Fluoxetine (as fluoxetine hydrochloride)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about fluoxetine. It does not contain all
the available information. It does not take the place of talking to your doctor or
All medicines have risks and benefits. Your doctor has weighed the risks of you using
this medicine 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 your medicine.
You may want to read it again.
What this medicine is used for
The name of your medicine is Fluoxetine. It contains the active ingredient fluoxetine
(as fluoxetine hydrochloride).
Fluoxetine belongs to a group of medicines called selective serotonin reuptake inhibitors
(SSRIs). Serotonin is one of the chemicals in your brain which helps control your
mood. Fluoxetine and other SSRIs are thought to help by increasing the amount of serotonin
in your brain.
Fluoxetine is used to treat:
obsessive compulsive disorder (OCD)
premenstrual dysphoric disorder (PDD)
Depression is longer lasting and/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 imbalance affects your whole body
and can cause emotional and physical symptoms such as feeling low in spirit, loss
of interest in activities, being 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. Fluoxetine corrects this chemical imbalance and may help relieve
the symptoms of depression.
Check with your doctor if you need more information about obsessive compulsive disorder
The symptoms of OCD vary from patient to patient.
This medicine is not expected to affect your ability to drive a car or operate machinery,
but make sure you know how it affects you beforehand, as it can make some people dizzy
or drowsy, and affect judgement, thinking and motor skills.
Ask your doctor if you have any questions about why this medicine has been prescribed
Your doctor may have prescribed this medicine for another reason.
There is not enough information to recommend the use of this medicine for children
under the age of 18 years.
Before you take this medicine
When you must not take it
Do not take this medicine if you have an allergy to:
any medicine containing fluoxetine
any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Do not take this medicine if you are taking other medicines called Monoamine Oxidase
These may be used for the treatment of depression (phenelzine, tranylcypromine or
moclobemide), Parkinson's disease (selegiline) or infections (linezolid).
Do not take fluoxetine until 14 days after stopping any MAOI, and do not take MAOIs
until at least 5 weeks after stopping fluoxetine.
Taking fluoxetine with a MAOI may cause a serious reaction with signs such as a sudden
increase in body temperature, very high blood pressure, rigid muscles, nausea, vomiting
and/or fits (convulsions).
Do not take this medicine if you are taking pimozide (Orap), a medicine used to treat
disturbances in the way people think, feel or act.
Taking pimozide together with fluoxetine may alter the rhythm of your heart.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives
Tell your doctor if you are pregnant, or plan to become pregnant.
There have been reports that babies exposed to fluoxetine and other antidepressants
during the third trimester of pregnancy may develop complications after birth.
Do not take this medicine whilst pregnant until you and your doctor have discussed
the risks and benefits involved.
Tell your doctor if you are breastfeeding, or plan to breastfeed.
Fluoxetine can pass into breast milk. Do not take this medicine whilst breast-feeding
until you and your doctor have discussed the risks and benefits involved
Tell your doctor if you have or have had any medical conditions, especially the following:
epilepsy, fits or convulsions (seizures)
heart disease or a heart attack
a bleeding disorder or a tendency to bleed more than usual
thoughts or actions relating to self-harm or suicide
intolerance or allergy to lactose – these capsules contain lactose
Tell your doctor if you drink alcohol.
Although drinking alcohol is unlikely to affect your response to fluoxetine, your
doctor may suggest avoiding alcohol while you are being treated for depression.
If you have not told your doctor about any of the above, tell them before you start
taking this medicine.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you can
get without a prescription from a pharmacy, supermarket or health food shop.
Some combinations of medicines may increase the risk of having serious side effects.
These serious side effects may be life-threatening.
In particular, do not take fluoxetine if you are taking the following other medicines:
pimozide, used to treat disorders which affect the way you think, feel or act
monoamine oxidase inhibitors (MAOIs), which are also used for treating depression
(phenelzine, tranylcypromine or moclobemide), certain infections (linezolid), and
Parkinson's disease (selegiline)
Some other medicines may interact with fluoxetine. These include:
other medicines used to treat depression, obsessive compulsive disorder or premenstrual
dysphoric disorder (PMDD), such as sertraline, citalopram, paroxetine and fluvoxamine
medicines used to treat anxiety called benzodiazepines (e.g. diazepam, alprazolam)
medicines called antipsychotics, used to treat certain mental and emotional conditions
(e.g. haloperidol and clozapine)
lithium, used to treat mood swings and some types of depression
medicines used to control fits, such as carbamazepine and phenytoin
warfarin, used to thin the blood
sleeping tablets or sedatives
flecainide, used to treat irregular heart beats
tryptophan, contained in some multivitamin and herbal preparations
sumatriptan, and other medicines called triptans used to treat migraines
tramadol, a strong pain-killer
St John's wort (Hypericum perforatum), a herbal remedy
tamoxifen, a medicine for treatment or prevention of breast cancer.
