Serimel 50 mg film-coated tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Sertraline

Доступна з:

Clonmel Healthcare Ltd

Код атс:

N06AB; N06AB06

ІПН (Міжнародна Ім'я):

Sertraline

Дозування:

50 milligram(s)

Фармацевтична форма:

Film-coated tablet

Тип рецепту:

Product subject to prescription which may not be renewed (A)

Терапевтична области:

Selective serotonin reuptake inhibitors; sertraline

Статус Авторизація:

Marketed

Дата Авторизація:

2005-07-22

інформаційний буклет

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
SERIMEL 50 MG FILM-COATED TABLETS
SERIMEL 100 MG FILM-COATED TABLETS
Sertraline
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 Serimel is and what it is used for
2.
What you need to know before you take Serimel
3.
How to take Serimel
4.
Possible side effects
5.
How to store Serimel
6.
Contents of the pack and other information
1. HAT SERIMEL IS AND WHAT IT IS USED FOR
Serimel contains the active ingredient sertraline. Sertraline is one
of a group of medicines called
Selective Serotonin Re-uptake Inhibitors (SSRIs); these medicines are
used to treat depression and or
anxiety disorders.
SERIMEL CAN BE USED TO TREAT:

depression and prevention of recurrence of depression (in adults)

social anxiety disorder (in adults)

post traumatic stress disorder (PTSD) (in adults)

panic disorder (in adults)

obsessive compulsive disorder (OCD) (in adults and children and
adolescents aged 6-17 years old)
Depression is a clinical illness with symptoms like feeling sad,
unable to sleep properly or to enjoy life
as you used to.
OCD and panic disorders are illnesses linked to anxiety with symptoms
like being constantly troubled
by persistent ideas (obsessions) that make you carry out repetitive
rituals (compulsions).
PTSD is a condition that can occur after a very emotionally traumatic
experience, and has some
symptoms that are similar to depression and anxiety. Social anxiety
disorder (social phobia) is an illness
linked to anxiety. It

Характеристики продукта

Health Products Regulatory Authority
06 October 2021
CRN00CF7Z
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Serimel 50 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Serimel 50 mg film-coated tablets
One film-coated tablet contains 50 mg of sertraline (as sertraline
hydrochloride).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (Tablets)
Serimel 50 mg film-coated tablets
White film-coated caplet shaped tablet debossed with "50" on one side
and score line on the other side.
The tablets can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sertraline is indicated for the treatment of:
- major depressive episodes. Prevention of recurrence of major
depressive episodes
- panic disorder, with or without agoraphobia
- obsessive compulsive disorder (OCD) in adults and paediatric
patients aged 6-17 years
- social anxiety disorder
- post-traumatic stress disorder (PTSD)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Initial treatment_
_Depression and OCD_
Sertraline treatment should be started at a dose of 50 mg/day.
_Panic Disorder, PTSD, and Social Anxiety Disorder_
Therapy should be initiated at 25 mg/day. After one week, the dose
should be increased to 50 mg once daily. This dosage
regimen has been shown to reduce the frequency of early treatment
emergent side effects characteristic of panic disorder.
_Titration_
_Depression, OCD, Panic Disorder, Social Anxiety Disorder and PTSD_
Patients not responding to a 50 mg dose may benefit from dose
increases. Dose changes should be made in steps of 50 mg at
intervals of at least one week, up to a maximum of 200 mg/day. Changes
in dose should not be made more frequently than
once per week given the 24-hour elimination half-life of sertraline.
The onset of therapeutic effect may be seen within 7 days. However,
longer periods are usually necessary to demonstrate
therapeutic response, especially in OCD.
_Maintenance_
Health Products Regulatory Author