M-Rizatriptan: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

The name of your medicine is M-RIZATRIPTAN. It can only be obtained by prescription from your physician. The decision to use M-RIZATRIPTAN is one that you and your physician 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 physician. Your physician should evaluate you for heart disease in order to determine whether M-RIZATRIPTAN is appropriate for you.

What the medication is used for:

M-RIZATRIPTAN is intended to relieve your migraine headache and other associated symptoms of a migraine attack in adults. M-RIZATRIPTAN should not be used continuously to prevent or reduce the number of attacks you experience. Use M-RIZATRIPTAN 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. M-RIZATRIPTAN narrows the vessels and relieves the pain and other symptoms of migraine headache.

When it should not be used:

Do not take M-RIZATRIPTAN if you:

• are allergic to any of the ingredients (see What the nonmedicinal ingredients are section)

• have uncontrolled or severe high blood pressure

  • have heart disease or history of heart disease
  • have severe liver disease
  • have had a stroke or transient ischemic attack (TIA)
  • have or have had blood vessels problems, including ischemic bowel disease
  • take monoamine oxidase (MAO) inhibitors such as moclobemide, phenelzine, tranylcypromine, or pargyline, or have taken MAO inhibitors within the last two weeks.

M-RIZATRIPTAN should not be used to relieve pain other than that associated with migraine headache.

M-RIZATRIPTAN should not be used within 24 hours of treatment with another 5-HT₁ agonist such as sumatriptan (Imitrex*), naratriptan (Amerge*) or zolmitriptan (Zomig*), or ergotamine-type medications such as ergotamine, dihydroergotamine or methysergide.

Please also see WARNINGS AND PRECAUTIONS.

What the medicinal ingredient is:

rizatriptan benzoate

What the non-medicinal ingredients are:

Iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch.

What dosage forms it comes in:

Tablets

M-RIZATRIPTAN 5 mg are pale pink colored, capsule shaped tablet debossed with “HP” on one side and “244” on other side.

M-RIZATRIPTAN 10 mg are pale pink colored, capsule shaped tablet debossed with “HP” on one side and “245” on other side.

WARNINGS AND PRECAUTIONS

If the answer to any of the following questions is YES or if you do not know the answer, then please speak with your physician before you take any M-RIZATRIPTAN.

• Are you pregnant? Do you think you might be pregnant? Are you trying to become pregnant? Are you using inadequate contraception? Are you breast feeding?

• 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, rapid heartbeats or irregular heartbeats? Do you have angina?
• Have you ever had heart or blood vessel disease? Have you had a heart attack or stroke?
• Do you have risk factors for heart disease, such as: high blood pressure, high cholesterol, smoking,
• diabetes, or strong family history of heart disease? Are you post-menopausal, or a male over 40?
• 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 Imitrex* (sumatriptan succinate/sumatriptan) or Amerge* (naratriptan as naratriptan hydrochloride), Zomig* (zolmitriptan) or migraine medications containing ergotamine, dihydroergotamine, or methysergide?
• Are you taking any medications for depression such as selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine, duloxetine, or monoamine oxidase inhibitors (MAOIs)?
• Have you ever experienced numbness on one side of your body when you have a headache?
• Have you ever had, or do you have epilepsy or seizures?
• Have you ever had, or do you have liver disease or kidney disease?
• Is this headache different from your usual migraine attacks?
• Are you over 65 years of age?

Continuous use of M-RIZATRIPTAN:

If you take M-RIZATRIPTAN too often, this may result in you getting chronic headaches or marked increases in the frequency of your migraine attacks. In such cases, you should contact your doctor, as you may have to stop taking M-RIZATRIPTAN.

If you are not sure whether you should take M-RIZATRIPTAN, contact your physician or pharmacist.

M-RIZATRIPTAN use during pregnancy:

Do not use M-RIZATRIPTAN 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 physician.

INTERACTIONS WITH THIS MEDICATION

If you are taking any other migraine medication, check with your physician first before taking M-RIZATRIPTAN and inform your physician of any other medications you may be taking, including those obtained without a prescription.

