Entacapone Orion

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

entacapone

Available from:

Orion Corporation

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:

2011-08-18

Patient Information leaflet

18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENTACAPONE ORION 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 Orion is and what it is used for
2.
What you need to know before you take Entacapone Orion
3.
How to take Entacapone Orion
4.
Possible side effects
5.
How to store Entacapone Orion
6.
Contents of the pack and other information
1.
WHAT ENTACAPONE ORION IS AND WHAT IT IS USED FOR
Entacapone Orion tablets contain entacapone and are used together with
levodopa to treat Parkinson’s
disease. Entacapone Orion aids levodopa in relieving the symptoms of
Parkinson's disease.
Entacapone Orion 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 ORION
DO NOT TAKE ENTACAPONE ORION

if you are allergic to entacapone or to peanut or soya 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 Orion);

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 suf

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Entacapone Orion 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg entacapone.
Excipients with known effect
Each film-coated tablet contains 0.53 mg soya lecithin, and 7.9 mg
sodium as a constituent of the
excipients.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Brownish-orange, oval, biconvex film-coated tablet with "COMT"
engraved on one 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/bens