IMPORTANT: PLEASE READ

PART III: CONSUMER INFORMATION WARNINGS AND PRECAUTIONS Pr ® ZOLOFT Treatment with these types of medication is most safe and (sertraline hydrochloride) effective when you and your doctor have good communication about how you are feeling. This leaflet is part III of a three-part "Product Monograph" published when ZOLOFT was approved for ZOLOFT is not for use in children under 18 years of age. sale in Canada and is designed specifically for Consumers. Changes in Feelings and Behaviour: This leaflet is a summary and will not tell you everything It is important that you have good communication with your about ZOLOFT. Contact your doctor or pharmacist if doctor about how you feel. Discussing your feelings and you have any questions about the drug. treatment with a friend or relative who can tell you if they think you are getting worse is also useful. Please read this information carefully before you start to take Some patients may feel worse when first starting or changing your medicine, even if you have taken this drug before. the dose of drugs such as ZOLOFT. You may feel more

anxious or may have thoughts of hurting yourself or others, ABOUT THIS MEDICATION especially if you have had thoughts of hurting yourself before. These changes in feelings can happen in patients treated with What the medication is used for: drugs like ZOLOFT for any condition, and at any age, ZOLOFT has been prescribed to you by your doctor to relieve although it may be more likely if you are aged 18 to 24 years your symptoms of the following conditions: old. If this happens, see your doctor immediately. Do not  Depression (feeling sad, a change in appetite or weight, stop taking ZOLOFT on your own. difficulty concentrating or sleeping, feeling tired, headaches, unexplained aches and pain) Taking ZOLOFT may increase your risk of experiencing  Obsessive-compulsive disorder sexual problems, which may continue after ZOLOFT has been  (repeated, unexpected panic attacks) discontinued. Tell your doctor if you experience symptoms such as a decreased , erectile dysfunction or ejaculation What it does: failure. ZOLOFT belongs to a group of medicines known as , more specifically to the family of medicines Taking ZOLOFT may increase your risk of breaking a bone if called SSRIs (Selective Inhibitors). you are elderly or have osteoporosis or have other major risk factors for breaking a bone. You should take extra care to ZOLOFT is thought to work by increasing the levels of a avoid falls especially if you get dizzy or have low blood chemical in the brain called serotonin (5-hydroxytryptamine). pressure. When it should not be used: Before taking ZOLOFT tell your doctor or pharmacist:  Do not use ZOLOFT if you are allergic to it or to any of  all your medical conditions the components of its formulation (see list of components  if you have a history of: at the end of this section). Stop taking the drug and o seizures contact your doctor immediately if you experience an o disease allergic reaction or any severe or unusual . o kidney disease  Do not use ZOLOFT if you are currently taking or have o high cholesterol recently taken inhibitors, o heart disease antidepressants (e.g. sulphate, o heart rhythm problems sulphate, ) o slow heart beat  Do not use ZOLOFT at the same time as o are taking medications for your heart manic episodes What the medicinal ingredient is: o Sertraline Hydrochloride  if in your family there is a history of: o people younger than 50 years of age having a heart What the nonmedicinal ingredients are: attack cornstarch; lactose (anhydrous); magnesium stearate; sodium  if the levels of electrolytes in your body are either too lauryl sulfate. Capsule shells contain gelatin, titanium dioxide high or too low or you have a condition (such as an and dye D & C Yellow #10. Capsules 25 and 50 mg also eating disorder) that can affect your electrolyte levels contain dye FD & C Yellow #6 and capsules 100 mg also  if you have had a stroke contain dye FD& C #40. The capsules do not contain  if you are known to have heart problems (or tartrazine or gluten. predispositions) related to a genetic expression (or What dosage forms it comes in: modification, variant) ZOLOFT is available as 25 mg (yellow capsule), 50 mg (white  if you have had a head injury and yellow capsule) and 100 mg (orange capsule).  if you have diabetes  if you have a bleeding disorder or have been told that you have low platelets.

 if you have blood pressure problems; ZOLOFT (sertraline hydrochloride) – Product Monograph Page 51 of 54 IMPORTANT: PLEASE READ

