hovid-Escitalopram Tablet 20 mg

Country: Malaysia

Language: English

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

Active ingredient:

ESCITALOPRAM OXALATE

Available from:

HOVID BERHAD

INN (International Name):

ESCITALOPRAM OXALATE

Units in package:

30 Tablets; 10 Tablets; 100 Tablets

Manufactured by:

HOVID BERHAD

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
HOVID-ESCITALOPRAM TABLET
_ _
Escitalopram (as oxalate) (10mg, 20mg)
Page no.
WHAT IS IN THIS LEAFLET
1. What hovid-Escitalopram is used
for
2. How hovid-Escitalopram works
3. Before you use hovid-Escitalopram
4. How to use hovid-Escitalopram
5. While you are using it
6. Side effects
7. Storage and Disposal of hovid-
Escitalopram
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
11. Serial Number
WHAT HOVID-ESCITALOPRAM IS USED
FOR
hovid-Escitalopram contains
escitalopram and is used to treat:
•
depression
•
panic disorder with or without
agoraphobia (fear of public or open
spaces)
•
social anxiety disorder/social
phobia (fear or avoidance of social
situations)
•
obsessive-compulsive disorder
(OCD) (persistent, obsessive
thoughts that make you carry out
repetitive behaviour)
HOW HOVID-ESCITALOPRAM WORKS
hovid-Escitalopram contains the
active substance escitalopram. hovid-
Escitalopram belongs to a group of
antidepressants called selective
serotonin reuptake inhibitors (SSRIs).
These medicines act on the serotonin-
system in the brain by increasing the
serotonin level. Disturbances in the
serotonin-system are considered an
important factor in the development
of depression and related diseases.
BEFORE YOU USE HOVID- ESCITALOPRAM
_- When you must not use it _
Do not take:
•
if you are allergic to escitalopram
or any of the other ingredients of
this medicine (listed in section
_Product Description_
).
•
If you take other medicines which
belong to a group called
monoamine oxidase inhibitors
(MAOIs) (see subsection
_Taking _
_other medicines_
). Taking hovid-
Escitalopram with a MAOI may
cause a serious, sometimes fatal,
reaction with features resembling
serotonin syndrome (see section
Side effects).
•
at the same time as taking pimozide
(used in the treatment of mental
disorders or nervous system
disorders)
•
_- Before you start to use it _
Please tell your doctor if you have
any other condition or illness,

Summary of Product characteristics

HOVID-ESCITALOPRAM TABLET
VIESC01-var4
DESCRIPTION
hovid-Escitalopram Tablet 10mg:
Oval,
white
film-coated
tablet,
shallow
convex and scored on one face
hovid-Escitalopram Tablet 20mg:
Oval,
white
film-coated
tablet,
shallow
convex with ‘H’, ‘D’ and break bar embossed
on one face
COMPOSITION
hovid-Escitalopram Tablet 10mg:
Escitalopram oxalate 12.775mg equivalent
to Escitalopram 10mg
hovid-Escitalopram Tablet 20mg:
Escitalopram oxalate 25.55mg equivalent to
Escitalopram 20mg
PHARMACODYNAMICS
Escitalopram
is
a
selective
inhibitor
of
serotonin (5-HT) re-uptake with high affinity
for the primary binding site. It also binds to
an
allosteric
site
on
the
serotonin
transporter, with a 1000 fold lower affinity.
Escitalopram has no or low affinity for a
number
of
receptors
including
5-HT1A,
5-HT2, DA D1 and D2 receptors, α1-, α2-,
β-adrenoceptors, histamine H1, muscarine
cholinergic,
benzodiazepine,
and
opioid
receptors.
The inhibition of 5-HT re-uptake is the only
likely mechanism of action explaining the
pharmacological
and
clinical
effects
of
escitalopram.
PHARMACOKINETICS
ABSORPTION
Absorption
is
almost
complete
and
independent of food intake. (Mean time to
maximum
concentration
(mean T
max
)
is
4
hours
after
multiple
dosing).
As
with
racemic
citalopram,
the
absolute
bioavailability of escitalopram is expected
to be about 80%.
DISTRIBUTION
The
apparent
volume
of
distribution
(Vd,β/F) after oral administration is about 12
to 26 L/kg. The plasma protein binding is
below 80% for escitalopram and its main
metabolites.
METABOLISM
Escitalopram is metabolised in the liver to
the
demethylated
and
didemethylated
metabolites.
Both
of
these
are
pharmacologically active. Alternatively, the
nitrogen
may
be
oxidised
to
form
the
N-oxide metabolite.
Both parent substance and metabolites are
partly
excreted
as
glucuronides.
After
multiple dosing the mean concentrations of
the demethyl and didemethyl metabolites
are usually 28-31% and <5%, respectively, of
the
escitalopram
concentration.
Biotransformation
of
escitalopram
to