QBREXZA safety:

understanding the Safety & Some POssible Side effects

When used as directed, prescription QBREXZA™ (glycopyrronium) cloth is an effective way to treat excessive underarm sweating (or axillary hyperhidrosis) in adults and children 9 years of age and older.

Who should not use QBREXZA?

QBREXZA is an anticholinergic medicine, meaning it blocks the neurotransmitters that cause excessive sweat. Do not use QBREXZA if you have certain medical conditions that can be made worse by taking an anticholinergic such as glaucoma, severe ulcerative colitis or certain other serious bowel problems associated with severe ulcerative colitis, myasthenia gravis, and Sjögren’s syndrome.

Talk to your healthcare provider if you are not sure if you have a medical condition that can be made worse by taking an anticholinergic medicine.

Before using QBREXZA, tell your doctor about all of your medical conditions, including if you:

  • have prostate or bladder problems, or problems passing urine
  • have kidney problems
  • are pregnant or plan to become pregnant
    (It is not known if QBREXZA will harm your unborn baby)
  • are breastfeeding or plan to breastfeed
    (It is not known if QBREXZA passes into your breast milk)

Talk to your doctor about the best way to feed your baby during treatment with QBREXZA.

What should I tell my doctor before taking QBREXZA?

Tell your healthcare provider about all of your medical conditions, including if you:

  • have prostate or bladder problems, or problems passing urine
  • have kidney problems
  • are pregnant or plan to become pregnant. It is not known if QBREXZA will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if QBREXZA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with QBREXZA.

Know the medicines you take, and tell your doctor about all of them, including prescription ones, over-the-counter products, vitamins, and herbal supplements. QBREXZA may affect the way other medicines work, which could lead to side effects. And don’t forget to tell your doctor if you take anticholinergic medicines.

And whenever you’re prescribed a new medicine, it’s generally a good idea to share a list of your current ones with your pharmacist too.

What should I avoid while using QBREXZA?

Know the medicines you take, and tell your doctor about all of them, including prescription ones, over-the-counter products, vitamins, and herbal supplements. QBREXZA may affect the way other medicines work, which could lead to side effects. And don’t forget to tell your doctor if you take anticholinergic medicines.

What are the possible side effects of QBREXZA?

The most common side effects include:

  • dry mouth
  • dilation of the pupils of your eyes (mydriasis)
  • sore throat
  • skin redness, burning/stinging or itching in underarm area
  • headache
  • problems with urination
  • blurred vision
  • nasal dryness
  • throat, eye, and skin dryness
  • constipation

But QBREXZA can also cause serious side effects. Those include:

  • New or worsened urinary retention (the inability to empty the bladder completely). People who use QBREXZA may develop new or worse urinary retention. It can be caused by a blockage in your bladder, and can happen in men who have a larger than normal prostate. Symptoms of urinary retention may include:
    • difficulty urinating
    • urinating frequently
    • urination in a weak stream or drips
    • full bladder or difficulty emptying your bladder (distended bladder)

    If you have these symptoms, stop using QBREXZA and call your doctor right away.

  • Problems with control of your body temperature. QBREXZA can cause you to have decreased sweating in areas other than the underarm area which could cause you to become overheated and to develop heat illness. When in hot or very warm temperatures, watch for lack of sweating on your body and stop using QBREXZA if you develop lack of sweating on your body.

Stop using QBREXZA and call your doctor right away if you develop any of these symptoms of heat illness:

  • hot, red skin
  • decreased alertness or passing out (unconsciousness)
  • fast, weak pulse
  • fast, shallow breathing
  • increased body temperature (fever)
  • Blurred vision. If you develop blurred vision during treatment with QBREXZA, call your doctor, stop using QBREXZA and do not drive, or operate machinery, or do hazardous work until your vision is clear.

These are not all the possible side effects of QBREXZA

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

The FDA-approved patient product information can be found at pi.dermira.com/QbrexzaPPI.pdf

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