ZOLOFT TABLET 50MG

Krajina: Malajzia

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktívna zložka:

SERTRALINE HYDROCHLORIDE

Dostupné z:

PFIZER (MALAYSIA) SDN. BHD.

INN (Medzinárodný Name):

SERTRALINE HYDROCHLORIDE

Počet v balení:

30 Tablet Tablets

Výrobca:

Pfizer Manufacturing Deutschland GmbH.

Príbalový leták

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP_)
ZOLOFT
®
TABLETS
Sertraline Hydrochloride (50 mg)
1
WHAT IS IN THIS LEAFLET
1.
What ZOLOFT is used for
2.
How ZOLOFT works
3.
Before you use ZOLOFT
4.
How to use ZOLOFT
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
ZOLOFT
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT ZOLOFT IS USED FOR
ZOLOFT can be used to treat:
-
Depression.
-
Obsessive compulsive disorder
(OCD) in which a person has
uncontrollable, reoccurring
thoughts (obsessions) and
behaviors (compulsions) that he
or she feels the urge to repeat
over and over).
-
Panic disorder (an anxiety
disorder characterized by
reoccurring unexpected panic
attacks).
-
Post-traumatic stress disorder
(PTSD) (a disorder that develops
in some people who have
experienced a traumatic event).
-
Social anxiety disorder (also
called social phobia).
ZOLOFT can be used to prevent the
recurrences of all the diseases stated
above.
Your doctor has decided that this
medicine is suitable for treating your
illness.
You should ask your doctor if you are
unsure why you have been given
ZOLOFT.
HOW ZOLOFT WORKS
ZOLOFT is one of the group of
medicines called selective serotonin
re-uptake inhibitors (SSRIs).
Serotonin is a substance found
naturally in the human body. If the
amount of serotonin is not balanced,
it can lead to, symptoms of
depression and anxiety. ZOLOFT
blocks the reuptake of serotonin in
nerves and thus corrects the
imbalance.
BEFORE YOU USE ZOLOFT
_-_
_When you must not use it_
-
If you are allergic (hypersensitive)
to sertraline or any of the other
ingredients of ZOLOFT.
-
If you are taking or have taken
medicines called monoamine
oxidase inhibitors (MAOIs).
-
If you are taking another medicine
called Pimozide (a medicine for
mental disorders such as
psychosis).
_Pregnancy and lactation_
The safety of ZOLOFT has not fully
been established in pregnant women.
ZOLOFT will only be given to you
when pregnant if your doctor
considers tha

Súhrn charakteristických

Pfizer Confidential
Page 1of 15
LPD Title :Sertraline Hydrochloride
LPD Date :11 March 201 9
Country :Malaysia
Reference Document :CDS version 22 dated 31 May 2017, UK SmPC dated January 201 8
Reason fo
r change :Update to ADR frequencies and frequency categories. Retained SOCs in ADR section as per BoH recommendation.
1. NAME OF MEDICINAL PR ODUCT
ZOLOFT ®
2. QUALITATIVE AND QUANTITATIVE COMPOSI TION
Sertraline is available as film -coated tablets for oral administration containing sertraline
hydrochloride equivalent to 50 mg sertraline.
3. PHARMACEUTICAL FORM
White to off white film coated capsular shaped tablet engraved with “ZLT” and “50” with
scoreline on one side and “Pfizer” on the other.
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
Sertraline is indicated for the treatment of symptoms of depression, including depression
accompanied by symptoms of anxiety, in patients with or without a history of mania. Following
satisfactory response, continuation with sertraline therapy is effective in preventing relapse of the
initial episode of depression or recurrence of further depressive episodes.
Sertraline is indicated for the treatment of obsessive -compulsive disorder (OCD). Following
satisfactory response, continuation with sertraline therapy is effective in preventing relapse of the
initial episode of OCD.
Sertraline is indicated for the treatment of pa nic disorder, with or without agoraphobia. Following
satisfactory response, continuation with sertraline therapy is effective in preventing relapse of the
initial episode of panic disorder.
Sertraline is indicated for the treatment of post -traumatic stres s disorder (PTSD). Following
satisfactory response, continuation with sertraline therapy is effective in preventing relapse of the
initial episode of PTSD.
Sertraline is indicated for the treatment of social phobia (social anxiety disorder). Following
sat isfactory response, continuation with sertraline therapy is effective in preventing relapse of the
initial episode of social phobia.