Sertraline Auro 100 mg, filmomhulde tabletten

Riik: Holland

keel: hollandi

Allikas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Toimeaine:

SERTRALINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; SERTRALINE

Saadav alates:

Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN

ATC kood:

N06AB06

INN (Rahvusvaheline Nimetus):

SERTRALINEHYDROCHLORIDE COMPOSITION corresponding to ; SERTRALINE

Ravimvorm:

Filmomhulde tablet

Koostis:

CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; METHYLCELLULOSE (E 461) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Manustamisviis:

Oraal gebruik

Terapeutiline ala:

Sertraline

Toote kokkuvõte:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); METHYLCELLULOSE (E 461); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Loa andmise kuupäev:

2014-01-17

Infovoldik

SERTRALINE APOTEX 50 MG FILM-COATED TABLETS
SERTRALINE APOTEX 100 MG FILM-COATED TABLETS
MODULE 1.3
Product Information
Version: 29.06.2021
MODULE 1.3.1
Package Leaflet
Replaces : 28.11.2020
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SERTRALINE APOTEX 50 MG FILM-COATED TABLETS SERTRALINE APOTEX 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 Sertraline is and what it is used for
2.
What you need to know before you take Sertraline
3.
How to take Sertraline
4.
Possible side effects
5.
How to store Sertraline
6.
Contents of the pack and other information
1.
WHAT SERTRALINE IS AND WHAT IT IS USED FOR
Sertraline contains the active ingredient sertraline. Sertraline is
one of a group of medicines called
Selective Serotonin Reuptake Inhibitors (SSRIs).
These medicines are used to treat depression and/ or anxiety
disorders.
Sertraline 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, children and
adolescents aged 6-17 years
old).
Depression is a clinical illness with symptoms like feeling sad,
unable to sleep properly or unable
to enjoy life as you used to.
SERTRALINE APOTEX 50 MG FILM-COATED TABLETS
SERTRALINE APOTEX 100 MG FILM-COATED TABLETS
MODULE 1.3
Product Information
Version: 29.06.2021
MODULE 1.3.1
Package Leaflet
Replaces : 28.11.2020
2
Obs

Toote omadused

SERTRALINE APOTEX 50 MG FILM-COATED TABLETS
SERTRALINE APOTEX 100 MG FILM-COATED TABLETS
MODULE 1.3
Product Information
Version: 29.06.2021
MODULE 1.3.1
Summary of Product Characteristics
Replaces :
28.11.2020
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sertraline Apotex 50 mg film-coated tablets
Sertraline Apotex 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Sertraline Apotex 50 mg film-coated tablets:_
Each film-coated tablet contains sertraline
hydrochloride equivalent to 50 mg sertraline.
_Sertraline Apotex 100 mg film-coated tablets:_
Each film-coated tablet contains sertraline
hydrochloride equivalent to 100 mg sertraline.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Sertraline 50mg film-coated tablets are 4 x 8 mm bluish purple oval
scored film coated tablets
engraved “APO” on one side, “SE” bisect “50” on the other
side.
Sertraline 100mg film-coated tablets are 5 x 10 mm yellow oval scored
film coated tablets
engraved “APO” on one side, “SER” bisect “100” on the
other side.
The tablet 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
SERTRALINE APOTEX 50 MG FILM-COATED TABLETS
SERTRALINE APOTEX 100 MG FILM-COATED TABLETS
MODULE 1.3
Product Information
Version: 29.06.2021
MODULE 1.3.1
Summary of Product Characteristics
Replaces :
28.11.2020
2
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 b