Levodopa/Carbidopa/Entacapone Sandoz 100/25/200 mg, filmomhulde tabletten

Valsts: Nīderlande

Valoda: holandiešu

Klimata pārmaiņas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktīvā sastāvdaļa:

CARBIDOPA 1-WATER 27 mg/stuk SAMENSTELLING overeenkomend met ; CARBIDOPA 0-WATER 25 mg/stuk ; ENTACAPONE 200 mg/stuk ; LEVODOPA 100 mg/stuk

Pieejams no:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATĶ kods:

N04BA03

SNN (starptautisko nepatentēto nosaukumu):

CARBIDOPA 1-WATER 27 mg/stuk SAMENSTELLING overeenkomend met ; CARBIDOPA 0-WATER 25 mg/stuk ; ENTACAPONE 200 mg/stuk ; LEVODOPA 100 mg/stuk

Zāļu forma:

Filmomhulde tablet

Kompozīcija:

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

Ievadīšanas:

Oraal gebruik

Ārstniecības joma:

Levodopa, Decarboxylase Inhibitor And Comt Inhibitor

Produktu pārskats:

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);

Autorizācija datums:

2016-04-05

Lietošanas instrukcija

Sandoz B.V.
Page 1/10
Levodopa/Carbidopa/Entacapone Sandoz, filmomhulde tabletten
RVG 116859-65
1313-v3
1.3.1.3 Bijsluiter
Mei 2020 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVODOPA/CARBIDOPA/ENTACAPONE SANDOZ 50/12,5/200 MG, FILMOMHULDE
TABLETTEN
LEVODOPA/CARBIDOPA/ENTACAPONE SANDOZ 75/18,75/200 MG, FILMOMHULDE
TABLETTEN
LEVODOPA/CARBIDOPA/ENTACAPONE SANDOZ 100/25/200 MG, FILMOMHULDE
TABLETTEN
LEVODOPA/CARBIDOPA/ENTACAPONE SANDOZ 125/31,25/200 MG, FILMOMHULDE
TABLETTEN
LEVODOPA/CARBIDOPA/ENTACAPONE SANDOZ 150/37,5/200 MG, FILMOMHULDE
TABLETTEN
LEVODOPA/CARBIDOPA/ENTACAPONE SANDOZ 175/43,75/200 MG, FILMOMHULDE
TABLETTEN
LEVODOPA/CARBIDOPA/ENTACAPONE SANDOZ 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

Produkta apraksts

Sandoz B.V.
Page 1/16
Levodopa/Carbidopa/Entacapone Sandoz, filmomhulde tabletten
RVG 116859-65
1313-v3
1.3.1.1 Summary of Product Characteristics
Mei 2020
SUMMARY OF PRODUCT CHARACERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levodopa/Carbidopa/Entacapone Sandoz 50/12,5/200 mg, filmomhulde
tabletten
Levodopa/Carbidopa/Entacapone Sandoz 75/18,75/200 mg, filmomhulde
tabletten
Levodopa/Carbidopa/Entacapone Sandoz 100/25/200 mg, filmomhulde
tabletten
Levodopa/Carbidopa/Entacapone Sandoz 125/31,25/200 mg, filmomhulde
tabletten
Levodopa/Carbidopa/Entacapone Sandoz 150/37,5/200 mg, filmomhulde
tabletten
Levodopa/Carbidopa/Entacapone Sandoz 175/43,75/200 mg, filmomhulde
tabletten
Levodopa/Carbidopa/Entacapone Sandoz 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 carbidopaanhydrous
/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 co