IMPORTANT: PLEASE READ
to ZYPREXA or any of the ingredients listed in the PART IIIA: CONSUMER INFORMATION “Nonmedicinal Ingredients” section of this leaflet. Signs of allergic reaction may include a skin rash, itching, shortness PrZYPREXA® of breath or swelling of the face, lips or tongue. (olanzapine tablets) What the medicinal ingredient is: PrZYPREXA® ZYDIS® ZYPREXA tablets and ZYPREXA ZYDIS orally (olanzapine orally disintegrating tablets) disintegrating tablets contain the active ingredient called olanzapine. This leaflet is part III of a three-part "Product Monograph" published when ZYPREXA was approved What the nonmedicinal ingredients are: for sale in Canada and is designed specifically for ZYPREXA Tablets: Consumers. This leaflet is a summary and will not tell ZYPREXA tablets contain the following inactive you everything about ZYPREXA. Contact your doctor ingredients: carnauba wax, crospovidone, hydroxypropyl or pharmacist if you have any questions about the drug. cellulose, hydroxypropyl methylcellulose, lactose, magnesium stearate, and microcrystalline cellulose. Keep this information with your medicine in case you need to read it again. The colour coating and ink contain some or all of the following ingredients: FD&C Blue No.2 Aluminum Lake, polyethylene glycol, polysorbate 80, Synthetic Red Iron ABOUT THIS MEDICATION Oxide, titanium dioxide, triacetin.
The name of your medicine is ZYPREXA and your doctor ZYPREXA Zydis Orally Disintegrating Tablets: has prescribed it to help relieve the symptoms that are ZYPREXA Zydis contains the following inactive bothering you. ZYPREXA can help to control your ingredients: aspartame, gelatin, mannitol, sodium methyl symptoms and reduce the risk of relapse. Although paraben, and sodium propyl paraben. ZYPREXA cannot cure your symptoms, it can help you keep them under control as you continue your treatment. What dosage forms it comes in: ZYPREXA Tablets: What the medication is used for: ZYPREXA tablets are available in 2.5 mg, 5 mg, 7.5 mg, ZYPREXA is used to treat symptoms of schizophrenia and 10 mg, 15 mg, and 20 mg strengths. related psychotic disorders as well as those of bipolar disorder. ZYPREXA Zydis: ZYPREXA Zydis orally disintegrating tablets are available Your doctor may have prescribed ZYPREXA for another in 5 mg, 10 mg, 15 mg, and 20 mg strengths. reason. Ask your doctor if you have any questions about why ZYPREXA has been prescribed for you. WARNINGS AND PRECAUTIONS What it does: ZYPREXA belongs to a group of medicines called Serious Warnings and Precautions antipsychotics. ZYPREXA is used to treat symptoms of Studies with various medicines of the group to which schizophrenia and related psychotic disorders as well as ZYPREXA belongs, including ZYPREXA, when used in those of bipolar disorder. Schizophrenia may cause elderly patients with dementia have been associated with symptoms such as hallucinations (e.g. hearing, seeing, or an increased rate of death. ZYPREXA is not indicated in sensing things which are not there), delusions, unusual elderly patients with dementia. suspiciousness, feeling withdrawn, lack of emotions. People with schizophrenia may also feel depressed, anxious or tense. Signs and symptoms of bipolar mania include but are Before starting ZYPREXA and to get the best possible not limited to: feeling invincible or all powerful, inflated treatment, be sure to tell your doctor if you: self-esteem, racing thoughts, easily lose your train of are pregnant or plan to become pregnant thought, overreaction to what you see or hear, are breast feeding or plan on breast feeding misinterpretation of events, speeded-up activity, talking have had an allergic reaction to any medicine which you very quickly, talking too loudly, or talking more than usual, have taken previously to treat your current condition decreased need for sleep, and poor judgment. have diabetes or a family history of diabetes have a history of any problems with the way your heart When it should not be used: beats or have any heart problems Do not take ZYPREXA if you have had an allergic reaction
ZYPREXA® Product Monograph Page 1 of 9 have a history of stroke or high blood pressure concentrations of olanzapine in your blood. have risk factors for developing blood clots such as: a family history of blood clots, age over 65, smoking, You should also tell your doctor if you are taking obesity, recent major surgery (such as hip or knee carbamazepine as it may lead to lower concentrations of replacement), immobility due to air travel or other reason, ZYPREXA in your blood, making ZYPREXA less or take oral contraceptives ("The Pill"). effective. are a smoker have ever had blackouts or seizures Only take other medicines while you are on ZYPREXA if are taking any other medicines (prescriptions or your doctor tells you that you can. DO NOT give over-the-counter medicines) ZYPREXA to anyone else. Your doctor has prescribed it drink alcoholic beverages or use drugs for you and your condition. exercise vigorously or work in hot or sunny places have a history of liver problems, hepatitis, or yellowing of PROPER USE OF THIS MEDICATION the eyes and skin (jaundice) have prostate problems Usual dose: have intestinal congestion (paralytic ileus) The most important thing about taking ZYPREXA is to have raised pressure within the eye (glaucoma) take it the way your doctor has prescribed - the right dose, suffer from lactose intolerance because ZYPREXA every day. Your doctor has decided on the best dosage for tablets contain lactose you based on your individual situation and needs. Your cannot take phenylalanine because ZYPREXA Zydis doctor may increase or decrease your dose depending on contains aspartame, a source of phenylalanine. your response.
