Contains the active ingredient mirtazapine
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons
living in Australia. This page contains answers to some common
. It does
not contain all the information that is known about
. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks
and benefits. Your doctor has weighed the risk of you using this medicine
against the benefits he/she expects it will have for you. If you have
any concerns about using this medicine, ask your doctor or pharmacist.
Bookmark or print this page, you may need to read it again.
What this medicine is used for
The name of your medicine is APO-Mirtazapine. It contains the active ingredient mirtazapine.
It is used to treat depression.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed
this medicine for another reason.
This medicine is available only with a doctor's prescription.
How it works
Depression is longer lasting or more severe than the "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. Mirtazapine corrects this chemical imbalance and may help relieve the symptoms of depression.
There is no evidence that this medicine is addictive.
Use in children
This medicine must not be used in children or adolescents under 18 years of age.
Before you take this medicine
When you must not take it
Do not take this medicine if:
You are taking other medicines called monoamine oxidase inhibitor (MAOI) or have been taking an MAOI within the last 14 days.
MAOIs may be used for the treatment of depression (phenelzine, tranylcypromine, moclobemide), Parkinson's disease (selegiline),
infections (linezolid), or diagnosis of certain conditions/treatment of certain blood disorders (methylene blue).
There may be others MAOIs also so check with your doctor or pharmacist.
You are hypersensitive to, or have had an allergic reaction to mirtazapine or any of the ingredients listed at the end of
Some of the symptoms of an allergic reaction may include cough, shortness of breath, wheezing or difficulty breathing; swelling
of the face, lips, tongue, throat or other parts of the body, rash, itching or hives on the skin; fainting or hayfever-like
If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately
or go to the Accident and Emergency department at the nearest hospital.
The expiry date (EXP) printed on the pack has passed.
The packaging is torn, shows signs of tampering or it does not look quite right.
Before you start to take it
Before you start taking this medicine, tell your doctor if:
You have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
You have or have had any medical conditions, especially the following:
thoughts of suicide or self-harm
epilepsy (fits or convulsions)
liver problems, such as jaundice
low blood pressure
any mental illness (e.g. schizophrenia, bipolar disorder)
glaucoma (increased pressure in the eyes)
difficulties in urination as a result of an enlarged prostate
unexplained high fever, sore throat and mouth ulcers
low sodium levels in your blood (hyponatraemia).
You are currently pregnant or you plan to become pregnant. Do not take this medicine whilst pregnant until you and your doctor
have discussed the risks and benefits involved.
When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent
pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin
during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor
You are currently breast-feeding or you plan to breast-feed. Do not take this medicine whilst breast-feeding until you and
your doctor have discussed the risks and benefits involved.
You are planning to have surgery or an anaesthetic.
You are currently receiving or are planning to receive dental treatment.
You are taking or are planning to take any other medicines, This includes vitamins and supplements that are available from
your pharmacy, supermarket or health food shop.
Some medicines may interact with mirtazapine. These include:
other medicines for depression, (e.g. SSRIs, venlafaxine, nefazodone) anxiety, obsessive compulsive disorders or pre-menstrual
MAOIs (such as phenelzine, tranylcypromine, moclobemide, linezolid, methylene blue and selegiline)
medicines to help you sleep or calm down (e.g. benzodiazepines and tranquillisers)
other sedatives especially antipsychotics, antihistamine and opioids
medicines containing St. John's Wort (hypericum perforatum)
phenytoin or carbamazepine, medicines used to treat epilepsy
warfarin, a medicine used to prevent blood clotting
linezolid and erythromycin, both antibiotics
rifampicin, a medicine used to treat tuberculosis
medicines to treat fungal infections, such as ketoconazole
cimetidine, a medicine used to treat reflux or stomach ulcers
medicines to treat migraine attacks, such as sumatriptan, naratriptan and zolmitriptan
tramadol, a strong painkiller
tryptophan, found in some preparations bought in health food shops.
If you are taking any of these you may need a different dose or you may need to take different medicines.
Other medicines not listed above may also interact with mirtazapine.
How to take this medicine
Follow carefully all directions given to you by your doctor or pharmacist. Their instructions may be different to the information
in this leaflet.
