Sofpironium topical

Sofpironium topical is applied to underarm skin to treat excessive sweating (hyperhidrosis) in adults and children who are at least 9 years old.

Sofpironium topical may also be used for other purposes that are not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Sofpironium topical is usually applied once daily at bedtime.

Do not take by mouth. Topical medicine is for use only on the underarm skin.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Do not apply sofpironium topical if the underarms have been shaved or deodorant has been applied within the last 8 hours.

Wait at least 30 minutes before applying sofpironium topical if you have exercised, showered, or washed the underarm skin.

Apply 1 pump of medicine to clean, dry underarm skin. Do not use on open wounds or broken skin.

Do not cover treated skin with a bandage or with plastic.

Do not cover treated areas with clothing for at least 5 minutes after applying sofpironium topical.

Wash your hands after applying this medicine. Any medicine on your hands could cause blurred vision if you later touch your eyes.

Store in an upright position at room temperature, away from moisture and heat.

Sofpironium topical gel is flammable. Do not use near high heat or open flame. Do not smoke until the gel has completely dried on your skin.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

You should not use sofpironium topical if you have:

• severe ulcerative colitis or other serious bowel problems;
• glaucoma;
• myasthenia gravis; or
• Sjogren's syndrome.

Tell your doctor if you have or have ever had:

• prostate, bladder, or urination problems; or
• kidney disease.

It is not known if sofpironium topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using sofpironium topical.

Get emergency medical help if you have signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Sofpironium topical may cause serious side effects. Stop using sofpironium topical and call your doctor right away if you experience:

• little or no sweating in hot conditions (such as during exercise or while exposed to high heat);
• fever, hot or red skin;
• rapid or shallow breathing;
• weak and rapid pulse;
• feeling light-headed, as if you might faint.
• trouble urinating (or a weak stream of urine);
• increased urination; or
• painful urination.

Common side effects of sofpironium topical may include:

• problems with urination;
• dry mouth;
• dilated pupils, blurred vision; or
• pain, redness, swelling, itching, or irritation at the application site.

This is not a complete list of side effects and others may happen. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Hyperhidrosis:

Maintenance dose: 1 pump under each arm once daily at bedtimeUse: For the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older

Usual Pediatric Dose for Hyperhidrosis:

9 to 18 years:Maintenance dose: 1 pump under each arm once dailyUse: For the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older

Apply the medicine as soon as possible, but skip the missed dose if it is nearly time for your next dose. Do not apply two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid getting too hot or dehydrated while exercising and in hot weather. Sofpironium topical decreases sweating, and you may be at a higher risk for heat stroke.

Do not shower or wash the area where you applied sofpironium topical for at least 8 hours after applying.

Sofpironium topical may cause blurred vision and could affect your reactions. Do not drive or engage in hazardous activities until you know how this medicine will affect you.

Sometimes it is not safe to use certain medicines together. Some drugs can change the blood levels of other drugs you take, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially:

• bronchodilator asthma medication;
• cold or allergy medicine (Benadryl and others);
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;
• medicine to treat overactive bladder; or
• medicine to treat Parkinson's disease.

Other drugs may affect sofpironium topical, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.