It is important for your doctor to have this information Although ZYPREXA cannot cure your condition, it can before prescribing your treatment and dosage. help relieve your symptoms. If your symptoms improve or disappear, it is probably because your treatment is Effects on Newborns: working. Studies have shown that, after coming off In some cases, babies born to a mother taking ZYPREXA medication, a relapse of symptoms occurs in about 2 out of during pregnancy have experienced symptoms that are 3 patients and is more than double that of patients staying severe and require the newborn to be hospitalized. on their medication. That is why it is so important to keep Sometimes, the symptoms may resolve on their own. Be taking ZYPREXA, even after your symptoms have prepared to seek immediate emergency medical attention improved or disappeared. ZYPREXA should be taken for for your newborn if they have difficulty breathing, are as long as you and your doctor believe it is helping you. overly sleepy, have muscle stiffness, or floppy muscles (like a rag doll), are shaking, or are having difficulty feeding. Proper Handling Instructions ZYPREXA Tablets: ZYPREXA tablets should be swallowed whole with a INTERACTIONS WITH THIS MEDICATION glass of water. ZYPREXA tablets can be taken with or without food.
Tell all doctors, dentists and pharmacists who are treating ZYPREXA Zydis: you that you are taking ZYPREXA. ZYPREXA Zydis should be handled carefully with dry hands. Tell your doctor or pharmacist that you are taking ZYPREXA before you start taking any new medicines.
A combination of ZYPREXA with the following medicines might make you feel drowsy: medicines taken for anxiety or to help you sleep Follow the instructions below: medicines taken for depression. 1. Separate one blister cell from the strip by tearing along the dotted line. The effects of alcohol could be made worse while taking 2. Carefully peel off the backing foil. ZYPREXA. It is recommended that you DO NOT drink 3. Gently push the tablet out from the bottom of the alcohol while taking ZYPREXA. blister. 4. Avoid touching the tablet with your hands. Put You should tell your doctor if you are taking fluvoxamine the tablet directly into your mouth. It will begin to (antidepressant), ketoconazole (antifungal), or ciprofloxacin dissolve in your mouth within a few seconds. You (antibiotic), as these medicines may lead to higher can also place the tablet directly into a full glass
ZYPREXA® Product Monograph Page 2 of 9 of water, milk, coffee, orange juice or apple juice. monthly period. On rare occasions, after prolonged use in Stir and drink all of the contents immediately. men, medicines of this type have been associated with breast enlargement. As well, abnormal liver function tests Overdose: have been reported on occasion.
In case of drug overdose, contact a health care practitioner, Your doctor should check your body weight before starting hospital emergency department or regional Poison Control ZYPREXA and continue to monitor it for as long as you Centre immediately, even if there are no symptoms. are being treated.
