ZELDOX ziprasidone (as hydrochloride monohydrate) 40mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ziprasidone hydrochloride monohydrate, Quantity: 45.3 mg (Equivalent: ziprasidone, Qty 40 mg)

Available from:

Viatris Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: magnesium stearate; indigo carmine; titanium dioxide; lactose monohydrate; pregelatinised maize starch; Gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

20 capsules, 60 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Zeldox (ziprasidone) is indicated for: (i) the treatment of schizophrenia, related psychoses, prevention of relapse and for maintenance of clinical improvement during continuation therapy; and (ii) as monotherapy for the short term treatment of acute manic or mixed episodes associated with bipolar I disorder.

Product summary:

Visual Identification: No.4 blue cap/blue body capsule marked "Pfizer" and "ZDX 40"; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2001-10-29

Patient Information leaflet

ZELDOX
®
(ZELL-DOCKS)
_ziprasidone hydrochloride (zi-pra-si-don hi-dro-klor-ride)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zeldox.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Zeldox against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ZELDOX IS USED
FOR
_WHAT ZELDOX IS FOR_
Zeldox is used to treat schizophrenia
and bipolar disorder.
Your doctor may have prescribed
Zeldox for another reason.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT
ZELDOX OR WHY ZELDOX HAS BEEN
PRESCRIBED FOR YOU.
SCHIZOPHRENIA
Schizophrenia is a mental illness. It
varies from person to person, but can
involve:
•
hallucinations: the person sees,
hears, feels, smells or tastes
something that is not actually
there; most commonly a person
may hear voices
•
delusions: a delusion is a false
belief held by a person which is
not held by others of the same
cultural background
•
disturbed or disorganised thinking
•
poor memory and concentration
•
loss of emotion and expression
•
loss of motivation and energy
•
difficulty interacting with others,
leading to social isolation.
BIPOLAR DISORDER
Bipolar disorder is a mental illness
where a person cycles through:
•
'manic' phases - with symptoms
such as over-activity, irritability/
elation and limited need for sleep
•
'depressive' phases - with
symptoms such as depressed
mood, anxiety, difficulty making
decisions, concentrating and
hopelessness.
_HOW ZELDOX WORKS_
Zeldox belongs to a group of
medicines called atypical
antipsychotics/neuroleptics. It
contains the ingredient ziprasidone.
SCHIZOPHRENIA
Researchers do not know exactly
what causes schizophrenia, but they
do know that many people with

Summary of Product characteristics

Version: ujpzeldc11021
Supersedes: ujpzeldc10221
Page 1 of 25
AUSTRALIAN PRODUCT
INFORMATION -
ZELDOX
 (ZIPRASIDONE HYDROCHLORIDE
MONOHYDRATE) CAPSULES
1. NAME OF THE MEDICINE
Ziprasidone hydrochloride monohydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZELDOX capsules containing ziprasidone hydrochloride monohydrate
equivalent to 20 mg,
40 mg, 60 mg or 80 mg ziprasidone.
EXCIPIENT(S) WITH KNOWN EFFECT
•
Lactose monohydrate
For the full list of excipients, see Section 6.1 - List of excipients.
3.
PHARMACEUTICAL FORM
ZELDOX is supplied for oral administration as capsules.
ZELDOX 20 mg capsules: No.4 blue/white capsules, marked “Pfizer”
and “ZDX 20”.
ZELDOX 40 mg capsules: No.4 blue capsules, marked “Pfizer” and
“ZDX 40”.
ZELDOX 60 mg capsules: No.3 white capsules, marked “Pfizer” and
“ZDX 60”.
ZELDOX 80 mg capsules: No.2 blue/white capsules, marked “Pfizer”
and “ZDX 80”.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ZELDOX (ziprasidone) is indicated:
•
for the treatment of schizophrenia, related psychoses, prevention of
relapse and for
maintenance of clinical improvement during continuation therapy;
_ _
•
as monotherapy for the short term treatment of acute manic or mixed
episodes associated
with bipolar I disorder.
Version: ujpzeldc11021
Supersedes: ujpzeldc10221
Page 2 of 25
4.2 DOSE AND METHOD OF ADMINISTRATION
USE OF ZELDOX CAPSULES
For oral use. ZELDOX capsules should be taken with food and swallowed
whole without
chewing, crushing or opening beforehand.
SCHIZOPHRENIA
The recommended dose in treatment of schizophrenia is 40 mg twice
daily taken with food.
Daily dosage may subsequently be adjusted on the basis of individual
clinical status up to
80 mg twice daily. Dosage adjustments, if indicated, should generally
occur at intervals of not
less than 2 days. The maximum recommended dose of 80 mg twice daily
may be reached as
early as Day 3 of treatment.
Ziprasidone is effective in the treatment of acutely exacerbated
patients and in maintaining the
clinical imp