Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about PROZAC. It does not contain all
the available information. It does not take the place of talking with your doctor
All medicines have risks and benefits.
Your doctor has weighed the risks of you taking PROZAC against the benefits they expect
it will have for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with this medicine.
You may need to read it again.
What PROZAC is used for
PROZAC is used to treat:
obsessive compulsive disorder (OCD)
premenstrual dysphoric disorder (PMDD)
Ask your doctor if you have any questions about why PROZAC has been prescribed for
Your doctor may have prescribed PROZAC for another reason.
PROZAC belongs to a group of medicines called selective serotonin reuptake inhibitors
(SSRIs). SSRIs are thought to work by their action on brain chemicals called amines
which are involved in controlling mood.
PROZAC is available only with a doctor's prescription.
PROZAC is not recommended for use in children and adolescents under 18 years of age.
Before you take PROZAC
When you must not take it
Do not take PROZAC if you are allergic to
any medicines 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 PROZAC if you are taking another medicine for depression called a monoamine
oxidase inhibitor (MAOI) or have been taking a MAOI within the last 14 days. Check
with your doctor or pharmacist if you are unsure as to whether or not you are taking
If you do take PROZAC while you are taking a MAOI, you may experience shaking (tremor),
shivering, muscle stiffness, fever, rapid pulse, rapid breathing or confusion.
Do not take PROZAC if you are taking another medicine called pimozide to treat disturbances
in thinking, feelings and behaviour. Taking pimozide together with PROZAC may alter
the rhythm of your heart.
Do not take PROZAC if the packaging is torn or shows signs of tampering or the capsules
do not look quite right.
Do not take PROZAC if the expiry date on the pack has passed.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking PROZAC, 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.
Your doctor will discuss the risks and benefits of taking PROZAC during pregnancy.
If PROZAC is taken during pregnancy, you should be careful, particularly at the end
of pregnancy. Transitory withdrawal symptoms have been reported rarely in the newborn
after maternal use in the last 3 months of pregnancy. If you take PROZAC near the
end of your pregnancy there may be an increased risk of heavy vaginal bleeding shortly
after birth, especially if you have a history of bleeding disorders. Your doctor or
midwife should be aware that you are taking PROZAC so they can advise you.
Tell your doctor if you are breastfeeding or wish to breastfeed.
Tell your doctor if you have, or have had, any medical conditions, especially the
a bleeding disorder or a tendency to bleed more than usual
Tell your doctor if you drink alcohol.
Although drinking alcohol is unlikely to affect your response to PROZAC, 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 other medicines
Tell your doctor if you are taking any other medicines, including any that you buy
without a prescription from a pharmacy, supermarket or health food shop.
Some combinations of medicines may increase the risk of serious side effects and are
potentially life threatening.
Some medicines may be affected by PROZAC, or may affect how well it works. These
monoamine oxidase inhibitors (MAOIs), medicines used to treat some types of depression.
You should stop taking MAOIs at least two weeks before starting PROZAC
lithium, a medicine used to treat mood swings and some types of depression
SNRIs, SSRIs and other medicines for depression, obsessive compulsive disorder or
premenstrual dysphoric disorder (PMDD)
sleeping tablets or sedatives
medicines used to relieve anxiety
medicines used to treat certain mental and emotional conditions, also called antipsychotics
medicine used to treat disturbances in thinking, feelings and behaviour, such as pimozide
medicines used to control fits
medicines used to prevent blood clots, such as warfarin
flecainide, a medicine used to treat some heart conditions
St John's Wort
medicines used to relieve pain, such as tramadol
sumitriptan, a medicine used to treat migraine.
Your doctor can tell you what to do if you are taking any other medicines.
If you are not sure whether you are taking any of these medicines, check with your
doctor or pharmacist.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking PROZAC.
Do not start taking other medicines for depression without checking with your doctor.
Do this even if you have already stopped taking PROZAC.
Monoamine oxidase inhibitors (MAOIs), which are other medicines used for depression,
may interfere with PROZAC. You should not start a MAOI for at least 5 weeks after
How to take PROZAC
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 instructions on the box, ask your doctor or pharmacist
How much to take
Your doctor will tell you how much PROZAC you need to take each day.
The usual dose for PROZAC is one capsule taken once a day. Your doctor may increase
or decrease your dose depending on your condition.
For premenstrual dysphoric disorder (PMDD), PROZAC 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.
How to take it
Swallow the capsules whole with a glass of water.
When to take it
PROZAC is usually taken as a single morning dose.
If your doctor tells you to take PROZAC twice a day, take a dose in the morning and
Take your medicine at about the same time each day.
Taking it at the same time each day will 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
Continue taking PROZAC for as long as your doctor recommends.
