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Please consider the following safety information and warnings when using this medication. It is important to understand the potential risks and take the necessary precautions to ensure your health and safety.

• Smoking and Heart Health: If you are a female aged 35 or older who smokes, using hormonal birth control such as Quartette can significantly increase your risk of serious cardiovascular issues, including stroke, heart attack, and blood clots. It is advised to discuss safer birth control options with your healthcare provider if you smoke.

• Blood Clots and Stroke Risk: Quartette can elevate the risk of developing blood clots, which may occur in the lungs (pulmonary embolism), legs (deep vein thrombosis), brain (stroke), or heart (heart attack). This risk is heightened for smokers over 35, individuals over 40, those who have recently undergone surgery with prolonged bed rest, and those who started Quartette less than a month after childbirth. Conditions such as high blood pressure, obesity, high cholesterol, diabetes, and high estrogen doses also contribute to this risk. Seek immediate medical attention if you experience symptoms of a blood clot.

• Irregular Bleeding: Users of Quartette may experience irregular bleeding or spotting, especially during initial three months of use. This can range from light staining to bleeding similar to a regular period. Continue taking the medication as directed but consult your provider if the bleeding persists or is concerning.

• High Blood Pressure: Quartette may cause increased blood pressure, particularly in older females or those who have been using birth control for an extended period. It is not recommended for individuals with uncontrolled high blood pressure. Regular monitoring of blood pressure is advised, and alternative birth control methods should be considered if blood pressure issues arise.

• Blood Sugar and Cholesterol Concerns: Quartette may raise blood sugar and cholesterol levels. Individuals with diabetes, prediabetes, or high triglycerides should consult their provider before starting Quartette, as they may be at increased risk for pancreatitis. Regular monitoring is necessary if you have these conditions.

• Headaches and Migraines: Inform your healthcare provider if you develop new or worsening migraines or headaches while using Quartette. Discontinuation may be necessary if these symptoms persist or become severe.

• Cancer Risks: There is a potential increased risk of breast and cervical cancer associated with Quartette. Those with a history of breast cancer or long-term use of combined oral contraceptives should discuss risks with their healthcare provider.

• Liver Issues: Though rare, Quartette may cause liver damage or tumors. This risk is higher with earlier formulations of contraceptives with higher estrogen levels. Avoid use if you have existing liver problems and contact your provider if you notice symptoms such as fatigue, abdominal pain, or jaundice.

• Drug Interactions: Certain medications may alter the effectiveness of Quartette or increase the likelihood of side effects. Inform your healthcare provider or pharmacist about all medications you are taking to avoid interactions.

Contraindications

Avoid using this medication if you have the following conditions or factors, as it may lead to serious health risks:

• Women over 35 who smoke
• Current or past blood clots
• History of heart attack or stroke
• Heart valve issues or irregular heartbeat with increased clot risk
• Conditions that promote blood clotting
• Uncontrolled high blood pressure
• Diabetes with complications affecting kidneys, eyes, nerves, or blood vessels
• Severe migraines with aura or neurological symptoms
• Any migraines in women over 35
• Liver issues, including tumors or cancer
• Unexplained vaginal bleeding
• Pregnancy
• Current or past breast cancer
• Use of specific hepatitis C medications containing ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir.

Please ensure you consult with your healthcare provider to fully understand the implications of using this medication in relation to your health history and current conditions.

When using this medication, it's important to be aware of potential side effects, which range from common and typically mild to rare but serious conditions. Common side effects include nausea, vomiting, headaches, and acne. Some individuals may also experience bloating, breast tenderness, swelling of the ankles or feet due to fluid retention, and changes in weight. Vaginal bleeding between periods is also possible, particularly during the initial months of use. These symptoms are generally manageable, but if they persist or worsen, consulting a healthcare provider is advisable.

More serious side effects, while uncommon, should be addressed promptly. These include severe mood changes, such as new or worsening depression, anxiety attacks, or migraines. If you notice lumps in the breast, severe abdominal pain, or significant changes in vaginal bleeding patterns, contact a healthcare provider immediately. Rare but critical conditions include blood clots, leading to heart attacks or strokes. Symptoms such as chest pain, sudden dizziness, severe headaches, or difficulty speaking require urgent medical attention. Other concerning symptoms include signs of liver problems, such as yellowing of the skin or eyes, and ectopic pregnancy signs, like sharp stomach cramps and dizziness.

A very serious allergic reaction is rare but warrants immediate medical help if symptoms like rash, severe dizziness, or difficulty breathing occur. While this is not a comprehensive list of all potential side effects, any new or unusual symptoms should prompt a discussion with a healthcare provider to ensure your safety and well-being while using this medication.