AJALOPRAM 15 MG ORODISPERSIBLE TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ESCITALOPRAM OXALATE

Boleh didapati daripada:

AJ RESEARCH & PHARMA SDN. BHD.

INN (Nama Antarabangsa):

ESCITALOPRAM OXALATE

Unit dalam pakej:

14 Tablets

Dikeluarkan oleh:

GENEPHARM S.A

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
1
AJALOPRAM ORODISPERSIBLE
TABLET
Escitalopram 5mg, 10mg, 15mg & 20mg.
WHAT IS IN THIS LEAFLET
1.
What Ajalopram Orodispersible
Tablet is used for
2.
How Ajalopram Orodispersible
Table works
3.
Before you use Ajalopram
Orodispersible Tablet
4.
How to use Ajalopram
Orodispersible Tablet
5.
While you are using Ajalopram
Orodispersible Tablet
6.
Side Effects
7.
Storage and Disposal Ajalopram
Orodispersible Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT AJALOPRAM ORODISPERSIBLE
TABLET IS USED FOR:
Escitalopram is indicated for the
treatment of:
-
Major depressive disorders
-
Panic disorder with or without
agoraphobia (e.g., fear of leaving
the house, entering shops, being
in crowds and in public places).
-
Social anxiety disorder (social
phobia).
-
Generalized anxiety disorder.
-
Obsessive-compulsive disorder.
HOW AJALOPRAM ORODISPERSIBLE
TABLET WORKS:
Escitalopram is an antidepressant
which belongs to the ‘SSRI’ group
(selective serotonin reuptake
inhibitors).
BEFORE YOU USE AJALOPRAM
ORODISPERSIBLE TABLET:
_When you must not use it: _
•
If you are allergic to escitalopram
or any of the other ingredients of
this medicine.
•
If you take other medicines
which belong to a group called
MAO inhibitors, including
moclobemide (used in the
treatment of depression) and
linezolid (an antibiotic).
•
If you are born with or have had
an episode of abnormal heart
rhythm (seen at ECG; an
examination to evaluate how the
heart is functioning).
•
If you take medicines for heart
rhythm
problems
or that
may
affect the heart’s rhythm.
_Before you start to use it: _
Tell your healthcare provider
about all the medicines you take,
including prescription and over-
the-counter medicines, vitamins,
and herbal supplements.
_Taking other medicines _
Tell your
healthcare provider if you take any
og the following:
•
Reversible, selective MAO-A
inhibitor: Moclobemide (used to
treat depression).
•
Reversible, non- selective

Ciri produk

Proposed Package Insert
Brand or Product Name
Ajalopram Orodispersible Tablet 5 mg
Ajalopram Orodispersible Tablet 10 mg
Ajalopram Orodispersible Tablet 15 mg
Ajalopram Orodispersible Tablet 20 mg Name and Strength
Each orodispersible tablet contains Escitalopram Oxalate 6.3875 mg equivalent to 5mg
escitalopram.
Each orodispersible tablet contains
Escitalopram Oxalate 12.775 mg equivalent to Escitalopram
10mg
Each orodispersible tablet contains Escitalopram oxalate 19.1625 mg
equivalent to Escitalopram
15mg.
Each orodispersible tablet contains Escitalopram oxalate 25.55 mg
equivalent to Escitalopram
20mg
Product Description
5mg:White to off- white round, flat tablets with beveled edges and engraved with “5” on one side.
10mg:White
to off- white round, flat tablets with beveled edges and engraved with “10” on one
side.
15mg:White to off- white round, flat tablets with beveled edges and engraved with “15” on one
side.
20mg:White to off-white round, flat tablets with beveled edges and e ngraved with “20” on one
side. Pharmacodynamics
Pharmacotherapeutic group: antidepressants, selective serotonin reuptake inhibitors ATC
-code: N 06 AB 10 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.