COMTAN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ENTACAPONE

Available from:

NOVARTIS ISRAEL LTD

ATC code:

N04BX02

Pharmaceutical form:

FILM COATED TABLETS

Composition:

ENTACAPONE 200 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ORION CORPORATION, FINLAND

Therapeutic group:

ENTACAPONE

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:

2014-05-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
THE MEDICINE IS DISPENSED WITH
A DOCTOR’S PRESCRIPTION ONLY
COMTAN
®
200 mg
Film-coated tablets
THE ACTIVE INGREDIENT
Each tablet contains: Entacapone 200 mg
INACTIVE INGREDIENTS:
See section 6 “Further Information”.
READ THIS PACKAGE INSERT CAREFULLY IN ITS ENTIRETY BEFORE
USING THE MEDICINE. This leaflet contains concise information
about the medicine. If you have further questions, refer to the
doctor or pharmacist.
This medicine has been prescribed for the treatment of your
ailment. Do not pass it on to others. It may harm them even if it
seems to you that their ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Comtan is used to treat Parkinson’s disease, in combination with
levodopa/carbidopa or levodopa/benserazide.
Parkinson’s disease is a disorder of the nervous system. It is
caused
by a lack of dopamine, a natural substance that is produced in
the brain. Dopamine relays messages in the part of the brain that
controls muscle movement. When too little dopamine is produced,
problems with movement result.
Levodopa increases the level of dopamine in the brain. Comtan
aids levodopa in relieving the symptoms of Parkinson’s disease,
such as shaking of the limbs, stiffness and slowness of movements,
which make it difficult to perform daily activities.
Comtan has no effect on the symptoms of Parkinson’s disease
unless taken with levodopa.
You may receive additional medicines to treat your condition.
If you have any additional questions about how Comtan works and
why Comtan has been prescribed for you, ask the doctor.
THERAPEUTIC GROUP:
Catechol-O-methyl transferase inhibitor.
2. BEFORE USING THE MEDICINE
X DO NOT USE THE MEDICINE IF:
you are hypersensitive (allergic) to the active ingredient,
entacapone, or to any of the medicine’s other ingredients.
you have a liver disease.
you have a tumor of the adrenal gland (pheochromocytoma; this
may increase the risk of severe high blood pressure).
you ar

Summary of Product characteristics

COM API FEB14 CL V8
COR CPO CL
REF BPI 180613
ע עבקנ הז ןולע טמרופ
"
ודי לע רשואו קדבנ ונכותו תואירבה דרשמ
י
ראורבפב
2014
COMTAN
®
(entacapone)
200 mg film-coated tablets
PRESCRIBING INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
COMTAN
®
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablet containing 200 mg entacapone.
For a full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Brownish-orange, oval, biconvex film-coated tablet with Comtan
®
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 patients with Parkinson’s disease and
end-of-dose motor
fluctuations, who cannot be stabilized 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 to
30% by
Page 2
COM API FEB14 CL V8 COR CPO CL
REF BPI 180613
extending the dosing intervals and/or by reducing the amount of
levodopa per dose, according
to the clinical condition of the patient.
Entacapone increases the bioavailability of levodopa from standard
levodopa/benserazide
preparations slightly more (5 to 10%) than from standard
levodopa/carbidopa preparations.
Hence, patients who are taking st