Chemmart Mirtazapine

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Mirtazapine

Available from:

Apotex Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

CHEMMART MIRTAZAPINE

_Contains the active ingredient mirtazapine_
CONSUMER MEDICINE INFORMATION

_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_

WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about mirtazapine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Chemmart Mirtazapine. It contains
the active ingredient mirtazapine.
It is used to treat depression.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Depression is longer lasting or more
severe than the "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. Mirtazapine corrects this
chemical imbalance and may help
reliev

Summary of Product characteristics

Product Information 
– Australia 

Chemmart Mirtazapine Tablets 
Page 1 
CHEMMART MIRTAZAPINE TABLETS 

NAME OF THE MEDICINE 
Mirtazapine 

Chemical Name: 
(±)-1,2,3,4,10,14b-hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benz- 
azepine. 

Structural Formula: 

Molecular Formula: 
C
17
H
19
N
3 

Molecular Weight: 
265.36 

CAS Registry Number:  61337-67-5 

DESCRIPTION  
Mirtazapine is a white to creamy white crystalline powder which is slightly soluble in water. 

Each mirtazapine tablet contains mirtazapine as the active ingredient. In addition, each tablet contains 
the  following  inactive  ingredients:  lactose,  cellulose  microcrystalline,  croscarmellose  sodium, 
magnesium  stearate,  hypromellose,  hydroxypropylcellulose,  macrogol  8000,  titanium  dioxide,  iron 
oxide yellow CI 77492 (15 mg and 30 mg),
iron oxide red CI 77491 (30 mg only). 

PHARMACOLOGY 
Mirtazapine is a tetracyclic piperazinoazepine analogue to mianserin, a chemical structure unrelated to 
tricyclic  antidepressants,  monoamine  oxidase  inhibitors  (MAOIs)  or  selective  serotonin  reuptake 
inhibitors (SSRIs). 

PHARMACOLOGICAL ACTIONS 
Mirtazapine is an antidepressant, which can be given as treatment for episodes of major depression.

The  presence  of  symptoms  such  as  anhedonia,  psychomotor  inhibition,  sleep  disturbances  (early 
wakening) and weight loss, increase the chance of a positive response.  Other symptoms are loss of 
interest, suicidal thoughts and changes in mood (better in
the evening than in the morning). 

The results of three pivotal placebo-controlled double-blind studies (161 patients received placebo and 
161  patients  received  mirtazapine)  have  demonstrated  that  mirtazapine  is  statistically  significa