ZYPINE ODT olanzapine 15 mg orally disintegrating tablet blister pack

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

olanzapine, Quantity: 15 mg

Dostupno od:

Alphapharm Pty Ltd

INN (International ime):

Olanzapine

Farmaceutski oblik:

Tablet, orally disintegrating

Sastav:

Excipient Ingredients: sodium lauryl sulfate; mannitol; microcrystalline cellulose; Guar Gum; crospovidone; magnesium stearate; colloidal anhydrous silica; aspartame

Administracija rute:

Oral

Jedinice u paketu:

5, 28, 7

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

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.

Proizvod sažetak:

Visual Identification: Light yellow to yellow coloured, plain to mottled, round, flat faced, bevelled edged tablets debossed with "M" on one side and "OE3" on 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: Child resistant closure

Status autorizacije:

Licence status A

Datum autorizacije:

2012-06-21

Uputa o lijeku

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

Svojstava lijeka

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, sulfites and
gluten from wheat.
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 – approximately 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 – approximately 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 – approximately 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 – approximately 10.2
mm
normal convex, white film-coated tablets debossed with “OZ” over
“10” on one
side and “G” on the other side.
_ZYPINE ODT ORALLY DISINTEGRATING TABLETS _
ZYPINE ODT are yellow orally disintegrating tablets.
ZYPINE ODT
5 mg
:
Each 5 mg ODT contains 5 mg of olanzapine – Light yellow to yellow
coloured,
plain to mottled, round, flat faced, bevelled edged tablets debossed
with “M” on
one side and “OE1” on other side.
ZYPINE
®
& ZYPINE
®
ODT – PRODUCT INFORMATION
2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Olanzapine is indicated for the treatment of schizophrenia and related
psychoses.
Ol