The length of treatment with PROZAC will depend on how quickly your symptoms improve.
Most medicines of this type take time to work so don't be discouraged if you do not
feel better right away. While some symptoms will be relieved sooner than others, PROZAC
commonly takes two to four weeks before improvement is really apparent.
If you do not start to feel better in about four weeks, check with your doctor.
If you forget to take it
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, 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.
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 Poisons Information Centre (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 PROZAC. Do this even if there are no signs of
discomfort or poisoning. You may need urgent medical attention.
If you have taken too much PROZAC, you may feel sick in the stomach, vomit, feel restless,
agitated or excited.
While you are taking PROZAC
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking PROZAC.
Tell all doctors, dentists and pharmacists who are treating you that you are taking
Tell your doctor if you become pregnant while taking PROZAC.
Your doctor will discuss the risks and benefits of taking PROZAC during pregnancy.
Keep all of your doctor's appointments so that your progress can be checked.
The symptoms of depression or other psychiatric conditions may include thoughts of
harming yourself or suicide. These symptoms may continue or get worse during the first
one or two months of treatment until the full antidepressant effect of PROZAC becomes
apparent. This is more likely to occur in young adults under 25 years of age.
If you or someone you know is demonstrating any of the following warning signs, contact
your doctor or a mental health professional right away or go to the nearest hospital
worsening of your depression
thoughts or talk of death or suicide
thoughts or talk of self-harm or harm to others
any recent attempts at self-harm
increase in aggressive behaviour, irritability or any other unusual changes in behaviour
All mentions of suicide or violence must be taken seriously.
Things to be careful of
If you experience drowsiness, do not drive, operate machinery or do anything else
that could be dangerous.
Things you must NOT do
Do not stop taking your medicine or lower the dosage without checking with your doctor.
Suddenly stopping PROZAC 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 PROZAC you are taking before stopping completely.
Do not take the herbal remedy St. John's Wort while you are being treated with PROZAC.
If you are already taking the herbal remedy, stop taking St. John's Wort and mention
it to your doctor at your next visit.
Do not drive or operate machinery until you know how PROZAC affects you.
PROZAC may cause drowsiness in some people.
Do not give PROZAC to anyone else, even if they have the same condition as you.
Do not let yourself run out of PROZAC over the weekend or on holidays.
Do not use PROZAC to treat any other complaints unless your doctor tells you to.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking PROZAC.
PROZAC may have unwanted side effects in some people. All medicines can have side
effects. Sometimes they are serious, most of the time they are not. You may need
medical treatment if you get some of the side effects.
Side effects vary from patient to patient and often lessen with continued use.
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:
upset stomach, diarrhoea
loss of appetite, weight loss, changes in taste, dry mouth
trouble sleeping, unusual dreams
excessive sweating, flushing, chills
lesions of skin and mucous membrane
fever and joint aches
more frequent urination
changes in vision.
If any of the following happen, tell your doctor immediately or go to Accident and
Emergency at your nearest hospital:
itching, skin rash or hives
shortness of breath, wheezing or trouble breathing
swelling of the face, lips, tongue or other parts of the body
convulsions or fits
fast, irregular heart beat
abnormal bleeding or bruising
sudden switches of mood to one of overactivity and uninhibited behaviour.
loss of coordination
The above list includes very serious side effects. You may need urgent medical attention
Children and Adolescents
Headaches are very common side effects.
Weight loss and decreased height gain have been observed in association with the use
of PROZAC in children and adolescent patients. This is similar to other medicines
that belong to the group of medicines called selective serotonin reuptake inhibitors
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
After taking PROZAC
Keep your capsules in the blister pack until it is time to take them.
If you take your capsules out of the blister pack they may not keep as well.
Keep your capsules in a cool dry place where the temperature stays below 30 degrees
Do not store PROZAC 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 it 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 PROZAC or the expiry date has passed, ask
your pharmacist what to do with any medicine that is left over.
What it looks like
PROZAC capsules are available in packs of 28.
The capsules are coloured green and off-white and are marked with "Lilly" and "3105".
PROZAC capsules contain 20 mg of fluoxetine as the active ingredient. They also contain:
pre-gelatinized maize starch
iron oxide yellow CI77492
patent blue V CI42051
edible black ink.
PROZAC capsules are gluten free.
PROZAC is a product of:
Eli Lilly Australia Pty Limited
112 Wharf Road
WEST RYDE NSW 2114
Eli Lilly and Company (NZ) Limited
PO Box 109 197, Newmarket
Telephone (09) 523 9300
Australian Registration Number:
PROZAC Capsules 20mg:
AUST R 14653
This leaflet was revised in June 2021