ZELDOX CAPSULE 40MG

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE

Verfügbar ab:

UPJOHN (MALAYSIA) SDN. BHD.

INN (Internationale Bezeichnung):

ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE

Einheiten im Paket:

100Capsule Capsules; 30Capsule Capsules; 100 Capsules; 30 Capsules

Hergestellt von:

PFIZER IRELAND PHARMACEUTICALS

Gebrauchsinformation

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ZELDOX
®
CAPSULE
Ziprasidone hydrochloride monohydrate (40 mg, 60 mg)
1
WHAT IS IN THIS LEAFLET
1.
What ZELDOX is used for
2.
How ZELDOX works
3.
Before you use ZELDOX
4.
How to use ZELDOX
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of ZELDOX
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT ZELDOX IS USED FOR
Schizophrenia:
ZELDOX is used for the management of
a mental disorder known as
schizophrenia and other psychotic
disorders, and for maintenance of clinical
improvement and prevention of relapse
during continuation therapy.
Bipolar mania:
ZELDOX is also used for the treatment
of manic or mixed episodes associated
with bipolar disorder with or without
psychotic features.
Bipolar I disorder:
ZELDOX is used for the short-term
treatment of manic or mixed episodes
associated with bipolar I disorder.
ZELDOX is also used along with lithium
or valproate for the maintenance
treatment of bipolar I disorder.
HOW ZELDOX WORKS
ZELDOX capsules belong to a group of
medicines called antipsychotics. It works
by changing the activity of certain
natural substances in the brain.
BEFORE YOU USE ZELDOX
-
_When you must not use it_
- if you are allergic (hypersensitive) to
ZELDOX or any of the other
ingredients of ZELDOX capsules.
Signs of an allergic reaction include
rash, itching, swelling in the face or
lips, difficulty in breathing.
- if you have recently had a heart
attack.
-
- if you have heart rhythm problems
and are taking certain medicines for
it (Class IA and III antiarrhythmic
drugs).
- if you have uncompensated heart
failure.
- if you have long QT interval
syndrome.
_Pregnancy and lactation_
You should not take ZELDOX capsules
during pregnancy unless you are told
otherwise by your doctor because there is
a risk that this medicine may harm your
baby. ZELDOX should be used during
pregnancy only if the potential benefit to
the mother justifies the potential risk to
t

Fachinformation

Pfizer Confidential
LPD Title : Ziprasidone Capsules (Zeldox)
LPD Date : 20 January 2020
Country : Malaysia
Reference Documents : CDS Version 1 7.0 dated 14 September 201 8, Sweden SmPC (Date of
approval - 05 July 201 9)
Reason for Change : PfLEET 2018 -0038356 Addition of falls as a warning : PfLEET 2019 -0054001 BoH Query for a ddition of ADRs as per BoH directive dated 23 Oct 2018 : PfLEET 2019 -0056574 (S2), Update Lactation section as per BoH
recommendation : PfLEET 2019 -0054001 (S1), Add footnote for Sleep Aponea ADR in
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