sign in sign up
<<
Home , Antidepressant, Fluoxetine

IMPORTANT: PLEASE READ

PART III: CONSUMER INFORMATION What dosage forms it comes in: PROZAC Capsules are available in 10 mg (green) and 20 mg (green and yellow) strengths. PrPROZAC® ( Hydrochloride) WARNINGS AND PRECAUTIONS This leaflet is part III of a three-part "Product Monograph" published when PROZAC was approved for sale in Canada and is designed specifically for During treatment with these types of , it is Consumers. This leaflet is a summary and will not tell important that you and your doctor have good ongoing you everything about PROZAC. Contact your doctor or communication about how you are feeling. pharmacist if you have any questions about the . PROZAC is not for use in children under 18 years of age. Please read this information before you start to take your , even if you have taken this drug before. New or Worsened Emotional or Behavioural Problems Keep this information with your medicine in case you Particularly in the first few weeks or when doses are need to read it again. adjusted, a small number of patients taking of this type may feel worse instead of better. They may experience new or worsened feelings of agitation, hostility, , ABOUT THIS , or thoughts about , self-harm or harm to others. Suicidal thoughts and actions can occur in any age What the medication is used for: group but may be more likely in patients 18 to 24 years old. PROZAC has been prescribed by your doctor to relieve your Should this happen to you or those in your care, consult symptoms of: your doctor immediately. Close observation by a doctor is  (feeling sad, a change in appetite or weight, necessary in this situation. Do not discontinue your difficulty concentrating or sleeping, feeling tired, medication on your own. , unexplained aches and pain)  Bulimia (eating disorder, characterized by self-induced You may be more likely to think like this if you have vomiting after eating) previously had thoughts about harming yourself.  Obsessive-compulsive disorder (recurrent and , feeling, idea, or sensation; recurrent You may find it helpful to tell a relative or close friend that pattern of behaviour, or unwanted thoughts or actions) you are depressed or have an , and ask them to read this leaflet. You might ask them to tell you if they What it does: think your depression or anxiety is getting worse, or if they PROZAC belongs to a group of called selective are worried about changes in your behaviour. inhibitors (SSRIs). PROZAC is thought to work by increasing the levels of a chemical in the PROZAC has an effect on the electrical activity of the called serotonin (5-hydroxytryptamine). In very rare cases, this effect can lead to disturbances in heart rhythm. These heart rhythm disturbances are more likely in When it should not be used: patients with risk factors, such as heart disease, or in the Do not use PROZAC if you: presence of certain drugs. In general, females and people more  are allergic to it or any of the components of its than 65 years in age are at higher risk. It is important to follow formulation (see What the nonmedicinal ingredients the instructions of your doctor with regard to dosing. If you are:). experience any symptoms of a possible heart rhythm  are currently or have recently taken the drug disturbance, such as , (sensation of rapid, . pounding, or irregular heart beat), fainting, or , you  are currently or have recently taken monamine oxidase should seek immediate medical attention. anti- (e.g. sulphate, ). Before starting PROZAC, tell your doctor or pharmacists:  if you have ever had an allergic reaction to any What the medicinal ingredient is: medication PROZAC capsules contain the active ingredient fluoxetine  if you have QT/QTc prolongation or a family history of hydrochloride. QT/QTc prolongation;  if you have a heart disease; What the nonmedicinal ingredients are:  if you have a personal history of fainting spells; PROZAC 10 mg and 20 mg capsules contain benzyl ,  if you have a family history of sudden cardiac death at butyl paraben, carboxymethylcellulose sodium, edetate < 50 years; calcium disodium, F D & C Blue No. 1, gelatin, iron oxide  if you have electrolyte disturbances (e.g., low yellow, methyl paraben, propyl paraben, silicone, sodium or magnesium levels) or conditions that could propionate, sodium lauryl sulfate, starch, and titanium lead to electrolyte disturbances (e.g., vomiting, , dioxide. dehydration);  if you use , enemas and/or There is no gluten, lactose, sulfite, or tartrazine in PROZAC.  all your medical conditions, including a history of or kidney problems, seizures or blackouts, , bleeding disorder or have been told that you have low Persistent Pulmonary Hypertension (PPHN) and newer . :  if you had a recent fracture or were told you have The use of SSRIs, including PROZAC, during late osteoporosis or risk factors for osteoporosis. pregnancy, may increase the risk of a serious lung condition  any medications (prescription or nonprescription) you called persistent pulmonary hypertension of the newborn are taking or have recently taken, especially monoamine (PPHN) that causes breathing difficulties in newborns soon oxidase (MAO) inhibitors (e.g., phenelzine sulfate, after birth. In the general population, PPHN is known to sulfate, moclobemide or selegeline) or occur in about 1 or 2 per 1000 newborns but this may be thioridazine, or , acetylsalicylic acid (e.g., increased 2 to 6 times in babies whose mothers used SSRIs Aspirin) and other non-steroidal anti-inflammatory during late pregnancy. drugs (e.g., ibuprofen).  