Escitalopram 20mg/ml Oral drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Escitalopram

Available from:

Chanelle Medical Unlimited Company

ATC code:

N06AB; N06AB10

INN (International Name):

Escitalopram

Dosage:

20 milligram(s)/millilitre

Pharmaceutical form:

Oral drops, solution

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:

2012-03-23

Patient Information leaflet

ID: PL 166-0171
VERSION: 11
REVIEW DATE:04/01/2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
ESCITALOPRAM 20 MG / ML ORAL DROPS, SOLUTION
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 is and what it is used for
2.
What you need to know before you take Escitalopram
3.
How to take Escitalopram
4.
Possible side effects
5.
How to store Escitalopram
6.
Contents of the pack and other information
Escitalopram 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.
Disturbances in the
serotonin-system are considered an important factor in the development
of depression and
related diseases.
Escitalopram
20 mg/ml oral drops solution 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) in adults
above 18 years of age.
It may take a couple of weeks before you start to feel better.
Continue to take
Escitalopram
,
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.
DO NOT TAKE ESCITALOPRAM:
•
If you are allergic to escitalopram or any of the other ingredients of
this medicine
(listed in section 6).
•
If you take ot

Summary of Product characteristics

Health Products Regulatory Authority
15 May 2023
CRN00DF4W
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escitalopram 20mg/ml Oral drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains:
20 mg escitalopram (as 25.56 mg escitalopram oxalate).
Each drop contains 1 mg of escitalopram.
Excipients with known effect:
Each drop contains 4.7mg of ethanol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral drops, solution
A clear solution with a bitter taste.
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 (20 drops) has not been
demonstrated.
_Major depressive episodes_
Usual dosage is 10 mg (10 drops) once daily. Depending on individual
patient response, the dose may be increased to a
maximum of 20 mg (20 drops) 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 (5 drops) is recommended for the first week
before increasing the dose to 10 mg (10 drops) daily. The
dose may be further increased, up to a maximum of 20 mg (20 drops)
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 (10 drops) 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 (5 drops) or increased to a maximum of 20 mg
(20 drops) daily.
Health Products Regulatory Authority
15 May 2023
CRN00