Sofpironium Gel

What is this medication?

SOFPIRONIUM (sof pie roe nee um) treats excessive sweating. It works by decreasing the amount of sweat your body makes.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Sofdra

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bowel blockage
• Glaucoma
• Heart disease
• Inflammatory bowel disease, such as ulcerative colitis
• Irregular heartbeat or rhythm
• Kidney disease
• Myasthenia gravis
• Sjogren's syndrome
• Stomach or intestine problems
• Trouble passing urine
• An unusual or allergic reaction to sofpironium, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for external use only. Do not take by mouth. Wash your hands before and after use. Do not get it in your eyes. If you do, rinse your eyes with plenty of cool tap water. Use it as directed on the prescription label at the same time every day. Do not use it more often than directed. Keep using it unless your care team tells you to stop.

Apply a thin film of the medication to the affected area. Do not apply to burned or damaged skin. Do not cover with an airtight bandage such as a plastic-covered bandage.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 9 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medication?

• Antihistamines for allergy, cough and cold
• Atropine
• Certain medications for bladder problems, such as oxybutynin, tolterodine
• Certain medications for Parkinson disease, such as benztropine, trihexyphenidyl
• Certain medications for stomach problems, such as dicyclomine, hyoscyamine
• Certain medications for travel sickness, such as scopolamine
• Ipratropium

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This medication may give you blurred vision. Do not drive or operate machinery until you know how this medication affects you.

Avoid extreme heat (e.g., hot tubs, saunas). This medication can cause you to sweat less than normal. Your body temperature could increase to dangerous levels, which may lead to heat stroke.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Burning, itching, crusting, or peeling of treated skin
• Fever that does not go away, decreased sweating
• Trouble passing urine

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Blurry vision
• Burning or pain at application site
• Dilated pupils
• Dry mouth
• Headache

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

This medication is flammable. Avoid exposure to heat, fire, flame, and smoking.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.