IMPORTANT: PLEASE READ

 have a circulation problem in your legs that causes PART III: CONSUMER INFORMATION cramp-like pains when you walk (peripheral vascular disease). Pr Sandoz Naratriptan  have uncontrolled or severe high blood pressure. Naratriptan Tablets  have severe liver or kidney disease. 2.5 mg  have taken another migraine medication such as naratriptan (as naratriptan hydrochloride) IMITREX® (sumatriptan), ZOMIG® (zolmitriptan), MAXALT® (rizatriptan), or AXERT® (almotriptan) or Please read this leaflet carefully before you take Sandoz ergotamine-type medications such as ergotamine, Naratriptan. This leaflet is a summary and will not tell dihydroergotamine or methysergide within the last 24 you everything about Sandoz Naratriptan. Please do not hours. throw away this leaflet until you have finished your medicine. You may need to read this leaflet again. Contact Sandoz Naratriptan should not be used to relieve pain your doctor or pharmacist if you have any questions other than from a migraine headache. about the drug. What the medicinal ingredient is: Naratriptan (as naratriptan hydrochloride) ABOUT THIS MEDICATION

What the nonmedicinal ingredients are: The name of your medicine is Sandoz Naratriptan. It can be Aluminum Lake FD&C Blue #2, Cellulose Microcrystalline, obtained only by prescription from your doctor. The decision Croscarmellose Sodium, Hypromellose, Iron Oxide Yellow, to use Sandoz Naratriptan is one that you and your doctor Lactose Anhydrous, Lactose Monohydrate, Magnesium should make jointly, taking into account your individual Stearate, Titanium Dioxide, Triacetin. preferences and medical circumstances. If you have risk factors for heart disease (such as high blood pressure, high What dosage forms it comes in: cholesterol, obesity, diabetes, smoking, strong family history Sandoz Naratriptan is available as a 2.5 mg tablet. of heart disease), or you are postmenopausal or a male over 40, you should tell your doctor, who should evaluate you for heart disease, in order to determine if Sandoz Naratriptan is WARNINGS AND PRECAUTIONS appropriate for you. Sandoz Naratriptan is not recommended for people over What the medication is used for: 65 years of age or for children under the age of 18. Sandoz Naratriptan is intended to relieve your migraine headache and other associated symptoms of a migraine BEFORE you use Sandoz Naratriptan, talk to your attack. Sandoz Naratriptan should not be used doctor or pharmacist if you: continuously to prevent or reduce the number of attacks  have or have had blood vessel problems, including you experience. Use Sandoz Naratriptan only to treat an ischemic bowel disease actual migraine headache attack.  are pregnant, think you might be pregnant, you are trying to become pregnant, you are using inadequate What it does: contraception, or you are breast-feeding Migraine headache is believed to be caused by a widening of  have or had any pain or tightness in the chest (which the blood vessels in the head. Sandoz Naratriptan narrows may or may not spread to your neck, jaw, or upper arm), these vessels and relieves the pain and other symptoms of heart or blood vessel disease, angina, shortness of migraine headache. breath, or irregular heartbeat  have had a heart attack, stroke or mini-stroke (also When it should not be used: called a transient ischemic attack or TIA) Do not take Sandoz Naratriptan if you:  have risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking,  are allergic to naratriptan or any of the ingredients (see strong family history of heart disease, or you are What the nonmedicinal ingredients are section). postmenopausal or a male over 40)  have heart problems or a history of heart problems, such as  have ever had to stop taking this or any other heart failure or chest pains (angina) or have had a heart medication because of an allergy or other problems attack.  have or have had epilepsy or seizures  have had a stroke or a mini-stroke (transient ischemic attack or TIA).

