Myrbetriq 8 mg/mL oral suspension,extended release

Generic name:
Mirabegron extended-release suspension - oral

Pronunciation
(MIR-a-BEG-ron)

Brand name(s)
Myrbetriq

This medication is used to treat a certain bladder problem (neurogenic detrusor overactivity-NDO). NDO is a bladder control condition caused by brain, spinal cord, or nerve problems. Symptoms may include frequent urination, strong sudden urges to urinate, or involuntary loss of urine (incontinence). Mirabegron works by relaxing a certain bladder muscle (detrusor), which helps the bladder hold more urine and lessens symptoms of NDO.

Read the Patient Information Leaflet if available from your pharmacist before you start taking mirabegron and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food as directed by your doctor, usually once daily. You will receive this medication from the pharmacy as a suspension that has been prepared by your pharmacist. Shake the bottle well for 1 minute before use. Then let it stand until the foam on top of the suspension is gone (about 1 to 2 minutes). If the granules have not mixed well, shake the bottle well again for 1 minute and let it stand until the foam is gone. Carefully measure the dose using a special measuring device/spoon. Disregard any bubbles when measuring. Do not use a household spoon because you may not get the correct dose. Take within 1 hour after you have measured out the dose. Wash the special measuring device/spoon after each use and let it air dry.

If the suspension will not be used for 2 or more days, shake the bottle well for 1 minute each day.

The dosage is based on your medical condition, weight, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition does not get better or if it gets worse.

Constipation, pain/swelling of the nose or throat, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

• burning/painful urination

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking mirabegron, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• other bladder problems (such as blockage)
• high blood pressure
• kidney problems
• liver problems

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include flecainide, propafenone, thioridazine, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure) may be done while you are taking this medication. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is more than 12 hours after the missed dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature. Discard any unused portion after 28 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.