Escitalopram 20mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Escitalopram oxalate

Dostępny od:

Milpharm Ltd

Kod ATC:

N06AB10

INN (International Nazwa):

Escitalopram oxalate

Dawkowanie:

20mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 04030300; GTIN: 8901175020324

Ulotka dla pacjenta

PACKAGE LEAFLET:
INFORMATION FOR THE USER
ESCITALOPRAM 10 MG
FILM-COATED TABLETS
ESCITALOPRAM 20 MG
FILM-COATED TABLETS
Escitalopram
N13105
Black
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
1.
WHAT ESCITALOPRAM IS AND WHAT IT IS USED FOR
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 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 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ESCITALOPRAM
DO NOT TAKE ESCITALOPRAM:
-
if you are allergic to escitalopram or any of
the other ingredients of this medicine (listed in
section 6).
-
i

Charakterystyka produktu

OBJECT 1
Escitalopram 20mg tablets
Summary of Product Characteristics Updated 02-Aug-2021 | Aurobindo
Pharma - Milpharm Ltd.
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Escitalopram 20 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 20 mg escitalopram (as oxalate).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Escitalopram 20 mg: White to off – white colored, oval shaped,
film-coated, biconvex tablets debossed with
'F' on one side and '56' on the other side with a deep scoreline
between '5' and '6'. The size is 11.6 mm X 7.1
mm.
The 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