Do not take M-RIZATRIPTAN if you take monoamine oxidase (MAO) inhibitors such as moclobemide, phenelzine, tranylcypromine, or pargyline, or have taken MAO inhibitors within the last two weeks.

Ask your physician for instructions about taking M-RIZATRIPTAN if you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine, duloxetine for depression. A life-threatening condition called serotonin syndrome can happen when medicines called triptans, such as M-RIZATRIPTAN, and medicines used to treat depression and mood disorders called SSRIs and SNRIs are used together. Signs and symptoms of serotonin syndrome include the following: restlessness, diarrhea, hallucinations, coma, loss of coordination, nausea, fast heartbeat, vomiting, increased body temperature, changes in blood pressure and overactive reflexes.

PROPER USE OF THIS MEDICATION

REMEMBER: this medicine was prescribed only for YOU. Only a physician knows who can use it safely. Never give it to someone else. It may harm them, even if their symptoms are the same as yours.

Usual dose:

For adults, the usual dosage is 5 or 10 mg, as recommended by your physician. The dose should be taken as soon as your migraine appears, but it may be taken at any time during your migraine headache.

Leave the M-RIZATRIPTAN in its package until you are ready to take it. Do not push the tablets through the blister; rather, peel open the blister pack with dry hands. If you are taking a tablet, swallow your dose with water.

A second dose may be taken if your headache returns. Repeat doses cannot be taken any sooner than 2 hours following the first dose. Do not take more than 20 mg in any 24-hour period.

For any attack where you have no response to the first dose, do not take a second dose without first consulting your physician.

Overdose:

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Although the vast majority of M-RIZATRIPTAN users have not experienced any significant problems, you should be aware of the following side effects:

Common side effects

• Sensations of pain, pressure or tightness in the chest, neck, throat, jaw or arms. If this happens to you, then discuss it with your physician before using any more M-RIZATRIPTAN. If the chest pain is severe (may resemble an angina attack) or does not go away, stop taking drug and call your physician immediately.
• Tingling, heat, heaviness or pressure, dizziness, tiredness, or feeling sick. Tell your physician if you have any of these symptoms.

• Drowsiness. Do not drive or operate machinery until you are sure that you are not drowsy.

• Irregular or rapid heartbeats. If this happens to you, stop taking drug and then discuss it with your physician before using any more M-RIZATRIPTAN.

Uncommon side effects

• Rapid onset of numbness or weakness on one side of the body (often beginning in one arm). If this occurs, stop taking drug and call your physician immediately.
• Muscle pain. If this occurs, stop taking drug and call your physician immediately.

Rare side effects

• Shortness of breath, wheeziness, heart throbbing, swelling of the eyelids, face, tongue or lips; or a skin rash or skin lumps or hives or spasms of blood vessels of the extremities including coldness and numbness of the hands and feet. These effects happen rarely, but if any do occur, do not take any more M-RIZATRIPTAN and contact your physician immediately.
• Sudden or severe abdominal pain. If this occurs, stop taking drug and call your physician immediately.

Very rare side effects

• There have been very rare reports of seizures. If this occurs, stop taking drug and call your physician immediately.
• Spasm of the blood vessels of the colon (large bowel). If this occurs, stop taking drug and call your physician immediately.

If you feel unwell in any other way or have symptoms that you do not understand or find distressing, you should contact your physician immediately.

If you have a troublesome symptoms or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

HOW TO STORE IT

Keep out of reach and sight of children. M-RIZATRIPTAN could be harmful to children.

Store your medication between 15°C and 30°C.

If your physician decides to stop your treatment, do not keep any leftover medicine unless your physician tells you to do so.

If your medicine has expired, do not use it. It is recommended to take leftover medication to a pharmacy for proper disposal.

REPORTING SIDE EFFECTS

MORE INFORMATION

If you want more information about M-RIZATRIPTAN:

•

• 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://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by

  contacting Mantra Pharma Inc. at medinfo@mantrapharma.ca or at 1-833-248-7326.

1000 rue Du Lux, Suite 201

Brossard, Quebec

J4Y 0E3

Last Revised: MAY 16, 2024