if you are taking (used to treat breast cancer) If you are pregnant and taking an SSRI, or other newer anti-  any natural or herbal products you are taking (e.g. St. , you should discuss the risks and benefits of the John's Wort) various treatment options with your doctor. It is very  if you are pregnant or thinking about becoming important that you do NOT stop taking these medications pregnant, or if you are breast feeding without first consulting your doctor. See  your habits of alcohol and /or street drug consumption AND WHAT TO DO ABOUT THEM section for more  if you drive a vehicle or perform hazardous tasks during information. your work Taking PROZAC may increase your risk of breaking a bone Angle-closure Glaucoma if you are elderly or have osteoporosis or have other major PROZAC can cause an acute attack of glaucoma. Having risk factors for breaking a bone. You should take extra care your eyes examined before you take PROZAC could help to avoid falls especially if you get dizzy or have low blood identify if you are at risk of having angle-closure glaucoma. pressure. Seek immediate medical attention if you experience: • eye pain • changes in vision INTERACTIONS WITH THIS MEDICATION • swelling or redness in or around the eye. Serious Drug Interactions Effects on Pregnancy and Newborns Do not use PROZAC if you are taking or have recently If you are already taking PROZAC and have just found out taken: that you are pregnant, you should talk to your doctor as soon • inhibitor (e.g., phenelzine, as possible. tranylcypromine, moclobemide or , , ) Taking PROZAC in early stages of pregnancy: • Thioridazine Some studies have suggested a small increased risk of birth defects affecting the heart in babies whose mothers took You should tell your doctor if you are taking or have PROZAC during the first few months of pregnancy. In the recently taken any medications (prescription, nonprescription general population, about 1 in 100 babies are born with a or natural/herbal), especially: heart defect. The studies found that this increased to about 2  other anti-depressants, such as SSRIs, certain tricylics, in 100 babies whose mothers took PROZAC during early drugs used to treat schizophrenia, or bipolar depression pregnancy. (e.g. )  anti-infectives Taking PROZAC in later stages of pregnancy:  cancer drugs  asthma drugs Possible complications at birth (from taking any newer  drugs to treat and vomiting , including PROZAC):  painkillers Post-marketing reports indicate that some newborns whose  diuretics mothers took an SSRI (selective serotonin reuptake  certain medicines which may affect blood clotting and inhibitor) or other newer anti-depressant during pregnancy increase bleeding, such as oral anticoagulants (e.g., have developed complications at birth requiring prolonged warfarin, dabigatran), acetylsalicylic acid (e.g. Aspirin) hospitalization, breathing support and tube feeding. and other non-steroidal anti-inflammatory drugs (e.g. Reported symptoms included feeding and/or breathing ibuprofen) difficulties, seizures, tense or overly relaxed muscles,  tamoxifen, which is used to treat breast cancer jitteriness and constant crying.  certain medicines used to treat patients with irregular heart beats (antiarrhythmics) In most cases, the newer anti-depressant was taken during  certain drugs used to treat diabetes the third trimester of pregnancy. These symptoms are  other drugs that affect serotonin, such as lithium, consistent with either a direct of the anti- linezolid, drugs containing , St. Johns Wort, depressant on the baby, or possibly a discontinuation used to treat syndrome caused by sudden withdrawal from the drug.  certain medicines used to treat pain, such as fentanyl These symptoms normally resolve over time. However, if (used in anaesthesia or to treat ), , your baby experiences any of these symptoms, contact your , meperidine, , doctor as soon as you can.  certain medicines used to treat cough, such as  dizziness such as benzodiazapines  anxiety  nervousness As with many drugs that work directly on the brain, use of  drowsiness alcohol while taking PROZAC should be limited/moderate.  (difficulty falling or staying asleep)  fatigue  PROPER USE OF THIS MEDICATION  diarrhea  upset stomach  It is very important that you take PROZAC exactly as  dry mouth your doctor has instructed.  loss of appetite  PROZAC is usually taken once a day. It may be taken  excessive sweating with or without food. If you are taking capsules, you should swallow the capsules whole; do not chew them. PROZAC does not usually affect people’s normal activities.  You should continue to take your medicine even if you However, some people feel sleepy while taking it, in which do not feel better, as it may take a number of weeks for case they should not drive or operate machinery. your medicine to work.  Keep taking your PROZAC until the doctor tells you to Although psychiatric disorders may be associated with stop. decreases in sexual desire, performance and satisfaction,  Talk to your doctor before you stop taking your treatment with this medication may also affect sexual medication on your own. functioning. Occasionally, these symptoms may continue after stopping PROZAC. Remember: This medicine has been prescribed only for you. Do not PROZAC can raise your levels of a hormone called give it to anybody else, as they may experience “” (measured with a blood test). Symptoms of high undesirable effects, which may be serious. prolactin may include: In men: breast swelling, difficulty in getting or maintaining Usual adult dose: erections, or other . Depression In women: breast discomfort, leakage of milk from the Usual initial dose: 20 mg a day in the morning. breasts, missed menstrual periods, or other problems with Maximum dose: 60 mg a day. your cycle.

