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Details for: JAMP-ZOLMITRIPTAN

Company: JAMP PHARMA CORPORATION

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02421623JAMP-ZOLMITRIPTANZOLMITRIPTAN2.5 MGTABLETORAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

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 JAMP-ZOLMITRIPTAN (see “WHAT THE NONMEDICINAL INGREDIENTS ARE”)
  • you have a history, or any symptoms or signs of a heart condition
  • you suffer from chest pain, occurring either on exertion or at rest (the latter condition is known as Prinzmetal’s Angina)
  • 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

    JAMP-ZOLMITRIPTAN tablets contain 2.5 mg of zolmitriptan as the active ingredient.

    What the non-medicinal ingredients are

    JAMP-ZOLMITRIPTAN contains: anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, magnesium stearate and the film coating ingredients are as follows: Hypromellose, Polyethylene glycol, Yellow iron oxide and Titanium dioxide.

    What dosage form it comes in

    JAMP-ZOLMITRIPTAN is supplied in tablets of 2.5 mg in blister packs containing 6 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 (including a fast heart beat called Wolff-Parkinson-Whit syndrome)? 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)?

    • As with other migraine treatments, using too much JAMPZOLMITRIPTAN can cause daily headaches or can make your migraine headaches worse. Ask your doctor if you think that this is the case for you. You may need to stop using JAMP-ZOLMITRIPTAN to correct the problem.

    JAMP-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)
  • Herbal remedies containing St John’s wort

    • 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 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 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

    • JAMP-ZOLMITRIPTAN may commonly 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.
    Serious side effects and what to do about them
    Symptom / effect Talk to your health care professional Only if severe Talk to your health care professional In all cases Stop taking drug and get immediate medical help
    Common (frequency greater than or equal to 1% but in less than 10% of patients)
    Irregular heart beat   ✔  
    Sensation of pain, pressure of 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
    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 JAMPZOLMITRIPTAN, 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 between 15oC 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 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 post-menopausal female, or a male over 40), tell your doctor. Your doctor should evaluate you for heart disease in order to determine if JAMP-ZOLMITRIPTAN are appropriate for you.

    If you want more information about JAMP-ZOLMITRIPTAN:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website (www.jamppharma.com), or by calling 1-866-399-9091.

    • This leaflet was prepared by:

    JAMP Pharma Corporation
    1310 rue Nobel
    Boucherville, Québec
    J4B 5H3, Canada

    Date of Revision: July 13, 2020
    Date modified: