ENTACAPONE MEDOCHEMIE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ENTACAPONE

Available from:

DEVRIES & CO. LTD

ATC code:

N04BX02

Pharmaceutical form:

FILM COATED TABLETS

Composition:

ENTACAPONE 200 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

MEDOCHEMIE LTD, CYPRUS

Therapeutic area:

ENTACAPONE

Therapeutic indications:

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

Authorization date:

2023-10-31

Patient Information leaflet

page 1 of 6
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is dispensed with a doctor's prescription only
ENTACAPONE MEDOCHEMIE
Coated Tablets
THE ACTIVE INGREDIENT AND ITS CONTENT:
Each tablet contains 200 mg entacapone
INACTIVE INGREDIENTS:
See section 6 “additional information”.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet
contains concise information about this medicine. If you have any
further
questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others.
It may harm them, even if it seems to you that their illness is
similar.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Entacapone Medochemie is used for the treatment of Parkinson’s
disease, in
combination with levodopa/carbidopa or levodopa/benserazid.
THERAPEUTIC GROUP:
Catechol-O-methyl transferase inhibitor.
Entacapone Medochemie aids levodopa in relieving the symptoms of
Parkinson’s
disease.
Entacapone Medochemie has no effect on relieving the symptoms of
Parkinson’s
disease unless taken with levodopa.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you are sensitive (allergic) to the active ingredient entacapone, or
to any
of the other additional ingredients this medicine contains (see
section 6).
•
you have a tumor of the adrenal gland (pheochromocytoma; this may
increase the risk of severe high blood pressure).
•
you are taking certain antidepressants (ask your doctor or pharmacist
whether the antidepressant you are taking can be taken together with
Entacapone Medochemie).
•
you have liver disease.
•
you have ever suffered from a rare reaction to antipsychotic medicines
called neuroleptic malignant syndrome (NMS). See section 4 “side
effects”
for the characteristics of NMS.
•
you have ever suffered from a rare muscle disorder called
rhabdomyolysis
page 2 of 6
which is not a result of injury.
•
you are pregnant or breastfeeding.
SPECIAL WARNINGS REGARDING THE USE OF THIS M

Summary of Product characteristics

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