Teva-Zolmitriptan Od (Teva Canada, 1.0 mg, 1 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

The name of your medicine is TEVA-

ZOLMITRIPTAN or TEVA-ZOLMITRIPTAN OD which can only be obtained by prescription from your doctor. The decision to use TEVA-

ZOLMITRIPTAN/ TEVA-ZOLMITRIPTAN OD is one that you and your doctor should make jointly, taking into account your individual preferences and medical circumstances. If you have risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease, or you are a post-menopausal female, or a male over 40), tell your doctor. Your doctor should evaluate you for heart disease in order to determine if TEVA-ZOLMITRIPTAN/TEVA-ZOLMITRIPTAN OD is appropriate for you.

WHAT THE MEDICATION IS USED FOR:

TEVA-ZOLMITRIPTAN and TEVA-

ZOLMITRIPTAN OD belong to a group of anti-migraine drugs called 5-HT1 agonists. TEVA-ZOLMITRIPTAN/TEVA-ZOLMITRIPTAN OD is used to relieve your migraine headache and other associated symptoms of a migraine attack.

TEVA-ZOLMITRIPTAN/TEVA-ZOLMITRIPTAN OD should not be used continuously to prevent or reduce the number of attacks you experience. Use TEVA-

ZOLMITRIPTAN/TEVA-ZOLMITRIPTAN OD

only to treat an actual migraine headache attack.

WHAT IT DOES:

Migraine headache is believed to be caused by a widening of the blood vessels in the head. TEVA-ZOLMITRIPTAN/TEVA-ZOLMITRIPTAN OD narrows the vessels and relieves the pain and other symptoms of migraine headache.

WHEN IT SHOULD NOT BE USED:

TEVA-ZOLMITRIPTAN/TEVA-ZOLMITRIPTAN OD should not be used if:

• you are allergic to zolmitriptan or any of the other ingredients in TEVA-ZOLMITRIPTAN/ TEVA-ZOLMITRIPTAN OD (see “WHAT THE IMPORTANT NONMEDICINAL INGREDIENTS ARE”)
• you have a history, or any symptoms or signs of a heart condition
• you have severe or uncontrolled hypertension
• you are taking or have recently taken (within 24 hours) an ergotamine containing or ergot-like drug, or another triptan used to treat migraines
• you have another type of headache that is different from a migraine attack
• you are taking or have recently taken (within 2 weeks) a monoamine oxidase inhibitor (MAOI)

WHAT THE MEDICINAL INGREDIENT IS:

TEVA-ZOLMITRIPTAN/ TEVA-ZOLMITRIPTAN OD tablets contain 1 mg and 2.5 mg of zolmitriptan as the active ingredient.

WHAT THE IMPORTANT NONMEDICINAL INGREDIENTS ARE:

TEVA-ZOLMITRIPTAN tablets contain: lactose spray dried, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and the Film Coating ingredients are as follows:

1 mg:

FD&C Blue/Brilliant Blue FCF Aluminum 3 - 5% Lake, Iron Oxide Yellow, Macrogol/Polyethylene Glycol 3350, Polyvinyl Alcohol, Talc, Titanium Dioxide.

2.5 mg:

Iron Oxide Yellow, Macrogol/Polyethylene Glycol 3350, Polyvinyl Alcohol, Talc, Titanium Dioxide.

TEVA-ZOLMITRIPTAN OD tablets contain: aspartame, citric acid, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, mannitol, magnesium stearate, orange flavour,

sodium bicarbonate.

WHAT DOSAGE FORMS IT COMES IN: TEVA-ZOLMITRIPTAN is supplied in

conventional tablets of 1 mg and 2.5 mg in blister packs containing 3 or 6 tablets and bottles of 50 tablets.

TEVA-ZOLMITRIPTAN OD is supplied in orally disintegrating tablets of 1 mg and 2.5 mg in blister packs containing 2 or 6 tablets.

WARNINGS AND PRECAUTIONS

BEFORE you use TEVA-ZOLMITRIPTAN/TEVA-ZOLMITRIPTAN OD, talk to your doctor or pharmacist if the answer to any of the following questions is YES, or if you do not know the answer:

• Are you pregnant, think you might be

  pregnant, or trying to become pregnant? Are you using inadequate contraception? Are you breastfeeding?

• Do you or have you ever experienced any

  pain or tightness in the chest, (which may or may not spread to your neck, jaw, or upper arm), shortness of breath, or irregular heart beats? Do you have angina? Have you ever had heart or blood vessel disease? Do you have a history of cerebral bleeding? Have you had a heart attack or stroke?

• Do you have risk factors for heart disease,

  such as: high blood pressure, high cholesterol, smoking, obesity, diabetes, or strong family history of heart disease?

• Do you have a condition called

  phenylketonuria (a specific blood disorder)?

• Do you have rare hereditary problems of

  galactose intolerance?

• Are you post-menopausal or a male over 40?
• Do you have high blood pressure?

• Have you ever had to stop taking this or any

  other medication because of an allergy or other problems?

• Are you taking any other migraine 5-HT1

  agonist medications such as sumatriptan succinate, naratriptan hydrochloride, rizatriptan benzoate, almotriptan malate or migraine medications containing ergotamine, dihydroergotamine, or methysergide?

• Are you taking any medications for

  depression such as selective serotonin reuptake inhibitors (SSRI’s), for example, fluoxetine hydrochloride, sertraline hydrochloride, fluvoxamine maleate, paroxetine hydrochloride, etc., or serotonin

  norepinephrine reuptake inhibitors (SNRIs), for example, venlafaxine hydrochloride, or monoamine oxidase inhibitors (MAOIs), for example, phenelzine sulfate, tranylcypromine sulfate or moclobemide?

