Esciprex 20 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Escitalopram

Available from:

Rowex Ltd

ATC code:

N06AB; N06AB10

INN (International Name):

Escitalopram

Dosage:

20 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:

Marketed

Authorization date:

2011-08-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESCIPREX 5 MG FILM-COATED TABLETS
ESCIPREX 10 MG FILM-COATED TABLETS
ESCIPREX 15 MG FILM-COATED TABLETS
ESCIPREX 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 Esciprex is and what it is used for
2.
What you need to know before you take Esciprex
3.
How to take Esciprex
4.
Possible side effects
5.
How to store Esciprex
6.
Contents of the pack and other information
1.
WHAT ESCIPREX IS AND WHAT IT IS USED FOR
Esciprex contains the active substance escitalopram. Esciprex 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 as an important factor in the development of
depression and related
diseases.
Esciprex 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 Esciprex, 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 ESCIPREX
DO NOT TAKE ESCIPREX

if you are allergic to escitalopram or any of the other ingredients of
this medicine (listed in sect

Summary of Product characteristics

Health Products Regulatory Authority
04 April 2022
CRN00CD6W
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Esciprex 20 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of escitalopram (as oxalate).
Excipient with known effect
Each film-coated tablet contains 173.34 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round film-coated tablet with cross breaking notch on both
sides, with diameter of 9.2-9.8 mm.
The tablet can be divided into four 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.
Health Products Regulatory Authority
04 April 2022
CRN00CD6W
Page 2 of 13
Social anxiet