Consumer Information for: PMS-ZOLMITRIPTAN ODT

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

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

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

When it should not be used

pms-ZOLMITRIPTAN/ pms-ZOLMITRIPTAN ODT should not be used if

  • You are allergic to zolmitriptan or any of the other ingredients in pms-ZOLMITRIPTAN/ pms-ZOLMITRIPTAN ODT (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

Zolmitriptan

What the non-medicinal ingredients are

pms-ZOLMITRIPTAN contains: Colloidal Silicon Dioxide, Hydroxypropyl Methylcellulose, Iron Oxide Yellow, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Starch Glycolate, Talc, Titanium Dioxide.

pms-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 form it comes in

pms-ZOLMITRIPTAN
Tablets: 2.5 mg

pms-ZOLMITRIPTAN ODT
Orally Dispersible Tablets: 2.5 mg

Warnings and precautions

BEFORE you use pms-ZOLMITRIPTAN/ pms-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 heartbeats (including a fast heartbeat called Wolff-Parkinson-White 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 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 pms-ZOLMITRIPTAN/pms-ZOLMITRIPTAN ODT 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 pms-ZOLMITRIPTAN/ pms-ZOLMITRIPTAN ODT to correct the problem.

pms-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 pms-ZOLMITRIPTAN/ pms-ZOLMITRIPTAN ODT during pregnancy:

Do not use pms-ZOLMITRIPTAN or pms-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, vitamins, minerals, natural supplements or alternative medicines 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 conventional tablet in half. The pms-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 dose with water.

For pms-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 pms-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

If you think you have taken too much pms-ZOLMITRIPTAN/ pms-ZOLMITRIPTAN ODT, contact your healthcare professional, 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 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

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 healthcare professional Only if severe Talk to your healthcare 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 heartbeat   ✔  
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, allergic reactions including swelling of the eyelids, face, lips, mouth, tongue or neck; 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     ✔

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

How to store

Keep your medicine in a safe place where children cannot reach it. pms-ZOLMITRIPTAN and pms-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 side effects

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

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

If you want more information about pms-ZOLMITRIPTAN or pms-ZOLMITRIPTAN ODT:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/indexeng.jsp), or by contacting the sponsor Pharmascience Inc. at: 1-888-550-6060.

This leaflet was prepared by:

    Pharmascience Inc.
    Montréal, Canada
    H4P 2T4

www.pharmascience.com

Last revised: April 15, 2020

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