Cipralex 20mg/ml oral drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Escitalopram oxalate

Available from:

Lundbeck Ltd

ATC code:

N06AB10

INN (International Name):

Escitalopram oxalate

Dosage:

20mg/1ml

Pharmaceutical form:

Oral drops

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030300; GTIN: 5702157141326

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CIPRALEX 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 Cipralex is and what it is used for
2.
What you need to know before you take Cipralex
3.
How to take Cipralex
4.
Possible side effects
5.
How to store Cipralex
6.
Contents of the pack and other information
1.
WHAT CIPRALEX IS AND WHAT IT IS USED FOR
_ _
Cipralex
contains
the
active
substance
escitalopram.
Cipralex
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.
Cipralex 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) in adults above 18
years of age.
It may take a couple of weeks before you start to feel better.
Continue to take Cipralex, 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 CIPRALEX
DO NOT TAKE CIPRALEX:
•
If you are allergic to escitalopram or any of the other ingredients of
this medicine
(listed in section 6).
•
If you take other me

Summary of Product characteristics

OBJECT 1
CIPRALEX ORAL DROPS SOLUTION, 20MG/ML
Summary of Product Characteristics Updated 11-Aug-2017 | Lundbeck
Limited
1. Name of the medicinal product
CIPRALEX 20 mg/ml oral drops, solution
2. Qualitative and quantitative composition
Each ml of solution contains:
20 mg escitalopram (as 25.551 mg escitalopram oxalate).
Each drop contains 1 mg escitalopram.
Excipients with known effect: each drop contains 4.7 mg ethanol
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral drops, solution
Clear, nearly colourless to yellowish 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
Safety of daily doses above 20 mg (20 drops) has not been
demonstrated.
Cipralex is administered as a single daily dose and may be taken with
or without food.
Cipralex oral drops, solution can be mixed with water, orange juice or
apple juice.
Turn the bottle completely upside down. If no drops come out, tap the
bottle lightly to start the flow.
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 dro