Entacapone 200mg Film-Coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ENTACAPONE

Available from:

Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland

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Withdrawn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:

2012-04-12

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ENTACAPONE 200 MG FILM-COATED TABLETS
Entacapone
(Referred to as Entacapone Tablets in the remainder of the leaflet)
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, 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 of the side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Entacapone Tablets are and what they are used for
2. What you need to know before you take Entacapone Tablets
3. How to take Entacapone Tablets
4. Possible side effects
5. How to store Entacapone Tablets
6. Contents of the pack and other information
1. WHAT ENTACAPONE TABLETS ARE AND WHAT THEY ARE USED FOR
1. WHAT ENTACAPONE TABLETS ARE AND WHAT THEY ARE USED FOR
Entacapone Tablets contain entacapone and are used together with
levodopa to treat Parkinson’s
disease. Entacapone Tablets aids levodopa in relieving the symptoms of
Parkinson's disease.
Entacapone Tablets 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 TABLETS
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENTACAPONE TABLETS
DO NOT TAKE ENTACAPONE TABLETS
• 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
Tablets);
• if you have liver disease;
• if you have ever suffered

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Entacapone 200 mg Film-Coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200mg entacapone.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Brownish-orange, oval, biconvex film-coated tablet with “W477”
engraved 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%) more than from standard
levodopa/carbidopa preparations.
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Hence, patients w