Levodopa/Carbidopa/Entacapone Accord 100 mg/25 mg/200 mg Filmdragerad tablett

国: スウェーデン

言語: スウェーデン語

ソース: Läkemedelsverket (Medical Products Agency)

有効成分:

entakapon; karbidopa (monohydrat); levodopa

から入手可能:

Accord Healthcare B.V.

ATCコード:

N04BA03

INN（国際名）:

entacapone; carbidopa (monohydrate); levodopa

投薬量:

100 mg/25 mg/200 mg

医薬品形態:

Filmdragerad tablett

構図:

levodopa 100 mg Aktiv substans; entakapon 200 mg Aktiv substans; karbidopa (monohydrat) 27 mg Aktiv substans

処方タイプ:

Receptbelagt

製品概要:

Förpacknings: Burk, 30 tabletter; Burk, 130 tabletter; Burk, 100 tabletter

認証ステータス:

Avregistrerad

承認日:

2016-03-31

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE USER
Levodopa/Carbidopa/Entacapone Accord 50 mg/12.5 mg/200 mg film-coated
tablets
Levodopa/Carbidopa/Entacapone Accord 75 mg/18.75 mg/200 mg film-coated
tablets
Levodopa/Carbidopa/Entacapone Accord 100 mg/25 mg/200 mg film-coated
tablets
Levodopa/Carbidopa/Entacapone Accord 125 mg/31.25 mg/200 mg
film-coated tablets
Levodopa/Carbidopa/Entacapone Accord 150 mg/37.5 mg/200 mg film-coated
tablets
Levodopa/Carbidopa/Entacapone Accord 200 mg/50 mg/200 mg film-coated
tablets
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
contains three active substances (levodopa, carbidopa
and entacapone) in one
film-coated tablet. 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
DO NOT TAKE IF YOU
-
are allergic to levodopa, carbidopa or entacapone, or any of the other
ingredients of this medicine
(listed

製品の特徴

Module 1
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levodopa/Carbidopa/Entacapone Accord 50 mg/12.5 mg/200 mg film-coated
tablets
Levodopa/Carbidopa/Entacapone Accord 75 mg/18.75 mg/200 mg film-coated
tablets
Levodopa/Carbidopa/Entacapone Accord 100 mg/25 mg/200 mg film-coated
tablets
Levodopa/Carbidopa/Entacapone Accord 125 mg/31.25 mg/200 mg
film-coated tablets
Levodopa/Carbidopa/Entacapone Accord 150 mg/37.5 mg/200 mg film-coated
tablets
Levodopa/Carbidopa/Entacapone Accord 200 mg/50 mg/200 mg film-coated
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of levodopa, 12.5 mg of
carbidopa and 200 mg of entacapone.
Each film-coated tablet contains 75 mg of levodopa, 18.75 mg of
carbidopa and 200 mg of
entacapone.
Each film-coated tablet contains 100 mg of levodopa, 25 mg of
carbidopa and 200 mg of entacapone.
Each film-coated tablet contains 125 mg of levodopa, 31.25 mg of
carbidopa and 200 mg of
entacapone.
Each film-coated tablet contains 150 mg of levodopa, 37.5 mg of
carbidopa and 200 mg of
entacapone.
Each film-coated tablet contains 200 mg of levodopa, 50 mg of
carbidopa and 200 mg of entacapone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
50 mg/12.5 mg/200 mg: Light brown to grayish red colored, round,
approximately 11.3 mm in
diameter, biconvex, film-coated tablets with debossed “50” on one
side and plain on other side.
75 mg/18.75 mg/200 mg: Light brown to light pink colored, oval shaped,
approximately 15.2 mm in
length and 7.2 mm in width, film-coated tablets with debossed “75”
on one side and plain on other
side.
100 mg/25 mg/200 mg: Light brown to grayish red colored, oval shaped,
approximately 16.7 mm in
length and 7.7 mm in width, film-coated tablets with debossed
“100” on one side and plain on other
side.
125 mg/31.25 mg/200 mg: Light brown to light pink colored,
elongated-ellipse shaped, approximately
15.2 mm in length and 9.7 mm in width, film-coated tablets