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This document outlines crucial safety warnings and contraindications for the use of Junel 1/20, an oral contraceptive. Please read carefully and consult with your healthcare provider if you have any questions or concerns.

• Cigarette Smoking and Cardiovascular Risks: If you smoke, using Junel 1/20 increases the risk of serious cardiovascular events such as strokes, heart attacks, and blood clots. This risk is heightened in females over 35 who smoke. Discuss alternative birth control options with your healthcare provider if you are a smoker.

• Blood Clots and Strokes: Junel 1/20 may elevate the risk of developing blood clots, which can lead to pulmonary embolism, deep vein thrombosis, stroke, or heart attack. Seek immediate medical attention if you experience symptoms of a blood clot. Higher risk is associated with females over 35 who smoke, individuals over 40 who do not smoke, recent surgery with extended bed rest, starting Junel 1/20 less than a month postpartum, high blood pressure, obesity, high cholesterol, diabetes, and higher estrogen doses.

• Irregular Bleeding: Users may experience irregular bleeding or spotting, particularly in the first three months of usage. This may range from light staining to bleeding akin to a regular period. If problematic, discuss alternative options with your provider. A missed period warrants a pregnancy test or consultation with your provider.

• High Blood Pressure: Junel 1/20 can lead to elevated blood pressure. Monitoring is advised, and individuals with high blood pressure or kidney issues should consult a provider for safer birth control methods. Blood pressure typically normalizes after discontinuation of the medication.

• Blood Sugar and Cholesterol: The medication may increase blood sugar and cholesterol levels. Individuals with diabetes, prediabetes, or high cholesterol should be monitored regularly if opting to use Junel 1/20.

• Headaches: Report any new or worsening headaches or migraines to your provider. Discontinuation may be necessary if these symptoms persist or become severe.

• Cancer Risk: There is a potential increased risk of breast and cervical cancer with Junel 1/20 use, especially for individuals with a history of these cancers or prolonged use of oral contraceptives.

• Drug Interactions: Some medications can diminish the effectiveness of Junel 1/20, increasing pregnancy risk. Notable examples include carbamazepine and phenytoin. Use additional contraception for at least 28 days after discontinuing these medications. Inform your provider of all medications you are taking to avoid harmful interactions.

Contraindications: Junel 1/20 should not be used if you have:

• A current or prior history of blood clots.
• Conditions predisposing you to clotting.
• Cerebral vascular or coronary artery disease.
• A current or past history of breast cancer.
• Unexplained vaginal bleeding.
• Jaundice during pregnancy or past birth control use.
• Liver tumors or cancer.
• Pregnancy.
• Are taking hepatitis C medications containing ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir.

Please ensure you discuss any of these conditions or medications with your healthcare provider before using Junel 1/20.

Common side effects:

• Nausea
• Vomiting
• Stomach cramps
• Bloating
• Bleeding between periods
• Spotting
• Changes in menstrual flow
• Missed periods
• Swelling
• Breast changes
• Weight fluctuations
• Mental depression
• Vaginal yeast infection

Less common but important to monitor:

• Skin condition causing brown spots or patches
• Migraines
• Allergic rashes

Serious side effects:

• Heart attack symptoms (chest pain, stomach discomfort, sweating, nausea, dizziness)
• Stroke symptoms (sudden numbness or weakness in the arm, leg, or face, confusion, vision problems, headache, difficulty walking)
• Deep vein thrombosis (leg cramps, swelling, pain, muscle tightness)
• Pulmonary embolism (cough, chest pain, breathing difficulties, racing heart)