LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 200/50/200 Milligram Film Coated Tablet

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

LEVODOPA, CARBIDOPA, ENTACAPONE

متاح من:

Teva Pharma B.V.

ATC رمز:

N04BA03

INN (الاسم الدولي):

LEVODOPA, CARBIDOPA, ENTACAPONE

جرعة:

200/50/200 Milligram

الشكل الصيدلاني:

Film Coated Tablet

نوع الوصفة الطبية :

Product subject to prescription which may be renewed (B)

المجال العلاجي:

Dopa and dopa derivatives Dopa and dopa derivatives

الوضع إذن:

Authorised

تاريخ الترخيص:

2014-11-03

نشرة المعلومات

1 

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 50 MG/12.5 MG/200 MG FILM-COATED
TABLETS 
LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 75 MG/18.75 MG/200 MG FILM-COATED
TABLETS 
LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 100 MG/25 MG/200 MG FILM-COATED
TABLETS 
LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 125 MG/31.25 MG/200
MG FILM-COATED TABLETS 
LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 150 MG/37.5 MG/200 MG FILM-COATED
TABLETS 
LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 175 MG/43.75 MG/200
MG FILM-COATED TABLETS 
LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 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 Teva is and what it is
used for 
2.  What you need to know before you
take Levodopa/Carbidopa/Entacapone Teva 
3.  How to take Levodopa/Carbidopa/Entacapone Teva 
4.  Possible side effects 
5.  How to store Levodopa/Carbidopa/Entacapone Teva 
6.  Contents of the pack and other information 

1. 
WHAT LEVODOPA/CARBIDOPA/ENTACAPONE TEVA IS AND WHAT IT IS USED
FOR 

Levodopa/Carbidopa/Entacapone Teva contains three active
substances (levodopa, carbidopa and 
entacapone) in one film-coated tablet. Levodopa/Carbidopa/Entacapone
Teva is used for the treatment of 
Parkinson’s disease. 

Parkinson’s disease is caused by low levels of a

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levodopa/Carbidopa/Entacapone Teva 200mg/ 50mg/ 200mg Film-coated
Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of levodopa, 50 mg of
carbidopa and 200 mg of entacapone.
Excipient with known effect:
Each film-coated tablet contains 80 mg of lactose anhydrous.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Oblong, biconvex, brown tablet, marked with “200” on one side,
plain on the other.
Dimensions: approx. 17x9 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levodopa/Carbidopa/Entacapone Teva is indicated for the treatment of
adult patients with Parkinson’s disease and end-
of-dose motor fluctuations not stabilised on levodopa/dopa
decarboxylase (DDC) inhibitor treatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The optimum daily dose must be determined by careful titration of
levodopa in each patient. The daily dose should be
preferably optimised using one of the seven available tablet strengths
(50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg 100 mg/25 mg/200 mg, 125
mg/31.25 mg/200 mg,
150 mg/37.5 mg/200 mg, 175 mg/43.75 mg/200 mg or 200 mg/50 mg/200 mg
levodopa/carbidopa/entacapone).
Patients should be instructed to take only one
Levodopa/Carbidopa/Entacapone Teva tablet per dose administration.
Patients receiving less than 70-100 mg carbidopa a day are more likely
to experience nausea and vomiting. While the
experience with total daily dose greater than 200 mg carbidopa is
limited, the maximum recommended daily dose of
entacapone is 2,000 mg and therefore the maximum dose is 10 tablets
per day for the Levodopa/Carbidopa/Entacapone
Teva strengths of 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100
mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg
and 150 mg/37.5 mg/200 mg. Ten tablets of
Levodopa/Carbidopa/Entacapone Teva 150 mg/37.5 mg/200 mg equals
375 mg of carbidopa a day. According to this daily carbidopa dose, the
maximum recommended daily 1