Consumer Information for: MYRBETRIQ
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
MYRBETRIQ treats the symptoms of an overactive bladder such as:
- suddenly needing to empty your bladder (called urgency)
- having to empty your bladder more than usual (called urinary frequency)
- not being able to control when you empty your bladder (called urgency incontinence)
What it does
MYRBETRIQ contains mirabegron. It works by relaxing the bladder smooth muscle, thereby reducing the symptoms of an overactive bladder.
When it should not be used
- you have very high uncontrolled blood pressure
- if you are allergic to mirabegron or any of the ingredients in MYRBETRIQTM
- women who are pregnant or breastfeeding
What the medicinal ingredient is
Mirabegron
What the non-medicinal ingredients are
butylated hydroxytoluene, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyethylene oxide, yellow ferric oxide and red ferric oxide (25 mg only).
What dosage form it comes in
Extended-release tablets, 25 mg, 50 mg
Warnings and precautions
BEFORE you use MYRBETRIQ talk to your doctor or pharmacist if:
- you have problems emptying your bladder or if you have weak urine stream
- you are pregnant or trying to become pregnant
- you are breastfeeding or planning to breastfeed
- you have severe liver problems
- you have severe kidney problems
- you have an eye problem called Glaucoma
- you have high blood pressure or a history of high blood pressure
- you have any heart disorder, including an irregular heartbeat, an abnormal electrical signal called “prolongation of the QT interval” or a known history of QT interval prolongation
- you have a history of ischemic heart disease or a heart rate that is higher than normal
MYRBETRIQ should not be given to patients under 18 years of age.
Interactions with this medication
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. MYRBETRIQ may affect the way other medicines work, and other medicines may affect how MYRBETRIQ works. You may need to change the dosage or stop taking one of the medicines.
MYRBETRIQ may interact with the following medications:
- Propafenone, or Flecainide, drugs used to treat irregular heartbeats
- Digoxin
- Drugs known to increase the heartbeat or elevate blood pressure
- Drugs known to prolong the QT/QTc interval and/or cause torsade de pointes
Proper use of this medication
Usual starting dose
25 mg once daily with or without food. The tablet should be swallowed whole with a glass of water. Do not crush or chew the tablet. Based upon your response and tolerability, your doctor may increase your dose to 50 mg once daily. The maximum dose for MYRBETRIQ is 50 mg once daily.
Overdose
Missed Dose
If you forget to take your medicine, then take your next dose at the normal time. Do not take a double dose to make up for a forgotten dose. If you miss several doses, tell your doctor and follow the advice given to you.
Side effects and what to do about them
As with all medications, MYRBETRIQ can cause side effects. The possible common side effects are as follows:
- Increased blood pressure
- Cold symptoms (Nasopharyngitis)
- Urinary tract infection
- Constipation
- Diarrhea
- Dizziness
- Headache
- Nausea
- Itching
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Uncommon | |||
| Rash / Urticaria (hives) | ✔ | ||
| Urinary Retention (the inability to empty your bladder) | ✔ | ||
| Atrial fibrillation (rapid and irregular heart beat) | ✔ | ||
| Cerebrovascular accident (stroke) | ✔ | ||
| Rare | |||
| Angioedema (swelling of the face or tongue, difficulty breathing) | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking MYRBETRIQTM, contact your doctor or pharmacist.
How to store
Keep out of the reach and sight of children. Store at 25°C (77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F).
Reporting 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 1-866-234-2345
- 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 0701D
Ottawa, Ontario
K1A 0K9
Postage-paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site 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
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.astellas.ca
or by contacting the sponsor, Astellas Pharma Canada, Inc., at:
1-888-338-1824
This leaflet was prepared by Astellas Pharma Canada, Inc.
Last revised: June 02, 2016
15H054-MIR-CA
MYRBETRIQ® is a trademark of Astellas Pharma Inc.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| JAMP FEBUXOSTAT | 02490870 | JAMP PHARMA CORPORATION | FEBUXOSTAT 80 MG |