Lustral 50mg Film-coated Tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Sertraline hydrochloride

Доступна з:

Imbat Limited

Код атс:

N06AB; N06AB06

ІПН (Міжнародна Ім'я):

Sertraline hydrochloride

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:

Not marketed

Дата Авторизація:

2005-01-07

інформаційний буклет

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
LUSTRAL
® 50 MG FILM-COATED TABLETS
sertraline
Your medicine is available using the above name but will be
referred to as Lustral throughout this leaflet.
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 Lustral is and what it is used for
2.
What you need to know before you take Lustral
3.
How to take Lustral
4.
Possible side effects
5.
How to store Lustral
6.
Contents of the pack and other information
1.
WHAT LUSTRAL IS AND WHAT IT IS USED FOR
Lustral contains the active substance 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.
Lustral 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 an

Характеристики продукта

Health Products Regulatory Authority
29 January 2020
CRN009L6R
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lustral 50mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg sertraline (as hydrochloride).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the UK_
White, capsule shaped, film coated, scored tablets coded 'ZLT 50' on
one side and 'PFIZER' on the other.
_Product imported from Spain_
White, capsule shaped, film-coated, scored tablets coded 'ZLT-50' on
one side and 'PFIZER' on the other.
The tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
As per PA0822/001/004
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/001/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Product imported from the UK_
Tablet Core:
Calcium hydrogen phosphate
Microcrystalline cellulose
Hydroxypropylcellulose
Sodium starch glycolate (Type A)
Magnesium stearate
Macrogol
Film Coating:
Titanium dioxide (E171)
Hypromellose
Macrogol
Polysorbate 80
_Product imported from Spain_
Calcium hydrogen phosphate dihydrate (E341)
Microcrystalline cellulose (E460)
Hydroxypropylcellulose (E463)
Sodium starch glycolate
Magnesium stearate (E572)
Hypromellose (E464)
Macrogol
Polysorbate-80 (E433)
Health Products Regulatory Authority
29 January 2020
CRN009L6R
Page 2 of 3
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30 °C.
6.5 NATURE AND CONTENTS OF CONTAINER
Overlabelled carton or carton containing blister strips
Pack size: 28 tablets _(product imported from the UK)_, 30 tablets
_(product imported from Spain)_
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Imbat Limited
Unit