AMIRA moclobemide 150mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

moclobemide

Available from:

Alphapharm Pty Ltd

INN (International Name):

Moclobemide

Authorization status:

Registered

Patient Information leaflet

AMIRA
_Moclobemide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about AMIRA.
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 AMIRA
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 IS AMIRA
The name of your medicine is
AMIRA.
AMIRA belongs to a group of
medicines called antidepressants.
It contains the active ingredient
called moclobemide.
AMIRA is available in two strengths:
150 mg and 300 mg tablets.
WHAT AMIRA IS USED
FOR
Antidepressants are used to treat
depression and work on the central
nervous system. They are thought to
work by their action on brain
chemicals called amines, which are
involved in controlling mood.
There are many different types of
medicines used to treat depression.
AMIRA belongs to a group of
medicines called reversible inhibitors
of monoamine oxidase (ARIMA).
Your doctor, however, may have
prescribed AMIRA for another
purpose.
Ask your doctor if you have any
questions why AMIRA has been
prescribed for you.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
AMIRA
_DO NOT TAKE AMIRA IF:_
•
You have ever had an allergic
reaction to AMIRA or any of the
ingredients listed at the end of
this leaflet
•
You are suffering from severe
confusion
•
You are taking:
•
clomipramine (Anafranil)
•
selegeline (Eldepryl)
•
bupropion (Zyban)
•
triptans (a family of medicines
commonly used to treat
migraines e.g. Triptazig)
•
pethidine
•
tramadol (Durotram, Zydol)
•
dextromethorphan (often
found in cough and cold
medicines)
•
linezolid (Zyvox)
•
you are taking other medications
known as selective serotonin
reuptake inhibitors or tricyclic
antidepressants.
Taking AMIRA with these medicines
may

Summary of Product characteristics

AMIRA
_Moclobemide _
PRODUCT INFORMATION
NAME OF THE MEDICINE
Active ingredient
:
moclobemide
Chemical name
:
4-chloro-N-[2-(4-morpholinyl) ethyl] benzamide
Structural formula
:
O
N
H
N
O
Cl
Molecular formula
:
C
13
H
17
ClN
2
O
2
Molecular weight
:
268.74
CAS Registry no.
:
71320-77-9
DESCRIPTION
Moclobemide is a white to slightly reddish crystalline powder. It
contains no crystal water and is not
hygroscopic. It is soluble in water at 0.4 g / 100 mL. The pKa is
approximately 6.2.
Other ingredients of AMIRA 150 mg & 300 mg tablets are: Lactose,
pregelatinised maize starch, sodium starch
glycollate, povidone, magnesium stearate, hypromellose,
microcrystalline cellulose, PEG-8 stearate, propylene
glycol and titanium dioxide. In addition to the above excipients the
150 mg tablets also contain a colouring
agent yellow iron oxide.
PHARMACOLOGY
PHARMACODYNAMICS
Moclobemide is an antidepressant that affects the monoaminergic
cerebral neurotransmitter system by means of
a reversible inhibition of monoamine oxidase. There are two types of
monoamine oxidases, A & B, which vary
in their substrate specificity. Moclobemide is relatively selective
for type A monoamine oxidase. At a 300 mg
dose, the inhibition of monoamine oxidase A is approximately 80% while
that of monoamine oxidase B is
approximately 20-30%. The inhibition is short-lasting (approximately
24 hours).
The metabolism of dopamine, noradrenaline and serotonin is decreased
by this effect, and this leads to
increased extracellular concentrations of these neuronal transmitters.
As a result of its elevating effect on mood
and psychomotor activity, moclobemide relieves symptoms such as
dysphoria, exhaustion, lack of drive and
poor ability to concentrate. These effects most often appear within
the first week of therapy. Although
moclobemide has no sedative properties it does increase total sleep
time. Moclobemide does not impair
alertness or reaction time.
Moclobemide appears to be suitable for ambulatory treatment as it is
not sedating and does not impair vigilance
or