Enore 50 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

SERTRALINEHYDROCHLORIDE 55,95 mg/stuk SAMENSTELLING overeenkomend met ; SERTRALINE 50 mg/stuk

Beschikbaar vanaf:

Pfizer B.V. Rivium Westlaan 142 2909 LD CAPELLE A/D IJSSEL

ATC-code:

N06AB06

INN (Algemene Internationale Benaming):

SERTRALINEHYDROCHLORIDE 55,95 mg/stuk SAMENSTELLING overeenkomend met ; SERTRALINE 50 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYETHYLEENGLYCOL (E 1521) ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLYETHYLEENGLYCOL (E 1521) ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Sertraline

Product samenvatting:

Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); HYPROLOSE (E 463); HYPROMELLOSE (E 464); MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POLYETHYLEENGLYCOL (E 1521); POLYSORBAAT 80 (E 433); TITAANDIOXIDE (E 171);

Autorisatie datum:

2012-10-08

Bijsluiter

Package leaflet
NLD 23C21
1
NLD 23C21
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENORE 50 MG FILMOMHULDE TABLETTEN
ENORE 100 MG FILMOMHULDE TABLETTEN
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 Enore is and what it is used for.
2.
What you need to know before you take Enore.
3.
How to take Enore.
4.
Possible side effects.
5.
How to store Enore.
6.
Contents of the pack and other information.
1.
WHAT ENORE IS AND WHAT IT IS USED FOR
Enore 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.
Enore 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
illne

Productkenmerken

Samenvatting van de productkenmerken
NLD 23C21
1
NLD 23C21
SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAME OF THE MEDICINAL PRODUCT
Enore 50 mg filmomhulde tabletten
Enore 100 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sertraline 50 mg film-coated tablets:
Each film-coated tablet contains sertraline hydrochloride equivalent
to 50 mg sertraline.
Sertraline 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
Sertraline 50 mg film-coated tablets are white, capsular shaped,
film-coated scored tablets marked
“ZLT 50” or “LTL 50” or “SER 50” on one side and
‘PFIZER’ on the other. The tablet can be divided
into equal doses.
Sertraline 100 mg film-coated tablets are white, capsular shaped,
film-coated tablets marked “ZLT
100” or “LTL 100” or “SER 100” on one side and ‘PFIZER’
on the other.
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.
_ _
Samenvatting van de productkenmerken
NLD 23C21
2
_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 cha