Mylan-Zolmitriptan: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

ABT THIS

The name of your medicine is Mylan-Zolmitriptan which can only be obtained by prescription from your doctor. The decision to use Mylan-Zolmitriptan 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 Mylan-Zolmitriptan is appropriate for you.

WHAT THE MEDICATION IS USED FOR:

Mylan-Zolmitriptan belongs to a group of anti- migraine drugs called 5-HT₁ agonists. Mylan-Zolmitriptan is used to relieve your migraine headache and other associated symptoms of a migraine attack.

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

WHEN IT SHOULD NOT BE USED:

Mylan-Zolmitriptan should not be used if:

• you are allergic to zolmitriptan or any of the other

  ingredients in Mylan-Zolmitriptan (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:

Mylan-Zolmitriptan tablets contain 2.5 mg of zolmitriptan as the active ingredient.

WHAT THE IMPORTANT NONMEDICINAL INGREDIENTS ARE:

Mylan-Zolmitriptan contains: hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

Coating: hypromellose, iron oxide yellow, polyethyleneglycol, and titanium dioxide.

WHAT DOSAGE FORMS IT COMES IN:

Mylan-Zolmitriptan is supplied in tablets of 2.5 mg in blister packs containing 6 tablets.

WARNINGS AND PRECAUTIONS

BEFORE you use Mylan-Zolmitriptan 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 Mylan-Zolmitriptan too often, it may make your headaches worse. If this happens, your doctor may tell you to stop taking Mylan-Zolmitriptan.

Mylan-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 Mylan-Zolmitriptan during pregnancy: Do not use Mylan-Zolmitriptan 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

PRER USE OF THIS MEDI

USUAL DOSE:

Adults

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.

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.

SIDE EFFECTS AND WHAT TO DO ABOUT

THEM

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

Commonly reported side effects of zolmitriptan are:

• feeling sick
• vomiting
• dizziness
• tiredness
• weakness

Mylan-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 Mylan-Zolmitriptan contact your doctor or pharmacist.

HOW TO STORE IT

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

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 on line 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 National Office Health Canada

  Postal Locator 0701E

  Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guideline are available on the MedEffect™ Canada Web Site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of the side effect, please contact your health professional The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

FOATION

NOTE: This CONSUMER INFORMATION leaflet provides you with the most current information at the time of printing.

For the most current information, the Consumer Information Leaflet plus the full Product Monograph, prepared for health professionals can be found by:

Contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379, or

Downloading from Mylan’s website at

http://www.mylan.ca

Mylan Pharmaceuticals ULC

85 Advance Road

Etobicoke, Ontario

M8Z 2S6

Issued: May 17, 2013