Mirabegron Oral tablet, extended-release
What is this medicine?
MIRABEGRON (MIR a BEG ron) is used to treat overactive bladder. This medicine reduces the amount of bathroom visits. It may also help to control wetting accidents.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
difficulty passing urine
high blood pressure
an unusual or allergic reaction to mirabegron, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
certain medicines for bladder problems like fesoterodine, oxybutynin, solifenacin, tolterodine
MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
It may take 8 weeks to notice the full benefit from this medicine.
You may need to limit your intake tea, coffee, caffeinated sodas, and alcohol. These drinks may make your symptoms worse.
Visit your doctor or health care professional for regular checks on your progress. Check your blood pressure as directed. Ask your doctor or health care professional what your blood pressure should be and when you should contact him or her.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
chest pain or palpitations
severe or sudden headache
high blood pressure
fast, irregular heartbeat
redness, blistering, peeling or loosening of the skin, including inside the mouth
signs of infection - fever or chills, pain or difficulty passing urine
trouble passing urine or change in the amount of urine
Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
March 21, 2017
U.S. FDA-approved Package Insert