 any medications (prescription or non-prescription) which Angle-closure Glaucoma you are taking or have recently taken (within last 14 ZOLOFT can cause an acute attack of glaucoma. Having your days), especially monoamine oxidase (MAO) inhibitors eyes examined before you take ZOLOFT could help identify if (e.g. phenelzine sulfate, tranylcypromine sulfate, you are at risk of having angle-closure glaucoma. Seek moclobemide) or any other antidepressants, pimozide (an immediate medical if you experience: drug), drugs used to treat diabetes, drugs  eye pain used to thin the blood (anticoagulant), the antibiotic  changes in vision , methylthioninium chloride (methylene blue) or  swelling or redness in or around the eye drugs that affect serotonin (including but not limited to fentanyl, fenfluramine and ).  if you are pregnant or thinking about becoming pregnant, INTERACTIONS WITH THIS MEDICATION or if you are breast feeding; Do not use ZOLOFT if you are taking or have recently  if you have a recent bone fracture or were told you have taken monoamine oxidase inhibitors. osteoporosis or risk factors for osteoporosis  your habits of and/or street drug consumption; You should avoid taking St. John’s Wort if you are taking  any natural or herbal products you are taking (e.g., St. ZOLOFT. John’s Wort). You should tell your doctor if you are taking or have recently  if you drive a vehicle or perform hazardous tasks during taken any medications (prescription, non-prescription or your work. natural/herbal), especially:  if you have ever had any allergic reaction to medications,  other antidepressants, such as SSRIs and certain food, etc;  other drugs that affect serotonin such as, , Effects on Pregnancy and Newborns , linezolid, , tryptophan, triptans used to If you are already taking ZOLOFT and have just found treat migraines out that you are pregnant, you should talk to your doctor  certain medicines used to treat pain, such as fentanyl immediately. You should also talk to your doctor if you (used in anaesthesia or to treat chronic paint), tramadol, are planning to become pregnant. , meperidine, , Some newborns whose mothers took an SSRI (selective  certain medicines used to treat cough, such as serotonin ) or other newer anti-depressants, such as ZOLOFT, during pregnancy have developed  certain medicines used to treat schizophrenia complications at birth requiring prolonged hospitalization,  certain medicines used to treat bipolar depression, such as breathing support and tube feeding. Reported symptoms lithium included feeding and/or breathing difficulties, seizures, tense  or other medications used to treat high blood or overly relaxed muscles, jitteriness and constant crying. pressure and angina In most cases, the SSRI or other newer anti-depressant was  certain medicines which may affect blood clotting and taken during the third trimester of pregnancy. These increase bleeding, such as oral anti-coagulants (e.g. symptoms are consistent with either a direct adverse effect of , dabigatran), acetylsalicylic acid (e.g. Aspirin) the anti-depressant on the baby, or possibly a discontinuation and other non-steroidal anti-inflammatory drugs (e.g. syndrome caused by sudden withdrawal from the drug. These ibuprofen) symptoms normally resolve over time. However, if your baby  certain medicines used to treat epilepsy experiences any of these symptoms, contact your doctor as  cimetidine soon as you can.  In general, drinking alcoholic beverages should be kept to a minimum or avoided completely while taking ZOLOFT.

Persistent Pulmonary Hypertension (PPHN) and newer antidepressants: PROPER USE OF THIS MEDICATION When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like ZOLOFT may increase Usual dose: the risk of a serious lung condition in babies, called persistent  It is very important that you take ZOLOFT exactly as pulmonary hypertension of the newborn (PPHN), that causes your doctor has instructed. breathing difficulties in newborns soon after birth, making the  Never increase or decrease the amount of ZOLOFT you, baby breathe faster and appear bluish. These symptoms or those in your care if you are a caregiver or guardian, usually begin during the first 24 hours after the baby is born. If are taking unless your doctor tells you to this happens to your baby you should contact your doctor  Do not stop taking this medication without consulting immediately. your doctor.  As with all antidepressants improvement with ZOLOFT is If you are pregnant and taking an SSRI, or other newer gradual. You should continue to take ZOLOFT even if , you should discuss the risks and benefits of the you do not feel better, as it may take several weeks for various treatment options with your doctor. It is very your medication to work. Improvement may be gradual. important that you do NOT stop taking these medications without first consulting your doctor.

ZOLOFT (sertraline hydrochloride) – Product Monograph Page 52 of 54 IMPORTANT: PLEASE READ

 ZOLOFT should be taken with food either in the morning treatment with ZOLOFT. or the evening. You should swallow the capsule whole, do

