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CONSUMER INFORMATION
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dihydroergotamine.

CAFERGOT*

Ergotamine tartrate and Caffeine Tablets USP This leaflet is part III of a three-part "Product Monograph" published when CAFERGOT* was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about CAFERGOT*. Contact your doctor or pharmacist if you have any questions about the drug.

Have conditions which predispose you to an excessive contraction of blood vessels (vasospastic reactions) such as: heart disease (particularly angina pectoris), vascular disease, inadequately controlled hypertension (high blood pressure), septic conditions (a serious complication of an infection) and shock. Have a severe liver disease. Have a severe kidney disease. Are pregnant, think you may be, are trying to become pregnant, or are using inadequate contraception (see Pregnant women). If you are breast feeding (see Nursing women).

ABOUT THIS MEDICATION What the medication is used for: CAFERGOT* tablets are intended to relieve your migraine headache and other associated symptoms of a migraine attack. Use CAFERGOT* tablets only to treat an actual migraine attack. CAFERGOT* tablets should not be used continuously to prevent or reduce the number of attacks you experience. CAFERGOT* should not be used to relieve pain other than that associated with migraine headache.

CAFERGOT* should not be used for the treatment of other types of headaches that are different from migraine attacks. What the medicinal ingredients are: Ergotamine tartrate and caffeine. What the nonmedicinal ingredients are: Each tablet also contains the following inactive ingredients: cellulose microcrystalline, iron oxide pigment yellow, magnesium stearate, maize starch, talc and tartraric acid. What dosage forms it comes in: CAFERGOT* is available in tablets containing 1 mg ergotamine tartrate USP and 100 mg caffeine USP.

What it does: Migraine headache is believed to be caused by a widening of the blood vessels in the head. CAFERGOT* narrows the vessels and relieves the pain and other symptoms of migraine attacks. Caffeine may increase the absorption of ergotamine from the gastrointestinal tract and may help to relieve migraine. When it should not be used: Do not take CAFERGOT* if you:

WARNINGS AND PRECAUTIONS Serious Warnings and Precautions Some medicines used to treat infection and HIV/AIDS may cause an increase in the amount of CAFERGOT* in the blood, increasing the risk of serious side effects. You should not take CAFERGOT* if you are treated with any of these medicines (see When it should not be used). Take special care with CAFERGOT* if you:

Are allergic to the active ingredients ergotamine and caffeine; to other ergot alkaloids; or to any other ingredient in the CAFERGOT* tablets (see What the nonmedicinal ingredients are). Are being treated for an infection with so-called macrolide antibiotics, for example: erythromycin, troleandomycin, clarithromycin. Are being treated for HIV/AIDS with medicines like ritonavir, nelfinavir, indinavir or delavirdine. Are being treated for fungal infection with medicines like ketoconazole, itraconazole or voriconazole. Are being treated with other agents which constrict blood vessels and are used to treat migraine such as triptans [ie. lamotriptan, sumatriptan, rizatriptan, eletriptan, zolmitriptan], or other drugs containing ergot alkaloids such as

Have pleural fibrosis (thickening of the serous membranes that covers the lungs and lines the chest cavity). Have retroperitoneal fibrosis (thickening of the serous membrane that covers the gut system and lines the abdominal wall). Have mild to moderate impairment of liver function. 1

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Are taking selective serotonin reuptake inhibitors (SSRIs) such as Prozac (fluoxetine), Paxil (paroxetine), and Zoloft (sertraline), or serotonin norepinephrine reuptake inhibitors (SNRIs) such as Effexor XR (venlafaxine), two types of drugs used to treat depression or other disorders.

