Mirabegron

What it is used for

• Mirabegron extended-release tablets are prescription medicine that can be used to treat adults with the following symptoms due to a condition called overactive bladder (OAB):
  • Urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
  • Urgency: a strong need to urinate right away
  • Frequency: urinating often

It is not known if mirabegron extended-release tablets are safe and effective in children under 3 years of age.

How to take it

• Take mirabegron extended-release tablets exactly as your doctor tells you to take it.
• You should take 1 mirabegron extended-release tablet 1 time a day.
• You should take mirabegron extended-release tablets with water and swallow the tablet whole.
• Do not chew, break, or crush the tablet.
• Adults can take mirabegron extended-release tablets with or without food.
• If you miss a dose of mirabegron extended-release tablets, take it as soon as possible. If it has been more than 12 hours since taking the last dose of mirabegron extended-release tablets, skip that dose and take the next dose at the usual time.
• If you take too much mirabegron extended-release tablets, call your doctor or go to the nearest hospital emergency room right away.

Side effects, and when to stop

Mirabegron extended-release tablets may cause serious side effects, including:

• increased blood pressure. Mirabegron extended-release tablets may cause your blood pressure to increase or make your blood pressure worse if you have a history of high blood pressure. You and your doctor should check your blood pressure while you are taking mirabegron extended-release tablets. Call your doctor if you have increased blood pressure.
• inability to empty your bladder (urinary retention). Mirabegron extended-release tablets may increase your chances of not being able to empty your bladder if you have bladder outlet obstruction or if you are taking other medicines to treat overactive bladder. Tell your doctor right away if you are unable to empty your bladder.
• angioedema. Mirabegron extended-release tablets may cause an allergic reaction with swelling of the lips, face, tongue, or throat with or without difficulty breathing. Stop using mirabegron extended-release tablets and go to the nearest hospital emergency room right away.

Adults with Overactive Bladder

The most common side effects of mirabegron extended-release tablets include:

• high blood pressure
• pain or swelling of the nose or throat (nasopharyngitis)
• urinary tract infection
• headache

Tell your doctor if you have any side effect that bothers you, does not go away, or if you have swelling of the face, lips, tongue or throat, hives, skin rash or itching while taking mirabegron extended-release tablets.

These are not all the possible side effects of mirabegron extended-release tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088 or Lupin Pharmaceuticals, Inc. at 1-800-399-2561.

Who should not take it

Do not take mirabegron extended-release tablets if you are allergic to mirabegron or any of the ingredients in mirabegron extended-release tablets. See the end of this Patient Information leaflet for a complete list of ingredients in mirabegron extended-release tablets.

Before you take mirabegron extended-release tablets, tell your doctor about all of your medical conditions, including if you:

• have liver problems.
• have kidney problems.
• have very high uncontrolled blood pressure.
• have trouble emptying your bladder or you have a weak urine stream.
• are pregnant or plan to become pregnant. It is not known if mirabegron extended-release tablets will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if mirabegron passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take mirabegron extended-release tablets.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Mirabegron extended-release tablets may affect the way other medicines work, and other medicines may affect how mirabegron extended-release tablets work.

Especially tell your doctor if you take:

• thioridazine (Mellaril or Mellaril-S)
• flecainide (Tambocor)
• propafenone (Rythmol)
• digoxin (Lanoxin)
• solifenacin succinate (VESIcare)

Storing it

• Store mirabegron extended-release tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep the bottle closed. Throw away (discard) medicine that is out of date or no longer needed.

Keep mirabegron extended-release tablets and all medicines out of the reach of children.

General information about the safe and effective use of mirabegron extended-release tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use mirabegron extended-release tablets for a condition for which it was not prescribed.

Do not give mirabegron extended-release tablets to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about mirabegron extended-release tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about mirabegron extended-release tablets that is written for health professionals.