These medicines may be affected by fluoxetine or may affect how well it works. You
may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
Do not start taking other medicines for depression without talking to your doctor
first. Do this even if you have already stopped taking fluoxetine.
Monoamine oxidase inhibitors (MAOIs), which are other medicines used for depression,
may interfere with fluoxetine. You should not start a MAOI for at least 5 weeks after
How to take this medicine
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the directions, ask your doctor or pharmacist for help.
How much to take
The usual starting dose of fluoxetine is one 20 mg capsule each morning.
Your doctor may increase or decrease this dose depending on how you respond to this
For premenstrual dysphoric disorder (PMDD), fluoxetine may be prescribed to be taken
every day or only during a certain part of the month. Your doctor will prescribe the
dosing schedule that is right for you
Do not stop taking your medicine or change your dosage without first checking with
How to take it
Swallow the capsule whole with a full glass of water.
When to take it
Fluoxetine is usually taken as a single dose in the morning.
If your doctor tells you to take fluoxetine twice a day, take one dose in the morning
and one at midday.
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
It does not matter if you take this medicine before 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 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 to 6 weeks to feel any real improvement.
Even when you feel well, you will usually have to take this medicine for several months
or even longer to make sure that the benefits will last.
Occasionally the symptoms of depression or other psychiatric conditions may include
thoughts of harming yourself or committing suicide. It is possible that these symptoms
may continue or increase until the full anti-depressant effect of your medicine becomes
apparent (i.e. one to two months).
You or anyone close to you or caring for you should watch for these symptoms and tell
your doctor immediately or go to the nearest hospital if you have any distressing
thoughts or experiences during this initial period or at any other time.
Contact your doctor if you experience any worsening of your depression or other symptoms
at any time during your treatment.
If you forget to take it
If it is almost time to take 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, and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (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 of this medicine. Do this even
if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too much fluoxetine you may be sick or feel sick, agitated, restless,
excitable or hyperactive or you may have convulsions (fits).
While you are taking this medicine
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking fluoxetine.
Tell all doctors, dentists and pharmacists who are treating you that you are taking
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
It may affect other medicines used during surgery.
If you become pregnant or start to breastfeed while taking this medicine, tell your
Symptoms such as feeding difficulty, vomiting, tremor, irritability and constant crying
have been reported in newborn babies after mothers have taken fluoxetine in the last
3 months of pregnancy.
Tell your doctor if you develop a rash or hives.
If you are about to have any blood tests, tell your doctor that you are taking this
It may interfere with the results of some tests.
Tell your doctor if you have not taken your medicine exactly as prescribed.
Otherwise the doctor will think that it is not working and change your treatment unnecessarily
Tell your doctor if you feel that the medicine is not helping your condition.
Keep all your doctor's appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working
and to prevent unwanted side effects.
Occasionally, the symptoms of depression may include thoughts of suicide or self-harm.
It is possible that these symptoms continue or get worse during the first one to two
months of taking fluoxetine until the medicine starts to work completely. This is
more likely to occur in young adults under 25 years of age (i.e. 18 to 24 years of
age) and have not used antidepressant medicines before.
If you or someone you know or care for demonstrates any of the following warning signs
of suicide-related behaviour while taking fluoxetine, contact a doctor immediately,
or even go to the nearest hospital for treatment:
thoughts or talk of death or suicide
thoughts of talk of self-harm or harm to others
any recent attempts of suicide or self-harm
increase in aggressive behaviour, irritability or agitation or any other unusual changes
in behaviour or mood
worsening of depression.
All mentions of suicide or violence must be taken seriously.
Tell your doctor if you get a headache or start to feel dizzy, confused, forgetful,
weak, unsteady or unable to concentrate.
Some people (especially older people and/or those taking diuretics/water tablets)
may experience a lack of sodium in the blood when taking this medicine. Make sure
to drink plenty of fluids.
If you are being treated for depression, be sure to discuss with your doctor any problems
you may have and how you feel, especially any feelings of severe sadness, thoughts
of suicide, bursts of unusual energy, anger or aggression, or if you become particularly
agitated or restless.
This will help your doctor to determine the best treatment for you.
Things you must not do
Do not take this medicine to treat any other complaints unless your doctor tells you
Do not give your medicine to anyone else, even if they have the same condition as
Do not stop taking your medicine or lower the dosage without checking with your doctor.
If you stop taking it suddenly, your condition may worsen, or you may have unwanted
Suddenly stopping fluoxetine may cause symptoms such as dizziness, anxiety, headache,
feeling sick or tingling or numbness of the hands or feet.
Your doctor may want you to gradually reduce the amount of fluoxetine you are taking
before stopping completely.