Show the health care practitioner your bottle of tablets. Do Your doctor should take blood tests before starting this even if there are no signs of discomfort or poisoning. ZYPREXA. They will monitor blood sugar, and the The most common signs if you have taken too much number of infection fighting white blood cells. Your ZYPREXA are drowsiness and slurred speech. doctor should continue to monitor your blood for as long as you are being treated. Missed Dose: Take your prescribed dose at the same time each day. If you If you have high levels of prolactin (measured with a blood miss a dose of ZYPREXA by a few hours, take the dose test) and a condition called hypogonadism you may be at when you remember. If most of the day has passed, wait increased risk of breaking a bone due to osteoporosis. This until your next scheduled dose and try not to miss any more. occurs in both men and women. Do not take 2 doses at once. Do not be alarmed by this list of possible side effects. You may not experience any of them. If any of these side SIDE EFFECTS AND WHAT TO DO ABOUT effects are experienced, they are usually mild and THEM temporary.
Like other medicines, ZYPREXA can cause some side The following table is based on data from placebo- effects. These side effects are most likely to be minor and controlled clinical trials and from post-marketing data. temporary. However, some may be serious and need medical attention. Many of the side effects are dose related, SERIOUS SIDE EFFECTS, HOW OFTEN THEY so it is important not to exceed your prescribed dose. The HAPPEN AND WHAT TO DO ABOUT THEM most common side effects of oral ZYPREXA are: drowsiness Talk with your Stop taking weight gain doctor or drug and dizziness Symptom / effect pharmacist call your increased appetite doctor or fluid retention Only if In all pharmacist constipation severe cases dry mouth Common a feeling of restlessness (akathisia) New or worsening constipation decreased blood pressure upon rising from a lying or sitting position Uncommon
1 Events of stuttering (disruptive speech) and increased Slow heartbeat salivation (salivary hypersecretion) were uncommonly Rare reported. You should also tell your doctor if you notice any symptoms that worry you, even if you think the problems Liver inflammation [symptoms * are not connected with the medicine or are not listed here. of fever, yellow skin or eyes, dark urine, weakness, abdominal pain, nausea, Because some people experience drowsiness, you should vomiting, loss of appetite, avoid driving a car or operating machinery until you know itching]2 how ZYPREXA affects you. Some people may feel dizzy in the early stages of treatment, especially when getting up Low white blood cell count from a lying or sitting position. This side effect usually [symptoms of infection, such as cold, flu-like symptoms, fever, passes after taking ZYPREXA for a few days. sore throat, as well as weakness or general feeling of After prolonged use in women, medicines of this type can unwellness]2 cause milk secretion or changes in the regularity of their
ZYPREXA® Product Monograph Page 3 of 9 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 Stop taking Talk with your Stop taking doctor or drug and doctor or drug and Symptom / effect pharmacist call your Symptom / effect pharmacist call your doctor or doctor or Only if In all pharmacist Only if In all pharmacist severe cases severe cases Rash2 (see also Allergic fever. Reaction below) 1 Identified from the clinical trial database. 2 Identified from adverse events reported after release onto * Seizure [i.e., loss of market. consciousness with 3 2 Identified from data from 5 placebo-controlled trials in elderly uncontrollable shaking (“fit”)] patients with dementia-related psychosis. Very Rare * If you think you have these side effects, it is important that you seek medical advice from your doctor immediately. Allergic reaction [symptoms * include skin rash, hives, This is not a complete list of side effects. For any 2 swelling, difficulty breathing] unexpected effects while taking ZYPREXA, contact your Bruise easily, excessive doctor or pharmacist. bleeding2 HOW TO STORE IT High fever, muscle rigidity, * rapid heartbeat, profuse sweating, irregular pulse1,2 All medicines should be kept out of the reach of children. ZYPREXA should be stored in its original package at Increased thirst & hunger, room temperature, in a dry place and out of direct light. frequent urination1,2 The expiry date of this medicine is printed on the package Muscle twitching or abnormal * label. Do not use the medicine after this date. If your movements of the face or doctor tells you to stop taking ZYPREXA or you find that tongue2 they have passed their expiry date, please return any left over medicine to your pharmacist. Blood clots: swelling, pain and redness in an arm or leg that can be warm to touch. You may develop sudden chest pain, REPORTING SUSPECTED SIDE EFFECTS difficulty breathing and heart palpitations2 You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by Pancreas inflammation one of the following 3 ways: [symptoms of severe abdominal ------pain, fever, nausea, vomiting]2 Report online at www.healthcanada.gc.ca/medeffect Long-lasting (greater than 4 Call toll-free at 1-866-234-2345 hours in duration) and painful Complete a Canada Vigilance Reporting Form erection of the penis2 and: Sudden weakness or numbness * - Fax toll-free to 1-866-678-6789, or in the face, arms, or legs, and - Mail to: Canada Vigilance Program speech or vision problems3 Health Canada Postal Locator 0701E Very dark (“tea coloured”) Ottawa, Ontario urine, muscle tenderness and/or K1A 0K9 aching2 Postage paid labels, Canada Vigilance Serious skin reactions: (Drug Reporting Form and the adverse reaction Reaction with Eosinophilia and reporting guidelines are available on the Systemic Symptoms MedEffect™ Canada Web site at [DRESS]): skin rash or redness www.healthcanada.gc.ca/medeffect. developing into widespread rash with blisters and peeling NOTE: Should you require information related to the skin, swollen lymph nodes and management of side effects, contact your health
ZYPREXA® Product Monograph Page 4 of 9 professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
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.
