Espran 10mg Tablets

País: Malásia

Língua: inglês

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

Ingredientes ativos:

ESCITALOPRAM OXALATE

Disponível em:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

DCI (Denominação Comum Internacional):

ESCITALOPRAM OXALATE

Unidades em pacote:

30 Tablet Tablets; 100Tablet Tablets

Fabricado por:

TORRENT PHARMACEUTICALS LTD.

Folheto informativo - Bula

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
ESPRAN TABLET
Escitalopram Oxalate (5mg, 10mg, 20mg)
1
WHAT IS IN THIS LEAFLET
1.
What is Espran is used for
2.
How Espran works
3.
Before you use Espran
4.
How to use Espran
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Espran
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT ESPRAN IS USED FOR
It is indicated for the treatment of
more severe form of depression
HOW ESPRAN WORKS
Espran contains an active substance
called Escitalopram. Espran belongs
to a group of antidepressants called
Selective Serotonin Reuptake
Inhibitors (SSRIs).
Espran act by increasing the
serotonin level in the brain.
Disturbances in the serotonin level
are considered an important factor
in the development of depression
and related diseases.
BEFORE YOU USE ESPRAN
-
_When you must not use it _
Do not take Espran if:
•
You are allergic (hypersensitive)
to Escitalopram or Citalopram or
any of the other ingredients of
Espran (see section
PRODUCT
DESCRIPTION
).
•
You take other medicines that
belong to a group called
monoamine oxidase inhibitors
(MAOIs) used for the treatment
or within 14 days of
discontinuing treatment with an
MAOI.
_Pregnancy and breastfeeding _
_ _
Do not take Espran if you are
pregnant, trying to get pregnant or
think you may be pregnant.
Do not take Espran if you are
breastfeeding. Ask your doctor or
pharmacist for advice before taking
any medicine.
-
_Before you start to use it _
Please tell your doctor if you have
any other condition or illness, as your
doctor may need to take this into
consideration. In particular, tell your
doctor:
•
If you have epilepsy. Treatment
with Espran should be stopped if
seizures occur for the first time,
or if there is an increase in the
seizure frequency.
•
If you have diabetes. Treatment
with Espran may alter glucose
control. Insulin and/or oral
antidiabetic dosage may need to
be adjusted.
•
If you have a decreased level of
sodium in the blood.
•
If you ha

Características técnicas

PRODUCT NAME
:
ITEM / PACK
:
DESIGN STYLE
:
CODE
:
DIMENSIONS (MM)
:
THERAPEUTIC RANGE :
ART WORK SIZE
:
DATE
:
Reviewed By
NO. OF COLORS: 1
COUNTRY : Malaysia
Front/Back
Espran
Insert
S/S
180 x 290
-
xxxxxxxxxx-5253
Black
02-07-2012
PANTONE SHADE NOS.:
ACTIVITIES
DEPARTMENT
NAME
SIGNATURE
DATE
Prepared By
PKG.DEV
PKG.DEV
RA
Reviewed By
LOCATION :
Chhatral
CQA
Approved By
Elderly Patients (> 65 years of age)
Initial treatment with half the usually recommended dose and a lower
maximum dose should be considered.
Children and Adolescents (<18 years)
ESPRAN should not be used in the treatment of children and adolescents
under the age of 18 years.
Reduced Renal Function
Dosage adjustment is not necessary in patients with mild or moderate
renal
impairment. Caution is advised in patients with severely reduced renal
function (CL
CR
less than 30 ml/min.).
Reduced Hepatic Function
An initial dose of 5mg daily for the first two weeks of treatment is
recommended. Depending on individual patient response, the dose may be
increased to 10 mg daily.
Poor Metabolisers of CYP2C19
For patients who are known to be poor metabolisers with respect to
CYP2C19, an initial dose of 5 mg daily during the first two weeks of
treatment is recommended. Depending on individual patient response,
the
dose may be increased to 10mg daily.
Discontinuation symptoms
When stopping treatment with ESPRAN the dose should be gradually
reduced over a period of at least one to two weeks in order to avoid
possible discontinuation symptoms.
MODE OF ADMINISTRATION: Oral
CONTRAINDICATIONS:
MONOAMINE OXIDASE INHIBITORS (MAOIS)
Concomitant use in patients taking monoamine oxidase inhibitors
(MAOIs)
is contraindicated.
HYPERSENSITIVITY TO ESCITALOPRAM OR CITALOPRAM
Escitalopram
is
contraindicated
in
patients
with
a
hypersensitivity
to
escitalopram
or
citalopram
or
any
of
the
inactive
ingredients
in
Escitalopram.
WARNING AND PRECAUTIONS:
Antidepressants should not be used in the treatment of children and
adolescents under age at l8 years. Suicide related behaviors (s