Entacapone Teva

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

entacapone

Available from:

Teva Pharma B.V.

ATC code:

N04BX02

INN (International Name):

entacapone

Therapeutic group:

Anti-Parkinson drugs

Therapeutic area:

Parkinson Disease

Therapeutic indications:

Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.

Product summary:

Revision: 10

Authorization status:

Authorised

Authorization date:

2011-02-18

Patient Information leaflet

20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENTACAPONE TEVA 200 MG FILM-COATED TABLETS
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 Entacapone Teva is and what it is used for
2.
What you need to know before you take Entacapone Teva
3.
How to take Entacapone Teva
4.
Possible side effects
5.
How to store Entacapone Teva
6.
Contents of the pack and other information
1.
WHAT ENTACAPONE TEVA IS AND WHAT IT IS USED FOR
Entacapone Teva tablets contain entacapone and are used together with
levodopa to treat Parkinson’s
disease. Entacapone Teva aids levodopa in relieving the symptoms of
Parkinson's disease. Entacapone
Teva has no effect on relieving the symptoms of Parkinson´s disease
unless taken with levodopa.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENTACAPONE TEVA
DO NOT TAKE ENTACAPONE TEVA
•
if you are allergic to entacapone or any of the other ingredients of
this medicine (listed in
section 6);
•
if you have a tumour of the adrenal gland (known as pheochromocytoma;
this may increase the
risk of severe high blood pressure);
•
if you are taking certain antidepressants (ask your doctor or
pharmacist whether your
antidepressive medicine can be taken together with Entacapone Teva);
•
if you have liver disease;
•
if you have ever suffered from a rare reaction to antipsychotic
medicines called neuroleptic
malignant syndrome (NMS). See section 4 Possible side effects for the
characteristics of NMS;
•
if you have ever suffered from a rare muscle disorder

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Entacapone Teva 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg entacapone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Light brown, biconvex, ellipse-shaped film-coated tablets with
approximately 18 mm length and
10 mm width, embossed ‘E200’ on one side, plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Entacapone is indicated as an adjunct to standard preparations of
levodopa/benserazide or
levodopa/carbidopa for use in adult patients with Parkinson’s
disease and end-of-dose motor
fluctuations, who cannot be stabilised on those combinations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Entacapone should only be used in combination with
levodopa/benserazide or levodopa/carbidopa.
The prescribing information for these levodopa preparations is
applicable to their concomitant use
with entacapone.
Posology
One 200 mg tablet is taken with each levodopa/dopa decarboxylase
inhibitor dose. The maximum
recommended dose is 200 mg ten times daily, i.e. 2,000 mg of
entacapone.
Entacapone enhances the effects of levodopa. Hence, to reduce
levodopa-related dopaminergic adverse
reactions, e.g. dyskinesias, nausea, vomiting and hallucinations, it
is often necessary to adjust
levodopa dosage within the first days to first weeks after initiating
entacapone treatment. The daily
dose of levodopa should be reduced by about 10-30% by extending the
dosing intervals and/or by
reducing the amount of levodopa per dose, according to the clinical
condition of the patient.
If entacapone treatment is discontinued, it is necessary to adjust the
dosing of other antiparkinsonian
treatments, especially levodopa, to achieve a sufficient level of
control of the parkinsonian symptoms.
Entacapone increases the bioavailability of levodopa from standard
levodopa/benserazide preparations
slightly (5-10%) more than from standard levodo