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This safety and warning information is designed to inform you about the potential risks and necessary precautions when using the medication Junel 1/20. Please read carefully and consult your healthcare provider for any questions or concerns.

• Cigarette Smoking and Heart Problems: Smoking while using combined oral contraceptives, such as Junel 1/20, significantly increases the risk of serious health issues, including strokes, heart attacks, and blood clots. This risk is especially heightened for women over 35 who smoke. Consult your healthcare provider about alternative birth control options if you smoke.

• Blood Clots and Strokes: Junel 1/20 may increase the likelihood of developing blood clots in various parts of the body, including the lungs, legs, brain, and heart. Emergency medical attention is required if any symptoms of a blood clot appear. Higher risk factors include being over 35 and smoking, being over 40 and not smoking, recent surgery with prolonged bed rest, postpartum period, high blood pressure, obesity, high cholesterol, diabetes, and a higher dose of estrogen.

• Irregular Bleeding: Users of Junel 1/20 may experience irregular bleeding or spotting, particularly in the first three months. This may range from light spotting to bleeding similar to a regular period. If this becomes problematic, consult your healthcare provider for alternative options. If a period is missed, conduct a pregnancy test or contact your provider.

• High Blood Pressure: Junel 1/20 can cause an increase in blood pressure. Regular monitoring is advised, especially for those with a history of hypertension or kidney issues. Discontinuing the medication may return blood pressure to normal. Risks are higher for older individuals, prolonged COC use, high blood pressure, and kidney issues.

• High Blood Sugar and Cholesterol: This medication can elevate blood sugar and cholesterol levels. Individuals with diabetes, prediabetes, or high cholesterol should discuss potential risks with their healthcare provider and may require regular monitoring.

• Headache: Notify your provider if new or worsening headaches or migraines occur while taking Junel 1/20. Discontinuation may be necessary if symptoms persist or become severe.

• Risk of Cancer: There is a potential increased risk for breast and cervical cancer with Junel 1/20 use, particularly for those with a history of these cancers or long-term COC use.

• Medication Interactions: Certain drugs can reduce the effectiveness of Junel 1/20, increasing the risk of pregnancy. These include medications like carbamazepine and phenytoin. Use a backup birth control method for 28 days after stopping these medications. Some drugs may increase Junel 1/20 levels, leading to more side effects. Inform your healthcare provider about all medications you are taking.

Contraindications: Do not use Junel 1/20 if you have current or past blood clots, clotting disorders, cerebral vascular or coronary artery disease, current or past breast cancer, unexplained vaginal bleeding, jaundice during pregnancy or previous COC use, liver tumors or cancer, pregnancy, or if taking certain hepatitis C medications. Always consult with your healthcare provider before starting this medication if any of these conditions apply to you.

Common side effects:

• Nausea
• Vomiting
• Stomach cramps
• Bloating
• Changes in menstrual cycle
• Swelling
• Breast changes
• Weight fluctuations
• Mentally depressed
• Vaginal yeast infection

Less common but important to monitor:

• Skin condition with brown spots or patches
• Migraines
• Allergic rash

Serious side effects:

• Heart attack symptoms
• Stroke symptoms
• Deep vein thrombosis
• Pulmonary embolism