How much to take
Your doctor or pharmacist will tell you how much of this medicine you should take. This will depend on your condition and
whether you are taking any other medicines.
The usual starting dose is 15 mg per day. Your doctor may slowly increase your dose depending on how you respond to mirtazapine.
The effective dose for most people is usually between 30 mg and 45 mg per day.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
How to take it
Swallow the tablet(s), without chewing, together with some water or other fluid.
When to take it
This medicine should preferably be taken as a single night-time dose before going to bed.
If recommended by your doctor, your dose may be taken in sub-doses equally divided over the day (e.g. once in the morning
and once at night-time before going to bed).
Take this medicine at the same time or times each day.
Taking it at the same time each day will have the best effect and will also help you remember when to take it.
It does not matter if you take it before, with or after food.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
For depression, the length of treatment will depend on how quickly your symptoms improve. Most antidepressants take time
to work, so do not be discouraged if you don't feel better right away.
Some of your symptoms may improve in 1-2 weeks, but it can take up to 2-4 weeks to feel the full benefit of the medicine.
Even when you feel well, you will usually have to take your medicine for 4-6 months, or even longer, to make sure the benefits
Make sure you have enough to last over weekends and holidays.
If you forget to take it
If you forget to take your dose before going to bed, do not take the missed dose the next morning, because it may cause drowsiness
or sleepiness during the day. Wait until the next evening before taking your normal dose.
Do not take a double dose to make up for the missed dose.
If you forget your morning dose, simply take it together with your evening dose.
If you forget your evening dose, do not take it with the next morning dose. Skip the missed dose and continue treatment with
your normal morning and evening doses.
If you have forgotten both doses, you should not make up for the missed doses; the next day, just continue with your normal
morning and evening doses.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.
If you take too much (overdose)
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons
Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you take too much mirtazapine you may feel drowsy, dizzy, confused, agitated, have increased heart rate or lose consciousness.
While you are taking this medicine
Things you must do
Tell your doctor that you are taking this medicine if:
you are about to be started on any new medicine
you are pregnant or are planning to become pregnant
you are breast-feeding or are planning to breast-feed
you are about to have any blood tests
you are going to have surgery or an anaesthetic or are going into hospital.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor
regularly for a check-up.
Tell your doctor immediately if you develop fever, chills, sore throat or mouth ulcers or experience other signs of infections.
In rare cases mirtazapine can cause a shortage of white blood cells, resulting in lowering body resistance to infection.
These symptoms may appear after 2-6 weeks of treatment.
Tell your doctor immediately or go to the nearest hospital for treatment if you have any suicidal thoughts or other mental/mood
Young adults aged 18 to 24 are at particularly high risk of having this happen to them.
Occasionally, the symptoms of depression or other psychiatric conditions may include thoughts of harming yourself or committing
suicide. Until the full antidepressant effect of the medicine becomes apparent, it is possible that these symptoms may increase
in the first few weeks of treatment.
If you or someone you know is demonstrating any of the following warning signs of suicide while taking this medicine, contact
your doctor or health professional immediately or go to the nearest hospital for treatment:
thoughts or talk of death or suicide
thoughts or talk of self-harm or harm to others
any recent attempts to self-harm
increase in aggressive behaviour, irritability or agitation.
All mention of suicide or violence must be taken seriously.
If you have diabetes take care to monitor your blood sugar levels. Your diabetes medication may need to be adjusted.
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 unnecessarily.
Tell your doctor if you feel this medicine is not helping your condition.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
Things you must not do
Give this medicine to anyone else, even if their symptoms seem similar to yours
Take your medicine to treat any other condition unless your doctor or pharmacist tells you to
Stop taking your medicine suddenly, or change the dosage, without first checking with your doctor.
Stopping your medicine suddenly may cause nausea, headache, dizziness, anxiety or agitation.
Your doctor may want to gradually reduce the amount of medicine you are taking before stopping completely.
Things to be careful of
Be careful when driving or operating machinery until you know how this medicine affects you.
This medicine may cause drowsiness, sleepiness or dizziness in some people and affect alertness and concentration. If any
of these occur, do not drive, operate machinery or do anything else that could be dangerous.
Be careful when drinking alcohol while taking mirtazapine.
