CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about AMIRA 150 and AMIRA 300 tablets.
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 150 and AMIRA 300 tablets against the benefits they expect it will have for
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 AMIRA 150 and AMIRA 300 are used for
The name of your medicine is AMIRA 150 or AMIRA 300. The medicine contains the active
ingredient called moclobemide.
AMIRA 150 and AMIRA 300 belong to a group of medicines called antidepressants. 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
There are many different types of medicines used to treat depression. AMIRA 150 and
AMIRA 300 belong to a group of medicines called reversible inhibitors of monoamine
Your doctor, however, may have prescribed AMIRA 150 or AMIRA 300 for another purpose.
Ask your doctor if you have any questions about why AMIRA 150 or AMIRA 300 has been
prescribed for you.
This medicine is available only with a doctor's prescription.
Do not give AMIRA 150 or AMIRA 300 to children or adolescents under 18 years of age.
The safety and effectiveness of AMIRA 150 or AMIRA 300 in this age group has not been
Before you take AMIRA 150 or AMIRA 300
Do not take AMIRA 150 or AMIRA 300 if:
you have ever had an allergic reaction to moclobemide or any of the ingredients listed
in the Ingredients section of this leaflet
you are suffering from severe confusion
you are taking:
triptans (a family of medicines commonly used to treat migraines e.g. Triptazig)
tramadol (Durotram, Zydol)
dextromethorphan (often found in cough and cold medicines)
you are taking other medications known as selective serotonin reuptake inhibitors
or tricyclic antidepressants.
Taking AMIRA 150 or AMIRA 300 with these medicines may cause a serious reaction called
serotonin syndrome. This can cause a sudden increase in body temperature, high blood
pressure and convulsions.
Do not take AMIRA 150 or AMIRA 300 after the expiry date (EXP) printed on the pack.
It may have no effect at all or, worse, an entirely unexpected effect if you take
it after the expiry date.
Do not take AMIRA 150 or AMIRA 300 if the packaging is torn or shows signs of tampering
or if the tablets appear damaged in some way.
If it has expired or is damaged, return the product to your pharmacist for disposal.
If you are not sure if you should be taking AMIRA 150 or AMIRA 300, talk to your doctor.
You must tell your doctor if:
1. You are allergic to any other medicines, foods, dyes or preservatives.
2. You have any other health problems including:
high blood pressure
a personal history or family history of bipolar disorder
mental illness other than depression, including schizophrenia, agitation and excitation
thyrotoxicosis (a condition of excessive thyroid hormones)
phaeochromocytoma (a rare tumour of adrenal gland)
rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or
3. You are pregnant or intend to become pregnant.
4. You are breastfeeding or wish to breastfeed.
Your doctor will discuss the risks and benefits of using AMIRA 150 or AMIRA 300 when
pregnant and while breastfeeding.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you have
bought from a pharmacy, supermarket or health food shop.
Some commonly used medicines that may interfere with AMIRA 150 or AMIRA 300 are:
dextromethorphan (often found in cough and cold medicines)
proton pump inhibitors
serotonin agonists (e.g. buspirone, sumatriptan)
St. John's wort (Hypericum) - containing phytotherapeutic products.
opiates e.g. morphine, fentanyl and codeine
Other antidepressant medicines may interfere with AMIRA 150 or AMIRA 300 such as fluoxetine,
fluvoxamine, paroxetine, sertraline, amitryptyline and nortriptyline, trimipramine
and maprotiline, venlafaxine, clomipramine, citalopram and paroxetine.
Moclobemide may cause an additional drop in blood pressure if you are taking metoprolol.
Your doctor or pharmacist has a complete list of medicines to avoid while taking AMIRA
150 or AMIRA 300.
If you have not told your doctor about any of the above, tell them before you start
taking AMIRA 150 or AMIRA 300.
How to take AMIRA 150 or AMIRA 300
Take AMIRA 150 or AMIRA 300 exactly as your doctor has prescribed.
How much to take
Your doctor will tell you how many AMIRA 150 or AMIRA 300 tablets to take each day.
The usual dose is between 300 mg and 600 mg per day. The tablets are taken twice daily
How to take it
The tablets should be swallowed whole with a glass of water after meals.
You should follow your doctor's instructions carefully if changing from one antidepressant
to another and report any unexpected effects if they occur.
When to take it
AMIRA 150 and AMIRA 300 should be taken morning and evening at the end of your meal.
How long to take AMIRA 150 or AMIRA 300
For depression, the length of treatment will depend on how quickly your symptoms improve.
Most antidepressants take time to work so don't be discouraged if you don't feel better
right away. Some of your symptoms may improve in 1 or 2 weeks but, it can take up
to 4 or 6 weeks to feel any real improvement. Even when you feel well, you will usually
have to take AMIRA 150 or AMIRA 300 for several months or even longer to make sure
the benefits will last. Continue taking it until your doctor tells you to stop.
If you forget to take AMIRA 150 or AMIRA 300
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to. Otherwise, take it as soon as you remember then go back
to taking it as soon as you would normally.
Do not double a dose to make up for one you have missed.
