AUROZAPINE 15 mirtazapine 15 mg tablets blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

mirtazapine, Quantity: 15 mg

Διαθέσιμο από:

Strides Pharma Science Pty Ltd

INN (Διεθνής Όνομα):

Mirtazapine

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

Excipient Ingredients: hyprolose; magnesium stearate; colloidal anhydrous silica; maize starch; lactose monohydrate; titanium dioxide; hypromellose; iron oxide yellow

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

60, 30

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

Treatment of major depression including relapse prevention.

Περίληψη προϊόντος:

Visual Identification: Yellow, biconvex capsule shaped film coated tablets with a score line in between '0' and '8' on one side and 'A' debossed on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2012-01-25

Φύλλο οδηγιών χρήσης

AUROZAPINE™ 15, 30 & 45
CONSUMER MEDICINE INFORMATION
Mirtazapine film-coated tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions people ask about
AUROZAPINE. 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 AUROZAPINE
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 AUROZAPINE IS USED FOR
AUROZAPINE is used in the treatment of depression including relapse
prevention.
Depression is longer lasting or more severe than "low moods" everyone
has from time to time due
to the stress of everyday life. It is thought to be caused by a
chemical imbalance in parts of the brain.
This affects your whole body and can cause emotional and physical
symptoms such as feeling low
in spirit, loss of interest in activities, unable to enjoy life, poor
appetite or overeating, disturbed sleep,
often waking up early, loss of sex drive, lack of energy and feeling
guilty over nothing.
This medicine corrects this chemical imbalance and may help relieve
the symptoms of depression.
Your doctor, however, may prescribe it for another purpose.
You must follow all the directions given to you by your doctor. They
can differ from the information
in this leaflet.
ALWAYS ASK YOUR DOCTOR IF YOU NEED MORE INFORMATION.
AUROZAPINE is not addictive.
AUROZAPINE is only available with a doctor's prescription.
BEFORE YOU TAKE IT
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE AUROZAPINE:

if you are allergic to medicines containing mirtazapine; or

if you are allergic to any of the ingredients listed at the end of
this leaflet.
Some of the symptoms of an allergic reaction may include skin rash,
itching or hives, swelling of the
face, lips, mouth, throat or other parts of the body, shortness of
breath, wheezing or troub

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Page 1 of 15
PRODUCT INFORMATION
AUROZAPINE
TM 15, 30 & 45
FILM-COATED TABLETS
NAME OF THE MEDICINE
Active substance:
Mirtazapine
Chemical name:
(14bRS)-2-methyl-1,2,3,4,10,14b-hexahydropyrazino[2,1-
a]pyrido[2,3-c][2]benzazepine
Molecular formula:
C
17
H
19
N
3
Molecular weight:
265.4
CAS number:
61337-67-5
Chemical structure:
_ _
DESCRIPTION
Mirtazapine is a tetracyclic piperazinoazepine analogue of mianserin,
a chemical structure
unrelated to tricyclic antidepressants, monoamine oxidase inhibitors
or selective serotonin
reuptake inhibitors. Mirtazapine is a white or almost white powder,
slightly hygroscopic to
hygroscopic. It is freely soluble in anhydrous ethanol and practically
insoluble in water.
AUROZAPINE
tablets
contain
the
following
inactive
ingredients:
lactose,
hydroxypropylcellulose, maize starch, colloidal anhydrous silica,
hydroxypropyl cellulose and
magnesium stearate.
15 mg tablet also contains Opadry Complete Film Coating System
20A2052560 Yellow.
30 mg tablet also contains Opadry Complete Film Coating System
20A56788 Brown.
45 mg tablet also contains Opadry Complete Film Coating System
20A58806 White.
PHARMACOLOGY
PHARMACODYNAMICS
Mirtazapine is an antidepressant, which can be given as treatment for
episodes of major
depression. Mirtazapine is an antagonist of central α
2
-auto and hetero-adrenoceptors which
causes an increase in both noradrenaline and serotonin release. The
effect of released
serotonin is exerted specifically via 5-HT
1
type receptors, because 5-HT
2
and 5-HT
3
type
receptors are specifically blocked by mirtazapine. Mirtazapine is
accordingly a noradrenergic
and specific serotonergic antidepressant. The α
2
, 5-HT
2
and 5-HT
3
antagonistic effects all
contribute to the antidepressant profile of mirtazapine. The
presentation of mirtazapine is as
a racemate. The two enantiomers contribute differently to its
pharmacological profile. The α
2
and 5-HT
2
receptor blocking activity is contained in the (S)+ enantiomer,
whereas the 5-HT
3
receptor
blocking
activity
is
contained
in
t