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When considering the use of hormonal birth control such as Safyral, it's crucial to be aware of several important safety considerations. These include potential risks, contraindications, and special precautions for specific populations. Please review the following information thoroughly and consult your healthcare provider if you have any questions or concerns.

• Smoking and Cardiovascular Risks: If you are a smoker, especially females over 35, using combined oral contraceptives like Safyral significantly increases your risk of serious cardiovascular events, such as strokes, heart attacks, and blood clots. It is strongly advised to avoid smoking while on this medication. Discuss alternative birth control methods with your healthcare provider if you smoke.

• Blood Clots and Stroke: Safyral can elevate the risk of blood clots forming in various parts of the body, including the lungs, legs, brain, and heart. This risk is higher for those over 35 who smoke, have recently had surgery, are within a month postpartum, have high blood pressure, obesity, diabetes, or are on higher estrogen doses. Seek immediate medical help if you experience symptoms of a blood clot.

• Cancer Risks: There is a potential, though not conclusively proven, risk of breast and cervical cancer associated with long-term use of Safyral and other combined oral contraceptives. Those with a history of breast cancer should exercise caution.

• Liver Concerns: While rare, Safyral may cause liver issues, including liver damage and tumors. This is more common with older contraceptive formulations with higher estrogen levels. Individuals with existing liver problems should be particularly cautious.

• High Blood Pressure: Use of Safyral may increase blood pressure. Regular blood pressure monitoring is recommended, and if uncontrolled high blood pressure is present, an alternative contraceptive method might be necessary.

• Metabolic Effects: This medication can affect blood sugar and lipid levels, potentially leading to conditions like pancreatitis. Those with diabetes or high triglycerides should have regular check-ups to monitor these levels.

• Neurological Effects: Headaches, including migraines, may occur. If you experience new or worsening headaches, contact your healthcare provider.

• Depression: If you notice symptoms of depression or worsening mood, inform your healthcare provider as it may necessitate discontinuing the medication.

• Drug Interactions: Certain drugs can decrease Safyral's effectiveness or increase its side effects. Use additional contraceptive methods if taking medications like carbamazepine or phenytoin. Inform your healthcare provider of all medications you are taking.

• Potassium Levels: Safyral may increase potassium levels, especially if combined with other potassium-raising drugs. Monitoring is advised for those with kidney, liver, or adrenal issues.

Contraindications:

• Avoid using Safyral if you have kidney, liver, or adrenal gland issues, a high risk of blood clots, certain heart or blood vessel problems, unexplained uterine bleeding, uncontrolled diabetes, or are pregnant. It is also contraindicated for individuals with hormone-sensitive breast cancer, specific types of migraines, or if currently using Viekira Pak.

Always consult your healthcare provider to ensure Safyral is safe for you, especially if you fall into any high-risk categories.

When taking this medication, some individuals may experience common side effects such as nausea, vomiting, headaches, or migraines. Other typical symptoms include abdominal cramps, bloating, breast tenderness, or pain, as well as swelling of the ankles or feet due to fluid retention. Additionally, changes in weight and spotting or irregular periods may occur, especially in the initial months of use. Although these side effects are usually mild, consult your healthcare provider if they persist or worsen.

There are also other side effects to be aware of, including mood changes and depression. While less common, these symptoms can impact your daily life and should be discussed with your healthcare provider if you notice them.

Serious side effects, though rare, require immediate medical attention. These include symptoms of a heart attack, such as chest pain, sweating, nausea, and dizziness, or signs of a stroke, like sudden numbness or weakness in the limbs, confusion, or difficulty seeing or walking. Blood clots, such as deep vein thrombosis, can present as leg cramps, swelling, or pain, while pulmonary embolism may cause cough, chest pain, or trouble breathing. Additionally, liver issues can manifest as yellowing of the skin or eyes, tiredness, and stomach pain.

Although a very serious allergic reaction is rare, seek urgent medical help if you experience symptoms like a rash, severe dizziness, or trouble breathing. It’s important to monitor your health and report any new or worsening symptoms to your healthcare provider.

Some medications that may interact with this drug include aromatase inhibitors like anastrozole, exemestane, and letrozole; atazanavir/cobicistat; fezolinetant; ospemifene; tamoxifen; and tranexamic acid. Drospirenone can increase your potassium levels. Inform your doctor if you regularly use other medications that also elevate potassium, such as aliskiren, ACE inhibitors like benazepril and lisinopril, angiotensin receptor blockers like losartan and valsartan, heparin, NSAIDs like ibuprofen and naproxen, and potassium-sparing diuretics such as spironolactone and triamterene.

Certain drugs can reduce the effectiveness of hormonal birth control by lowering its hormone levels, potentially leading to pregnancy. These include griseofulvin, modafinil, rifamycins like rifampin and rifabutin, ritonavir, St. John's wort, and certain seizure medications such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, and topiramate, as well as some HIV medications like nelfinavir and nevirapine. Always inform your doctor when you start any new medication and discuss whether you require an additional method of birth control. If you experience any new spotting or breakthrough bleeding, notify your doctor, as these may indicate that your birth control is less effective.

This medication may also affect certain lab tests, such as those measuring blood clotting factors and thyroid function, possibly leading to incorrect results. Ensure all healthcare providers and lab personnel are aware that you are using this medication.