Tolvon

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Mianserin hydrochloride

Patient Information leaflet

TOLVON
®

_Mianserin hydrochloride_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tolvon.
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 Tolvon
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 TOLVON IS USED
FOR
Tolvon is used in the treatment of
depression.
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 imbalance
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 have
prescribed Tolvon for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
Tolvon is available only with a
doctor's prescription.
Tolvon is not addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE TOLVON:
•
if you are allergic to medicines
containing mianserin
hydrochloride.
•
if you are allergic to any of the
ingredients listed at the end of
this leaflet.
Some 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 troubled breathing.
DO NOT TAKE TOLVON:
•
if you suffer from mania, a
mental condition characterised by
episodes of overactivity, elation
or irritab

Summary of Product characteristics

TOLVON A130819 V2 

Page 1 of 7 
CCDS-MK3443-TB-052013

PRODUCT INFORMATION 
TOLVON

(I) 
NAME OF THE MEDICINAL PRODUCT 

TOLVON - mianserin hydrochloride BP 
_ _
_ _
_ _
_ _
C
18
H
20
N
2
,HC1            300.8          
  CAS No. 21535-47-7_ _
_ _
(II) 
DESCRIPTION 

Mianserin hydrochloride is known chemically as:
1, 2, 3, 4, 10, 14b-hexahydro-2-methyldibenzo [c,f] 
pyrazino [1,2-a] azepine monohydrochloride. It is an odourless,
creamy white, crystalline powder that 
is soluble in water, ethanol, methanol and chloroform. It
belongs to the tetracyclic series of 
antidepressant compounds, the piperazinoazepines. These are
chemically different from the common 
tricyclic antidepressants. MW: 300.8.  The empirical formula
is C
18
H
20
N
2
HCl.

COMPOSITION: mianserin hydrochloride 

LIST OF EXCIPIENTS: Tolvon tablets contain potato starch, silica
colloidal anhydrous, magnesium 
stearate,
methyl cellulose, calcium hydrogen phosphate, hypromellose, macrogol 8000 and
titanium 
dioxide (171). 

(III) 
PHARMACOLOGY 

PHARMACODYNAMIC PROPERTIES 

Mianserin, the active component
of Tolvon, belongs to the piperazino-azepine group of compounds 
which are chemically not related
to the tricyclic antidepressants (TCAs).  Its structure
lacks the basic 
side-chain which is considered to be responsible for the
anticholinergic activity of the TCAs.  Tolvon 
increases central noradrenergic neurotransmission by alpha
2
-autoreceptor blockade and 
noradrenaline-reuptake inhibition.  In addition, interactions with
serotonin receptors in the central 
nervous system have been found.
 Human pharmaco-EEG studies have confirmed the antidepressant 
profile of Tolvon.  The antidepressant efficacy of Tolvon
has been demonstrated in placebo-controlled 
trials and has been shown to be similar to
other currently us