NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
PROZAC® V3.0
fluoxetine hydrochloride
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 or pharmacist.
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:
depression
obsessive compulsive disorder (OCD)
premenstrual dysphoric disorder (PMDD)
Ask your doctor if you have any questions about why PROZAC has been prescribed for you.
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 a MAOI.
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 or tablets 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 or dyes.
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.
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 following:
liver problems
kidney problems
fits
diabetes
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 PROZAC.
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 include:
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
tryptophan
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 stopping PROZAC.
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 for help.
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 or one tablet 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.
If you cannot swallow the tablets, disperse them in water.
Swirl the tablet in half a glass of water until it falls apart, then drink it immediately.
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 at noon.
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 hints.
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 PROZAC.
Tell your doctor if you become pregnant while taking PROZAC.
Your doctor will discuss the risks and benefits of taking PROZAC during pregnancy. If PROZAC is used 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.
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 for treatment:
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 or mood
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.
Side effects
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 of them.
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:
nausea, vomiting
upset stomach, diarrhoea
loss of appetite, weight loss, changes in taste, dry mouth
trouble sleeping, unusual dreams
nervousness, anxiety
drowsiness, weakness
dizziness
excessive sweating, flushing, chills
lesions of skin and mucous membrane
fever and joint aches
sexual problems
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
muscle spasms
tremors
twitches
convulsions or fits
fast, irregular heart beat
abnormal bleeding or bruising
sudden switches of mood to one of overactivity and uninhibited behaviour.
sudden fever
hallucinations
loss of coordination
confusion
overactive reflexes
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
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 (SSRIs).
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
Storage
Keep your capsules or tablets in the blister pack until it is time to take them.
If you take your capsules or tablets 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 C.
Keep your tablets in a cool dry place where the temperature stays below 25 degrees C.
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.
Disposal
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.
Product description
What it looks like
PROZAC capsules and tablets are available in packs of 28.
The capsules are coloured green and off-white and are marked with “Lilly” and “3105”.
The tablets are white and scored and marked with 4400.
Ingredients
Capsules
PROZAC capsules contain 20 mg of fluoxetine as the active ingredient. They also contain:
pre-gelatinized maize starch
dimeticone 350
gelatin
iron oxide yellow CI77492
patent blue V CI42051
titanium dioxide
edible black ink.
Tablets
PROZAC tablets contain 20 mg of fluoxetine as the active ingredient. They also contain:
microcrystalline cellulose
saccharin sodium
mannitol
sorbitol
colloidal anhydrous silica
maize starch
sodium stearylfumarate
crospovidone
peppermint flavouring
aniseed flavouring.
PROZAC capsules and tablets are gluten free.
Supplier
PROZAC is a product of:
Eli Lilly Australia Pty Limited
112 Wharf Road
WEST RYDENSW2114
Eli Lilly and Company (NZ) Limited
PO Box 109 197, Newmarket
Auckland
Telephone (09) 523 9300
Australian Registration Number:
PROZAC Capsules 20mg:
AUST R 14653
PROZAC Tablets 20mg:
AUST R 61081
This leaflet was revised in December 2019
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