Levodopa/Carbidopa/Entacapone Mylan 75 mg/18,75 mg/200 mg Filmdragerad tablett

Negara: Swedia

Bahasa: Swedia

Sumber: Läkemedelsverket (Medical Products Agency)

Bahan aktif:

entakapon; karbidopa (vattenfri); levodopa

Tersedia dari:

Mylan AB

Kode ATC:

N04BA03

INN (Nama Internasional):

entacapone; carbidopa (anhydrous); levodopa

Dosis:

75 mg/18,75 mg/200 mg

Bentuk farmasi:

Filmdragerad tablett

Komposisi:

levodopa 75 mg Aktiv substans; karbidopa (vattenfri) 18,75 mg Aktiv substans; entakapon 200 mg Aktiv substans

Jenis Resep:

Receptbelagt

Ringkasan produk:

Förpacknings: Blister, 30 tabletter (Al); Blister, 100 tabletter (Al); Blister, 30 tabletter (plast/Al); Blister, 100 tabletter (plast/Al); Burk, 30 tabletter; Burk, 175 tabletter; Burk, 100 tabletter

Status otorisasi:

Avregistrerad

Tanggal Otorisasi:

2017-02-13

Selebaran informasi

Page
1
of
10
PACKAGE LEAFLET
Page
2
of
10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVODOPA/CARBIDOPA/ENTACAPONE MYLAN50 MG/12.5 MG/200 MG FILM-COATED
TABLETS
LEVODOPA/CARBIDOPA/ENTACAPONE MYLAN 75 MG/18.75 MG/200 MG FILM-COATED
TABLETS
LEVODOPA/CARBIDOPA/ENTACAPONE MYLAN 100 MG/25 MG/200 MG FILM-COATED
TABLETS
LEVODOPA/CARBIDOPA/ENTACAPONE MYLAN 125 MG/31.25 MG/200 MG FILM-COATED
TABLETS
LEVODOPA/CARBIDOPA/ENTACAPONE MYLAN 150 MG/37.5 MG/200 MG FILM-COATED
TABLETS
LEVODOPA/CARBIDOPA/ENTACAPONE MYLAN 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 Levodopa/Carbidopa/Entacapone Mylan is and what it is used for
2.
What you need to know before you take Levodopa/Carbidopa/Entacapone
Mylan
3.
How to take Levodopa/Carbidopa/Entacapone Mylan
4.
Possible side effects
5.
How to store Levodopa/Carbidopa/Entacapone Mylan
6.
Contents of the pack and other information
1.
WHAT LEVODOPA/CARBIDOPA/ENTACAPONE MYLAN IS AND WHAT IT IS USED FOR
Levodopa/Carbidopa/Entacapone Mylan contains three active substances
(levodopa, carbidopa and
entacapone) in one film-coated tablet. Levodopa/Carbidopa/Entacapone
Mylan 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

Karakteristik produk

Page
1
of
14
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levodopa/Carbidopa/Entacapone Mylan 50 mg/12.5 mg/200 mg film-coated
tablets
Levodopa/Carbidopa/Entacapone Mylan 75 mg/18.75 mg/200 mg film-coated
tablets
Levodopa/Carbidopa/Entacapone Mylan 100 mg/25 mg/200 mg film-coated
tablets
Levodopa/Carbidopa/Entacapone Mylan 125 mg/31.25 mg/200 mg film-coated
tablets
Levodopa/Carbidopa/Entacapone Mylan 150 mg/37.5 mg/200 mg film-coated
tablets
Levodopa/Carbidopa/Entacapone Mylan 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
A grey-purple film-coated, round shaped, biconvex, bevelled edge
tablet debossed with ‘M’ on one side
of the tablet and ‘LCE1’ on the other side, approximately 10.7 mm
in diameter.
A brown-pink film-coated, round shaped, biconvex, bevelled edge tablet
debossed with ‘M’ on one side
of the tablet and ‘LCE2’ on the other side, approximately 11.1 mm
in diameter.
A grey-purple film-coated, round shaped, biconvex, bevelled edge
tablet debossed with ‘M’ on one side
of the tablet and ‘LCE3’ on the other side, approximately 11.5 mm
in diameter.
A brown-pink film-coated, round shaped, biconvex, bevelled edge tablet
debossed with ‘M’ on one side
of the tablet and ‘LCE4’ on the other side, approximately 11.9 mm
in diameter.
A grey-purple fil