Elicea 10 mg film-coated tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ESCITALOPRAM OXALATE

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

ESCITALOPRAM OXALATE

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

KRKA, d.d., Novo mesto

Risalah maklumat

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ELICEA FILM-COATED TABLET
Escitalopram (10mg)
WHAT IS IN THIS
LEAFLET
1.
What _Elicea_ is use for
2.
How _Elicea_ works
3.
Before you use _Elicea_
4.
How to use _Elicea_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of _Elicea_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _ELICEA_
IS
USED
FOR
_Elicea_ contains escitalopram and is used
to treat depression (major depressive
episodes).
It may take a couple of weeks before you
start to feel better. You must talk to a
doctor if you do not feel better or if you
feel worse.
HOW _ELICEA_
WORKS
_Elicea_ 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 _ELICEA_
-
_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, _ _
_Pregnancy and lactation _
Do not take _Elicea _if you are pregnant,
trying to get pregnant or think you may
be pregnant. If you get pregnant while
taking _Elicea_, stop taking it immediately
and contact your doctor.
If you take _Elicea_ during the last 3
months of your pregnancy you should be
aware that the following effects may be
seen in your newborn baby: trouble with
breathing, bluish skin, fits, body
temperature changes, feeding difficulties,
vomiting, low blood sugar, stiff or floppy
muscles, vivid reflexes, tremor,
jitteriness, irritability, lethargy, constant
crying, sleepiness and sleeping
difficulties.
If your newborn baby has any of these
symptoms, please contact your doctor
immediately.
Make sure your midwife and/or doctor
know you are on _Elicea_.
It is expected that _Elicea_ will be excreted
into breast milk. D

Ciri produk

1.3.1
Escitalopram
SPC, Labeling and Package Leaflet
MY-Malaysia
PI_Text033560_2
- Updated:
Page 1 of 11
ELICEA
_Escitalopram_
NAME OF THE MEDICINAL PRODUCT
Elicea 10 mg film-coated tablets
COMPOSITION
Each film-coated tablet contains 10 mg escitalopram (as 12.78 mg
escitalopram oxalate).
PRODUCT DESCRIPTION
Tablets are white, oval, biconvex film-coated tablets, scored on one
side.
The tablet can be divided into equal doses.
THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
POSOLOGY AND METHOD OF ADMINISTRATION
This product is intended for oral use.
Safety of daily doses above 20 mg has not been demonstrated.
Elicea is administered as a single daily dose and may be taken with or
without food.
Major depressive episodes
Usual dosage is 10 mg once daily. Depending on individual patient
response, the dose may be
increased to a maximum of 20 mg daily.
Usually 2-4 weeks are necessary to obtain antidepressant response.
After the symptoms resolve,
treatment for at least 6 months is required for consolidation of the
response.
Elderly patients (> 65 years of age)
Initial dosage is 5 mg once daily. Depending on individual patient
response the dose may be increased
to 10 mg daily (see section Pharmacokinetic properties)
Children and adolescents (<18 years)
Elicea should not be used in the treatment of children and adolescents
under the age of 18 years (see
section Special warnings and precautions for use)
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.) (see section
Pharmacokinetic properties)
1.3.1
Escitalopram
SPC, Labeling and Package Leaflet
MY-Malaysia
PI_Text033560_2
- Updated:
Page 2 of 11
Reduced hepatic function
An initial dose of 5 mg daily for the first two weeks of treatment is
recommended in patients with mild
or moderate hepatic impairment. Depending on individual patient
response, the dose may be increased
to 10 mg daily (see section Pharmac