Entacapone Aurobindo 200mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ENTACAPONE

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

N04BX02

INN (International Name):

ENTACAPONE 200 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ENTACAPONE 200 mg

Prescription type:

POM

Therapeutic area:

ANTI-PARKINSON DRUGS

Authorization status:

Withdrawn

Authorization date:

2013-03-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ENTACAPONE AUROBINDO 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 or
nurse.
-
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 or
nurse. This includes any possible
any side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Entacapone Aurobindo is and what it is used for
2.
What you need to know before you take Entacapone Aurobindo
3.
How to take Entacapone Aurobindo
4.
Possible side effects
5.
How to store Entacapone Aurobindo
6.
Contents of the pack and other information
1.
WHAT ENTACAPONE AUROBINDO IS AND WHAT IT IS USED FOR
Entacapone Aurobindo tablets contain entacapone and are used together
with levodopa to treat
Parkinson’s disease. Entacapone Aurobindo aids levodopa in relieving
the symptoms of Parkinson's
disease. Entacapone Aurobindo 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 AUROBINDO
DO NOT TAKE ENTACAPONE AUROBINDO

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 Aurobindo);

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;

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Entacapone Aurobindo 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg entacapone.
Excipient: Each film-coated tablet contains 270.20 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Brownish-Orange coloured, oval shaped, film coated tablets debossed
with “Y 17” on one side and 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%)