Lexapro 15 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Escitalopram

Available from:

H. Lundbeck A/S

ATC code:

N06AB; N06AB10

INN (International Name):

Escitalopram

Dosage:

15 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Selective serotonin reuptake inhibitors; escitalopram

Authorization status:

Not marketed

Authorization date:

2002-10-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LEXAPRO 5 MG FILM-COATED TABLETS
LEXAPRO 10 MG FILM-COATED TABLETS
LEXAPRO 15 MG FILM-COATED TABLETS
LEXAPRO 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 Lexapro is and what it is used for
2.
What you need to know before you take Lexapro
3.
How to take Lexapro
4.
Possible side effects
5.
How to store Lexapro
6.
Contents of the pack and other information
1.
WHAT LEXAPRO IS AND WHAT IT IS USED FOR
_ _
Lexapro
contains
the
active
substance
escitalopram.
Lexapro
belongs
to
a
group
of
antidepressants called selective serotonin reuptake inhibitors
(SSRIs).
Lexapro 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 Lexapro, 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 LEXAPRO
DO NOT TAKE LEXAPRO
•
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 group called MAO
inhibitors, including
selegiline (used in the treatment of Parkinson´s disease),
moclobemide (used in the
treatment of depression) and linezolid (an ant

Summary of Product characteristics

Health Products Regulatory Authority
21 December 2023
CRN00DJMN
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lexapro 15 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg escitalopram (as oxalate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Oval, white, scored, film-coated tablet of 9.8 x 6.3 mm marked with
E” and “M on each side of the score on one side of the
tablet.
The 10, 15 and 20 mg tablets 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
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 res