caffeine intake and grapefruit juice may cause interactions. PROPER USE OF THIS MEDICATION Follow your doctors instructions carefully. Do not exceed the recommended dosage. Usual dose: Your doctor will tell you exactly how to take CAFERGOT*. CAFERGOT* should only be used to treat acute migraine attacks and it must not be used to prevent them. At the first sign of a migraine attack, swallow with some water 2 tablets of CAFERGOT*. This dose is usually enough to stop an attack. If the migraine attack does not go away, you can take 1 additional tablet every half hour at to a maximum of 6 tablets in one day. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose for the next attack. Do not take more than 6 tablets in one day. Do not take more than 10 tablets in one week. Do not use other ergot alkaloids or triptans for treating your migraine at the same time as CAFERGOT* (see When it should not be used for more information). If your migraine does not improve in spite of the recommended use of CAFERGOT*, contact your doctor or the emergency department of your local hospital. Do not give CAFERGOT* to children under the age of 18 years. How long to take CAFERGOT*? Do not use CAFERGOT* more often than instructed since otherwise you may have increased risk of serious side effects such as ergotism (severe constriction of blood vessels), fibrotic changes (thickening of the chest and abdominal linings) (see Side effects and what to do about them). Overdose: If you accidentally take too much CAFERGOT*, talk immediately to a doctor or pharmacist or go to the nearest hospital emergency department and bring your prescription, remaining tablets, or container with you. SIDE EFFECTS AND WHAT TO DO ABOUT THEM Like all medicines, CAFERGOT* can cause side effects. The most common side effects are nausea and vomiting. Other side effects include dizziness, abdominal pain, diarrhea, increase 2

If you use CAFERGOT* too often, it may make your headaches worse. If this happens, your doctor may tell you to stop taking CAFERGOT*. If any of these apply to you, tell your doctor before you take CAFERGOT*. Pregnant women If you are pregnant or think you may be pregnant, tell your doctor. CAFERGOT* must not be taken by pregnant women. Women who might get pregnant are advised to use effective contraception during treatment with CAFERGOT*. Nursing women Do not breast feed while taking CAFERGOT*. The active ingredient of CAFERGOT* may pass into breast milk and may affect your baby. If you wish to breast-feed, talk with your doctor before taking this medication. Driving and using machines Do not drive or use machines if you experience side effects such as dizziness, visual disturbance or vertigo. INTERACTIONS WITH THIS MEDICATION Tell your doctor or pharmacist if you are taking or have recently taken any other prescription or over-the-counter medicines, vitamins or natural health products during treatment with this medicine. Some medicines may increase the risk of serious side effects if taken concurrently with CAFERGOT*. Do not take CAFERGOT* if you:

Are being treated with any of the following medicines: erythromycin, troleandomycin, clarithromycin, ritonavir, nelfinavir, indinavir, delavirdine, ketoconazole, itraconazole or voriconazole. If you are being treated with other agents which constrict blood vessels and are used to treat migraine such as triptans [ie. lamotriptan, sumatriptan, rizatriptan, eletriptan, zolmitriptan], or other drugs containing ergot alkaloids such as dihydroergotamine.

In addition, nicotine (e.g. smoking), -blockers (such as propanolol, a medicine used to prevent migraine and also to treat high blood pressure), estrogen-based contraceptives, excessive

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in blood pressure, and fast or slow heartbeat. Additional side effects reported with CAFERGOT* at an unknown frequency: drowsiness, headache after drug use; visual disturbances. If any of these affects you severely, tell your doctor. SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect Talk with your doctor or pharmacist Only if severe Rare In all cases Stop taking drug and call your doctor or pharmacist

HOW TO STORE IT Discard any expired medicine or medicine no longer needed Store CAFERGOT* tablets below 25C, protect from light. Keep out of the reach and sight of children. 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: -------------------------------------------------------------------------1. Report online at www.healthcanada.gc.ca/medeffect 2. Call toll-free at 1-866-234-2345 3. 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.

Allergic reaction: such as rash, itching or hives on the skin; swelling of the face or other part of the body, wheezing or troubled breathing Ergotism: such as numbness and tingling in the fingers and toes, pale or cold hands or feet which may lead to blue discolouration of skin suggesting loss of circulation Various Fibrotic changes: shortness of breath, dry cough, or pain in the lower back, difficulty in passing urine or pain on urinating

MORE INFORMATION This document plus the full product monograph, prepared for health professionals can be found at: http://www.novartis.ca

Very rare

Ischemia: unexplained shortness of breath, pressure, squeezing, tightness of chest, pain, irregular heartbeat, persistent coughing, impaired vision, speech or use of arms or legs, confusion or altered consciousness

or by contacting the sponsor, Novartis Pharmaceuticals Canada Inc., at: 1-800-363-8883 Please consult your doctor or pharmacist with any questions or concerns you may have regarding your individual condition. This leaflet was prepared by Novartis Pharmaceuticals Canada Inc., 385 Bouchard Blvd, Dorval, Quebec, H9S 1A9. Last revised: November 26, 2012 CAFERGOT* is a registered trademark

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