Levodopa/Carbidopa/Entacapone Lorien 150 mg/37,5 mg/200 mg filmomhulde tabletten

Valsts: Nīderlande

Valoda: holandiešu

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

Aktīvā sastāvdaļa:

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

Pieejams no:

Laboratorios Lorien S.L Av. Josep Tarradellas 8, Atico 1a 08029 BARCELONA (SPANJE)

SNN (starptautisko nepatentēto nosaukumu):

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

Zāļu forma:

Filmomhulde tablet

Kompozīcija:

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

Autorizācija datums:

2020-06-23

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER
Levodopa/Carbidopa/Entacapone Lorien 50 mg/12,50 mg/200 mg filmomhulde
tabletten
Levodopa/Carbidopa/Entacapone Lorien 75 mg/18,75 mg/200 mg filmomhulde
tabletten
Levodopa/Carbidopa/Entacapone Lorien 100 mg/25 mg/200 mg filmomhulde
tabletten
Levodopa/Carbidopa/Entacapone Lorien 125 mg/31,25 mg/200 mg
filmomhulde tabletten
Levodopa/Carbidopa/Entacapone Lorien 150 mg/37,5 mg/200 mg filmomhulde
tabletten
Levodopa/Carbidopa/Entacapone Lorien 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 signs 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 Levodopa/Carbidopa/Entacapone Lorien 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 LEVODOPA/CARBIDOPA/ENTACAPONE LORIEN IS AND WHAT IT IS USED FOR
Levodopa/Carbidopa/Entacapone Lorien contains three active substances
(levodopa, carbidopa
and entacapone) in one film-coated tablet.
Levodopa/Carbidopa/Entacapone Lorien 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 LEVODOPA/CARBIDOPA/ENTACAP

Produkta apraksts

SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAME OF THE MEDICINAL PRODUCT
Levodopa/Carbidopa/Entacapone Lorien 50 mg/12,50 mg/200 mg filmomhulde
tabletten
Levodopa/Carbidopa/Entacapone Lorien 75 mg/18,75 mg/200 mg filmomhulde
tabletten
Levodopa/Carbidopa/Entacapone Lorien 100 mg/25 mg/200 mg filmomhulde
tabletten
Levodopa/Carbidopa/Entacapone Lorien 125 mg/31,25 mg/200 mg
filmomhulde tabletten
Levodopa/Carbidopa/Entacapone Lorien 150 mg/37,5 mg/200 mg filmomhulde
tabletten
Levodopa/Carbidopa/Entacapone Lorien 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 200 mg of levodopa, 50 mg of
carbidopa anhydrous (as 54 mg
Carbidopa monohydrate) and 200 mg of entacapone.
Excipient with known effect:
_Levodopa/Carbidopa/Entacapone Lorien 50 mg/12.5 mg/200 mg film-coated
tablets _
Each film-coated tablet of 50 mg levodopa/12.5 mg carbidopa
anhydrous/200 mg entacapone
contains 112 mg of lactose (as lactose monohydrate).
_Levodopa/Carbidopa/Entacapone Lorien 75 mg/18.75 mg/200 mg
film-coated tablets _
Each film-coated tablet of 75 mg/levodopa/18.75 mg of carbidopa
anhydrous/200 mg entacapone
contains 124 mg of lactose (as lactose monohydrate).
_Levodopa/Carbidopa/Entacapone Lorien 100 mg/25mg/200 mg film-coated
tablets _
Each film-coated tablet of 100