Sandoz Mirabegron: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Sandoz Mirabegron 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:

Sandoz Mirabegron 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 Sandoz Mirabegron

• women who are pregnant or breastfeeding

What the medicinal ingredient is:

Mirabegron

What the nonmedicinal ingredients are:

Polyethylene Oxide, Mw 2,000,000, Polyethylene Glycol,

Mw 8000, Hydroxypropylcellulose, Butylhydroxytoluene, Magnesium Stearate, Hypromellose-type 2910, Polyethylene Glycol, Mw 6000, Ferric Oxide-Yellow, Titanium Dioxide.

What dosage forms it comes in:

Extended-release tablets, 50 mg

WARNINGS AND PRECAUTIONS

BEFORE you use Sandoz Mirabegron 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

Sandoz Mirabegron 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. Sandoz Mirabegron may affect the way other medicines work, and other medicines may affect how Sandoz Mirabegron works. You may need to change the dosage or stop taking one of the medicines.

Sandoz Mirabegron 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 Sandoz Mirabegron is 50 mg once daily.

Note: Sandoz Mirabegron is only available in 50 mg tablets.

Overdose:

If you think you, or a person you are caring for, have taken too much Sandoz Mirabegron, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

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, Sandoz Mirabegron 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

Serious side effects and what to do about them

This is not a complete list of side effects. For any unexpected effects while taking Sandoz Mirabegron, contact your doctor or pharmacist.

HOW TO STORE IT

Keep out of the reach and sight of children. Store at room temperature (15°C to 30°C). Protect from light

REPORTING SIDE EFFECTS

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

--------------------------------------------------------------------------

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345

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 Sandoz Mirabegron:

• 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; the manufacturer’s website [www.sandoz.ca], or by calling 1-800-361-3062.

Last revised: AUG 29, 2025