Glycopyrronium Topical

WHY is this medicine prescribed?

Topical glycopyrronium is used to treat excessive underarm sweating in adults and children 9 years of age and older. Topical glycopyrronium is in a class of medications called anticholinergics. It works by blocking the activity of a certain natural substance that triggers the sweat glands to produce sweat.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Topical glycopyrronium comes as a pre-moistened medicated cloth to apply to the underarm skin. It is usually applied once a day. Use glycopyrronium topical at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use topical glycopyrronium exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Apply glycopyrronium only in the underarm area. Do not apply on other body areas. Do not let the medication get into your eyes.

Apply this medication to clean, dry, intact skin only. Do not apply to broken skin. Do not cover the treated area with a plastic dressing.

Topical glycopyrronium is flammable. Do not use this medication near a source of heat or open flame.

To use topical glycopyrronium, follow these steps:

1. Carefully open the pouch to avoid tearing the glycopyrronium cloth.
2. Unfold the glycopyrronium cloth and apply the medication by wiping across one entire underarm one time.
3. Using the same glycopyrronium cloth, wipe across the other underarm one time.
4. Throw away the used cloth in the trash out of reach of children and other people. Do not reuse a glycopyrronium cloth.
5. Wash your hands right away after you apply the medication and have thrown away the cloth. Do not touch your eyes or the area around your eyes until you have washed your hands. Topical glycopyrronium may still be on your hands and may cause you to have blurred vision.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using topical glycopyrronium,

• tell your doctor and pharmacist if you are allergic to glycopyrronium, any other medications, or any of the ingredients in glycopyrronium medicated cloths. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had glaucoma (increased pressure in the eye that may lead to vision loss), any type of blockage in the digestive system, ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), any other bowel problems associated with ulcerative colitis, myasthenia gravis (a disorder of the nervous system that causes muscle weakness), or Sjogren syndrome (disorder of the immune system that causes dry eyes and mouth). Your doctor will probably tell you not to use topical glycopyrronium.

• tell your doctor if you have or have ever had difficulty urinating, urinary obstruction (a blockage of urine flowing out of the bladder), benign prostatic hypertrophy (BPH, enlargement of the prostate), or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using topical glycopyrronium, call your doctor.

• you should know that using topical glycopyrronium may cause you to have blurred vision. If you develop blurred vision during your treatment, stop using the medication and call your doctor. Do not drive, operate machinery, or do hazardous work until your vision improves.

• you should know that using topical glycopyrronium reduces the body's ability to cool off by sweating. When in very hot temperatures, stop using topical glycopyrronium if you notice that you are not sweating. If you experience any of the following symptoms, call your doctor immediately: hot, red skin; decreased alertness; loss of consciousness; fast, weak pulse; fast, shallow breathing; or fever.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra glycopyrronium topical glycopyrronium to make up for a missed dose.

What SIDE EFFECTS can this medicine cause?

Glycopyrronium may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dryness of the mouth, nose, throat, eyes, or skin
• widened pupils (black circles in the middle of the eyes)
• sore throat
• headache
• burning, stinging, itching, or redness in the underarm area
• constipation

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, stop using topical glycopyrronium and call your doctor immediately:

• urinating frequently, difficulty urinating, or urinating in a weak stream or drips

Glycopyrronium may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• flushing
• fever
• fast heartbeat
• abdominal pain
• widened pupils
• blurred vision
• difficulty urinating

What OTHER INFORMATION should I know?

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.