Sofpironium (sof-pir-OH-nee-um)

Treats excessive underarm sweating.

Brand Name(s):

Sofdra

When This Medicine Should Not Be Used:

How to Use This Medicine:

Gel/Jelly

• Your doctor will tell you how much medicine to use. Do not use more than directed. Apply this medicine at bedtime.
• This medicine is for use on the underarms only. Do not get it in your eyes or any other part of the body.
• Gel:
  • Wash your hands with soap and water before and after you use this medicine.
  • Apply the medicine to clean, dry, intact skin on your underarm areas only.
  • Do not shower or wash your underarms for at least 8 hours after applying this medicine. Do not apply to broken skin. Do not apply this medicine if you have shaved or applied deodorant within the last 8 hours. Do not apply this medicine if you have exercised, showered, or washed your underarm within the last 30 minutes.
  • Do not allow your clothes to touch your underarm for 5 minutes after applying it. Do not touch your underarms after applying the medicine.
  • Do not cover the treated area with a bandage unless directed by your doctor.
  • This medicine is flammable. Do not smoke or go near an open flame until the gel is dry.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Apply a dose as soon as you can. If it is almost time for your next dose, wait until then and apply a regular dose. Do not apply extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how sofpironium works. Tell your doctor if you are using paroxetine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, prostate or bladder problems, or trouble passing urine.
• This medicine may cause urinary retention (trouble passing urine or not fully emptying the bladder).
• 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.
• This medicine may keep you from sweating enough, which may cause your body to get too hot. Be careful in hot weather, and while you exercise or use a sauna or hot tub.
• Do not use this medicine to treat a skin problem your doctor has not examined.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision
• Change in how much or how often you urinate, difficult or painful urination
• Unable to sweat, feeling overheated, unexplained high fever

If you notice these less serious side effects, talk with your doctor:

• Dry mouth
• Mouth or throat pain
• Pain, redness, swelling, itching, or irritation in the underarm area

If you notice other side effects that you think are caused by this medicine, tell your doctor

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