Escitalopram Krka 10mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ESCITALOPRAM

Available from:

KRKA DD Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenia

ATC code:

N06AB10

INN (International Name):

ESCITALOPRAM 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ESCITALOPRAM 10 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Authorised

Authorization date:

2014-04-15

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESCITALOPRAM KRKA 5 MG FILM-COATED TABLETS
ESCITALOPRAM KRKA 10 MG FILM-COATED TABLETS
ESCITALOPRAM KRKA 15 MG FILM-COATED TABLETS
ESCITALOPRAM KRKA 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 Escitalopram Krka is and what it is used for
2.
What you need to know before you take Escitalopram Krka
3.
How to take Escitalopram Krka
4.
Possible side effects
5.
How to store Escitalopram Krka
6.
Contents of the pack and other information
1.
WHAT ESCITALOPRAM KRKA IS AND WHAT IT IS USED FOR
Escitalopram Krka contains escitalopram and 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).
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.
Disturbances in the serotonin-system are considered an important
factor in the development of
depression and related diseases.
It may take a couple of weeks before you start to feel better.
Continue to take Escitalopram Krka,
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 ESCITALOPRAM KRKA
D

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Escitalopram Krka 5 mg film-coated tablets
Escitalopram Krka 10 mg film-coated tablets
Escitalopram Krka 15 mg film-coated tablets
Escitalopram Krka 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg escitalopram corresponding to
6.390 mg escitalopram oxalate.
Each film-coated tablet contains 10 mg escitalopram corresponding to
12.780 mg escitalopram
oxalate.
Each film-coated tablet contains 15 mg escitalopram corresponding to
19.170 mg escitalopram
oxalate.
Each film-coated tablet contains 20 mg escitalopram corresponding to
25.560 mg escitalopram
oxalate.
Excipient(s) with known effect:
Each 5 mg, 10 mg, 15 mg or 20 mg film-coated tablet contains 51.3 mg,
102.6 mg, 154 mg or
205.3 mg lactose (as lactose monohydrate), respectively.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
_5 mg film-coated tablets:_
white, round, biconvex film-coated tablets with bevelled edges and
diameter 5.5 mm, imprinted with
“5” in black colour on one side of the tablet.
_10 mg film-coated tablets:_
white, oval, biconvex film-coated tablets, scored on one side with
dimensions 9 x 6 mm, imprinted
with “10” in black colour on each side of the tablet. The tablet
can be divided into equal doses.
_15 mg film-coated tablets:_
white, round, biconvex film-coated tablets with bevelled edges and
diameter 8.5 mm, imprinted with
“15” in black colour on one side of the tablet.
_20 mg film-coated tablets:_
white, oval, biconvex film-coated tablets, scored on one side with
dimensions 12 x 7.5 mm, imprinted
with “20” in black colour on each side of the tablet. 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.
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Treatment of social anxiety disorder (social phobia).
Treatment of generalised an