Zeldox

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ziprasidone hydrochloride monohydrate 113.25mg equivalent to 100 mg ziprasidone

Available from:

Pfizer New Zealand Limited

INN (International Name):

Ziprasidone hydrochloride monohydrate 113.25 mg (equivalent to 100 mg ziprasidone)

Dosage:

100 mg

Pharmaceutical form:

Capsule

Composition:

Active: Ziprasidone hydrochloride monohydrate 113.25mg equivalent to 100 mg ziprasidone Excipient: Lactose monohydrate Magnesium stearate Pregelatinised maize starch

Units in package:

Blister pack, cold form aluminium, 20 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Pfizer Ireland Pharmaceuticals

Therapeutic indications:

Ziprasidone is indicated for the treatment of acute schizophrenia, and maintenance or continuation therapy.

Product summary:

Package - Contents - Shelf Life: Blister pack, cold form aluminium, sample - 20 capsules - 24 months from date of manufacture stored at or below 30°C - Blister pack, cold form aluminium - 60 capsules - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 60 capsules - 24 months from date of manufacture stored at or below 30°C

Authorization date:

1997-08-13

Patient Information leaflet

ZELDOX
®
1
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 man

Summary of Product characteristics

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NEW ZEALAND DATA SHEET
1. PRODUCT NAME
ZELDOX
®
20 mg, 40 mg, 60 mg and 80 mg capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20 mg capsule contains 22.652 mg ziprasidone hydrochloride
monohydrate equivalent to
20 mg ziprasidone
Each 40 mg capsule contains 45.3 mg ziprasidone hydrochloride
monohydrate equivalent to
40 mg ziprasidone
Each 60 mg capsule contains 67.95 mg ziprasidone hydrochloride
monohydrate equivalent to
60 mg ziprasidone
Each 80 mg capsule contains 90.6 mg ziprasidone hydrochloride
monohydrate equivalent to
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
20 mg capsules - No. 4 blue/white capsules, marked “Pfizer” and
ZDX 20.
40 mg capsules - No. 4 blue capsules, marked “Pfizer” and ZDX 40.
60 mg capsules - No. 3 white capsules, marked “Pfizer” and ZDX 60.
80 mg capsules - No. 2 blue/white capsules, marked “Pfizer” and
ZDX 80.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ziprasidone is indicated for the treatment of acute schizophrenia,
and maintenance or
continuation therapy.
Ziprasidone is also indicated as a monotherapy for the short term
treatment of acute manic or
mixed episodes associated with bipolar 1 disorder.
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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.
USE IN ADULTS
_SCHIZOPHRENIA _
The recommended dose in treatment of schizophrenia is 40 mg twice
daily to be taken with
food (see Section 5.2 – Pharmacokinetic properties). Daily dosage
may subsequently be
adjusted on the basis of individual clinical status up to a maximum of
80 mg twice daily. If
indicated, the maximum recommended dose may be reached as early as day
3 of treatment.
_BIPOLAR MANIA _
The recommended dose in t