ZYPREXA is a trademark owned by Eli Lilly and Company. Zydis is a trademark owned by R.P. Scherer Technologies, Inc., a Catalent Pharma Solutions Company.
Last revised: April 10, 2020 ZYP-0004-CA-PMI-20200410
ZYPREXA® Product Monograph Page 5 of 9 ZYPREXA IntraMuscular contains the inactive ingredients PART IIIB: CONSUMER INFORMATION lactose monohydrate and tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during PrZYPREXA®IntraMuscular manufacturing to adjust pH. (olanzapine tartrate for injection) What dosage forms it comes in: This leaflet is part III of a three-part "Product ZYPREXA IntraMuscular is available as a single use vial Monograph" published when ZYPREXA was approved of olanzapine, as the tartrate, equivalent to 10 mg for sale in Canada and is designed specifically for olanzapine. It is to be administered by qualified healthcare Consumers. This leaflet is a summary and will not tell professionals only. you everything about ZYPREXA. Contact your doctor or pharmacist if you have any questions about the drug. WARNINGS AND PRECAUTIONS
ABOUT THIS MEDICATION Serious Warnings and Precautions Studies with various medicines of the group to which The name of your medicine is ZYPREXA IntraMuscular ZYPREXA belongs, including ZYPREXA, when used in and your doctor has treated you with it to help relieve the elderly patients with dementia have been associated with symptoms that are bothering you. ZYPREXA an increased rate of death. ZYPREXA is not indicated in IntraMuscular can help to control your symptoms. Although elderly patients with dementia. ZYPREXA IntraMuscular cannot cure your symptoms, it can help you keep them under control. Before being treated with ZYPREXA IntraMuscular and to What the medication is used for: get the best possible treatment, be sure to tell your doctor ZYPREXA IntraMuscular is used for the rapid control of if you: agitation in patients with schizophrenia and related psychotic disorders, and bipolar mania. are pregnant or plan to become pregnant are breast feeding or plan on breast feeding Your doctor may have treated you with ZYPREXA have had an allergic reaction to any medicine which you IntraMuscular for another reason. Ask your doctor if you have taken previously to treat your current condition have any questions about why you have been treated with have diabetes or a family history of diabetes ZYPREXA IntraMuscular. have a history of any problems with the way your heart beats or have any heart problems What it does: have a history of stroke or high blood pressure ZYPREXA IntraMuscular belongs to a group of medicines have risk factors for developing blood clots such as: a called antipsychotics. ZYPREXA IntraMuscular is used for family history of blood clots, age over 65, smoking, the rapid control of agitation in patients with schizophrenia obesity, recent major surgery (such as hip or knee and related psychotic disorders. Schizophrenia may cause replacement), immobility due to air travel or other symptoms such as hallucinations (e.g. hearing, seeing, or reason, or take oral contraceptives ("The Pill"). sensing things which are not there), delusions, unusual are a smoker suspiciousness, feeling withdrawn, lack of emotions. People have ever had blackouts or seizures with schizophrenia may also feel depressed, anxious or are taking any other medicines (prescriptions or tense. over-the-counter medicines) drink alcoholic beverages or use drugs When it should not be used: exercise vigorously or work in hot or sunny places You should not be treated with ZYPREXA IntraMuscular have a history of liver problems, hepatitis, or yellowing if you have had an allergic reaction to ZYPREXA Tablets, of the eyes and skin (jaundice) ZYPREXA Zydis or ZYPREXA IntraMuscular or any of have prostate problems the ingredients listed in the “Nonmedicinal Ingredients” have intestinal congestion (paralytic ileus) section of this leaflet. Signs of allergic reaction may include have raised pressure within the eye (glaucoma) a skin rash, itching, shortness of breath or swelling of the face, lips or tongue. have any unstable medical conditions suffer from lactose intolerance because What the medicinal ingredient