Dom-Zolmitriptan: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

The name of your medicine is Dom-ZOLMITRIPTAN or Dom-ZOLMITRIPTAN ODT which can only be obtained by prescription from your doctor. The decision to use Dom-ZOLMITRIPTAN/Dom-ZOLMITRIPTAN ODT 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 Dom-ZOLMITRIPTAN/ Dom-ZOLMITRIPTAN ODT are appropriate for you.

WHAT THE MEDICATION IS USED FOR:

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

Dom-ZOLMITRIPTAN/ Dom-ZOLMITRIPTAN ODT should not be used continuously to prevent or reduce the number of attacks you experience. Use Dom-ZOLMITRIPTAN/ Dom-ZOLMITRIPTAN ODT 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. Dom-ZOLMITRIPTAN/ Dom-ZOLMITRIPTAN ODT narrows the vessels and relieves the pain and other symptoms of migraine headache.

WHEN IT SHOULD NOT BE USED:

Dom-ZOLMITRIPTAN/ Dom-ZOLMITRIPTAN ODT should not be used if:

• You are allergic to zolmitriptan or any of the other ingredients in Dom-ZOLMITRIPTAN/Dom-ZOLMITRIPTAN ODT (see “WHAT THE 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:

Zolmitriptan

WHAT THE IMPORTANT NONMEDICINAL INGREDIENTS ARE:

Dom-ZOLMITRIPTAN contains: colloidal silicon dioxide, hydroxypropyl methylcellulose, iron oxide yellow, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, titanium dioxide.

Dom-ZOLMITRIPTAN ODT contains: citric acid anhydrous, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, orange flavour (artificial flavours, butylated hydroxyanisole, dextrin and modified food starch, maltodextrin, natural flavours), polyethylene glycol, sucralose micronized.

WHAT DOSAGE FORMS IT COMES IN:

Dom-ZOLMITRIPTAN

Tablets: 2.5 mg

Dom-ZOLMITRIPTAN ODT

Orally Dispersible Tablets: 2.5 mg

WARNINGS AND PRECAUTIONS

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

Dom-ZOLMITRIPTAN 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 Dom-ZOLMITRIPTAN/ Dom-ZOLMITRIPTAN ODT during pregnancy: Do not use Dom-

ZOLMITRIPTAN or Dom-ZOLMITRIPTAN ODT 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

The usual dosage is 2.5 mg, or lower if recommended by your doctor. A lower dose can be obtained by manually breaking a conventional tablet in half. The Dom-ZOLMITRIPTAN ODT 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. Swallow your conventional tablet dosewith water.

For Dom-ZOLMITRIPTAN ODT orally dispersible tablets, the blister pack should be peeled open as shown on the foil (tablets should not be pushed through the foil). The Dom-ZOLMITRIPTAN ODT 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:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Although the vast majority of Dom-ZOLMITRIPTAN and Dom-ZOLMITRIPTAN ODT users have not experienced any significant problems, you should be aware that the following side effects may occur.

Commonly reported side effects of Dom-ZOLMITRIPTAN and Dom-ZOLMITRIPTAN ODT are:

• feeling sick
• vomiting
• dizziness
• tiredness
• weakness

Dom-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.

This is not a complete list of side effects. For any unexpected effects while taking Dom-ZOLMITRIPTAN and Dom-ZOLMITRIPTAN ODT, contact your doctor or pharmacist.

HOW TO STORE IT

Keep your medicine in a safe place where children cannot

reach it. Dom-ZOLMITRIPTAN and Dom-

ZOLMITRIPTAN ODT could be harmful to children. Store your medication between 15°C and 30°C.

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, 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

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting Dominion Pharmacal at 1-888-550-6060.

Dominion Pharmacal

Montréal, Canada

H4P 2T4

Last revised: March 21, 2016