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The following safety information outlines crucial warnings and precautions related to the use of Sofdra (sofpironium). It is important to understand these details and discuss any concerns with your healthcare provider.

• Difficulty Urinating: Sofdra (sofpironium) may lead to difficulty urinating, especially if you have an enlarged prostate or bladder-neck obstruction. Symptoms such as pain or swelling in the lower abdomen, trouble urinating, or a sudden urge to urinate require you to stop using the medication and seek medical advice promptly.

• Reduced Sweating in Hot Weather: This medication can inhibit sweating, increasing the risk of overheating, particularly in warm conditions or if you have certain health issues (like heart problems, high blood pressure, or diabetes) or are taking medications such as diuretics, beta blockers, or antipsychotics. Exercise caution in hot environments.

• Blurred Vision: Use of Sofdra (sofpironium) might cause blurred vision. Should this occur, discontinue use until your vision clears. Avoid activities needing clear vision, like driving or operating heavy machinery, until symptoms resolve. This risk is greater if you have a history of eye problems.

Contraindications:

Sofdra (sofpironium) should not be used if you have conditions that could amplify its anticholinergic effects. These include:

• Glaucoma
• Myasthenia gravis
• Sjögren's syndrome
• Severe ulcerative colitis

If any of these conditions apply to you, consult your healthcare provider before using Sofdra.

When using this medication, some individuals may experience common side effects such as a dry mouth, which occurs in 14% of users, and blurred vision, affecting 9%. Application site irritation, including pain, redness, inflammation, and itching, can occur in up to 8% of users. Additionally, 7% may notice dilated pupils. These effects are generally mild, but if they persist or worsen, consulting a healthcare provider is advisable for reassurance and guidance.

There are other side effects reported by some users, which include difficulty urinating, dry eyes, upper respiratory tract infections, flu-like symptoms, and headaches. While these effects are not common, if you experience them, and especially if they are severe, reaching out to a healthcare provider is recommended to address any concerns.

Rare but serious side effects require immediate medical attention. Allergic reactions, such as skin rash, itching, hives, and swelling of the face, lips, tongue, or throat, are critical signs. Additional severe effects include burning, itching, crusting, or peeling of the treated skin, persistent fever, decreased sweating, and trouble passing urine. If any of these occur, urgent medical care is necessary to ensure your safety. Always be attentive to your body's responses while using this medication and communicate any unusual symptoms to your healthcare provider.