ZIPRASIDONE GH ziprasidone (as hydrochloride) 20 mg capsule blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
09-09-2021
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
ziprasidone hydrochloride, Quantity: 21.72 mg (Equivalent: ziprasidone, Qty 20 mg)
Available from:
Generic Health Pty Ltd
INN (International Name):
Ziprasidone hydrochloride
Pharmaceutical form:
Capsule, hard
Composition:
Excipient Ingredients: Gelatin; magnesium stearate; pregelatinised maize starch; croscarmellose sodium; indigo carmine; colloidal anhydrous silica; titanium dioxide
Administration route:
Oral
Units in package:
60
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
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.
Product summary:
Visual Identification: size 4 capsule: white body, blue cap; 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 30 degrees Celsius; Container Closure: Child resistant closure
Authorization status:
Licence status A
Authorization date:
2015-03-05
Patient Information leaflet
CONSUMER MEDICINE INFORMATION
ZIPRASIDONE GH
(ZIPRASIDONE HYDROCHLORIDE) CAPSULES
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Ziprasidone GH.
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
Ziprasidone GH 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 ZIPRASIDONE GH IS
USED FOR
_WHAT_ _ZIPRASIDONE GH IS FOR _
Ziprasidone GH is used to treat
schizophrenia and bipolar
disorder.
Your doctor may have
prescribed Ziprasidone GH for
another reason.
ASK YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
QUESTIONS ABOUT ZIPRASIDONE
GH OR WHY ZIPRASIDONE GH
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 ZIPRASIDONE GH WORKS _
Ziprasidone GH belongs to a
group of medicines called
atypical antipsychotics/
neuroleptics. It contains the
ingredient ziprasidone.
SCHIZOPHRENIA
Researchers do not know
exactly wh
Read the complete document
Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION – ZIPRASIDONE GH
(ZIPRASIDONE HYDROCHLORIDE) CAPSULES
1
NAME OF THE MEDICINE
Ziprasidone hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ziprasidone GH is supplied for oral administration as capsules
containing ziprasidone hydrochloride
(anhydrous) equivalent to 20 mg, 40 mg, 60 mg and 80 mg ziprasidone.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Ziprasidone GH 20 mg capsules: Size 4 capsule, white body, blue cap.
Ziprasidone GH 40 mg capsules: Size 4 capsules, blue body, blue cap.
Ziprasidone GH 60 mg capsules: Size 3 capsules, white body, white cap.
Ziprasidone GH 80 mg capsules: Size 2 capsules, white body, blue cap.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ziprasidone capsules are 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
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
improvement during continuation therapy, in patients who have shown an
initial treatment response.
In maintenance treatment patients should be administered the lowest
effective dose. In many cases, a
dose of 20 mg twice daily may be sufficient.
Ziprasidone GH v3
Page 2 of 24
(ziprasidone hydrochloride) capsules
Long term treatment with ziprasidone is effective in the prevention of
recurrent exacerbation of the
illness
Read the complete document