  • Have you ever experienced numbness on one side of your body when you have a headache?
  • Have you ever had epilepsy or seizures?
  • Have you ever had liver disease?
  • Are you over 65 years of age?
  • Is this headache different from your usual migraine attacks?
  • Are you taking cimetidine (for treatment of indigestion or stomach ulcers) or a member of the quinolone family of antibiotics (for example ciprofloxacin)?

If you use TEVA-ZOLMITRIPTAN/TEVA-ZOLMITRIPTAN OD too often, it may make your headaches worse. If this happens, your doctor may tell you to stop taking TEVA-ZOLMITRIPTAN.

TEVA-ZOLMITRIPTAN/TEVA-

ZOLMITRIPTAN OD tablets contain lactose which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest milk or some sugars, talk to your doctor before taking this medicine.

Use of TEVA-ZOLMITRIPTAN/TEVA-ZOLMITRIPTAN OD during pregnancy:

Do not use TEVA-ZOLMITRIPTAN or TEVA-ZOLMITRIPTAN OD if you are pregnant, think you might be pregnant, are trying to become pregnant or are using inadequate contraception, unless you have discussed this with your doctor.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist about any other drugs you take, including:

• other 5-HT1 agonist migraine drugs (sumatriptan succinate, naratriptan hydrochloride, rizatriptan benzoate, almotriptan malate) or migraine drugs that contain ergotamine, dihydroergotamine, methysergide
• drugs for depression such as selective serotonin reuptake inhibitors (SSRI’s), for example, fluoxetine hydrochloride, sertraline hydrochloride, fluvoxamine maleate, paroxetine hydrochloride, etc., or serotonin norepinephrine reuptake inhibitors (SNRIs), for example, venlafaxine hydrochloride, or monoamine oxidase inhibitors (MAOIs), for example, phenelzine sulfate, tranylcypromine sulfate or

moclobemide

• drugs used to treat upset stomach or stomach

  ulcers (cimetidine)

• antibiotics from the quinolone family (for

  example ciprofloxacin)

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those that can be bought without a prescription.

PROPER USE OF THIS MEDICATION

USUAL DOSE:

Adults

TEVA-ZOLMITRIPTAN:

The usual dosage is 2.5 mg, or lower if recommended by your doctor. The dose should be taken as soon as your migraine appears, but it may be taken at any time during your migraine headache. Swallow your dose with water.

TEVA-ZOLMITRIPTAN OD:

The usual dosage is 2.5 mg, or lower if recommended by your doctor. The TEVA-ZOLMITRIPTAN OD, 2.5 mg orally dispersible tablets cannot be broken in half. The dose should be taken as soon as your migraine appears, but it may be taken at any time during your migraine headache. The TEVA-ZOLMITRIPTAN OD should be placed on the tongue, where it will dissolve with the saliva. Water is not needed for the dispersible tablet.

A second dose may be taken if your headache returns, but not sooner than 2 hours following the first tablet. For any attack where you have no response to the first dose, do not take a second dose without first consulting your doctor.

Do not administer more than 10 mg in any 24 hour period.

OVERDOSE:

If you have taken more medication than your doctor has instructed, contact either your doctor, hospital emergency department, or nearest poison control centre immediately.

In case of accidental overdose, consult a physician immediately or contact your regional Poison Control Centre.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Although the vast majority of TEVA-

ZOLMITRIPTAN and TEVA-ZOLMITRIPTAN OD users have not experienced any significant problems, you should be aware that the following side effects may occur.

Commonly reported side effects of TEVA-ZOLMITRIPTAN and TEVA-ZOLMITRIPTAN OD are:

• feeling sick
• vomiting
• dizziness
• tiredness
• weakness

TEVA-ZOLMITRIPTAN may cause drowsiness. Do not drive or operate machinery until you are sure that you are not drowsy.

Other common side effects include:

• muscle aches and pains
• difficulty swallowing
• dry mouth
• headache
• stomach pain

Uncommon side effects include:

• increase in the production of urine or in the frequency of urination Tell your doctor of these symptoms at your next visit.

Migraineurs may be at risk of certain cerebrovascular events such as cerebral bleeding and stroke. In very rare cases, as with other drugs of this type, such diseases have been reported in association with the use of zolmitriptan.

In very rare cases, as with other drugs of this type (5HT1 agonists), the following side effects have been reported:

• spasm of the blood vessels of the heart

• spasm of the blood vessels of the

  Gastro-Intestinal tract and spleen with possible infarctions

See the following table for what to do about serious side effects.

For any unexpected effects while taking TEVA-ZOLMITRIPTAN/TEVA-ZOLMITRIPTAN OD, contact your doctor or pharmacist.

HOW TO STORE IT

Keep your medicine in a safe place where children cannot reach it. TEVA-ZOLMITRIPTAN and TEVA-ZOLMITRIPTAN OD could be harmful to children. Store your medication between 15 and 30ºC, away from direct heat.

If your doctor decides to stop your treatment, return your medicine to the pharmacist for disposal. Do not take your medication after the expiry date on the package and blister foil.

Return the tablets to your pharmacist for disposal.

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, 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 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

This document plus the full prescribing information, prepared for health professionals can be found by contacting Teva Canada Limited:

at: 1-800-268-4127 ext. 1255005 (English); 1-877-777-9117 (French)

or druginfo@tevacanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: July 31, 2014