Consumer Medicine Information
PROZAC® 20
fluoxetine hydrochloride
20 mg capsules
What is in this leaflet
This leaflet is designed to provide you with answers to some common questions about this medicine. It does not contain all the available information and does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking PROZAC 20 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 is PROZAC 20 used for
- PROZAC 20 is used to treat depression and the anxiety associated with depression.
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.
PROZAC 20 corrects this chemical imbalance and may help relieve the symptoms of depression.
- PROZAC 20 is used to treat bulimia nervosa and obsessive compulsive disorder (OCD).
- PROZAC 20 can also be used to treat pre-menstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome (PMS).
Your doctor may have prescribed PROZAC 20 for another reason.
Ask your doctor if you have any questions about why PROZAC 20 has been prescribed for you.
PROZAC 20 contains the active ingredient called fluoxetine hydrochloride and belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs).
There is no evidence that PROZAC 20 is addictive.
PROZAC 20 is available only with a doctor's prescription.
Before taking PROZAC 20
Do NOT take PROZAC 20 if:
- you have had an allergic reaction to any medicines containing fluoxetine or to any of the inactive ingredients listed in the Ingredients section of this leaflet.
Signs of an allergic reaction may include rash, itching of the skin, shortness of breath and swelling of the tongue or face. - you are taking another medicine for depression called a monoamine oxidase inhibitor (MAOI) or have been taking a MAOI within the last 14 days. Taking PROZAC 20 with a MAOI medicine may cause a serious reaction with a sudden increase in body temperature, extremely high blood pressure and severe convulsions.
Check with your doctor or pharmacist if you are unsure as to whether or not you are taking a MAOI. - the packaging is torn or shows signs of tampering, the expiry date on the pack has passed, or if the capsules do not look quite right.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start taking PROZAC 20, tell your doctor if you:
- have had an allergic reaction to any medicine that you have taken previously to treat your current condition.
- have any health problems including kidney or liver disease, diabetes, have ever had fits or a tendency to bleed more than normal.
- have or have had Bipolar Disorder. Bipolar Disorder is a mental illness with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability
- are pregnant or intend to become pregnant. Your doctor will discuss the risks and benefits of taking PROZAC 20 during pregnancy. If PROZAC 20 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.
- are breast feeding or wish to breast feed.
There is no specific information available to recommend the use of PROZAC 20 in children.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking PROZAC 20.
Taking other medicines
Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or health food supplier.
Some commonly used medicines that may interfere with PROZAC 20 include:
- medicines used to treat depression such as SSRIs and SNRIs and other types of medicines for depression
- medicines used to relieve pain such as Tramadol
- medicines used to relieve migraine such as Sumitriptan
- monoamine oxidase inhibitors (MAOIs) (e.g. Nardil, Parnate, Aurorix).
- warfarin or other medicines that stop the blood from clotting
- medicines that increase the risk of bleeding (e.g. aspirin, certain types of antidepressants, atypical antipsychotic medicines and a group of medicines called NSAIDs which are used to relieve pain, swelling and other symptoms of inflammation including arthritis)
- central nervous system active medicines ( e.g. Phenytoin, Carbamazepine, Haloperidol, Alprazolam, Lithium, Imipramine hydrochloride, Desipramine, Diazepam, Clozapine
- oral antidiabetic medicines or insulin
These medicines may be affected by PROZAC 20 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.
How to take PROZAC 20
Follow carefully all directions given to you by your doctor and pharmacist even if they differ from the information contained in this leaflet.
If you do not understand the instructions on how to take PROZAC 20, ask your doctor or pharmacist for help.
How much to take
Your doctor will tell you how much PROZAC 20 you need to take each day. It is very important that you take your medicine as directed by your doctor. Taking more than this will not speed your recovery and taking less is unlikely to help you recover.
The usual daily dose for adults is 20 mg to treat depression, 20 mg continuously throughout the menstrual cycle for PMDD, 60 mg to treat bulimia, 20 mg to 60 mg to treat obsessive-compulsive disorder. For any condition, the total PROZAC 20 dosage should not exceed 80 mg each day. Your doctor may increase or decrease your dose depending on your condition.
PROZAC 20 is usually taken in the morning as a single dose. The capsule(s) should be swallowed whole with a glass of water.
When to take it
PROZAC 20 can be taken with or without food.
How long to take it
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 do not feel better right away. While some symptoms will be relieved sooner than others, PROZAC 20 commonly takes two to four weeks before improvement is really apparent. Continue taking PROZAC 20 for as long as your doctor recommends. If you do not start to feel better in about four weeks, check with your doctor.
For PMDD, the initial treatment period is six months, after which your condition should be reassessed with your doctor regarding the benefit of continued therapy.
If you forget a dose
Do not take an extra dose. Wait until the next day and then take your normal dose. Do not try to make up for missed doses by taking more than one dose at a time.
If you are not sure what to do, ask your doctor or pharmacist.
