APO-ZIPRASIDONE ziprasidone (as hydrochloride) 40 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ziprasidone hydrochloride, Quantity: 43.6 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Ziprasidone hydrochloride

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: sodium starch glycollate type B; titanium dioxide; indigo carmine; lactose monohydrate; purified water; macrogol 6000; ammonium chloride; sucrose; Gelatin; sodium lauryl sulfate; 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/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.; 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

APO-ZIPRASIDONE
1
APO-ZIPRASIDONE
_Contains the active ingredient ziprasidone hydrochloride _
CONSUMER MEDICINE INFORMATION
_ _
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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 this medicine
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 THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Ziprasidone. It contains the active
ingredient ziprasidone (as
ziprasidone hydrochloride).
It is used to treat schizophrenia and
bipolar disorder.
Ziprasidone belongs to a group of
medicines called atypical
antipsychotics/neuroleptics.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
ZIPRASIDONE IS AVAILABLE ONLY WITH
A DOCTOR'S PRESCRIPTION.
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, anxie

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-ZIPRASIDONE (ZIPRASIDONE HYDROCHLORIDE)
CAPSULES
1
NAME OF THE MEDICINE
Ziprasidone hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20 mg, 40 mg, 60 mg or 80 mg ziprasidone (as
hydrochloride) as the
active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Contains sugars (as lactose) and sulfites.
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
“20 mg” 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
“40 mg” 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
“60 mg” 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
“80 mg” on the body; filled with pale pink coloured powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC 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
DOSE AND METHOD OF ADMINISTRATION
APO-Ziprasidone capsules are intended for oral administration.
APO-Ziprasidone 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.