is: ZYPREXA IntraMuscular contain lactose ZYPREXA IntraMuscular contains the active ingredient called olanzapine (as the tartrate). It is important for your doctor to have this information, if possible, before starting your treatment. What the nonmedicinal ingredients are: Effects on Newborns: In some cases, babies born to a mother taking ZYPREXA ongoing treatment for your symptoms. Your doctor may during pregnancy have experienced symptoms that are discontinue treatment with ZYPREXA IntraMuscular and severe and require the newborn to be hospitalized. may continue olanzapine therapy with ZYPREXA tablets Sometimes, the symptoms may resolve on their own. Be or ZYPREXA Zydis orally disintegrating tablets or prepared to seek immediate emergency medical attention prescribe another drug for you depending on your for your newborn if they have difficulty breathing, are individual situation and needs. overly sleepy, have muscle stiffness, or floppy muscles (like a rag doll), are shaking, or are having difficulty feeding. Overdose: ZYPREXA IntraMuscular is given under the supervision of a qualified physician. Any overdose or missed dose INTERACTIONS WITH THIS MEDICATION should be managed by a qualified physician experienced in the use of intramuscular injections. Tell your doctor or pharmacist if you are taking ZYPREXA Tablets or ZYPREXA Zydis to treat your condition. SIDE EFFECTS AND WHAT TO DO ABOUT THEM A combination of ZYPREXA IntraMuscular with the following medicines might make you feel drowsy: Like other medicines, ZYPREXA IntraMuscular can cause medicines taken for anxiety or to help you sleep some side effects. These side effects are most likely to be medicines taken for depression. minor and temporary. However, some may be serious and need medical attention. Many of the side effects are dose The effects of alcohol could be made worse while being related, so it is important not to exceed the intended treated with ZYPREXA IntraMuscular. It is recommended treatment dose. The most common side effects of oral that you DO NOT drink alcohol while being treated with olanzapine are: ZYPREXA IntraMuscular. drowsiness weight gain You should tell your doctor if you are taking fluvoxamine dizziness (antidepressant), ketoconazole (antifungal), or ciprofloxacin increased appetite (antibiotic), as these medicines may lead to higher fluid retention concentrations of olanzapine in your blood. constipation dry mouth You should also tell your doctor if you are taking a feeling of restlessness (akathisia) carbamazepine as it may lead to lower concentrations of decreased blood pressure upon rising from a lying or olanzapine in your blood, making ZYPREXA sitting position IntraMuscular less effective. An infrequent side effect specific to intramuscular Only take other medicines while you are being treated with olanzapine is low blood pressure and/or fainting associated ZYPREXA IntraMuscular if your doctor tells you that you with decrease in heart rate. Events of increased salivation can. (salivary hypersecretion) were uncommonly reported.
PROPER USE OF THIS MEDICATION You may also feel weak after your treatment with ZYPREXA IntraMuscular. You should remain lying down if you feel dizzy or drowsy after injection. Your doctor Usual dose: will examine you to make sure that you are not ZYPREXA IntraMuscular is intended for intramuscular experiencing any of the above side effects, or are not use only. It is injected slowly, deep into the muscle mass. having any difficulties in breathing.
Your doctor will decide on the best dose for you based on Because some people experience drowsiness, you should your individual situation and needs. Your doctor may avoid driving a car or operating machinery until you know increase or decrease your dose depending on your response. how ZYPREXA IntraMuscular has affected you. Although most patients require only a single dose, your doctor may give you additional doses as necessary. You You should also tell your doctor if you notice any will receive no more than three injections in a 24-hour symptoms that worry you, even if you think the problems period. are not connected with the medicine or are not listed here.