not divide, crush or chew the capsules. Discontinuation Symptoms REMEMBER: This medicine has been prescribed only for Contact your doctor before stopping or reducing your dosage you. Do not give it to anybody else. If you have any of ZOLOFT. Symptoms such as dizziness, abnormal dreams, further questions, please ask your doctor or pharmacist. electric shock sensations, agitation, anxiety, difficulty Overdose: concentrating, headache, tremor, nausea, vomiting, sweating In case of overdose, contact your doctor, the regional Poison or other symptoms may occur after stopping or reducing the Control Centre, or the nearest hospital emergency department, dosage of ZOLOFT. Such symptoms may also occur if a dose even though you may not feel sick. Take your medicine with is missed. These symptoms usually disappear without needing you. treatment. Tell your doctor immediately if you have these or any other symptoms. Your doctor may adjust the dosage of Missed Dose: ZOLOFT to alleviate the symptoms. If you happen to miss a dose, do not take the missed dose. Just take your next dose at the right time. Do not take a double dose to make up for a forgotten dose. SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM SIDE EFFECTS AND WHAT TO DO ABOUT THEM Symptom / effect Talk with Seek Like all medications, ZOLOFT can cause some side effects. your doctor or immediate You may not experience any of them. For most patients these pharmacist emergency side effects are likely to be minor and temporary. However, medical Only In all attention some may be serious. Some of these side effects may be dose if cases related. Consult your doctor if you experience these or other severe side effects, as the dose may have to be adjusted. : feeling Uncommon  If you experience an allergic reaction (including red skin, restless and unable to sit or stand still hives, itching, swelling of the lips, face, tongue, throat, trouble Allergic reactions:  breathing, wheezing, shortness of breath, skin rashes, blisters rash, hives, swelling of the skin, sores or pain in the mouth or eyes) or any severe of the face, lips, or unusual side effects, stop taking the drug and contact your tongue or throat, doctor immediately. difficulty swallowing or breathing Some side effects of ZOLOFT are: Bruising or unusual   headache bleeding from the skin  nausea or other areas Liver Disorder:  dry mouth   diarrhea yellowing of the skin or eyes, dark urine,  loss of appetite abdominal pain,  sleepiness nausea, vomiting, loss  dizziness of appetite Low blood sugar:  insomnia   sexual problems including decreased libido, erectile symptoms of dysfunction and ejaculation failure dizziness, lack of energy, drowsiness  nervousness Low sodium level in   Tremor blood: symptoms of ZOLOFT does not usually affect people’s normal activities. tiredness, weakness, confusion combined However, some people feel sleepy while taking it, in which with achy, stiff or case they should not drive or operate machinery. uncoordinated Cases of loss of blood sugar level control including both muscles /: higher and lower-than normal sugar level have been reported  elevated or irritable in patients receiving SSRIs including ZOLOFT, with and mood, decreased need without pre-existing diabetes. Symptoms associated with low for sleep, racing blood sugar level in your blood include weakness, hunger, thoughts anxiety, sweating, numbness or tingling in your extremities. Uncontrollable  These are early warning symptoms and should not be ignored. movements of the Contact your doctor if you experience these symptoms. body or face ZOLOFT may raise cholesterol levels in some patients. Blood cholesterol tests may be required by your doctor during ZOLOFT (sertraline hydrochloride) – Product Monograph Page 53 of 54 IMPORTANT: PLEASE READ

SERIOUS SIDE EFFECTS, HOW OFTEN THEY Reporting Side Effects HAPPEN AND WHAT TO DO ABOUT THEM You can report any suspected side effects associated with the Symptom / effect Talk with Seek use of health products to Health Canada by: your doctor or immediate  Visiting the Web page on Adverse Reaction pharmacist emergency Reporting (http://www.hc-sc.gc.ca/dhp- medical mps/medeff/report-declaration/index-eng.php) for Only In all attention if cases information on how to report online, by mail or by severe fax; or Heart Rhythm  Calling toll-free at 1-866-234-2345.  problems: dizziness, increased heart rate, NOTE: Contact your health professional if you need fainting or seizures information about how to manage your side effects. The Gastrointestinal Rare  Canada Vigilance Program does not provide medical advice. bleeding: vomiting blood or passing blood in stools Glaucoma: swelling MORE INFORMATION  or redness in or around the eye, eye pain and changes in This document plus the full product monograph, prepared for vision health professionals can be found by contacting the sponsor, Seizures: loss of Upjohn Canada ULC, at: 1-800-463-6001  consciousness with Or at: www..ca uncontrollable shaking “fit” This leaflet was prepared by Upjohn Canada ULC Low Platelets: Unknown  Bruising or unusual Last revised: May 15, 2020 bleeding from the skin or other areas Upjohn Canada ULC : See  Kirkland, Québec H9J 2M5 Warnings a combination of most or all of the and ® Pfizer Products Inc. Precautions following; confusion, restlessness, sweating, Upjohn Canada ULC, Licensee shaking, shivering, © Upjohn Canada ULC, 2020 sudden jerking of the muscles, hallucinations, fast heartbeat Changes in feelings  or behaviour (, anxiety, suicidal or violent thoughts)

This is not a complete list of side effects. For any unexpected effects while taking ZOLOFT, contact your doctor or pharmacist

HOW TO STORE IT

 Store ZOLOFT at room temperature (15-30°C), in a dry place.  Keep container tightly closed.  Keep all medicines out of the reach and sight of children.  If your doctor tells you to stop taking ZOLOFT please return any leftover medicine to your pharmacist.

ZOLOFT (sertraline hydrochloride) – Product Monograph Page 54 of 54