In case of an overdose
Immediately telephone your doctor or the Poisons Information Centre on telephone 13
11 26 for advice, or go to Accident and Emergency at the nearest hospital, if you
think that you or anyone else may have taken too much AMIRA 150 or AMIRA 300. Do this
even if there are no signs of discomfort or poisoning. You may need urgent medical
Keep telephone numbers for these places handy.
Some signs and symptoms of overdose include nausea, vomiting, drowsiness, slurred
speech, reduced reflexes and agitation.
While you are taking AMIRA 150 or AMIRA 300
Things you must do
Tell all doctors, dentists, and pharmacists who are treating you that you are taking
AMIRA 150 or AMIRA 300.
Do not take any other medicines whether they require a prescription or not without
first telling your doctor.
Tell your doctor if you become pregnant while taking AMIRA 150 or AMIRA 300.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment
Tell your doctor if you feel the tablets are not helping your condition.
If you are being treated for depression, tell your doctor immediately if you feel
your condition has worsened or if you are experiencing suicidal thoughts.
Be sure to discuss with your doctor any problems you may have and how you feel. This
will help your doctor to determine the best treatment for you.
Be sure to keep all of your appointments with your doctor so that your progress can
Things you must not do
Do not stop taking AMIRA 150 or AMIRA 300 or lower the dose without first checking
with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not give this medicine to anyone else even if their symptoms seem similar to yours.
Do not use AMIRA 150 or AMIRA 300 to treat other complaints unless your doctor says
Things to be careful of
Be careful driving or operating machinery until you know how AMIRA 150 or AMIRA 300
AMIRA 150 or AMIRA 300 can cause dizziness in some people at first.
Although drinking alcohol is unlikely to affect your response to AMIRA 150 or AMIRA
300, your doctor may suggest avoiding alcohol while you are being treated for depression.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking AMIRA 150 or AMIRA 300.
AMIRA 150 or AMIRA 300 help most people with depression, but it may have unwanted
side effects in a few people. All medicines can have side effects. Sometimes they
are serious, most of the time they are not. You may need medical attention if you
get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
In the first week or two you may experience:
sleep disturbances, dizziness, nausea, headache, dry mouth
occasionally, the symptoms of depression may include thoughts of suicide or self-harm.
These symptoms may continue or get worse during the first one to two months of treatment
until the full antidepressant effect of the medicine becomes apparent. This is more
likely to occur if you are a young adult i.e. under 24 years of age.
Contact your doctor or a mental health professional right away, or go to Accident
and Emergency at your nearest hospital for treatment if you or someone you know is
demonstrating any of the following warning signs of suicide while taking AMIRA 150
or AMIRA 300:
thoughts or talk of death or suicide
thoughts or talk of self-harm or harm to others
any recent attempts of self-harm
increase in aggressive behaviour, irritability or agitation
worsening of depression
insomnia, nervousness, jitteriness
mania or hypomania (or onset of early symptoms).
All thoughts or talk of suicide or violence must be taken seriously.
Tell your doctor if you notice any of the following and they worry you:
insomnia, disturbed sleep, restlessness, dizziness, nausea, headache, anxiety, agitation,
feeling of confusion, diarrhoea, vomiting, paraesthesia, constipation, feeling of
fullness, upset stomach, dry mouth, blurred vision, skin rash, flushing.
This is not a complete list of all possible side effects. Others may occur in some
people and there may be some side effects not yet known.
Tell your doctor if you notice anything else that is making you feel unwell, even
if it is not on this list.
Ask your doctor or pharmacist if you don't understand anything in this list.
Do not be alarmed by this list of possible side effects. You may not experience any
After taking AMIRA 150 or AMIRA 300
Keep AMIRA 150 and AMIRA 300 where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Keep AMIRA 150 and AMIRA 300 in a cool dry place where the temperature stays below
Do not store it, or any other medicine, in the bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep your tablets in the blister pack until it is time to take them.
If you take the tablets out of the blister, they may not keep well.
If your doctor tells you to stop taking AMIRA 150 or AMIRA 300, or the tablets have
passed their expiry date, ask your pharmacist what to do with any tablets that are
What AMIRA 150 and AMIRA 300 look like
The tablets are available in two strengths.
AMIRA 150: oval, cylindrical, biconvex, pale yellow film coated tablet marked "150"
on one side with break bar on the other side.
AMIRA 300: oval, cylindrical, biconvex, white to yellow-white film coated tablet marked
"300" on one side with break bar on the other side.
Each AMIRA 150 tablet contains 150 mg of the active ingredient moclobemide.
Each AMIRA 300 tablet contains 300 mg of the active ingredient moclobemide.
AMIRA 150 and AMIRA 300 tablets both contain:
Lactose, maize starch, povidone (1201), sodium starch glycollate, magnesium stearate
(470), ethylcellulose, macrogol 6000, hypromellose (464), purified talc (553), and
are coloured with titanium dioxide (171).
AMIRA 150 tablets also contain yellow iron oxide (172).
AMIRA 150 and AMIRA 300 tablets are gluten free.
AMIRA 150 and AMIRA 300 come in boxes of 60 tablets.
Mylan Health Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 314 527
Alphapharm Pty Limited
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
The Australian Registration
AMIRA 150 - AUST R 288711
AMIRA 300 - AUST R 288712
This leaflet was prepared in September 2018.