Escitalopram Pinewood 15 mg film-coated tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Escitalopram oxalate

Dostępny od:

Pinewood Laboratories Ltd

Kod ATC:

N06AB10

INN (International Nazwa):

Escitalopram oxalate

Forma farmaceutyczna:

Film-coated tablet

Dziedzina terapeutyczna:

escitalopram

Status autoryzacji:

Not marketed

Data autoryzacji:

2023-06-23

Ulotka dla pacjenta

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESCITALOPRAM PINEWOOD 5 MG FILM-COATED TABLETS
ESCITALOPRAM PINEWOOD 10 MG FILM-COATED TABLETS
ESCITALOPRAM PINEWOOD 15 MG FILM-COATED TABLETS
ESCITALOPRAM PINEWOOD 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.
The name of this medicine is Escitalopram Pinewood film-coated
tablets, which will be called
Escitalopram Pinewood throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Escitalopram Pinewood is and what it is used for
2. What you need to know before you take Escitalopram Pinewood
3. How to take Escitalopram Pinewood
4. Possible side effects
5. How to store Escitalopram Pinewood
6. Contents of the pack and other information
1.
WHAT ESCITALOPRAM
PINEWOOD IS AND WHAT IT IS USED FOR
Escitalopram Pinewood contains the active substance escitalopram.
Escitalopram Pinewood 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 Pinewood 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 Pinewood,
even if

Charakterystyka produktu

Health Products Regulatory Authority
20 March 2024
CRN00F57C
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escitalopram Pinewood 15 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg escitalopram (as oxalate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off white, round shape, biconvex, film coated tablets
debossed with "15" on one side and plain on other side.
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 considere