Sertralin Actavis 100mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SERTRALINE

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

N06AB06

INN (International Name):

SERTRALINE 100 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

SERTRALINE 100 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Withdrawn

Authorization date:

2007-12-27

Patient Information leaflet

SERTRALIN ACTAVIS
Film-coated tablets
Sertraline 50mg, 100mg
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
- 
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. Do not pass it on to
others.  

It may harm them, even if their symptoms are the same as yours.
- 
If any of the side effects gets serious, or if you notice any side
effects not  

listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. 
What Sertralin Actavis is and what it is used for
2. 
Before you take Sertralin Actavis
3. 
How to take Sertralin Actavis
4. 
Possible side effects
5. 
How to store Sertralin Actavis
6. 
Further information.
1.  WHAT SERTRALIN ACTAVIS IS AND WHAT IT IS USED FOR
Sertralin Actavis belongs to the group of antidepressant medicines
(also called 
selective serotonin reuptake inhibitors, SSRIs).
Sertralin Actavis is used in the treatment of:
- 
Depressive illnesses (major depressive episodes)
- 
Obsessive-compulsive disorders (obsessive-compulsive thoughts and  

obsessive-compulsive actions)
- 
Panic attacks with or without agoraphobia
- 
Psychological reactions after a mentally stressful event
(post-traumatic  

stress syndrome)
- 
Anxiety when dealing with other people (social phobia).

2.  BEFORE YOU TAKE SERTRALIN ACTAVIS 
DO NOT TAKE SERTRALIN ACTAVIS
- 
if you are allergic (hypersensitive) to sertraline or any of the other

ingredients of Sertralin Actavis
- 
if you are taking medicines that belong to the group of MAO inhibitors

including selegiline (for Parkinson‘s disease) and moclobemide (for

depression)
- 
if you are taking medicines containing pimozide
- 
If you suffer from severe hepatic impairment.
TAKE SPECIAL CARE WITH SERTRALIN ACTAVIS
- 
if you have recently finished treatment with medicines that belong to

the group of MAO inhibitors (e

Summary of Product characteristics

 
Page 1 of 15 
SUMMARY OF THE PRODUCT CHARACTERISTICS

1 
N
AME OF THE 
M
EDICINAL 
P
RODUCT

_Sertralin Actavis 50 mg film-coated tablets_
_ _
_Sertralin Actavis 100 mg film-coated tablets_

2 
Q
UALITATIVE AND 
Q
UANTITATIVE 
C
OMPOSITION

_Sertralin Actavis 50 mg film-coated tablets: _
Each film-coated tablet contains 50 mg sertraline (as
hydrochloride). 

Excipient: 79,65 mg lactose monohydrate/film-coated tablet.

_Sertralin Actavis 100 mg film-coated tablets: _
Each film-coated tablet contains 100 mg

sertraline (as hydrochloride). 

Excipient: 159,3 mg lactose monohydrate/film-coated tablet.

For a full list of excipients, see 6.1. 
3 
P
HARMACEUTICAL 
F
ORM

Film-coated tablet 
_ _
_Sertralin Actavis 50 mg film-coated tablets_
_ _
White, oval, biconvex, film-coated tablets,  scored on one side,
other side with “L”markings 
_ _
_Sertralin Actavis 100 mg film-coated tablets_
_ _
White, round, biconvex, film-coated tablets,  scored on one side,
other side with “C” markings. 

The tablet can be divided into equal halves.

4 
C
LINICAL 
P
ARTICULARS

4.1 
THERAPEUTIC INDICATIONS 
Treatment of major depressive episodes.

Following a satisfactory response, Sertralin Actavis can be
given preventively against relapse or 
further depressive episodes. 
Treatment of obsessive compulsive disorder. 
Panic syndrome with or without agoraphobia. 

Post-traumatic stress disorder. 
Social phobia. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
_Adults _
_ _
_Major depressive episodes _
The usual daily dose is 50 mg sertraline. 

Page 2 of 15 
If required, the dose can be increased to 100 mg sertraline/day. The
maximum daily dose is 200 mg 
sertraline.

If dose increments are required, these should be made in steps of 50
mg at minimum intervals of 1 
week. Dose changes should not be performed more than once per week
due to elimination half-life 
of sertraline over 24 hours. 

During long term therap