Escitalopram Teva 20 mg/ml, druppels voor oraal gebruik, oplossing

Land: Nederland

Språk: nederlandsk

Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktiv ingrediens:

ESCITALOPRAMOXALAAT SAMENSTELLING overeenkomend met ; ESCITALOPRAM

Tilgjengelig fra:

Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM

ATC-kode:

N06AB10

INN (International Name):

ESCITALOPRAMOXALAAT COMPOSITION corresponding to ; ESCITALOPRAM

Legemiddelform:

Druppels voor oraal gebruik, oplossing

Sammensetning:

CITROENZUUR 0-WATER (E 330) ; ETHANOL 96 % 94 mg/ml ; NATRIUMHYDROXIDE (E 524) ; PROPYLGALLAAT (E 310) ; WATER, GEZUIVERD,

Administreringsrute:

Oraal gebruik

Terapeutisk område:

Escitalopram

Produkt oppsummering:

Hulpstoffen: CITROENZUUR 0-WATER (E 330); ETHANOL 96 % 94 mg/ml; NATRIUMHYDROXIDE (E 524); PROPYLGALLAAT (E 310); WATER, GEZUIVERD;

Autorisasjon dato:

2013-07-08

Informasjon til brukeren

Escitalopram, NL/H/2552/001, 08.07.21
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESCITALOPRAM TEVA 20 MG/ML, DRUPPELS VOOR ORAAL GEBRUIK, OPLOSSING
escitalopram
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What {Invented name} is and what it is used for
2.
What you need to know before you take {Invented name}
3.
How to take {Invented name}
4.
Possible side effects
5.
How to store {Invented name}
6.
Contents of the pack and other information
1.
WHAT {INVENTED NAME} IS AND WHAT IT IS USED FOR
{Invented name} contains the active substance escitalopram. {Invented
name} 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.
{Invented name} is used to treat depression (major depressive
episodes) and anxiety disorders (such as panic
disorder with or without agoraphobia, social anxiety disorder,
generalised anxiety disorder and obsessive-
compulsive disorder).
It may take a couple of weeks before you start to feel better.
Continue to take {Invented name}, even if it
takes some time before you feel any improvement in your condition.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE {INVENTED NAME}
DO NOT TAKE {INVENTED NAME}
-
If you are allergic to escitalopram or any of the other in

Preparatomtale

Escitalopram, NL/H/2552/001, 08.07.21
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Escitalopram Teva 20 mg/ml druppels voor oraal gebruik, oplossing
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 20 mg escitalopram (as oxalate).
Each drop contains 1 mg escitalopram.
Excipient with known effect
Each drop contains 4.7 mg ethanol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral drops, solution.
A clear solution with a bitter taste.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of
-
major depressive episodes
-
panic disorder with or without agoraphobia
-
social anxiety disorder (social phobia)
-
generalised anxiety disorder
-
obsessive-compulsive disorder
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Safety of daily doses above 20 mg (20 drops) has not been
demonstrated.
Major depressive episodes
Usual dosage is 10 mg (10 drops) once daily. Depending on individual
patient response, the dose may be
increased to a maximum of 20 mg (20 drops) 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.
Panic disorder with or without agoraphobia
An initial dose of 5 mg (5 drops) is recommended for the first week
before increasing the dose to 10 mg (10
drops) daily. The dose may be further increased, up to a maximum of 20
mg (20 drops) daily, dependent on
individual patient response.
Escitalopram, NL/H/2552/001, 08.07.21
2
Maximum effectiveness is reached after about 3 months. The treatment
lasts several months.
Social anxiety disorder
Usual dosage is 10 mg (10 drops) once daily. Usually 2-4 weeks are
necessary to obtain symptom relief. The
dose may subsequently, depending on individual patient response, be
decreased to 5 mg (5 drops) or
increased to a maximum of 20 mg (20 drops) daily.
Social anxiety disorder is a disease with a chronic course, and
treatment for 12 weeks is recommended to
consolidate re