Escitalopram Bluefish 5 mg film-coated tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Escitalopram oxalate

Διαθέσιμο από:

Bluefish Pharmaceuticals AB

Φαρμακολογική κατηγορία (ATC):

N06AB; N06AB10

INN (Διεθνής Όνομα):

Escitalopram oxalate

Δοσολογία:

5 milligram(s)

Φαρμακοτεχνική μορφή:

Film-coated tablet

Τρόπος διάθεσης:

Product subject to prescription which may not be renewed (A)

Θεραπευτική περιοχή:

Selective serotonin reuptake inhibitors; escitalopram

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

2014-03-28

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
ESCITALOPRAM BLUEFISH 5 MG FILM-COATED TABLETS
ESCITALOPRAM BLUEFISH 10 MG FILM-COATED TABLETS
ESCITALOPRAM BLUEFISH 15 MG FILM-COATED TABLETS
ESCITALOPRAM BLUEFISH 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, pharmacist or nurse.
This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Escitalopram Bluefish is and what it is used for
2.
What you need to know before you use Escitalopram Bluefish
3.
How to use Escitalopram Bluefish
4.
Possible side effects
5.
How to store Escitalopram Bluefish
6.
Contents of the pack and other information
1.
WHAT ESCITALOPRAM BLUEFISH IS AND WHAT IT IS USED FOR
Escitalopram Bluefish contains the active substance escitalopram.
Escitalopram Bluefish 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.
Escitalopram Bluefish 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, generalized
anxiety disorder and obsessive-compulsive disorder).
It may take a couple of weeks before you start to feel better.
Continue to take Escitalopram Bluefish, even if it
takes some time before you fell 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 USE ESCITALOPRAM BLUEFISH
DO NOT TAKE ESCITALOPRAM BLUEFISH
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Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
02 June 2021
CRN00C40T
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escitalopram Bluefish 5mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg escitalopram (as oxalate)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off white, round, bevelled biconvex film coated tablets of
approx. 5.2 mm debossed with ‘J’ on one side and ‘1’ on the
other side.
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
20mg 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
increased, up to a maximum of 20 mg daily, dependent on individual
patient response.
Maximum effectiveness is reached after about 3 months. The treatment
lasts several months.
Social anxiety disorder
Usual dosage is 10 mg 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 or
increased to a maximum of 20 mg daily.
Social anxiety disorder is a disease with a chronic course, and
treatment for 12 weeks is recommended to consolidate response.
Long-term treatment of responders has been studied for 6 months and
can be cons