDOPA 1-WATER SAMENSTELLING overeenkomend met ; CARBIDOPA 0-WATER ; ENTACAPONE ; LEVODOPA

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

N04BA03

INN (Algemene Internationale Benaming):

CARBIDOPA 1-WATER COMPOSITION corresponding to ; CARBIDOPA 0-WATER ; ENTACAPONE ; LEVODOPA

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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),

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 GEEL (E 172); 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
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

Productkenmerken

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