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The following information provides crucial safety details about Junel 1/20, a combined oral contraceptive. Please review these points carefully and discuss any concerns with your healthcare provider.

• Cigarette Smoking and Heart Problems: Smoking while using Junel 1/20 increases the risk of serious health issues such as strokes, heart attacks, and blood clots. This risk is especially high for women aged 35 and older. If you smoke, consult your healthcare provider about alternative birth control options.

• Blood Clots and Strokes: Junel 1/20 can increase the risk of blood clots in various parts of the body, such as the lungs, legs, brain, and heart. Those at higher risk include women over 35 who smoke, women over 40 who do not smoke, individuals with recent surgeries requiring prolonged bed rest, those starting the medication shortly after childbirth, and individuals with high blood pressure, obesity, high cholesterol, diabetes, or higher estrogen doses. Seek immediate medical attention if you notice any signs of a blood clot.

• Irregular Bleeding: Users may experience irregular bleeding or spotting, particularly within the first three months. This may range from light staining to period-like bleeding. Should this issue persist, consult your healthcare provider for alternative birth control solutions. If a period is missed, take a pregnancy test or consult your healthcare provider.

• High Blood Pressure: Junel 1/20 may increase blood pressure. Regular monitoring is advised, especially if you have existing high blood pressure or kidney issues. Discuss safer birth control methods with your provider if necessary.

• High Blood Sugar and Cholesterol: This medication may elevate blood sugar and cholesterol levels. If you have diabetes, prediabetes, or high cholesterol, speak with your provider before starting Junel 1/20. Regular monitoring will be necessary if you decide to use this contraceptive.

• Headaches: Report any new or worsening headaches to your provider. Persistent or severe headaches may require you to discontinue the medication.

• Cancer Risk: Some studies suggest Junel 1/20 might increase the risk of breast and cervical cancer, particularly with prolonged use. Discuss these risks with your healthcare provider, especially if there is a personal or family history of these cancers.

• Drug Interactions: Certain medications can reduce the effectiveness of Junel 1/20, potentially leading to pregnancy. Examples include carbamazepine and phenytoin. Use an additional birth control method for at least 28 days after stopping such medications. Other drugs may increase Junel 1/20 levels in your body, causing more side effects. Inform your provider or pharmacist about all medications you are taking to avoid interactions.

Contraindications: Junel 1/20 should not be used if you have or have had blood clots, conditions that increase clotting risk, cerebral vascular or coronary artery disease, breast cancer, unexplained vaginal bleeding, jaundice associated with pregnancy or past birth control use, liver tumors or cancer, or if you are pregnant. Additionally, avoid use if taking hepatitis C medications containing ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir. Always consult your healthcare provider under these conditions.

Common side effects:

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

Less common but important to monitor:

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

Serious side effects:

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

Blisovi Fe 1/20 is a combination oral contraceptive containing Ethinyl Estradiol and Norethindrone. While effective for birth control, it's important to be aware of potential interactions with other medications, supplements, and certain foods that can affect its efficacy or increase the risk of side effects.

Drug Interactions:

• Medications That May Decrease Effectiveness: Some drugs can reduce the effectiveness of Blisovi Fe 1/20, potentially leading to unintended pregnancy. These include:

  • Antibiotics: Rifampin and Rifabutin.
  • Anticonvulsants: Carbamazepine, Phenytoin, Phenobarbital, Topiramate, and Oxcarbazepine.
  • Antifungals: Griseofulvin.
  • HIV Medications: Certain protease inhibitors and non-nucleoside reverse transcriptase inhibitors.
  • Herbal Supplements: St. John's wort.

  If you're prescribed any of these, discuss alternative or additional contraceptive methods with your healthcare provider.

• Medications Affected by Blisovi Fe 1/20: This contraceptive can influence the metabolism of other drugs, leading to increased side effects or altered effectiveness. Notable examples include:

  • Corticosteroids: Such as Dexamethasone.
  • Theophylline: Used for respiratory conditions.
  • Cyclosporine: An immunosuppressant.
  • Tizanidine: A muscle relaxant.

  Regular monitoring and possible dosage adjustments may be necessary when combining these medications with Blisovi Fe 1/20.

Food and Lifestyle Interactions:

• Grapefruit Juice: Consuming grapefruit or its juice can elevate the blood levels of norethindrone, potentially increasing side effects. It's advisable to limit grapefruit intake while on this medication.

• Smoking: Smoking, especially in women over 35, significantly raises the risk of serious cardiovascular events like heart attacks and strokes when using combination oral contraceptives. It's strongly recommended to avoid smoking while taking Blisovi Fe 1/20.

Recommendations:

Always inform your healthcare provider about all medications, supplements, and herbal products you're currently using. This ensures they can assess potential interactions and provide guidance tailored to your health needs. If you experience unusual symptoms or side effects while on Blisovi Fe 1/20, seek medical advice promptly.