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The following safety information outlines the important risks and considerations associated with this medication. It is essential to understand these points and discuss any concerns with your healthcare provider.

• Cigarette Smoking and Heart Risks: Smoking while using combined oral contraceptives like Junel 1/20 significantly increases the risk of serious cardiovascular issues, such as strokes, heart attacks, and blood clots. This risk is particularly heightened for females over 35 who smoke. It is advisable to explore safer contraceptive options with your healthcare provider if you are a smoker.

• Blood Clots and Strokes: The use of Junel 1/20 can elevate the risk of developing blood clots, which may occur in various parts of the body, including the lungs, legs, brain, and heart. Seek immediate medical attention if you experience symptoms of a blood clot. Those at higher risk include smokers over 35, non-smokers over 40, individuals who have undergone recent surgery, or those with conditions such as high blood pressure, obesity, high cholesterol, or diabetes.

• Irregular Bleeding: Irregular bleeding or spotting may occur during the initial three months of taking Junel 1/20. This issue can range from light staining to heavy bleeding akin to a regular period. It may be temporary, but consult your provider if it becomes problematic. If a period is missed, take a pregnancy test or contact your provider.

• High Blood Pressure: Junel 1/20 may increase blood pressure. Regular monitoring is important, particularly for those with pre-existing high blood pressure or kidney problems. Consult your provider for alternative birth control methods if necessary.

• High Blood Sugar and Cholesterol: This medication can elevate blood sugar and cholesterol levels, posing a risk for individuals with diabetes, prediabetes, or high cholesterol. Close monitoring by a healthcare provider is recommended if taking Junel 1/20 under these conditions.

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

• Cancer Risks: Although study results vary, there is a potential increased risk for breast and cervical cancer associated with Junel 1/20. Individuals with a history of these cancers should consult their provider.

• Drug Interactions: Some medications can reduce the effectiveness of Junel 1/20, leading to potential pregnancy, while others can increase its concentration, causing more side effects. Inform your healthcare provider of all medications you are taking to prevent interactions.

Contraindications indicate situations where the medication should not be used due to potential health risks. Consult your healthcare provider if you have any of the following:

• Current or past blood clots or health conditions increasing clot risk.
• Cerebral vascular or coronary artery disease.
• Current or past breast cancer.
• Unexplained vaginal bleeding.
• Jaundice during pregnancy or past birth control use.
• Liver tumors or cancer.
• Pregnancy.
• Concurrent use of certain hepatitis C medications.

This information aims to ensure safe and informed use of Junel 1/20. Always consult with your healthcare provider for personalized advice and guidance.

Common side effects:

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

Less common but important to monitor:

• Skin conditions characterized by brown spots or patches
• Migraines
• Allergic rashes

Serious side effects:

• Signs of a heart attack
• Symptoms of a stroke
• Deep vein thrombosis
• Pulmonary embolism

When taking Larin 1/20, it's important to be aware of potential interactions with other medications, supplements, and certain foods, as these can affect the pill's effectiveness or increase the risk of side effects.

Medications That May Reduce Larin 1/20's Effectiveness:

Some drugs can decrease the levels of hormones in Larin 1/20, potentially making it less effective at preventing pregnancy. These include:

• Antibiotics: Certain antibiotics, such as Rifampin and Rifabutin, may reduce the effectiveness of Larin 1/20.

• Anticonvulsants: Medications used to treat seizures, including barbiturates, Carbamazepine, Phenytoin, and Topiramate, can lower hormone levels in the body.

• HIV Medications: Some drugs used to treat HIV, like nelfinavir and Nevirapine, may interfere with Larin 1/20.

• Herbal Supplements: St. John's wort, often used for depression, can decrease the effectiveness of hormonal contraceptives.

Medications That May Increase Side Effects:

Other drugs can raise hormone levels, leading to a higher risk of side effects:

• Atorvastatin: This cholesterol-lowering medication may increase the levels of hormones in Larin 1/20.

• Certain Antifungals: Medications like Ketoconazole and Itraconazole can elevate hormone levels.

Food Interactions:

• Grapefruit Juice: Consuming grapefruit juice may increase the blood levels of norethindrone, one of the hormones in Larin 1/20, potentially leading to more side effects. It's advisable to limit grapefruit intake while on this medication.

Other Considerations:

• Hepatitis C Treatments: Combining Larin 1/20 with certain hepatitis C medications, such as ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, can lead to significant liver enzyme elevations. It's recommended to discontinue Larin 1/20 before starting these treatments and consult your healthcare provider for alternative contraceptive methods.

Recommendations:

Always inform your healthcare provider about all medications, supplements, and herbal products you are currently using before starting Larin 1/20. This will help them assess potential interactions and determine if additional contraceptive methods are necessary. If you experience unusual symptoms or side effects while taking Larin 1/20, contact your healthcare provider promptly.