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The following safety information provides essential guidance on the use of Setlakin (levonorgestrel / ethinyl estradiol), particularly for those considering or currently using this medication. Please read carefully and discuss any concerns with your healthcare provider.

• Smoking and Heart Problems: If you smoke, using combined oral contraceptives like Setlakin significantly increases your risk of severe health issues, including stroke, heart attack, and blood clots. This risk is particularly heightened for women over 35 who smoke. Consider discussing safer birth control alternatives with your healthcare provider.

• Blood Clots and Stroke: This medication raises the risk of blood clots, which can occur in various parts of the body, such as the lungs (pulmonary embolism), legs (deep vein thrombosis), brain (stroke), and heart (heart attack). Seek emergency assistance if you notice symptoms like weakness, numbness, chest pain, or difficulty breathing. Notify your healthcare provider if you are undergoing surgery, as they may advise stopping the medication temporarily to reduce clot risks.

• Cancer Risks: There is a potential risk of breast and cervical cancer associated with Setlakin. If you have a history of breast cancer, avoid this medication as it may accelerate cancer growth. Regular self-checks and annual exams are recommended for early detection.

• Liver and Gallbladder Issues: Although rare, Setlakin can cause liver damage or tumors, more so with higher estrogen doses. Do not use if you have liver problems and report symptoms like fatigue or jaundice immediately. Discuss any gallbladder disease history with your doctor, as Setlakin may increase gallstone risks.

• Blood Sugar and Cholesterol: This medication may elevate blood sugar and triglyceride levels, so it's essential to monitor these if you have prediabetes or diabetes. Attend regular check-ups for effective management.

• High Blood Pressure: Setlakin can cause or worsen high blood pressure. Regular monitoring is advisable, and if you have uncontrolled high blood pressure, this medication may not be suitable.

• Headaches and Depression: Migraines or severe headaches require medical attention. If you experience depression symptoms, inform your healthcare provider, as they might recommend discontinuing the medication.

• Hereditary Angioedema: Estrogen-containing medications like Setlakin can trigger swelling attacks. Seek immediate medical help if swelling or breathing difficulties occur.

• Drug Interactions: Some medications, such as carbamazepine or phenytoin, can reduce Setlakin's effectiveness, leading to potential pregnancy. Use additional birth control methods for at least 28 days after stopping these medications. Always inform your healthcare provider of all medications you are taking to avoid harmful interactions.

• Contraindications: Do not use Setlakin if you have a history of blood clots, stroke, heart attack, certain cancers, liver issues, or uncontrolled medical conditions like high blood pressure or diabetes. It's also contraindicated if you're pregnant, have abnormal vaginal bleeding, or are taking specific hepatitis C medications.

This information aims to support safe and informed use of Setlakin. If any of the above risks concern you, consult with your healthcare provider to explore alternative options.

When taking this medication, you might experience some common side effects, which generally aren't a cause for concern unless they persist or worsen. These include nausea, vomiting, headaches, bloating, breast tenderness, mild weight changes, and fluid retention leading to swelling of the ankles or feet. Some individuals report vaginal spotting, especially in the initial months of use. You may also notice changes in your menstrual cycle, such as having a period once every three months while on active pills. If menstrual changes occur, such as missed periods during inactive pills, consult your healthcare provider to rule out pregnancy.

It's important to monitor your blood pressure, as this medication can cause an increase. If you experience high blood pressure readings, discuss this with your doctor. More serious side effects, though rare, require immediate medical attention. These include lumps in the breast, severe mood changes, intense stomach or abdominal pain, unusual vaginal bleeding patterns, dark urine, or yellowing of the eyes or skin.

This medication can occasionally lead to life-threatening conditions like blood clots, heart attacks, strokes, or pulmonary embolisms. Seek urgent care if you experience symptoms such as chest pain, confusion, severe dizziness, pain or swelling in the legs or groin, difficulty speaking, shortness of breath, or sudden severe headaches. A very serious allergic reaction is rare but requires immediate medical help if you notice a rash, severe itching or swelling, or trouble breathing.

Other side effects reported include mood swings, migraines, acne, and feelings of depression. If you experience any unusual or severe reactions, contact your healthcare provider promptly. While this list covers many potential side effects, it is not exhaustive. Always consult your doctor or pharmacist if you notice other unusual symptoms.