If you are having trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much
Immediately telephone your doctor or National Poisons Information Centre (0800 POISON or 0800 764 766) for advice or go to your nearest hospital Accident and Emergency Department if you think that you or anyone else has taken too much PROZAC 20. Do this even if there are no signs of discomfort or poisoning.
If you have taken too much PROZAC 20, you may experience: feeling sick in the stomach; vomiting; fits or convulsions; changes in mood ranging from drowsy to excited.
While you are taking PROZAC 20
Things you must do
Tell all doctors, dentists and pharmacists who are treating you that you are taking PROZAC 20. Tell your doctor or pharmacist before you start any new medicine while you are taking PROZAC 20.
Tell your doctor immediately if you develop a skin rash or hives while taking PROZAC 20.
Tell your doctor if you become pregnant while taking PROZAC 20. Your doctor will discuss the risks and benefits of taking PROZAC 20 during pregnancy. If PROZAC 20 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.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.
If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.
While taking this medicine, be sure to keep all appointments you and your doctor have scheduled so that your progress can be followed.
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:
- thoughts or talk of death or suicide
- thoughts or talk of self-harm or harm to others
- any recent attempts at self-harm
Tell your doctor if you feel that PROZAC 20 is not helping your condition.
Things you must NOT do
Do not take PROZAC 20 to treat any other complaints unless your doctor tells you to.
Do not stop taking PROZAC 20 or lower the dose without first checking with your doctor. Suddenly stopping PROZAC 20 may cause unwanted side effects.
Also, after you have stopped taking PROZAC 20, you should wait for at least 5 weeks before taking medications with MAOI activity.
Do not give PROZAC 20 to anyone else even if they have the same condition as you. Your doctor has prescribed it specifically for you and your condition.
Things to be careful of
Be careful driving or operating machinery until you know how PROZAC 20 affects you. PROZAC 20 may cause drowsiness in some people.
Although drinking moderate amounts of alcohol is unlikely to affect your response to PROZAC 20, your doctor may suggest avoiding alcohol while you are being treated for depression.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking PROZAC 20.
PROZAC 20 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. Many of the side effects are dose related, so it is important you never exceed the stated dose.
Do not be alarmed by the following list of possible 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:
Body as a whole: increased sensitivity to sunlight; dry mouth; excessive sweating; chills; weakness; itching; rash; hives.
Digestive system: nausea; vomiting, diarrhoea; indigestion; a change in taste.
Nervous system: unusual dreams; loss of appetite or weight loss; tremors; twitches; drowsiness; trouble sleeping; dizziness; nervousness; anxiety; impaired concentration or thought processes; headache; unsteadiness when walking; altered sense of one's own reality.
Urogenital system: sexual problems; more frequent urination; difficulty passing urine; changes in sex drive.
Others: yawn; unusual hair loss; changes in vision; dilated pupils.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
- Sudden signs of allergy such as itching, skin rash or hives, shortness of breath, wheezing or trouble breathing, swelling of the face, lips, tongue or other parts of the body
- difficulty swallowing
- muscle spasms, convulsions or fits
- fast, irregular heart beat
- abnormal bleeding or bruising
- sudden switches of mood to one of overactivity and uninhibited behaviour
- prolonged and painful erection.
These are serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.
This is not a complete list of all possible side effects.
Tell your doctor if you notice anything that is making you feel unwell, even if you think the problems are not connected with the medicine or are not listed in this leaflet.
After taking PROZAC 20
Storage
Keep your capsules in the blister pack until it is time to take them. If you take them out of the blister pack, they may not keep as well.
Keep your capsules in a cool dry place where the temperature stays below 25°C.
Do not store PROZAC 20 or any other medicine in the bathroom or near a sink.
Do not leave PROZAC 20 in the car on hot days. Heat and dampness can destroy some medicines.
All medicines should be kept where children cannot reach them. A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines.
There will be an expiry date (month, year) on the blister platform. PROZAC 20 should not be taken after this date because it may have lost some of its strength.
Disposal
If your doctor tells you to stop taking PROZAC 20 or you find that it has passed the expiry date, ask your pharmacist what to do with any medicine that is left over.
Product description
What it looks like
PROZAC 20 capsules are available in packs of 30.
PROZAC 20 capsules are coloured green and off-white and are marked with "Lilly" and "3105".
Ingredients
Each capsule contains 20 mg fluoxetine, plus the inactive ingredients maize starch and dimethicone 350. The capsule shell is made of gelatin and contains the following dyes: E131, E172, titanium dioxide and edible black ink.
PROZAC 20 capsules do not contain sugar and are gluten free.
Supplier
PROZAC 20 is distributed by:
Eli Lilly and Company (NZ) Limited
Level 3, Axon House
414-422 Khyber Pass Road, Newmarket
PO Box 109 197, Newmarket
Auckland
Telephone (09) 523 9300
This leaflet was revised in November 2006