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This safety and warning information outlines critical considerations when using Junel 1/20, a combined oral contraceptive. Please read carefully and discuss with your healthcare provider if you have any questions or concerns.

• Cigarette Smoking and Heart Risks: Smoking cigarettes while taking Junel 1/20 significantly increases the risk of severe heart problems, such as strokes, heart attacks, and blood clots. This risk is particularly high for females aged 35 and older. It's advised to consult your healthcare provider about alternative birth control options if you are a smoker.

• Blood Clots and Strokes: Using Junel 1/20 can elevate the risk of blood clots, which may lead to pulmonary embolism, deep vein thrombosis, strokes, or heart attacks. Seek immediate medical attention if you notice signs of blood clots, especially if you are over 35 and smoke, over 40 and don't smoke, have recently had surgery, or have risk factors like obesity, high blood pressure, high cholesterol, diabetes, or a higher estrogen dose.

• Irregular Bleeding: Some users may experience irregular bleeding or spotting, especially in the initial three months. The severity can range from light spotting to bleeding similar to a menstrual period. Continue taking your medication as prescribed, but consult your provider if bleeding persists or if you miss a period to rule out pregnancy.

• High Blood Pressure: Junel 1/20 may increase blood pressure. Regularly monitor your blood pressure, and discuss safer birth control alternatives with your provider if you have high blood pressure or kidney problems. Blood pressure levels typically normalize after discontinuing the medication.

• High Blood Sugar and Cholesterol Levels: The medication can raise blood sugar and cholesterol levels. If you have diabetes, prediabetes, or high cholesterol, consult your provider before starting Junel 1/20, as regular monitoring will be necessary.

• Headaches: Report any new or worsening migraines or headaches to your provider. Discontinuation of the medication may be required if symptoms persist or become severe.

• Cancer Risks: There is a potential increased risk of breast and cervical cancer associated with long-term use of Junel 1/20. Discuss your medical history, particularly if you have had breast or cervical cancer, with your healthcare provider.

• Medication Interactions: Some medications can reduce the effectiveness of Junel 1/20, potentially leading to pregnancy, while others can increase side effects. Inform your provider or pharmacist of all medications you are taking to avoid interactions. Use an alternative birth control method for at least 28 days after stopping medications like carbamazepine or phenytoin.

Contraindications: Do not use Junel 1/20 if you have a current or history of blood clots, conditions increasing clotting risk, cerebral vascular or coronary artery disease, breast cancer, unexplained vaginal bleeding, jaundice from previous contraceptive use, liver tumors or cancer, are pregnant, or are taking certain hepatitis C medications.

Consult your healthcare provider for further guidance and to ensure that Junel 1/20 is safe for your use.

Common side effects:

• Nausea
• Vomiting
• Stomach cramps
• Bloating
• Menstrual cycle irregularities
• Swelling
• Breast changes
• Weight fluctuations
• Feelings of depression
• Vaginal yeast infection

Less common but important to monitor:

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

Serious side effects:

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

When taking Junel Fe 1/20, it's important to be aware of potential interactions with other medications and certain foods that can affect its effectiveness and safety.

Medications That May Reduce Effectiveness:

• Antibiotics: Some antibiotics, such as Rifampin, can decrease the effectiveness of Junel Fe 1/20, potentially leading to unintended pregnancy.

• Anticonvulsants: Medications like Phenytoin, Phenobarbital, and Carbamazepine may lower the levels of hormones in Junel Fe 1/20, reducing its contraceptive efficacy.

• HIV Medications: Certain drugs used to treat HIV, including Ritonavir, can interfere with the effectiveness of hormonal contraceptives.

Medications That May Increase Side Effects:

• Prednisolone: Junel Fe 1/20 can increase blood levels of prednisolone, potentially intensifying side effects such as weight gain, high blood pressure, and mood changes.

• Theophylline: Used for asthma, theophylline levels may rise when taken with Junel Fe 1/20, increasing the risk of side effects like nausea and nervousness.

Food Interactions:

• Grapefruit Juice: Consuming grapefruit juice can elevate hormone levels in Junel Fe 1/20, possibly leading to increased side effects. It's advisable to limit grapefruit intake while on this medication.

• Caffeine: Junel Fe 1/20 may slow the breakdown of caffeine in the body, potentially enhancing caffeine-related side effects such as jitteriness and insomnia.

Recommendations:

• Consult Your Healthcare Provider: Before starting Junel Fe 1/20, inform your doctor about all medications, supplements, and herbal products you are currently using.

• Monitor for Side Effects: Be vigilant for any unusual symptoms or side effects and report them to your healthcare provider promptly.

• Use Additional Contraception if Necessary: If you're taking medications known to reduce the effectiveness of Junel Fe 1/20, consider using an additional non-hormonal contraceptive method, such as condoms, to ensure protection against unintended pregnancy.

Being aware of these interactions helps in maintaining the effectiveness of Junel Fe 1/20 and ensures your safety while using the medication.