Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using AMIRA 150 or AMIRA 300?
AMIRA 150 and AMIRA 300 contains the active ingredient moclobemide. AMIRA 150 and
AMIRA 300 belongs to a group of medicines called antidepressants. Antidepressants
are used to treat depression and work on the central nervous system.
For more information, see Section
1. Why am I using AMIRA 150 or AMIRA 300? in the full CMI.
2. What should I know before I use AMIRA 150 or AMIRA 300?
Do not use if you have ever had an allergic reaction to AMIRA 150 or AMIRA 300 or
any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I use AMIRA 150 or AMIRA 300? in the full CMI.
3. What if I am taking other medicines?
4. How do I use AMIRA 150 or AMIRA 300?
The usual dose is between 300 mg and 600 mg per day. The tablets are taken twice
daily after meals.
5. What should I know while using AMIRA 150 or AMIRA 300?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using AMIRA 150 or
AMIRA 300.
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.
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Things you should not do
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Do not take any other medicines whether they require a prescription or not without
first telling your doctor.
Do not stop taking AMIRA 150 or AMIRA 300 or lower the dose without first checking
with your doctor.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how AMIRA
150 or AMIRA 300 affects you.
AMIRA 150 or AMIRA 300 causes dizziness in some people at first.
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Drinking alcohol
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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.
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Looking after your medicine
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Keep AMIRA 150 or AMIRA 300 in a cool dry place where the temperature stays below
30°C.
Keep your tablets in the blister pack until it is time to take them.
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6. Are there any side effects?
Less serious side effects include disturbed sleep, dizziness, nausea, and headache.
Serious side effects include 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 and worsening of depression. Call your doctor
or a mental health professional straight away, or go straight to the Emergency Department
at your nearest hospital if you or someone you know notice any of these serious side
effects. All thoughts or talk of suicide or violence must be taken seriously.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
moclobemide
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using AMIRA 150 or AMIRA 300. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using AMIRA 150 or AMIRA 300.
Where to find information in this leaflet:
1. Why am I using AMIRA 150 or AMIRA 300?
AMIRA 150 or AMIRA 300 contains the active ingredient moclobemide. AMIRA 150 or AMIRA 300 belongs 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
mood.
There are many different types of medicines used to treat depression. AMIRA 150 or
AMIRA 300 belongs to a group of medicines called reversible inhibitors of monoamine
oxidase A.
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
established.
2. What should I know before I use AMIRA 150 or AMIRA 300?
Warnings
Do not use AMIRA 150 or AMIRA 300 if:
you are allergic to moclobemide, or any of the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can use this medicine.
you are suffering from severe confusion.
you are taking:
Clomipramine (Anafranil)
Selegiline (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 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.
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.
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.
Check with your doctor if you:
have any other medical conditions including
liver disease
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
glucose-galactose malabsorption.
take any medicines for any other condition
are allergic to any other medicines, foods, dyes or preservatives.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor will discuss the risks and benefits of using AMIRA 150 or AMIRA 300 when
pregnant and while breastfeeding.
If you have not told your doctor about any of the above, tell them before you start
taking AMIRA 150 or AMIRA 300.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with AMIRA 150 or AMIRA 300 and affect how it works.
These include:
cimetidine
dextromethorphan (often found in cough and cold medicines)
pethidine
selegiline
bupropion
triptans
tramadol
linezolid
proton pump inhibitors
serotonin agonists (e.g. buspirone, sumatriptan)
St. John's Wort (hypericum) - containing phytotherapeutic products.
opiates e.g. morphine, fentanyl and codeine
adrenergics
sibutramine
Other antidepressant medicines that may interfere with AMIRA 150 or AMIRA 300 include:
fluoxetine, fluvoxamine, paroxetine, sertraline, amitriptyline and nortriptyline,
trimipramine and maprotiline, venlafaxine, clomipramine, citalopram and paroxetine.
Metoprolol. Moclobemide may cause an additional drop in blood pressure if you are taking metoprolol.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect AMIRA 150 OR AMIRA 300.
4. How do I use AMIRA 150 or AMIRA 300?
How much to take
Follow the instructions provided by your doctor and use AMIRA 150 or AMIRA 300 until
your doctor tells you to stop.
The usual dose is between 300 mg and 600 mg per day. The tablets are taken twice daily
after meals.
When to take
AMIRA 150 or AMIRA 300 should be taken morning and evening at the end of your meal.
How to take AMIRA 150 or AMIRA 300
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.
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 use AMIRA 150 or AMIRA 300
AMIRA 150 or AMIRA 300 should be used regularly at the same time each day. If you
miss your dose at the usual time, 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 take a double dose to make up for the dose you missed.
If you use too much AMIRA 150 or AMIRA 300
If you think that you have used too much AMIRA 150 or AMIRA 300, you may need urgent
medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning. You may
need urgent medical attention.
Keep telephone numbers for these places handy.
Some signs and symptoms of overdose include nausea, vomiting, drowsiness, slurred
speech, reduced reflexes and agitation.
5. What should I know while using AMIRA 150 or AMIRA 300?
Things you should do
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
be checked.
Call your doctor straight away if you:
become pregnant while taking AMIRA 150 or AMIRA 300.
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 unnecessarily.
feel the tablets are not helping your condition.
Remind any doctor, dentist or pharmacist you visit that you are using AMIRA 150 or
AMIRA 300.
Things you should not do
Do not take any other medicines whether they require a prescription or not without
first telling your doctor.
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
to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how AMIRA
150 or AMIRA 300 affects you.
AMIRA 150 or AMIRA 300 causes dizziness in some people at first.
Drinking alcohol
Tell your doctor if you drink alcohol.
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.
Looking after your medicine
Keep AMIRA 150 or AMIRA 300 in a cool dry place where the temperature stays below
30°C.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Follow the instructions in the carton on how to take care of your medicine properly.
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.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
When to discard your medicine (as relevant)
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
left over.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking AMIRA 150 or AMIRA 300.
In the first week or two you may experience the following:
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.
Less serious side effects
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Less serious side effects
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What to do
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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
hypotension
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
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
of them.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What AMIRA 150 or AMIRA 300 contains
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Active ingredient
(main ingredient)
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AMIRA 150 - 150 mg moclobemide.
AMIRA 300 - 300 mg moclobemide.
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Other ingredients
(inactive ingredients)
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Lactose monohydrate
Maize starch
Povidone
Sodium starch glycollate
Magnesium stearate
Aquacoat ECD Ethylcellulose Aqueous Dispersion NF (ARTG PI No: 1973)
Macrogol 6000
Hypromellose
Purified talc
Titanium dioxide
Yellow iron oxide (only present in AMIRA 150)
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Potential allergens
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AMIRA 150 - Contains sugars as lactose.
AMIRA 300 - Contains lactose.
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Do not take this medicine if you are allergic to any of these ingredients.
What AMIRA 150 and AMIRA 300 looks like
AMIRA comes in two strengths of tablets.
AMIRA 150 is an oval, cylindrical, biconvex, pale yellow tablets marked "150" on one
side with a break bar on the other side. Blister packs of 60 (AUST R 288711).
AMIRA 300 is an oval, cylindrical, biconvex, white to yellow-white tablets marked
"300" on one side with a break bar on the other side. Blister packs of 60 (AUST R
288712).
Who distributes AMIRA
Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276
This leaflet was prepared in March 2022.
AMIRA® is a Viatris company trade mark
AMIRA_cmi\Mar22/00