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Before using this medication, it is crucial to understand the potential risks and necessary precautions associated with it. Please review the following safety information and consult your healthcare provider if you have any questions or concerns.

• Smoking and Blood Clots: Smoking while using combined hormonal birth control like Twirla (levonorgestrel/ethinyl estradiol) significantly increases the risk of blood clots, which can lead to severe complications such as heart attack or stroke. This risk is heightened in individuals over 35 and those who smoke more frequently. If you are 35 years old or older and smoke, you should not use this medication. Consider discussing alternative birth control options with your healthcare provider.

• Body Mass Index (BMI) Considerations: Twirla is not recommended for individuals with a BMI of 30 kg/m² or greater, as its efficacy in preventing pregnancy may be reduced, and the risk of blood clots is greater. If you have a higher BMI, discuss alternative birth control methods with your healthcare provider.

• Risk of Blood Clots: Using Twirla can cause blood clots that may obstruct blood flow to critical areas like the legs, lungs, heart, or brain, potentially resulting in serious health issues such as a heart attack or stroke. This risk is higher if you have a personal or family history of blood clots, are over 35 and smoke, have high blood pressure, diabetes, a BMI of 30 kg/m² or more, migraines with aura, or if you are immobile for extended periods.

• Liver Health: Twirla may impact liver function and increase the risk of liver damage, particularly if taken alongside certain hepatitis C medications. Those with a history of liver issues or tumors should consult their healthcare provider before using this medication.

• Blood Pressure Concerns: Twirla can elevate blood pressure. Inform your healthcare provider if you have hypertension. Regular monitoring of blood pressure may be advised, and discontinuation of the medication might be necessary if blood pressure readings become significantly elevated.

• Gallbladder Issues: There is an increased risk of gallbladder problems with Twirla use. Report any symptoms such as dark urine, light-colored stools, itchiness, or jaundice to your healthcare provider promptly.

• Blood Sugar Levels: Twirla might raise blood sugar levels, affecting those with diabetes or high blood sugar. Regular monitoring is advisable to manage any significant changes.

• Cholesterol Levels: Twirla can increase cholesterol and triglyceride levels, which may lead to pancreatitis. Those with a history of high triglyceride levels should discuss the risks with their healthcare provider.

• Menstrual Bleeding Changes: Some users may experience changes in menstrual bleeding patterns, including breakthrough bleeding or spotting, especially during the first three months. If these changes persist, consult your healthcare provider.

• Cancer Risks: There is inconclusive evidence regarding Twirla's impact on breast or cervical cancer risk. Those with a history of these cancers should exercise caution.

Contraindications: Do not use this medication if you have:

• A BMI of 30 kg/m² or more
• A high risk for blood clots or a history of blood clots
• Conditions like stroke, coronary artery disease, certain heart rhythm disorders, or uncontrolled high blood pressure
• Are over 35 years old and smoke or have migraines with aura
• Diabetes with complications such as high blood pressure or long-standing diabetes over 20 years
• Liver conditions or tumors
• Are currently pregnant or have a history of breast cancer
• Unexplained abnormal vaginal bleeding

If any of these conditions apply to you, consult your healthcare provider for alternative options.

When using this medication, some individuals might experience common side effects such as skin irritation, rash, itching, or changes in skin color at the application site. Mild symptoms like nausea, headache, bloating, breast tenderness, and weight changes are also possible. Occasionally, menstrual irregularities such as spotting or missed periods may occur, particularly during the initial months of use. Most of these side effects are mild, but if they persist or worsen, consult your healthcare provider.

More severe side effects, although rare, require immediate attention. These include symptoms of blood clots, which may manifest as swelling, pain, or warmth in the legs, trouble breathing, or chest pain. Serious cardiovascular events like heart attack or stroke can occur, with signs such as sudden weakness, severe headache, and changes in speech or vision. Liver or gallbladder problems may present as yellowing of the skin or eyes, dark urine, or severe abdominal pain.

Additionally, an increase in blood pressure is a potential side effect, so regular monitoring is advised. Mental health changes, such as new or worsening depression, may also occur. In rare instances, an allergic reaction could happen, presenting with symptoms such as rash, hives, swelling, or difficulty breathing. If you experience these serious effects, seek urgent medical care. Always stay vigilant for any unusual symptoms and contact your healthcare provider if you notice changes not listed here.