Lupilopram 20mg tablets

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
26-03-2019
Ciri produk Ciri produk (SPC)
26-03-2019

Bahan aktif:

ESCITALOPRAM OXALATE

Boleh didapati daripada:

Generic Health Sdn. Bhd.

INN (Nama Antarabangsa):

ESCITALOPRAM OXALATE

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

Jubilant Generics Limited

Risalah maklumat

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
LUPILOPRAM TABLETS
Escitalopram oxalate (10mg and 20mg)
1
WHAT IS IN THIS LEAFLET
1. What Lupilopram Tablets is used
for
2. How Lupilopram Tablets works
3. Before you take Lupilopram
Tablets
4. How to take Lupilopram Tablets
5. While you are using Lupilopram
Tablets
6. Side Effects
7. Storage and Disposal of
Lupilopram Tablets
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
1. WHAT LUPILOPRAM TABLETS IS USED
FOR
Lupilopram Tablets is used to treat
depression (major depressive
episodes) and anxiety disorders [such
as panic disorder with or without
agoraphobia (fear of leaving home,
entering shops or fear of being at
open and public places), social
anxiety disorder (fear or avoidance of
social situations) and obsessive-
compulsive disorder (persistent,
obsessive thoughts that make you
carry out repetitive behaviour)].
2. HOW LUPILOPRAM TABLETS WORKS
Lupilopram Tablets 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.
3. BEFORE YOU TAKE LUPILOPRAM
TABLETS
_WHEN YOU MUST NOT TAKE IT _
Do not take:

if you are allergic (hypersensitive)
to escitalopram or any of the other
ingredients of Lupilopram Tablets.

If you take other medicines that
belong to a group called
monoamine oxidase (MAO)
inhibitors, including selegiline
(used in the treatment of
Parkinson´s disease),
moclobemide (used in the
treatment of depression) and
linezolid (an antibiotic). Taking
Lupilopram with MAO inhibitors
may cause serious and sometimes
fatal reactions with features
resembling serotonin syndrome
such as high fever, agitation,
confusion, trembling and abrupt
contractions of muscles. If you
feel like this, contact your doctor.

If you are born with or have had
an episode of abnorma
                                
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Ciri produk

                                For the use of a registered medical practitioner or a hospital or a
laboratory only
LUPILOPRAM TABLETS 10 MG & 20 MG
PRODUCT NAME:
Lupilopram Tablets 10 mg
Lupilopram Tablets 20 mg
NAME AND STRENGTH OF ACTIVE INGREDIENT:
Each film-coated tablet contains:
Escitalopram Oxalate equivalent to Escitalopram 10 mg
Escitalopram Oxalate equivalent to Escitalopram 20 mg
PRODUCT DESCRIPTION:
ESCITALOPRAM TABLETS 10 MG
White, oval shaped, biconvex, film-coated tablets, with scoreline on
one side, debossed with ‘B’ on
left side of scoreline and ‘3’ on right side of scoreline and
plain on the other side.
ESCITALOPRAM TABLETS 20 MG
White, oval shaped, biconvex, film-coated tablets, with scoreline on
one side, debossed with ‘B4’ on
side of scoreline and plain on the other side.
PHARMACODYNAMICS / PHARMACOKINETICS:
Pharmacodynamic Properties
Pharmacotherapeutic groups: anti-depressants, selective serotonin
reuptake inhibitors
ATC-code: N06AB10
MECHANISM OF ACTION
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-HT
1A
, 5-HT
2
, DA D
1
and D
2
receptors, α
1
-, α
2
-, β-adrenoceptors, histamine H
1
, 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 (V
d
,
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.
BIOTRANSFORMATIO
                                
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