Remeron Soltab

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

Mirtazapine

Διαθέσιμο από:

Merck Sharp & Dohme Australia Pty Ltd

Kατηγορία:

Medicine Registered

Φύλλο οδηγιών χρήσης

REMERON SOLTAB
®

_Mirtazapine 15mg, 30mg and 45mg Orally Disintegrating Tablets_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about REMERON SolTab.
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 REMERON
SolTab 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 REMERON
SOLTAB IS USED FOR
REMERON SolTab 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
REMERON SolTab is not addictive.
BEFORE YOU TAKE
REMERON SOLTAB
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE REMERON SOLTAB:
•
IF YOU ARE ALLERGIC TO MEDICINES
CONTAINING MIRTAZAPINE
•
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 trouble breathing.
DO NOT TAKE RE

Αρχείο Π.Χ.Π.

RA 1065 AU S6 (ref8.0) 

A120504 v1 
1 
PRODUCT INFORMATION  

REMERON SOLTAB 
_Mirtazapine orally disintegrating tablets_ 

NAME OF THE MEDICINE 

REMERON SOLTAB 15 MG/ REMERON SOLTAB 30 MG/ REMERON SOLTAB 45 MG 

_Molecular Structure _

_Mirtazapine - INN name _
_Molecular Formula C_
_17_
_H_
_19_
_N_
_3 _
_ _
_Molecular Mass 265.36 _
_CHEMICAL NAME: _
_ (+)-1,2,3,4,10,14b-hexahydro-2-methyl-pyrazino[2,1-a]pyrido[2,3-_
_c][2]benzazepine. _
_ _
CAS No. 61337-67-5_ _

PHARMACEUTICAL FORM 
Tablet. 

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

QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each tablet contains 15 mg, 30 mg or 45 mg of mirtazapine. 

LIST OF EXCIPIENTS 
Remeron SolTab 15 mg, 30 mg and 45 mg tablets contain: 
sucrose, starch, hypromellose, povidone, Eudragit E100, magnesium stearate, mannitol, crospovidone, 
sodium bicarbonate, citric acid anhydrous, cellulose
microcrystalline, aspartame, and orange flavour SN 
027512. 

RA 1065 AU S6 (ref8.0) 

A120504 v1 
2 
PHARMACOLOGY 

Remeron SolTab (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 Remeron) have demonstrated that Remer