Taking this medicine with alcohol can make you sleepier and less alert.
Your doctor may suggest you avoid alcohol while being treated with this medicine.
Possible side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking mirtazapine or if you have
any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side
effects. Sometimes they are serious but most of the time they are not.
Tell your doctor or pharmacist if you notice any of the following:
drowsiness or sleepiness
increase in appetite, weight gain
occasional dizziness or faintness, especially when you get up quickly from a lying or sitting position
swollen ankles or feet as a result of fluid accumulation (oedema)
fluid retention with weight gain
tingling fingers or toes
muscle aches and pains
unable to sleep or stay asleep#
# may be symptoms of depression.
Tell your doctor as soon as possible if you notice any of the following.
These may be serious side effects. You may need medical attention.
itching or any type of skin rash or blistering, peeling or flaking skin
low sodium levels (feeling weak, sick, confused, exhausted, with muscle weakness or cramps)
feeling extremely restless and having an overwhelming urge to always be moving
numbness in the mouth
unusual changes in behaviour
eye pain (a possible sign of glaucoma or raised pressure in the eye).
If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident
and Emergency department at your nearest hospital.
These are very serious side effects. You may need urgent medical attention or hospitalisation.
thoughts or actions relating to suicide or self-harm
severe skin reaction which starts with painful red areas, then large blisters and ends with peeling of layers of skin. This
may be accompanied by fever and chills, aching muscles and generally feeling unwell.
chest pain, fast or irregular heartbeat
epilepsy or fits (seizures)
shaking or tremors
sudden muscle contractions (myoclonus)
fainting, cough and problems breathing (signs of a blood clot on the lung)
attack of excessive excitability (mania)
hallucinations (hearing, seeing or feeling things that are not there)
yellow colouring of eyes or skin; this may suggest problems with your liver
shaking or tremors
generalised fluid retention with weight gain
fever, sore throat, mouth ulcers, gastrointestinal (stomach, bowels) disturbances
fever, sweating, increased heart rate, uncontrollable diarrhoea, muscle contractions, shivering, overactive reflexes, restlessness,
mood changes and unconsciousness (serotonin syndrome).
Other side effects not listed above may occur in some patients.
Some side effects may occur with no symptoms, and may only be identified by tests. For example, high blood pressure, high
cholesterol or fat levels, changes in levels of white or red blood cells.
If you think you are having an allergic reaction to mirtazapine, do not take any more of this medicine and tell your doctor
immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
cough, shortness of breath, wheezing or difficulty breathing.
swelling of the face, lips, tongue, throat or other parts of the body
rash, itching or hives on the skin
Storage and disposal
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 30°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in
the car. Heat and dampness can destroy some medicines.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can
dispose of the remaining medicine safely.
What APO-Mirtazapine looks like
15 mg tablets
Pale Yellow, oval shaped, scored, film coated tablets, imprinted "APO" on one side and "MI" bisect "15" on the other side.
Blister packs and bottles of 30 tablets.
30 mg tablets
Light pink, oval shaped, scored, film coated tablets, imprinted "APO" on one side and "MI" bisect "30" on the other side.
Blister packs and bottles of 30 tablets.
45 mg tablets
White to off-white, oval shaped, unscored, film coated tablets, imprinted "APO" on one side and "MI-45" on the other side.
Blister packs and bottles of 30 tablets.
# Not all strengths and/or pack types may be available.
Each tablet contains 15 mg, 30 mg or 45 mg of mirtazapine as the active ingredient.
It also contains the following inactive ingredients:
iron oxide red CI 77491 (30 mg only)
iron oxide yellow CI 77492 (15 mg and 30 mg only).
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.
Australian Registration Numbers
APO-Mirtazapine 15 mg Tablets
Blister: AUST R 127666
Bottle: AUST R 127662
APO-Mirtazapine 30 mg Tablets
Blister: AUST R 127678
Bottle: AUST R 127677
APO-Mirtazapine 45 mg Tablets
Blister: AUST R 127685
Bottle: AUST R 127684
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
Apotex Pty Ltd is the licensee of the registered trademarks APO and APOTEX from the registered proprietor, Apotex Inc.
This leaflet was last updated in: