Consumer Information for: JAMP ZOLMITRIPTAN

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

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

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

When it should not be used

Jamp Zolmitriptan should not be used if:

  • you are allergic to zolmitriptan or any of the other ingredients in zolmitriptan tablets (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 tablets contain 2.5 mg of zolmitriptan as the active ingredient.

What the non-medicinal ingredients are

Zolmitriptan tablets contain: hypromellose, lactose anhydrous magnesium stearate, microcrystalline cellulose, polyethylene glycol 400 and 8000, red iron oxide, sodium starch glycolate, titanium dioxide.

What dosage form it comes in

Zolmitriptan tablets are supplied in 2.5 mg in packs of 2 blister strips, each containing 3 tablets.

Warnings and precautions

BEFORE you use Jamp 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 zolmitriptan tablets too often, it may make your headaches worse. If this happens, your doctor may tell you to stop taking zolmitriptan tablets.

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 Jamp Zolmitriptan during pregnancy:

Do not use Jamp 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

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 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 think you have taken too much Jamp Zolmitriptan contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Side effects and what to do about them

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

Commonly reported side effects of Jamp Zolmitriptan are:

  • feeling sick
  • vomiting
  • dizziness
  • tiredness
  • weakness

    • Jamp 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 Jamp 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 GastroIntestinal tract and spleen with possible infarctions

    • See the following table for what to do about serious side effects.
    Serious side effects and what to do about them
    Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and seek immediate emergency medical attention
    Common (frequency greater than or equal to 1% but in less than 10% of patients)
    Irregular heart beat   ✔  
    Sensations of pain, pressure or tightness in the chest, neck, throat, jaw, arms, or legs     ✔
    Sensations of tingling, heat, heaviness or pressure     ✔
    Uncommon (frequency greater than or equal to 0.1% but in less than 1% of patients)
    Fast heart rate   ✔  
    Temporary increase in blood pressure   ✔  
    Rare (frequency greater than or equal to 0.01% but in less than 0.1% of patients)
    Shortness of breath, wheeziness, heart throbbing, swelling of the eyelids, face, or lips; or a skin rash, itchy rash, skin lumps or hives, or swelling with fluid in the tissues     ✔
    Very rare (frequency in less than 0.01% of patients)
    Symptoms of a heart attack (chest pain, sweating, shortness of breath)     ✔
    Sudden or severe abdominal pain or bloody diarrhea     ✔
    For any unexpected effects while taking Zolmitriptan Tablets, contact your doctor or pharmacist.
    How to store

    Keep your medicine in a safe place where children cannot reach it. Jamp Zolmitriptan could be harmful to children. Store your medication at controlled room temperature (15ºC to 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 side effects

    You can report any suspected side effects associated with the use of health products to Health Canada by:

    • Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
    • Calling toll-free at 1-866-234-2345.

    NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

    More information

    The name of your medicine is Jamp Zolmitriptan which can only be obtained by prescription from your doctor. The decision to use Jamp 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 postmenopausal female, or a male over 40), tell your doctor.
    Your doctor should evaluate you for heart disease in order to determine if Jamp Zolmitriptan is appropriate for you.

    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 obtained by contacting the sponsor, Jamp Pharma Corporation 1-866-399-9091.

    This leaflet was prepared by Jamp Pharma Corporation .

    Date of Preparation: June 6, 2018

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