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This document outlines essential safety and warning information for the use of hormonal contraceptives, such as Balcoltra. Please review the following points carefully and consult your healthcare provider if you have any questions or concerns.

• Smoking and Cardiovascular Risk: Smoking while using contraceptives like Balcoltra can significantly elevate the risk of serious cardiovascular events, such as heart attacks and strokes. This risk is particularly high for individuals over 35 years old. If you smoke, discuss alternative birth control options with your healthcare provider.

• Blood Clots: Balcoltra may increase the risk of serious blood clots due to its estrogen content. These can occur anywhere in the body and may be life-threatening. Immediate medical attention should be sought if you experience symptoms of blood clots. Individuals at higher risk include those over 35 who smoke, those over 40 who do not smoke, individuals with recent surgery, or those with conditions like high blood pressure, obesity, high cholesterol, and diabetes.

• Cancer Risks: It is unclear if Balcoltra increases the risk of breast and cervical cancer; however, those with a history of these cancers should avoid using it. Regular screenings and consultations with your gynecologist are recommended if you have been using Balcoltra.

• Liver Issues: Avoid Balcoltra if you have liver problems, as it can increase the risk of benign liver tumors. Discontinue use and consult your doctor if you notice signs of liver complications, such as jaundice or fatigue.

• Gallbladder Disease: While rare, Balcoltra may increase the risk of gallbladder disease. Discuss any history of gallbladder issues with your healthcare provider before starting this medication.

• Blood Sugar and Triglycerides: Balcoltra can raise blood sugar and triglyceride levels. The risk is higher for individuals with pre-existing high levels of these substances.

• Blood Pressure: Monitor your blood pressure while taking Balcoltra, especially if you have a history of high blood pressure or kidney problems. Discuss risks with your healthcare provider.

• Headaches: Report any new or worsening headaches to your healthcare provider, as you may need to discontinue use if they persist.

• Irregular Bleeding: Some individuals may experience irregular bleeding or spotting, particularly during the first three months of use. If bleeding continues or becomes severe, contact your gynecologist.

• Drug Interactions: Certain medications can affect Balcoltra's efficacy and side effects. Inform your healthcare provider about all medications you are taking.

Contraindications: Balcoltra should not be used in the following cases:

• High risk of blood clots or history of cardiovascular events.
• Individuals over 35 who smoke or have migraines with aura.
• Uncontrolled high blood pressure, diabetes, obesity, coronary artery disease, or atrial fibrillation.
• Current or past liver disease or tumors.
• Pregnancy or history of breast cancer.
• Unexplained abnormal vaginal bleeding.
• Use of certain hepatitis C medications.

In the event of an overdose, seek immediate medical assistance or contact a poison control center. Keep this medication out of reach of children to prevent accidental ingestion, which can be particularly dangerous.

When taking this medication, you may experience some common side effects, which are usually mild and temporary. These include nausea, vomiting, headaches, abdominal cramps or bloating, breast tenderness, and fluid retention leading to swelling of the ankles or feet. Some individuals might notice changes in weight, spotting or abnormal bleeding between periods, and irregular or missed periods, particularly during the initial months of use. If these effects persist or worsen, it is advisable to consult your healthcare provider.

It's important to monitor your blood pressure regularly as this medication can cause an increase. Serious side effects, though rare, need immediate medical attention. Be vigilant for symptoms indicating possible blood clots, such as severe headaches, chest pain, shortness of breath, sudden dizziness, and swelling or warmth in the leg. Similarly, signs of a stroke or heart attack, like sudden numbness, weakness, or confusion, require urgent care.

Additional serious side effects include potential liver or gallbladder issues, marked by yellowing of the skin or eyes, dark urine, and severe abdominal pain. Mood changes, including new or worsening depression, and unusual changes in vaginal bleeding patterns should also be reported to your healthcare provider. Rarely, a serious allergic reaction may occur, with symptoms like rash, severe dizziness, and difficulty breathing. If you experience any unlisted effects or suspect an allergic reaction, seeking medical advice is crucial.