Bulimia If you experience any symptoms of a possible heart Recommended dose: 60 mg a day. rhythm disturbance, such as dizziness, palpitations, fainting or seizures, you should seek immediate medical Obsessive-Compulsive Disorder attention. Dose range: 20 to 60 mg a day. Discontinuation Symptoms Missed Dose Contact your doctor before stopping or reducing your If you forget to take a dose of PROZAC, take it as soon as dosage of PROZAC. Symptoms such as headache, you remember. Take your next dose at the next scheduled insomnia, paresthesias (numbness, tingling, burning, or time; do not try to make up for a missed dose by taking a prickling sensation) nervousness, anxiety, nausea, sweating, double dose the next time. dizziness, jitteriness and weakness and other symptoms have been reported after stopping PROZAC. These symptoms Overdose: usually disappear without needing treatment. Tell your doctor immediately if you have these or any other In case of drug overdose, contact a health care practitioner, symptoms. Your doctor may adjust the dosage of PROZAC hospital emergency department or regional Poison Control to alleviate the symptoms. See WARNINGS AND Centre immediately, even if there are no symptoms. PRECAUTIONS section for more information.

Effects on Newborns SIDE EFFECTS AND WHAT TO DO ABOUT THEM Some newborns whose mothers took an SSRI (Selective Serotonin Uptake Inhibitor) or other newer antidepressants Like other medications, PROZAC can cause some side during pregnancy have shown such symptoms as breathing effects. You may not experience any of them. For most and feeding difficulties, jitteriness and constant crying. If patients, side effects are likely to be minor and temporary. your baby experiences any of these symptoms, contact your However, some may be serious. Some of these side effects doctor as soon as you can. See WARNING AND may be dose related. Consult your doctor if you experience PRECAUTIONS section for more information. these or other side effects, as the dose may have to be adjusted.

The most common side effects of PROZAC are:  nausea SERIOUS SIDE EFFECTS, HOW OFTEN THEY SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM HAPPEN AND WHAT TO DO ABOUT THEM

Talk with your Seek Talk with your Seek doctor or immediate doctor or immediate pharmacist emergency pharmacist emergency Symptom / effect medical Symptom / effect medical Only if In assistance Only if In assistance severe all severe all cases cases Common Allergic reactions of the skin or [red skin, , eyes, dark urine] itching, swelling Uncontrollable of the lips, face, movements of the  tongue, throat, body or face trouble breathing, wheezing,  Low sodium level shortness of in blood breath, skin [symptoms of rashes, blisters of tiredness, weakness, the skin, sores or  pain in the mouth confusion or eyes] combined with achy, stiff or Allergic reactions uncoordinated (skin rash, hives  muscles] alone) Very Rare Serotonin Unknown Low Platelets: syndrome [a Bruising or combination of  unusual bleeding most or all of the from the skin or following; other areas confusion, Uncommon Hallucinations restlessness,  [strange visions  sweating, or sounds] shaking, Inability to shivering, high  urinate fever, hallucinations, [feeling sudden jerking of restless and  the muscles, fast unable to sit or heartbeat] stand still] See Warnings New or worsened Seizures [i.e. loss & emotional or of consciousness  Precautions behavioural with  problems uncontrollable shaking (“fit”)] [overactive This is not a complete list of side effects. For any unexpected behaviour and  effects while taking PROZAC, contact your doctor or pharmacist. thoughts] Gastrointestinal HOW TO STORE IT bleeding [vomiting blood  or passing blood Keep all medicines out of the reach and sight of children. in stools] PROZAC should be stored in its original package at room Angle-closure temperature, in a dry place and out of direct sunlight. The Glaucoma: eye expiry date of this medicine is printed on the package label. pain , changes in Do not use the medicine after the expiry date. If your doctor vision and  tells you to stop taking PROZAC or you find that they have Rare swelling or passed their expiry date, please return any left over medicine redness in or to your pharmacist. around the eye Liver disorder [symptoms include nausea, vomiting, loss of  appetite combined with itching, yellowing REPORTING SUSPECTED SIDE EFFECTS You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

● Report on line at: http://www.healthcanada.gc.ca/medeffect ● Call toll-free at 1-866-234-2345 ● Complete a Canada Vigilance Reporting Form and: ○ Fax toll-free to 1-866-678-6789 ○ Mail to: Canada Vigilance Program Health Canada Postal Locator 0701D Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at http://www.healthcanada.gc.ca/medeffect

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

PROZAC Capsules are manufactured by: Eli Lilly Canada Inc.

For more information, please contact your healthcare professionals or pharmacist first, or Eli Lilly Canada Inc. at: 1-888-545-5972, or visit the website at www.lilly.ca.

The information in this document is current as of the last revision date shown below. For the most current information please visit our website or contact us directly.

This leaflet was prepared by Eli Lilly Canada Inc., Toronto, Ontario, M5X 1B1.

You may need to read this package insert again. Please do not throw it away until you have finished your medicine.

PROZAC® (fluoxetine hydrochloride) is a trademark owned or licensed by , its subsidiaries or affiliates.

Last revised: January 25, 2021

PROZAC-CA-PM-0002-20210125