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 suffer from peripheral vascular disease (e.g., pain in the Signs and symptoms of serotonin syndrome include back of the legs while walking) or are prone to cold the following: restlessness, diarrhea, hallucinations, and/or pale or purplish hands and feet coma, loss of coordination, nausea, fast heartbeat,  are taking any other migraine medications such as vomiting, increased body temperature, changes in IMITREX® (sumatriptan), ZOMIG® (zolmitriptan), blood pressure and overactive reflexes. ® ® MAXALT (rizatriptan), or AXERT (almotriptan),  Other 5-HT1 receptor agonists, such as sumatriptan which may contain any triptan/5-HT1 agonists, or used to treat migraine. ergotamine, dihydroergotamine, or methysergide  Ergotamine also used to treat migraine, or similar  are taking any antidepressants classed as selective medicines such as methysergide. serotonin reuptake inhibitors (SSRIs), serotonin noradrenaline reuptake inhibitors (SNRIs) or other Tell your doctor or pharmacist if you are taking any of medications for depression these.  have ever experienced numbness or have had difficulty moving one side of your body when you have a PROPER USE OF THIS MEDICATION headache

 had or have any disease of the kidney or liver REMEMBER: this medicine was prescribed only for YOU.  experience a headache that is different from your usual Only a physician knows who can use it safely. Never give it migraine attacks to someone else. It may harm them, even if their symptoms are the same as yours. Continuous use of Sandoz Naratriptan Taking Sandoz Naratriptan too often may make your Usual dose: headaches worse or more frequent. If this happens to you, tell For adults, the usual dose is a single 1 mg* or 2.5 mg tablet your doctor. You may have to stop taking Sandoz (as recommended by your doctor) taken whole with water. Naratriptan. The tablet should be taken as soon as your migraine appears, but may be taken any time after the headache starts. A second If you are not sure whether you should take Sandoz tablet may be taken if your headache returns or if you need Naratriptan, contact your doctor or pharmacist. more relief, but not sooner than 4 hours following the first tablet. Driving and using machines Sandoz Naratriptan may make you drowsy. Do not drive or For an individual attack, if you have no response to the first operate machinery unless you are feeling alert. tablet, do not take a second tablet without first talking to your doctor. Do not take more than a total of 5 mg in any 24-hour The use of Sandoz Naratriptan During Pregnancy: period. Do not use Sandoz Naratriptan if you are pregnant, think you If you are taking any other migraine medicines, check with might be pregnant, are trying to become pregnant, or are not your doctor first before taking Sandoz Naratriptan. using adequate contraception, unless you have discussed this with your doctor. If you have kidney or liver disease, take as directed by your doctor. INTERACTIONS WITH THIS MEDICATION * Sandoz Naratriptan is not available as 1 mg strength.

Tell your doctor or pharmacist if you’re taking any other Overdose: medicines, if you have taken any recently, or if you start taking new ones. This includes medicines you’ve bought without a prescription. In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Some medicines must not be taken with Sandoz Naratriptan Centre immediately, even if there are no symptoms. and others may cause adverse effects if they’re taken with Sandoz Naratriptan. These include: SIDE EFFECTS AND WHAT TO DO ABOUT THEM  SSRIs (Selective Serotonin Reuptake Inhibitors) or

SNRIs (serotonin-noradrenaline reuptake inhibitors) Like all medicines, Sandoz Naratriptan can cause some side used to treat depression. A life-threatening condition effects. You may not experience any of them. For most called serotonin syndrome can happen when patients these side effects are likely to be minor and medicines called triptans, such as Sandoz Naratriptan, temporary. However, some may be serious. Consult your and medicines used to treat depression and mood doctor if you experience these or other side effects. disorders called SSRIs and SNRIs are used together.