Although ZYPREXA IntraMuscular cannot cure your Your doctor should check your body weight before starting condition, it can help relieve your symptoms. If your ZYPREXA and continue to monitor it for as long as you symptoms improve or disappear, it is probably because your are being treated. treatment is working. Your doctor may decide that you need
ZYPREXA® Product Monograph Page 7 of 9 Your doctor should take blood tests before starting SERIOUS SIDE EFFECTS, HOW OFTEN THEY ZYPREXA. They will monitor blood sugar, and the number HAPPEN AND WHAT TO DO ABOUT THEM of infection fighting white blood cells. Your doctor should continue to monitor your blood for as long as you are being Talk with your Stop treated. doctor or taking Symptom / effect pharmacist drug and call your If you have high levels of prolactin (measured with a blood Only if In all doctor or test) and a condition called hypogonadism you may be at severe cases pharmacist increased risk of breaking a bone due to osteoporosis. This occurs in both men and women. Allergic reaction [symptoms * include skin rash, hives, swelling, difficulty breathing]2 Do not be alarmed by this list of possible side effects. You may not experience any of them. If any of these side effects Bruise easily, excessive are experienced, they are usually mild and temporary. bleeding2 High fever, muscle rigidity, * The side effects listed below have been observed following rapid heartbeat, profuse administration of ZYPREXA tablets or ZYPREXA Zydis, sweating, irregular pulse1,2 but may also occur following administration of ZYPREXA IntraMuscular. The table is based on data from placebo- Increased thirst & hunger, 1,2 controlled clinical trials and from post-marketing data. frequent urination Muscle twitching or abnormal * movements of the face or SERIOUS SIDE EFFECTS, HOW OFTEN THEY tongue2 HAPPEN AND WHAT TO DO ABOUT THEM Blood clots: swelling, pain and Talk with your Stop redness in an arm or leg that can doctor or taking be warm to touch. You may pharmacist drug and develop sudden chest pain, Symptom / effect difficulty breathing and heart call your 2 Only if In all doctor or palpitations severe cases pharmacist Pancreas inflammation Common [symptoms of severe abdominal pain, fever, nausea, vomiting]2 New or worsening constipation Long-lasting (greater than 4 Uncommon hours in duration) and painful erection of the penis2 Slow heartbeat1 Sudden weakness or numbness * Rare in the face, arms, or legs, and speech or vision problems3 Liver inflammation [symptoms * of fever, yellow skin or eyes, Very dark (“tea coloured”) urine, dark urine, weakness, abdominal muscle tenderness and/or pain, nausea, vomiting, loss of aching2 appetite, itching]2 Serious skin reactions: (Drug Low white blood cell count Reaction with Eosinophilia and [symptoms of infection, such as Systemic Symptoms [DRESS]): cold, flu-like symptoms, fever, skin rash or redness developing sore throat, as well as weakness into widespread rash with or general feeling of blisters and peeling skin, swollen unwellness]2 lymph nodes and fever. Rash2 (see also Allergic 1 Identified from the clinical trial database. Reaction below) 2 Identified from adverse events reported after release onto market. Seizure [i.e., loss of * 3 Identified from data from 5 placebo-controlled trials in elderly consciousness with patients with dementia-related psychosis. uncontrollable shaking (“fit”)]2 * If you think you have these side effects, it is important that you seek medical advice from your doctor immediately. Very Rare
ZYPREXA® Product Monograph Page 8 of 9 This is not a complete list of side effects. For any ZYP-0003-CA-PMI-20200410 unexpected effects while taking ZYPREXA, contact your doctor or pharmacist.
HOW TO STORE IT
ZYPREXA IntraMuscular should be stored in its original package (unconstituted) between 15-30C. The expiry date of this medicine is printed on the package label. The medicine should not be used after this date. Reconstituted ZYPREXA IntraMuscular should be used immediately (within 1 hour) after reconstitution. Any unused portion of the reconstituted ZYPREXA IntraMuscular should be discarded.
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 online at 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, or - Mail to: Canada Vigilance Program Health Canada Postal Locator 0701E Ottawa, Ontario K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at 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 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.
ZYPREXA is a trademark owned by Eli Lilly and Company.
Last revised: April 10, 2020
ZYPREXA® Product Monograph Page 9 of 9