Consumer Information for: DOM-RIZATRIPTAN RDT
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
The name of your medicine is Dom-RIZATRIPTAN RDT. It can only be obtained by prescription from your physician. The decision to use Dom-RIZATRIPTAN RDT 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 Dom-RIZATRIPTAN RDT is appropriate for you.
Dom-RIZATRIPTAN RDT is intended to relieve your migraine headache and other associated symptoms of a migraine attack in adults. Dom-RIZATRIPTAN RDT should not be used continuously to prevent or reduce the number of attacks you experience. Use Dom- RIZATRIPTAN RDT 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. Dom-RIZATRIPTAN RDT narrows the vessels and relieves the pain and other symptoms of migraine headache.
When it should not be used
Do not take Dom-RIZATRIPTAN RDT if you:
- are allergic to any of the ingredients (see What the non-medicinal 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.
Dom-RIZATRIPTAN RDT should not be used to relieve
pain other than that associated with migraine headache.
Dom-RIZATRIPTAN RDT should not be used within 24
hours of treatment with another 5-HT1 agonist such as
sumatriptan, naratriptan or zolmitriptan, 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
Colloidal Silicon Dioxide, Crospovidone, Magnesium Stearate, Mannitol, Peppermint Flavour and Sucralose.
What dosage form it comes in
Orally Disintegrating Tablets:: 5 or 10 mg rizatriptan
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 Dom-RIZATRIPTAN RDT.
- 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 sumatriptan succinate/sumatriptan, or naratriptan as naratriptan hydrochloride, 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?
Continuous use of Dom-RIZATRIPTAN RDT: If you take Dom-RIZATRIPTAN RDT 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 Dom-RIZATRIPTAN RDT
If you are not sure whether you should take Dom- RIZATRIPTAN RDT, contact your physician or pharmacist.
Dom-RIZATRIPTAN RDTuse during pregnancy
:
Do not use Dom-RIZATRIPTAN RDT 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 Dom-
RIZATRIPTAN RDT and inform your physician of any
other medications you may be taking, including those
obtained without a prescription.
Do not take Dom-RIZATRIPTAN RDT 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 Dom-
RIZATRIPTAN RDT or 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 Dom-RIZATRIPTAN
RDT, 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.
Place Dom-RIZATRIPTAN RDT on your tongue. It will
dissolve rapidly and be swallowed with your saliva. No
liquid is needed to take the orally disintegrating 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
Side effects and what to do about them
Although the vast majority of rizatriptan benzoate 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 Dom-RIZATRIPTAN RDT. 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 Dom- RIZATRIPTAN RDT.
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 DomRIZATRIPTAN RDT 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 you physician immediately.
| 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 | |||
| Sensations of pain, pressure or tightness in the chest, neck, throat, jaw or arms | ✔ | ||
| Tingling, heat, heaviness or pressure in any part of the body | ✔ | ||
| Headache, dizziness, tiredness, nausea, vomiting, dry mouth, drowsiness | ✔ | ||
| Irregular or rapid heartbeats | ✔ | ||
| Uncommon | |||
| Rapid onset of numbness or weakness on one side of the body (often beginning in one arm) | ✔ | ||
| Muscle pain | ✔ | ||
| Rare | |||
| 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 | ✔ | ||
| Sudden or severe abdominal pain | ✔ | ||
| Very rare | |||
| Seizures | ✔ | ||
| Spasm of the blood vessels of the colon (large bowel) | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Dom-RIZATRIPTAN RDT, contact your physician or pharmacist.
How to store
Keep your medicine in a safe place where children cannot
reach it. Dom-RIZATRIPTAN RDT could be harmful to
children. Store your medication between 15°C and 30°C,
away from direct heat.
Protect from light and moisture.
If you are storing Dom-RIZATRIPTAN RDT, leave the
orally disintegrating tablets in their original package until
you are ready to take it.
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
You can help improve the safe use of health products
for Canadians by reporting serious and unexpected side
effects to Health Canada. Your report may help to
identify new side effects and change the product safety
information.
3 ways to report:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- 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 Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
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
This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Dominion Pharmacal at, 1-888-550-6060.
This leaflet was prepared by
Dominion Pharmacal
Montréal Quebec
H4P 2T4
Last revised: March 14, 2016
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