Cipralex 10mg tablets

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:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030300; GTIN: 5702157150809

Patient Information leaflet

1525,1526
14.04.20[18]
PATIENT INFORMATION LEAFLET
CIPRALEX
® 10 MG TABLETS /
ESCITALOPRAM 10 MG TABLETS
CIPRALEX
® 20 MG TABLETS /
ESCITALOPRAM 20 MG TABLETS
(escitalopram oxalate)
Your medicine is available using the above names but will be referred
to
as Cipralex throughout this leaflet. This medicine is also available
in
5 mg tablets.
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 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 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 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 antibiotic).
•
If you are born with or have had an episode of abnormal heart rhythm
(Seen at ECG; an examination to evaluate how the heart is
functioning).
•
If you take

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
CIPRALEX 10 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cipralex 10 mg: Each tablet contains 10 mg escitalopram (as oxalate)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Cipralex 10 mg: Oval, white, scored, film-coated tablet of 8 x 5.5 mm,
marked with "E” and “L" on each side of the score on one side of
the tablet.
The tablet 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
responders has been studied for 6 months and can be considered on