CIPRALEX 5 MG

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

ESCITALOPRAM AS OXALATE

Dostopno od:

LUNDBECK ISRAEL LTD.

Koda artikla:

N06AB10

Farmacevtska oblika:

FILM COATED TABLETS

Sestava:

ESCITALOPRAM AS OXALATE 5 MG

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

H. LUNDBECK A/S, DENMARK

Terapevtsko območje:

ESCITALOPRAM

Terapevtske indikacije:

Treatment of depression and panic disorder. Treatment of generalized anxiety disorder (GAD) treatment of social anxiety disorder (social phobia). Treatment of obsessive - compulsive disorder.

Datum dovoljenje:

2012-11-30

Navodilo za uporabo

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’
REGULATIONS (PREPARATIONS, 1986)
The medicine is marketed according to a doctor’s prescription only.
CIPRALEX
®
Tablets
10 MG, 15 MG, 20 MG
COMPOSITION: THE ACTIVE INGREDIENT AND ITS QUANTITY:
-
Cipralex 10 mg: each film coated tablet contains 10 mg escitalopram
(as oxalate)
-
Cipralex 15 mg: each film coated tablet contains 15 mg escitalopram
(as oxalate)
-
Cipralex 20 mg: each film coated tablet contains 20 mg escitalopram
(as oxalate)
INACTIVE INGREDIENTS:
See section 6.
-
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise
information about the medicine. If you have further questions, refer
to the doctor or the
pharmacist.
-
This medicine was prescribed for you. Do not pass it on to others. It
can harm them even if it
seems to you that their medical state is similar.
-
The medicine is not usually intended for children and adolescents
under the age of 18.
1. WHAT IS THE MEDICINE INTENDED FOR?
Cipralex is an antidepressant that belongs to the selective serotonin
reuptake inhibitors (SSRIs)
group. 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.
Cipralex is used to treat the following conditions:
Depression .
Panic Disorder
.
Generalized Anxiety Disorder (GAD).
Social anxiety disorder (SAD) (Social Phobia).
Obsessive-compulsive disorder.
It may take a few weeks until you start to feel better.
Continue taking the medicine even if it takes some time before you
feel any improvement.
Consult with your doctor if you do not feel any improvement or if you
feel worse.
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
-
You are sensitive (allergic) to the active ingredient or any of the
other ingredients that the
Antidepressants and anti-anxiety medications increase the risk of
suicidal thoughts and behavior in
children, adolescents, and young ad

Lastnosti izdelka

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CIPRALEX 10 mg tablets
CIPRALEX 15 mg tablets
CIPRALEX 20 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cipralex 10 mg: Each tablet contains 10 mg escitalopram (as 12.77 mg
escitalopram oxalate)
Cipralex 15 mg: Each tablet contains 15 mg escitalopram (as 19.16 mg
escitalopram oxalate)
Cipralex 20 mg: Each tablet contains 20 mg escitalopram (as 25.54 mg
escitalopram oxalate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
Cipralex 10 mg: Oval, white, scored, film-coated tablet of 8x5.5 mm
marked with "E” and “L" on each side of the
score on one side of the tablet.
Cipralex 15 mg: Oval, white, scored, film-coated tablet of 9.8x6.3 mm
marked with "E” and “M" on each side of
the score on one side of the tablet.
Cipralex 20 mg: Oval, white, scored, film-coated tablet of 11.5x7 mm
marked with "E” and “N" on each side of
the score on one side of the tablet.
The tablets can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of depression.
Treatment of panic disorder.
Treatment of generalised anxiety disorder (GAD).
Treatment of social anxiety disorder (SAD, social phobia).
•
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior
in
children, adolescents, and young adults in short-term studies. These
studies did
not show an increase in the risk of suicidal thoughts and behavior
with
antidepressant use in patients over age 25; there was a reduction in
risk with
antidepressant use in patients aged 65 and older [see Warnings and
Precautions
(4.4)].
In patients of all ages who are started on antidepressant therapy
monitor
closely for clinical worsening and emergence of suicidal thoughts and
behaviors. Advise families and caregivers of the need for close
observation and
communication with the prescriber [see Warnings and Precautions
(4.4)].
Page 2 of 13
Treatment of obsessive-compulsive