Sofpironium

WHY is this medicine prescribed?

Sofpironium is used to treat excessive underarm sweating in adults and children 9 years of age and older. Sofpironium 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?

Sofpironium comes as a gel to apply to the underarm skin. It is usually applied once daily at bedtime. Use sofpironium 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 sofpironium exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

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.

Sofpironium gel is flammable. Do not use this medication near smoking or a source of heat or open flame.

Before applying sofpironium gel, make sure that you do not shave or apply deodorant to your underarms within 8 hours. Also do not exercise or shower or wash your underarms within 30 minutes before application.

To apply the gel to your underarm areas, follow these steps:

1. If you are using the bottle for the first time, hold the bottle over a sink and press the pump down one or two times until you see gel coming out. Use water to wash the gel down the sink. Do not touch any gel in the sink.
2. Remove all clothing around both underarms.
3. Dry both underarms with a clean towel.
4. Put one full pump of gel onto the top of the applicator.
5. Spread the gel around your underarm using the applicator. Be careful not to touch the gel or get it on other areas of your body.
6. Repeat the application to your other underarm.
7. Let both underarms dry for 5 minutes. Keep clothing away from the area until it dries.
8. Rinse and dry applicator.
9. Wash your hands with soap and water.
10. Do not shower or wash your underarms for at least 8 hours after application.

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

What SPECIAL PRECAUTIONS should I follow?

Before using sofpironium,

• tell your doctor and pharmacist if you are allergic to sofpironium, any other medications, or any of the ingredients in sofpironium gel. Ask your pharmacist for a list of the ingredients.

• > tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while using sofpironium gel. 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 take sofpironium.

• 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 breast-feeding. If you become pregnant while taking sofpironium, call your doctor.

• you should know that using sofpironium 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 sofpironium reduces the body's ability to cool off by sweating. When in very hot temperatures, stop using sofpironium 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 sofpironium gel to make up for a missed dose.

What SIDE EFFECTS can this medicine cause?

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

• dry mouth
• blurred vision
• widened pupils (black circles in the middle of the eyes)
• pain, redness, itching, irritation, or rash in the underarm area

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

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

Sofpironium 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 (https://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 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. https://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 (https://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.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

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.