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This safety information outlines important risks and precautions associated with the use of estrogen products like Vivelle-Dot (estradiol patch). It is crucial to discuss these risks with your healthcare provider and to follow their guidance closely.

• Blood Clots and Cardiovascular Risks: Estrogens can increase the risk of developing blood clots, which could potentially lead to serious complications such as heart attacks or strokes. People with a personal or family history of blood clots, high blood pressure, diabetes, high cholesterol, tobacco use, obesity, or systemic lupus erythematosus (SLE) are at higher risk.

• Cancer Risks:

  • Uterine (Endometrial) Cancer: Estrogen use can elevate the risk of uterine cancer, especially with long-term use. Notify your doctor if you experience unusual vaginal bleeding. Taking progestin alongside estrogen may reduce this risk if you still have your uterus.
  • Breast Cancer: The use of estrogen with progestin can increase the risk of breast cancer, particularly with prolonged usage. Regular yearly breast exams, monthly self-exams, and mammograms are recommended. Contact your healthcare provider if you notice any breast changes.
  • Ovarian Cancer: There is a potential increased risk of ovarian cancer when using estrogen with progestin. Report any unusual vaginal symptoms to your doctor.

• Dementia: Estrogen, with or without progestin, may heighten the risk of dementia, especially in older adults. Discuss any memory concerns with your doctor.

• Gallbladder and Liver Issues: Estrogen use may lead to gallbladder problems. Seek medical attention if you experience persistent stomach pain, nausea, jaundice, or other related symptoms.

• Vision Problems: Rarely, estrogens can cause vision issues due to blood clots in the eye. Discontinue use and contact your healthcare provider if you have sudden vision changes.

• High Triglycerides: Estrogens may raise triglyceride levels, which can cause heart or pancreatic issues. Be vigilant for symptoms like sudden stomach pain or rapid heart rate.

• Thyroid Function: Estrogen can affect thyroid hormone levels. Those on thyroid medication may require dosage adjustments.

• Fluid Retention: Estrogen can cause edema, particularly in individuals with heart or kidney problems. Notify your doctor if you experience swelling or sudden weight gain.

• Severe Allergic Reactions: Report any signs of an allergic reaction, such as swelling or breathing difficulties, to a medical professional immediately.

• Worsening of Other Conditions: Estrogen might exacerbate conditions like asthma, diabetes, epilepsy, migraines, and lupus. Inform your doctor about all existing health conditions.

Contraindications: Avoid using this medication if you have abnormal vaginal bleeding, a history of breast cancer, estrogen-dependent cancer, blood clots, or clotting disorders, or if you have experienced a stroke, heart attack, or have liver problems. Consult your healthcare provider if any of these apply to you.

When using this medication, you might experience some common side effects that are generally mild. These include headaches, which affect up to 50% of users, common cold symptoms, breast tenderness, sinus swelling, and bleeding between periods. Other common effects are depression, back pain, sinus headaches, indigestion, weight gain, and joint pain. If these symptoms persist or worsen, it's advisable to consult with a healthcare provider.

There are additional side effects that some people may encounter, such as constipation, flu-like symptoms, pain in various parts of the body including the arms, legs, and neck, anxiety, trouble sleeping, nausea, vomiting, stomach cramps, migraine, and dizziness. While these effects may not be severe, monitoring them is important, and healthcare advice should be sought if they become bothersome.

On a more serious note, although rare, there are severe side effects that require immediate medical attention. These include signs of a heart attack, such as chest pain or tightness, and stroke symptoms like sudden trouble speaking or walking. There is also a risk of blood clots, which can manifest as deep vein thrombosis in the leg or a pulmonary embolism in the lung, and could present with symptoms like leg swelling or trouble breathing. Other serious concerns involve potential signs of cancer, gallbladder problems, and severe allergic reactions, which include symptoms like hives, swelling in the face or throat, and trouble breathing. Immediate medical care is essential if any of these serious side effects occur.

Certain medications can interact with the Vivelle-Dot (estradiol patch), so it is important to inform your doctor and pharmacist about any other medications or supplements you are taking, including prescription and over-the-counter drugs, vitamins, and herbal supplements.

Medications that are generally not recommended to be used with Vivelle-Dot include Tranexamic Acid. Your doctor might choose to not prescribe Vivelle-Dot or adjust your other medications if this interaction is a concern.

There are also medications that are usually not recommended to be taken with Vivelle-Dot, but may be necessary in some cases. If both medications are needed, your doctor might adjust the dosage or frequency of one or both. These include a wide range of drugs like abametapir, Amoxicillin, Carbamazepine, Dexamethasone, and St John's Wort, among others.

Additionally, using Vivelle-Dot with certain other drugs may increase the risk of side effects. However, the combination might still be the best treatment option for you. In such cases, your doctor may adjust how you use these medications. Examples include Atazanavir, Diazepam, Levothyroxine, and Warfarin.

Finally, Vivelle-Dot might interfere with certain lab tests, leading to inaccurate results. It is crucial that all healthcare providers and lab personnel are aware you are using this medication to avoid any potential issues.