Entacapone HEC 200 mg film-coated tablets

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ENTACAPONE

Available from:

MEDISPEC (M) SDN.BHD

INN (International Name):

ENTACAPONE

Units in package:

30 Tablets; 100 Tablets

Manufactured by:

Sunshine Lake Pharma Co., Ltd.

Patient Information leaflet

ENTACAPONE HEC 200MG FILM-COATED TABLETS
Entacapone (200mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Entacapone HEC is used for
2.
How Entacapone HEC works
3.
Before you use Entacapone HEC
4.
How to use Entacapone HEC
5.
While you are using it
6.
Side effects
7.
Storage and Disporal of Entacapone
HEC
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT ENTACAPONE HEC IS USED FOR
Entacapone
HEC
contains
entacapone
and is used together with levodopa to
treat Parkinson’s disease for those who
cannot
be
stabilised
on
levodapa
combinations.
HOW ENTACAPONE HEC WORKS
Entacapone HEC supports levodopa in
relieving
the
symptoms
of
Parkinson's
disease. Entacapone HEC has no effect
on
relieving
the
symptoms
of
Parkinson´s
disease
unless
taken
with
levodopa.
_ _
BEFORE YOU USE ENTACAPONE HEC
_- When you must not use it _
Do not take Entacapone HEC

if you are allergic to entacapone,
peanut,
soya
or
any
of
the
other
ingredients of this medicine;

if you have a tumour of the adrenal
gland,
known
as
a
pheochromocytoma

if
you
are
taking
certain
antidepressants. Ask your doctor or
pharmacist
whether
your
antidepressive
medicine
can
be
taken
together
with
Entacapone
HEC;

if you have liver disease;

if you have ever suffered from a
rare
reaction
to
antipsychotic
medicines
called
neuroleptic
malignant syndrome (NMS).

if you have ever suffered from a
rare
muscle
disorder
(rhabdomyolysis),
which
was
not
caused by injury.
_Pregnancy and breast-feeding _
Do not take Entacapone HEC if you are
pregnant, think you may be pregnant or
are planning to have a baby.
Do not take Entacapone HEC if you are
breast-feeding.
Ask
your
doctor
or
pharmacist for advice before taking this
medicine.
_- Before you start to use it _
Talk to your doctor or pharmacist before
taking Entacapone HEC:

if you have ever had a heart attack
or any other diseases of the heart

if you are taking a medicine which
may
cause
dizziness
or
light-
headedness
(l

Summary of Product characteristics

1 Product Name
2 Name & Strength of Active Ingredient(s) and Excipient
Full list of Excipients:
_Tablet core: _
Microcrystalline cellulose
Mannitol
Sodium Starch Glycolate (type A)
Povidone (K29/32)
Magnesium Stearate
_Film-coating:_
Polyvinyl Alcohol (Partly hydrolyzed)
Talc
Titanium Dioxide (E171)
Macrogol 3350
Iron Oxide Yellow (E172)
Lecithin (Soya)
Iron Oxide Red (E172)
3 Dosage Form
Film-coated tablet
4 Product Description
“S52” on one side and blank on the other side.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamics
Pharmacotherapeutic group: other dopaminergic agents, ATC
code: N04BX02.
Entacapone belongs to a new therapeutic class, COMT
COMT inhibitor designed for concomitant administration with
levodopa preparations. Entacapone decreases the metabolic loss
of levodopa to 3-O-methyldopa (3-OMD) by inhibiting the COMT
enzyme. This leads to a higher levodopa AUC. The amount of
levodopa available to the brain is increased. Entacapone thus
prolongs the clinical response to levodopa.
Entacapone inhibits the COMT enzyme mainly in peripheral
tissues. COMT inhibition in red blood cells closely follows the
plasma concentrations of entacapone, thus clearly indicating
the reversible nature of COMT inhibition.
Clinical studies
In two phase III, double-blind studies in a total of 376 patients
entacapone or placebo was given with each levodopa/dopa
decarboxylase inhibitor dose. The results are given in Table 2. In
study I, daily On time (hr) was measured from home diaries and
in study II, the proportion of daily On time was measured.
Table 2. Daily On time (Mean ±SD)
Study I: Daily On time (h)
Entacapone
(n=85)
Placebo
(n=86)
Difference
Baseline
9.3±2.2
9.2±2.5
Weeks
8-24
10.7±2.2
9.4±2.6
1 hr 20 min
(8.3%)
CI
95%
45 min, 1 hr
56 min
Study II: Proportion of daily On time (%)
Entacapone
(n=103)
Placebo
(n=102)
Difference
Baseline
60.0±15.2
60.8±14.0
Weeks
8-24
66.8±14.5
62.8±16.80
4.5% (0 hr 35 min)
CI
95%
0.93%,
7.97%
There were corresponding decreases in Off time.
The % change from baseline in Off time