ZYPINE olanzapine 2.5 mg tablet blister pack

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

olanzapine, Quantity: 2.5 mg

Verfügbar ab:

Alphapharm Pty Ltd

INN (Internationale Bezeichnung):

Olanzapine

Darreichungsform:

Tablet, film coated

Zusammensetzung:

Excipient Ingredients: crospovidone; magnesium stearate; pregelatinised maize starch; lactose monohydrate; maize starch; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin

Verabreichungsweg:

Oral

Einheiten im Paket:

28

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

Olanzapine is indicated for the treatment of schizophrenia and related psychoses. Olanzapine alone or in combination with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder. Olanzapine is indicated for preventing recurrence of manic, mixed or depressive episodes in bipolar I disorder.

Produktbesonderheiten:

Visual Identification: approximately 7.0 mm normal convex, white film coated tablet debossed with "OZ" over "2.5" on one side and "G" on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Berechtigungsstatus:

Licence status A

Berechtigungsdatum:

2011-11-07

Gebrauchsinformation

ZYPINE
®
; ZYPINE
® ODT
_olanzapine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zypine and Zypine
ODT (orally disintegrating tablets).
It does not contain all the available
information. It does not take the
place of talking with your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Zypine against
the benefits expected 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 ZYPINE IS USED
FOR
Zypine is used to treat:
•
Symptoms of schizophrenia and
related psychoses
•
Acute manic episodes associated
with Bipolar I Disorder (as a
short-term treatment) with Zypine
alone or in combination with
lithium or valproate.
•
Mood stabiliser that prevents
further occurrences of the
disabling high and low
(depressed) extremes of mood
associated with Bipolar I
Disorder
Zypine belongs to a group of
medicines called antipsychotics.
This medicine helps by correcting
chemical imbalances in the brain,
which may cause mental illness.
Schizophrenia is a mental illness
with disturbances in thinking,
feelings and behaviour. Bipolar I
Disorder is a mental illness with
symptoms such as feeling "high",
having excessive amounts of energy,
needing much less sleep than usual,
talking very quickly with racing
ideas and sometimes severe
irritability.
Zypine may be used alone, or in
combination with other medicines, to
treat your condition.
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.
There is not enough information to
recommend the use of this medicine
for children under the age of 18
years.
BEFORE YOU TAKE
ZYPINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ZYPINE IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
olanzapine
•
any of the ingredients listed at the
end of this leaflet.
•
any other similar

Fachinformation

AUSTRALIAN PRODUCT INFORMATION
ZYPINE
ZYPINE ODT
_Olanzapine _
1
NAME OF THE MEDICINE
Olanzapine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZYPINE Tablets
Each tablet contains either 2.5 mg, 5 mg, 7.5 mg or 10 mg of
olanzapine as the active ingredient.
Excipients with known effect: sugars as lactose and sulfites.
ZYPINE ODT orally disintegrating tablets (ODT)
Each ODT contains either 5 mg, 10 mg, 15 mg or 20 mg olanzapine as the
active ingredient.
Excipients with known effect: aspartame, phenylalanine and sulfites.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
ZYPINE Tablets
ZYPINE tablets are white film-coated tablets.
ZYPINE 2.5 mg
:
Each 2.5 mg tablet contains 2.5 mg of olanzapine – 7.0 mm normal
convex, white
film-coated tablets debossed with “OZ” over “2.5” on one side
and “G” on the other
side.
ZYPINE 5 mg
:
Each 5 mg tablet contains 5 mg of olanzapine – 8.0 mm normal convex,
white film-
coated tablets debossed with “OZ” over “5” on one side and
“G” on the other side.
ZYPINE 7.5 mg
:
Each 7.5 mg tablet contains 7.5 mg of olanzapine – 9.0 mm normal
convex, white
film-coated tablets debossed with “OZ” over “7.5” on one side
and “G” on the other
side.
ZYPINE 10 mg
:
Each 10 mg tablet contains 10 mg of olanzapine – 10.2 mm normal
convex, white
film-coated tablets debossed with “OZ” over “10” on one side
and “G” on the other
side.
ZYPINE & ZYPINE ODT – PRODUCT INFORMATION
2
ZYPINE ODT orally disintegrating tablets
ZYPINE ODT are yellow orally disintegrating tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Olanzapine is indicated for the treatment of schizophrenia and related
psychoses.
Olanzapine alone or in combination with lithium or valproate is
indicated for the short-term treatment of acute
manic episodes associated with Bipolar I Disorder.
Olanzapine is indicated for preventing recurrence of manic, mixed or
depressive episodes in Bipolar I Disorder.
4.2
DOSE AND METHOD OF ADMINISTRATION
ZYPINE