LEVODOPA/CARBIDOPA/ENTACAPONE MYLAN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LEVODOPA ; CARBIDOPA ; ENTACAPONE

Available from:

Generics (UK) Limited

ATC code:

N04BA03

INN (International Name):

LEVODOPA ; CARBIDOPA ; ENTACAPONE

Dosage:

150/37.5/200 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

levodopa, decarboxylase inhibitor and COMT inhibitor

Authorization status:

Not Marketed

Authorization date:

2016-02-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 175 MG/43.75 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levodopa/Carbidopa/Entacapone Mylan 150mg/37.5mg/200mg Film-coated
Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
Excipient with known effect:
Each film-coated tablet of 150 mg of levodopa/37.5 mg carbidopa/ 200
mg entacapone contains 166 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
150 mg levodopa/37.5 mg carbidopa/ 200 mg entacapone: Brownish red
coloured, oval shaped, biconvex, film coated
tablets debossed “150” on one side and plain on the other side.
Size:14.6 mm x 9.7 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levodopa/Carbidopa/Entacapone Mylan 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 Mylan 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
Mylan 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/