ZIPROX ziprasidone (as hydrochloride) 80 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ziprasidone hydrochloride, Quantity: 87.2 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Ziprasidone hydrochloride

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: sodium lauryl sulfate; sucrose; titanium dioxide; indigo carmine; ammonium chloride; sodium starch glycollate type B; lactose monohydrate; Gelatin; macrogol 6000; purified water; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ziprasidone is indicated for the treatment of schizophrenia, related psychoses, prevention of relapse and for maintenance of clinical improvement during continuation therapy. Ziprasidone is indicated as monotherapy for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder.

Product summary:

Visual Identification: Blue/White size '0' hard gelatin capsules imprinted in black ink with "CL65" on the cap and "80mg" on the body; filled with pale pink coloured powder.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-08-13

Patient Information leaflet

1
Z
ZIPROX CAPSULES
_Contains the active ingredient ziprasidone hydrochloride_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about ziprasidone. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on
the last page. More recent
information on this medicine may
be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do
not understand in this leaflet,
•
if you are worried about
taking your medicine, or
•
to obtain the most up-to-
date information.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your
medicine. You may want to read it
again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
ZIPROX. It contains the active
ingredient ziprasidone (as
ziprasidone hydrochloride).
It is used to treat schizophrenia
and bipolar disorder.
Ziprasidone is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
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 ove

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
ZIPROX
(Ziprasidone hydrochloride) capsules
1
NAME OF THE MEDICINE
Ziprasidone (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20 mg, 40 mg, 60 mg or 80 mg ziprasidone (base).
EXCIPIENT(S) WITH KNOWN EFFECT
Each capsule contains lactose monohydrate and sucrose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
20 MG CAPSULES: Blue/White size ‘4’ hard gelatin capsules
imprinted in black ink with “CL62” on the
cap and “20mg” on the body; filled with pale pink coloured powder.
40 MG CAPSULES: Blue/Blue size ‘2’ hard gelatin capsules imprinted
in black ink with “CL63” on the
cap and “40mg” on the body; filled with pale pink coloured powder.
60 MG CAPSULES: White/White size ‘1’ hard gelatin capsules
imprinted in black ink with “CL64” on the
cap and “60mg” on the body; filled with pale pink coloured powder.
80 MG CAPSULES: Blue/White size ‘0’ hard gelatin capsules
imprinted in black ink with “CL65” on the
cap and “80mg” on the body; filled with pale pink coloured powder.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
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
.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ZIPROX capsules are intended for oral administration. ZIPROX capsules
should be taken with food
and swallowed whole without chewing, crushing or opening beforehand.
2
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 d