Van-Rizatriptan ODT: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

The name of your medicine is VAN-Rizatriptan ODT. It can only be obtained by prescription from your physician. The decision to use VAN-Rizatriptan ODT 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 VAN-Rizatriptan ODT is appropriate for you.

What the medication is used for

VAN-Rizatriptan ODT is intended to relieve your migraine headache and other associated symptoms of a migraine attack in adults.

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

When it should not be used

Do not take VAN-Rizatriptan ODT 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.

VAN-Rizatriptan ODT should not be used to relieve pain other than that associated with migraine headache.

VAN-Rizatriptan ODT 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 nonmedicinal ingredients are:

VAN-Rizatriptan ODT contains the following non-medicinal ingredients: Microcrystalline cellulose, mannitol, croscarmellose sodium, Crospovidone CL-F, Glycine, Aspartame, Sodium Chloride, Monosodium Citrate anhydrous, Peppermint flavour, Magnesium Stearate.

What dosage forms it comes

VAN-Rizatriptan ODT is available in 5 and 10 mg orally disintegrating tablets.

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 VAN-Rizatriptan ODT.

• 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, obesity, 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 (MOIs)?
• 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?

Phenylketonuric patients:

You should be aware that this product contains phenylalanine (a component of aspartame). Each 5 mg VAN-Rizatriptan ODTcontains 1.12 mg phenylalanine and each 10 mg VAN-Rizatriptan ODTcontains 2.25 mg phenylalanine.

Continuous use of VAN-Rizatriptan ODT:

If you take VAN-Rizatriptan ODT 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 VAN-Rizatriptan ODT.

If you are not sure whether you should take VAN-Rizatriptan ODT, contact your physician or pharmacist.

VAN-Rizatriptan ODTuse during pregnancy:

Do not use VAN-Rizatriptan 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 physician.

INTERACTIONS WITH THIS MEDICATION

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

Do not take VAN-Rizatriptan ODTif 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 VAN-Rizatriptan ODTif 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 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.

If you are using VAN-Rizatriptan ODT, leave the orally disintegrating tablet in its package until you are ready to take it. Remove the tablet from the blister package with dry hands and place the tablet on your tongue. The tablet will dissolve rapidly and be swallowed with your saliva. No liquid is needed to take the tablet.

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:

In case of drug overdose, contact a health care practitioner, 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 VAN-Rizatriptan ODT 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 VAN-Rizatriptan ODT. 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 VAN-Rizatriptan ODT.

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 skin rash or skin lumps or hives or spasm 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 VAN-Rizatriptan ODT and call 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.

This is not a complete list of side effects. For any unexpected effects while taking VAN-Rizatriptan ODT, contact your physician or pharmacist.

HOW TO STORE IT

Keep your medicine in a safe place where children cannot reach it. VAN-Rizatriptan ODT could be harmful to children. Store your medication between 15°C and 30°C, away from direct heat.

If you are storing VAN-Rizatriptan ODT, do not remove the tablet from the blister package until you are ready to take the medicine inside.

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 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 online at: www.healthcanada.gc.ca/medeffect.
• Call toll-free at: 1-86-234-2345

• Complete a Canada Vigilance Reporting Form and:

  Fax toll-free to: 1-866-678-6789, or Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701E

  Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Forms and the adverse reaction reporting guidelines are available on the MedEffect^TM Canada website at:

www.healthcanada.gc.ca/medeffect.

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

MORE INFORMATION

For more information, please contact your doctor, pharmacist or other healthcare professional.

This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting Vanc Pharmaceuticals Inc.

Vanc Pharmaceuticals Inc. Unit-210, 2639 Viking Way

Richmond, BC V6V 3B7

Safety@vancpharm.com

www.vancpharm.com

Help line: +1-877-929-0699

Date of Preparation: 9 November, 2015