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This document presents essential safety and warning information regarding the use of certain hormonal birth control medications. Please review this carefully and consult your healthcare provider if you have any questions or concerns.

• Smoking and Cardiovascular Risks: Smoking cigarettes while using hormonal birth control, such as Balcoltra, significantly increases the risk of severe cardiovascular events like heart attack and stroke. This risk is particularly high for women over 35 years old. If you smoke, it is crucial to discuss safer contraceptive options with your healthcare provider.

• Blood Clots: The use of Balcoltra raises the risk of blood clots due to its estrogen content. These clots can be life-threatening and may occur throughout the body. Immediate medical attention is required if symptoms of a blood clot develop. Those at higher risk include women over 35 who smoke, individuals with high blood pressure, obesity, high cholesterol, or diabetes, and those restarting COCs shortly after childbirth or surgery.

• Cancer Risks: The relationship between Balcoltra and increased risk of breast and cervical cancer is not fully understood. However, long-term use of COCs (over five years) may elevate the risk of cervical cancer. If you have or have had breast or cervical cancer, do not use Balcoltra. Regular screenings and examinations are advised for early detection and management.

• Liver Concerns: Avoid Balcoltra if you have liver conditions such as hepatitis, cirrhosis, or liver tumors, as it may increase the risk of benign liver tumors. Signs of liver issues include jaundice, fatigue, and dark urine; if these symptoms occur, discontinue use and consult your healthcare provider.

• Gallbladder Issues: There is a potential increased risk of gallbladder disease associated with Balcoltra. If you have a history of gallbladder disease, discuss this with your healthcare provider before starting the medication.

• Blood Sugar and Triglyceride Levels: Balcoltra may elevate blood sugar and triglyceride levels, particularly in individuals already managing these conditions. Regular monitoring is recommended.

• High Blood Pressure: Hormonal contraceptives like Balcoltra can increase blood pressure. Those with a history of hypertension or kidney problems, or who are older or have been on COCs for a long duration, should be cautious and regularly monitor their blood pressure.

• Headaches: Report any new or worsening headaches or migraines to your healthcare provider, as this may necessitate discontinuing the medication.

• Irregular Bleeding: Some users may experience irregular bleeding, especially in the initial months of use. This typically resolves over time, but persistent or heavy bleeding should be evaluated by a healthcare provider.

• Drug Interactions: Certain medications may affect the efficacy and safety of Balcoltra. Discuss all current medications with your healthcare provider to determine potential interactions.

Contraindications: Do not use this medication if you have a high risk of blood clots, a history of cardiovascular events, are pregnant, have uncontrolled high blood pressure or certain liver conditions, or are using specific hepatitis C treatments. Always consult your healthcare provider to discuss any contraindications or concerns before starting this medication.

In case of an overdose, particularly with iron-containing products, seek medical assistance immediately or contact a poison control center. Keep all medications out of reach of children to prevent accidental ingestion.

When taking this medication, some individuals may experience common side effects such as headaches, nausea, abdominal cramps, bloating, and breast tenderness. These symptoms are generally mild and may improve over time. You might also notice changes in your menstrual cycle, such as spotting, missed, or irregular periods during the initial months of use. While these changes are common, if they persist or worsen, it's advisable to consult your healthcare provider.

Some users report other side effects like mood changes, acne, and depression. There may also be occurrences of vaginal yeast infections or missing a period. While these effects can be distressing, they are typically not severe but should be discussed with your healthcare professional if they cause concern.

It is important to be aware of rare but serious side effects related to blood clots, which can manifest as a heart attack or stroke. Symptoms to watch for include chest pain, sudden numbness, confusion, difficulty speaking, or severe headaches. Deep vein thrombosis, presenting as leg pain or swelling, and pulmonary embolism, with symptoms like chest pain and breathing difficulties, warrant immediate medical attention. Additionally, issues such as jaundice, dark urine, or severe abdominal pain may indicate liver or gallbladder problems and should be addressed promptly.

While a severe allergic reaction to this medication is rare, symptoms such as rash, severe dizziness, or trouble breathing require urgent medical care. Regular monitoring of blood pressure is recommended, as this medication can sometimes lead to increased blood pressure. Always report any new or worsening side effects to your healthcare provider to ensure appropriate management.

Some medications that can interact with this drug include aromatase inhibitors like anastrozole and exemestane, fezolinetant, ospemifene, tamoxifen, tizanidine, and tranexamic acid. Additionally, certain drugs might reduce the effectiveness of hormonal birth control by decreasing the levels of contraceptive hormones in your body, potentially leading to pregnancy. These include medications such as griseofulvin, modafinil, certain antibiotics like rifamycins (e.g., rifampin, rifabutin), ritonavir, St. John's wort, seizure treatments (e.g., barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), and some HIV medications like nelfinavir and nevirapine.

It's important to inform your healthcare provider when you begin any new medication, and discuss whether you should use additional reliable birth control methods. Notify your doctor if you experience unusual spotting or breakthrough bleeding, as these could indicate that your birth control is less effective.

This medication may also affect certain laboratory tests, such as those measuring clotting factors or thyroid function, which could result in inaccurate results. Ensure that all medical and laboratory personnel are aware that you are taking this medication.