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This document provides essential safety and warning information regarding the use of fesoterodine (Toviaz). It is crucial for patients and healthcare professionals to understand the potential risks and conditions in which this medication should not be used. If you have any concerns, please consult with your healthcare provider.

• Allergic Reactions: Fesoterodine may cause angioedema, which involves swelling of the face, lips, tongue, or throat. This allergic reaction can obstruct breathing and might occur after the initial dose or following multiple doses. Discontinue use immediately and seek emergency medical assistance if you experience these symptoms.

• Urinary and Gastrointestinal Concerns: Individuals with bladder blockages should avoid fesoterodine, as it may prevent complete bladder emptying, risking kidney damage and other complications. Additionally, those with stomach or intestinal blockages should not use this medication since it can exacerbate digestive issues. This is particularly concerning for those with a history of bladder issues, gastrointestinal blockages, or severe constipation.

• Vision Impairments: Fesoterodine can lead to vision changes, especially in patients with glaucoma. Those with uncontrolled narrow-angle glaucoma should avoid this medication. Consult your healthcare provider if you are uncertain about your glaucoma type or have a history of this condition.

• Drowsiness and Dizziness: The medication might cause dizziness, drowsiness, or decreased alertness, especially when initiating treatment or increasing the dose. Refrain from driving or engaging in activities that require concentration until you understand how fesoterodine affects you. This risk is heightened by alcohol consumption, the use of other sedative medications, or in individuals aged 65 and older.

• Myasthenia Gravis: If you have myasthenia gravis, a condition characterized by muscle weakness, consult your healthcare provider before using fesoterodine, as it could worsen your symptoms.

Contraindications

• Allergy to Tolterodine: Do not use fesoterodine if you are allergic to tolterodine (Detrol).

• Urinary Retention: Avoid this medication if you have a bladder blockage leading to urinary retention.

• Gastrointestinal Issues: Patients with a slow-moving gut should not take fesoterodine.

• Uncontrolled Narrow-angle Glaucoma: This condition contraindicates the use of fesoterodine.

In an event of an overdose, seek immediate medical attention. Always follow your healthcare provider's guidance when using this medication to ensure safety and efficacy.

When taking this medication, you may experience some common side effects that are typically mild and manageable. These include dry mouth, dry eyes, constipation, dizziness, drowsiness, blurred vision, and occasional urinary or respiratory tract infections. To alleviate dry mouth, consider sugarless candy, ice chips, or gum, and stay hydrated. For constipation, incorporate dietary fiber, adequate water intake, and regular exercise into your routine, and consult a pharmacist for suitable laxatives if needed.

While many people do not encounter severe issues, it is important to be aware of potential serious side effects. Contact your healthcare provider immediately if you experience persistent constipation lasting three or more days, severe abdominal pain, difficulty urinating, or symptoms of a kidney infection, such as painful urination, lower back pain, or fever. In rare cases, very serious side effects like a rapid heartbeat, fainting, or a severe allergic reaction, including rash, swelling, or difficulty breathing, may occur and require urgent medical attention.

Other reported side effects include diarrhea, indigestion, nausea, painful urination, cough, back pain, swelling, and insomnia. Remember, this list is not exhaustive. If you notice any unusual symptoms or side effects not mentioned here, it is important to reach out to your healthcare provider for advice.

Fesoterodine, known by its brand name Toviaz, can interact with several other medications and products. It's important to inform your doctor or pharmacist about all medicines and supplements you are taking, whether they are prescribed, over-the-counter, vitamins, or herbal supplements.

Certain products, such as potassium tablets or capsules, may not be recommended for use with fesoterodine. Additionally, other drugs can influence how fesoterodine is processed in your body, potentially affecting its efficacy. Notable examples include some azole antifungals like itraconazole and ketoconazole, and mifepristone.

If you're taking medications that induce drowsiness, such as opioid pain relievers (e.g., codeine, hydrocodone), sleep or anxiety medications (e.g., alprazolam, lorazepam, zolpidem), muscle relaxants (e.g., carisoprodol, cyclobenzaprine), or antihistamines (e.g., cetirizine, diphenhydramine), it's critical to discuss these with your healthcare provider, as they can amplify drowsiness, constipation, or blurred vision.

Always check the labels of all your medications, including those for allergies or colds, for ingredients that might cause these side effects. Consulting your pharmacist can help ensure the safe use of these products.