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 Swelling of the glands that produce saliva Common side effects – these may affect up to 1 in 10 people:  Changes in sense of taste  Ear, nose and throat infections  Nausea, vomiting SERIOUS SIDE EFFECTS, HOW OFTEN THEY  Drowsiness HAPPEN AND WHAT TO DO ABOUT THEM  Dizziness  Headache Symptom / effect Talk with your Stop taking  Dry mouth doctor or drug and call  Feeling tired or unwell pharmacist your doctor or pharmacist Only if In all Uncommon side effects – these may affect up to 1 in 100 severe cases people: Unusual Common  sensations,  Rise in blood pressure  Fainting, light-headedness including numbness,  Tremor tingling, feeling  Difficulty sleeping hot or pain in  Nose, throat and sinus infection any part of the body including  Urinary tract infections chest, neck,  Feeling full or bloated jaw, and throat  Stomach pain or discomfort

 Diarrhea Un- Unusual fast   Constipation common heartbeats, or a feeling of irregular  Muscle or joint pain, muscle cramps, or and/or forceful inflammation of the joints heartbeats;  Feeling anxious or depressed heaviness, pressure or  Difficulty with learning, perception, memory and tightness in any problem solving part of the body  Increased sense of touch including chest  Skin effects such as rash, itchiness, bumpiness and and throat; Feeling hot or cold sensitivity to light  Sweating  Feeling thirsty Unusually Rare   Sensitivity to sound slow heartbeats;

Unexpected or  Rare side effects – these may affect up to 1 in 1000 people: Rare prolonged  Nasal congestion (allergic rhinitis) bleeding,  Eye problems such as dry eyes, blurred vision and including from sensitivity to light your ears, nose, throat and eyes  Acid reflux or in the brain;  Hemorrhoids blood in the  Itchy or irritated mouth urine; convulsions;  Ulcers pain or difficulty  Muscle or joint stiffness when  Muscle twitches swallowing; allergic  Low blood pressure reactions  Poor balance or coordination, slowed movement (shortness of  Lack of energy or alertfulness, confusion breath, sudden wheeziness,  Aggression, agitation or detachment swelling of  Hair loss eyelids, face of  Red, flushed or inflamed skin lips, lumpy skin, rash or hives)  Ear effects such as infection, difficulty hearing, ringing sensation  Sudden, compelling urge to urinate

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SERIOUS SIDE EFFECTS, HOW OFTEN THEY REPORTING SUSPECTED SIDE EFFECTS HAPPEN AND WHAT TO DO ABOUT THEM You can report any suspected adverse reactions associated Symptom / effect Talk with your Stop taking with the use of health products to the Canada Vigilance doctor or drug and call Program by one of the following 3 ways: pharmacist your doctor or ------pharmacist . Report online at Only if In all www.healthcanada.gc.ca/medeffect severe cases . Call toll-free at 1-866-234-2345 Heart attack or  Very rare . Complete a Canada Vigilance Reporting Form and: symptoms of a - Fax toll-free to 1-866-678-6789, or heart attack (chest pain, shortness of - Mail to: Canada Vigilance Program breath); lower Health Canada abdominal pain Postal Locator 0701E and/or severe Ottawa, Ontario rectal bleeding K1A 0K9 (colonic ischemia); Postage paid labels, Canada Vigilance Reporting numbness, Form and the adverse reaction reporting guidelines tingling, cold or ™ pain in the hands are available on the MedEffect Canada Web site at or feet; pale or www.healthcanada.gc.ca/medeffect. purple discolouration; NOTE: Should you require information related to the stroke or mini- management of side effects, contact your health professional. stroke (transient The Canada Vigilance Program does not provide medical ischemic attack) advice.

This is not a complete list of side effects. For any unexpected effects while taking Sandoz Naratriptan, MORE INFORMATION contact your doctor or pharmacist. This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, HOW TO STORE IT Sandoz Canada Inc., at:

1-800-361-3062 Keep your medicine in a safe place where children cannot

reach and see it. It may be harmful to children. or by written request at:

145 Jules-Léger Your medication should be stored between 15-30°C and Boucherville QC away from heat and light. J4B 7K8

If your medication has expired (the expiration date is printed on Or by e-mail at : the treatment pack), do not use it. Throw it away. [email protected]

If your doctor decides to stop your treatment, do not keep any This leaflet was prepared by Sandoz Canada Inc. leftover medicine unless your doctor tells you to.

Last revised: July 22, 2017

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