Do not take the herbal remedy St. John's Wort while you are being treated with fluoxetine.
If you are already taking the herbal remedy, stop taking St. John's Wort and mention
it to your doctor at your next visit.
Things to be careful of
Be careful when driving or operating machinery until you know how this medicine affects
This medicine may make some people dizzy or drowsy, and affect judgement, thinking
and motor skills in some people. If you have any of these symptoms, do not drive,
operate machinery or do anything else that could be dangerous.
Be careful when drinking alcohol while you are taking this medicine.
If you drink alcohol, dizziness or drowsiness may be worse. Your doctor may suggest
avoiding alcohol while you are being treated for depression.
If you are diabetic, be sure to regularly monitor your blood glucose levels and tell
your doctor if these change significantly.
You should wait at least 5 weeks after stopping fluoxetine before starting any medicines
You should be aware that people who take antidepressants have an increased risk of
having a bone fracture, especially when first taking fluoxetine.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking this medicine.
All medicines can have side effects. Sometimes they are serious but most of the time
they are not.
Do not be alarmed by the following lists of side effects. You may not experience any
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
difficulty sleeping, unusual dreams, yawning
excessive sweating, chills, flushing
indigestion, nausea, vomiting
loss of appetite, weight loss, changes in taste, dry mouth, problems swallowing, heartburn
or chest pain, often after swallowing food or drink
changes in vision
drowsiness, tiredness, weakness, fatigue
dizziness (sometimes when you stand up too quickly)
low blood pressure
impaired sexual function
passing urine more frequently than normal
unusual hair loss or thinning
mild rash, itching or hives
increased sensitivity of the skin to sun
grinding your teeth
painful or enlarged breasts
unusual vaginal bleeding
lesions of skin and mucous membranes
fever and joint aches
changes in vision
The above list includes the more common side effects of your medicine.
Tell your doctor as soon as possible if you notice any of the following:
abnormal bleeding or bruising
abnormal or suspicious thinking
feeling unbalanced on your feet
problems moving smoothly, or making unusual movements
agitation, nervousness, anxiety, worsening of depression
restlessness and/or a need to move often (akathisia).
fixed, staring eyes
general swelling or swollen hands, ankles, feet or face or eye area due to fluid build-up
The above list includes serious side effects that may require medical attention. Serious
side effects are rare.
If any of the following happen, tell your doctor immediately or go to Accident and
Emergency at your nearest hospital:
sudden switch of mood to one of excitement, overactivity, talkativeness, uninhibited
behaviour or aggression, or if you become particularly agitated or restless.
changing emotions, including crying, changes in mood, trying to harm yourself, thoughts
of suicide and attempting suicide
problems with breathing
jaundice (yellowing of the skin and/or eyes), with or without other signs of hepatitis
or liver problems (loss of appetite, tiredness, feeling or being sick, dark urine,
stomach pain or swelling, confusion, unconsciousness)
palpitations, fast or irregular heart beats
difficulty in urinating
hallucinations, loss of coordination or confusion
a collection of symptoms including weight gain (despite loss of appetite), feeling
and being sick, muscle weakness and irritability
skin rash combined with inflamed blood vessels
Serotonin syndrome - sudden fever, hallucinations, restlessness, loss of coordination,
confusion and overactive reflexes with sweating, fast heart beat and muscle stiffness,
nausea vomiting and fits, which may lead to loss of consciousness
unusual muscle stiffness (with or without raised body temperature), poor control of
movement, muscle spasms, tremors or twitches
uncontrollable twitching or jerking movements of the arms and legs
thoughts of suicide or attempting suicide or self-harm
severe rash, with blisters and/ or excessive peeling of skin
you notice your stool is red, dark brown or black
symptoms of an allergic reaction including 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
The above list includes very serious side effects. You may need urgent medical attention
or hospitalisation. These side effects are very rare.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may occur in some patients.
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.
Protect it from sunlight. 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 tells you to stop taking this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine that is left over.
What Fluoxetine APOTEX looks like
Green/off-white hard gelatin, self- locked, size 2 capsule imprinted with 'FLX' and
'MIL' on cap/body in black edible ink, containing white powder. AUST R 273924.
Blister pack of 28 capsules.
Each capsule contains 20 mg of fluoxetine (as fluoxetine hydrochloride) as the active
It also contains the following inactive ingredients:
pre-gelatinised maize starch
brilliant blue FCF
iron oxide yellow
sodium lauryl sulfate
black edible ink (contains shellac, ethanol absolute, isopropyl alcohol, butan-1-ol,
propylene glycol, iron oxide black and purified water)
This medicine is lactose-free, gluten-free, sucrose-free, tartrazine-free and free
of other azo dyes.
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
APOTEX is a registered trade mark of Apotex Inc.
This leaflet was last updated in December 2019.