Escitalopram Grindeks 10 mg Filmdragerad tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

escitalopramoxalat

Tillgänglig från:

AS GRINDEKS

ATC-kod:

N06AB10

INN (International namn):

escitalopram oxalate

Dos:

10 mg

Läkemedelsform:

Filmdragerad tablett

Sammansättning:

escitalopramoxalat 12,776 mg Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Blister, 14 tabletter (Al); Blister, 14 tabletter (plast/Al); Blister, 28 tabletter (Al); Blister, 28 tabletter (plast/Al); Blister, 30 tabletter (Al); Blister, 30 tabletter (plast/Al); Blister, 56 tabletter (Al); Blister, 56 tabletter (plast/Al); Blister, 98 tabletter (Al); Blister, 98 tabletter (plast/Al); Blister, 100 tabletter (Al); Blister, 100 tabletter (plast/Al)

Bemyndigande status:

Godkänd

Tillstånd datum:

2023-06-16

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESCITALOPRAM GRINDEKS
5 MG FILM-COATED TABLETS
ESCITALOPRAM GRINDEKS 10 MG FILM-COATED TABLETS
ESCITALOPRAM GRINDEKS 20 MG FILM-COATED TABLETS
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.
Escitalopram 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.
[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 ingredients of
this medicine (listed in
section 6).
-
If you take other medicines which belong to a

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Escitalopram Grindeks 5 mg film-coated tablets
Escitalopram Grindeks 10 mg film-coated tablets
Escitalopram Grindeks 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg: Each film-coated tablet contains escitalopram oxalate equivalent
to 5 mg escitalopram.
10 mg: Each film-coated tablet contains escitalopram oxalate
equivalent to 10 mg escitalopram.
20 mg: Each film-coated tablet contains escitalopram oxalate
equivalent to 20 mg escitalopram.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
[Invented name] 5 mg: white to off-white, round, approximately 6 mm in
diameter, biconvex film-
coated tablet.
[Invented name] 10 mg: white to off-white, oval, approximately 8 mm x
6 mm, biconvex film-coated
tablet with inscription 1 and 0 on either side of score line on one
side.
The tablet can be divided into
equal doses.
[Invented name] 20 mg: white to off-white, oval, approximately 12 mm x
7 mm, biconvex film-coated
tablet with score line on one side. The tablet can be divided into
equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Treatment of major depressive episodes
-
Treatment of panic disorder with or without agoraphobia
-
Treatment of social anxiety disorder (social phobia)
-
Treatment of generalised anxiety disorder
-
Treatment of obsessive-compulsive disorder
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Safety of daily doses above 20 mg has not been demonstrated.
_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.
_Panic disorder with or without agoraphobia_
An initial dose of 5 mg is recommended for the first week before
increasing the dose to 10 mg daily.
The dose may be further i