Qbrexza (Topical application)

Glycopyrronium tosylate is used to treat excessive underarm sweating (primary axillary hyperhidrosis).

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your or your child's progress at regular visits to ensure that this medicine is working properly and to monitor for unwanted effects.

Do not use this medicine to treat a skin problem that your doctor has not examined.

This medicine may cause urinary retention (trouble passing urine or not fully emptying the bladder), especially if you have bladder blockage. Check with your doctor right away if you or your child has a decrease in urine volume, a decrease in the frequency of urination, difficulty in passing urine, a feeling of a full bladder, or painful urination.

This medicine may make it harder for your body to cool down. It could reduce how much you sweat. Your body might get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. Avoid very hot places. Call your doctor if drinking cool water and moving away from the heat does not help you cool down.

This medicine may cause blurred vision. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks versus the benefits. For this medicine, please think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how glycopyrronium tosylate affects children younger than 9 years of age. Safety and effectiveness have not been established for this age group.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of glycopyrronium tosylate.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before taking this medicine during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be taken together even if an interaction might occur. In such cases, your doctor may adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect the use of this medicine. Be sure to tell your doctor about any other medical issues, especially:

• Bladder issues (e.g., distended bladder, bladder-neck obstruction) or
• Enlarged prostate or
• Difficulty passing urine—Use with caution. This may worsen these conditions.

• Blood or vessel disease, especially during acute bleeding, unstable or
• Glaucoma or
• Myasthenia gravis (nerve or muscle disease) or
• Sjogren's syndrome (immune system disorder) or
• Stomach or bowel problems (e.g., paralytic ileus, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis)—This medicine should not be used in patients with these conditions.

• Kidney disease—Use with caution. The effects may be stronger because the medicine is removed more slowly from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Bigger, dilated, or enlarged pupils (black part of the eye)
• blurred vision
• different size pupils of the eyes
• trouble in urinating

Incidence not known

• Decrease in frequency of urination
• decrease in urine volume
• difficulty in emptying your bladder
• difficulty in passing urine (dribbling)
• painful urination

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Dry mouth
• fever
• headache
• increased sensitivity of the eyes to light
• muscle aches
• pain in the mouth or throat
• redness, burning, stinging, or itching of the skin
• sore throat
• stuffy or runny nose
• unusual tiredness or weakness

Less common

• Constipation
• dry eye
• dry skin
• dry throat
• nasal dryness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Qbrexza

Available Dosage Forms:

• Pad

Therapeutic Class: Cholinergic Antagonist

Pharmacologic Class: Antimuscarinic

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Apply this medicine to clean, dry skin on your underarm areas only. Do not get it into your eyes, nose, or mouth. Do not swallow the medicine or apply over broken skin.

To use the cloth:

• Wash your hands with soap and water before and after you use this medicine.
• Tear open the pouch and pull out the cloth.
• Unfold the cloth and wipe across one underarm one time. Use the same cloth and wipe across the other underarm one time.
• Do not apply this medicine to broken skin. Do not cover the treated area with a bandage unless your doctor has told you to.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cloth):For excessive sweating of the underarms: Adults and children 9 years of age and older—Apply 1 cloth to both underarm areas once every 24 hours. Children younger than 9 years of age—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep this medicine away from heat or flame.

• How do you use a Qbrexza cloth?