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This medication, Tri-Lo-Sprintec (norgestimate / ethinyl estradiol), requires careful consideration due to its potential health risks. Please review the following safety information and consult your healthcare provider if you have any questions or concerns.

• Smoking Risks: If you are 35 years or older and smoke, using this medication increases your risk of severe cardiovascular issues, including strokes, heart attacks, and blood clots. It's advisable to discuss alternative birth control options with your healthcare provider if you smoke.

• Blood Clots: This medication can elevate the risk of blood clots, which may form in various parts of the body like the lungs, legs, brain, or heart. Individuals over 35 who smoke, those with recent surgery or prolonged immobility, high blood pressure, obesity, high cholesterol, diabetes, or those using higher estrogen doses are at greater risk. Seek immediate medical attention if signs of a blood clot appear, such as sudden weakness, chest pain, or difficulty breathing.

• Cancer Risks: There is a potential increased risk of breast and cervical cancer associated with this medication, especially in those with a history of breast cancer or prolonged use of combined oral contraceptives (COCs). Regular check-ups and self-examinations are recommended for early detection.

• Liver Concerns: Rare cases of liver damage or tumors have been reported. Do not use this medication if you have existing liver problems. Contact your doctor immediately if you experience symptoms like fatigue, abdominal pain, or jaundice.

• Gallbladder Disease: There may be a slight increase in the risk of developing gallbladder disease. Consult your healthcare provider if you have a history of gallbladder issues before starting this medication.

• Blood Sugar and Triglycerides: This medication can raise blood sugar and triglyceride levels. Individuals with prediabetes, diabetes, or high triglycerides should consult their prescriber to consider alternative contraceptives or close monitoring.

• Blood Pressure: Tri-Lo-Sprintec may increase blood pressure. Regular monitoring is suggested, and those with uncontrolled high blood pressure should avoid this medication.

• Headaches: New or worsening headaches, particularly migraines, should be reported to your healthcare provider.

• Irregular Bleeding: Spotting or breakthrough bleeding may occur, especially within the first three months of use. Report any unusual vaginal bleeding to your healthcare provider.

• Depression: Notify your healthcare team of any new or worsening depression symptoms. In severe cases, discontinuation might be necessary.

• Drug Interactions: Some medications can reduce the effectiveness of Tri-Lo-Sprintec or increase side effects. Inform your healthcare provider of all medications you are taking to prevent interactions. Notably, if you are on hepatitis C treatment with Viekira Pak, you must stop Tri-Lo-Sprintec as it can lead to liver issues.

• Allergic Reactions: Rare allergic reactions to FD&C Yellow No. 5 (tartrazine) may occur. Seek medical help if you experience hives or itching.

Before using Tri-Lo-Sprintec, ensure you are not affected by any contraindications such as current or past blood clot issues, cerebrovascular or coronary artery disease, certain heart or liver conditions, migraines with aura, uncontrolled blood pressure, breast cancer, unexplained vaginal bleeding, pregnancy, or use of certain hepatitis C medications. Always consult your healthcare provider to ensure this medication is safe for you.

When taking this medication, some common side effects may occur, but they are generally mild and manageable. You might experience headache or migraine, nausea or vomiting, changes in breast tissue, stomach pain, period pain or alterations in menstrual bleeding, and mood changes. Additionally, some individuals report acne, vaginal infections, bloating, weight gain, and fatigue. These are typically not serious; however, consult your healthcare provider if they persist or worsen.

In rare cases, serious side effects can arise and require immediate medical attention. These include symptoms of a heart attack such as chest pain, stomach discomfort, sweating, nausea, and dizziness. Signs of a stroke, like sudden numbness or weakness in the arm, leg, or face, confusion, trouble seeing, headache, and difficulty walking, should also prompt urgent care. Deep vein thrombosis might present with leg cramps, swelling, pain, or muscle tightness, while pulmonary embolism could cause coughing, chest pain, breathing difficulties, and a racing heart. Serious liver issues may be indicated by yellowing of the skin or eyes, fatigue, or stomach pain.

Rare but critical allergic reactions could occur, characterized by rash, itching, swelling (particularly of the face, tongue, or throat), severe dizziness, or trouble breathing. It's vital to seek medical help right away if these symptoms appear. Monitoring for less frequent but significant issues, such as lumps in the breast, severe mood changes, or unusual changes in vaginal bleeding, is also advisable. Regularly checking your blood pressure is recommended, as this medication can cause it to rise. If you notice any additional side effects not mentioned here, reach out to your healthcare provider.