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This medication comes with important safety and warning information that should be considered carefully before use. The following points outline potential risks, necessary precautions, and special instructions for certain populations. Please review these details and discuss any concerns with your healthcare provider.

• Cigarette Smoking and Heart Problems: If you smoke cigarettes, using combined oral contraceptives (COCs) like Tri-Lo-Sprintec (norgestimate/ethinyl estradiol) can significantly increase your risk of serious cardiovascular events, including strokes, heart attacks, and blood clots. This risk is especially high for females over 35 years old who smoke. It's advisable to consult with your healthcare provider about safer birth control options.

• Blood Clots and Stroke Risks: Tri-Lo-Sprintec heightens the risk of blood clots, which can occur in areas such as the lungs, legs, brain, and heart. Emergency medical attention is crucial if you experience symptoms like weakness, numbness, chest pain, or difficulty breathing. Risks are elevated for smokers over 35, individuals with high blood pressure, obesity, recent surgery patients, and those with high cholesterol or diabetes.

• Cancer Risks: There is a potential risk of breast and cervical cancer associated with Tri-Lo-Sprintec. Those with a history of breast cancer or who have used COCs for extended periods should exercise caution and discuss risks with their healthcare provider.

• Liver Issues: Tri-Lo-Sprintec can lead to liver problems, although rare. Symptoms include fatigue, abdominal pain, or yellowing of the skin. Individuals with existing liver issues should not use this medication.

• Gallbladder Concerns: Some studies suggest a slight increase in gallbladder disease risk due to high levels of progestin and estrogen. If you have a history of gallbladder disease, consult your doctor before use.

• Blood Sugar and Triglycerides: Tri-Lo-Sprintec may raise blood sugar and triglyceride levels, posing a higher risk for individuals with prediabetes, diabetes, or high triglycerides. Monitoring and alternative birth control methods may be necessary.

• Blood Pressure: This medication can increase blood pressure, particularly in older adults or those with existing hypertension. Regular monitoring is recommended.

• Headaches and Migraines: Common with COCs, severe or new migraines require medical advice.

• Irregular Bleeding: Spotting or breakthrough bleeding is common initially. Persistent or unusual bleeding should be evaluated by a healthcare professional.

• Depression: Any new or worsening symptoms of depression should be reported to your healthcare provider.

• Drug Interactions: Some medications can affect the efficacy of Tri-Lo-Sprintec or increase side effects. Inform your healthcare provider of all medications you are taking.

• Allergic Reactions: Tri-Lo-Sprintec may contain FD&C Yellow No. 5, which can cause allergic reactions in some individuals. Medical attention is necessary if symptoms occur.

Contraindications: Do not use this medication if you have a history of blood clotting disorders, smoke and are over 35, have certain cardiovascular diseases, uncontrolled high blood pressure, liver issues, or are pregnant. Additionally, avoid use if taking specific hepatitis C medications or if you have certain types of migraines or diabetes complications.

Consult your healthcare provider to ensure this medication is safe for you, considering your medical history and any other treatments you may be receiving.

When taking this medication, some common side effects may be experienced, though they are often mild and temporary. These include headaches or migraines, nausea, vomiting, breast tenderness or changes, stomach pain, and changes in menstrual bleeding, such as spotting or irregular periods. Mood changes and bloating are also possible, along with weight fluctuations. If these symptoms persist or worsen, it is advisable to consult a healthcare provider for guidance.

There are other possible side effects that, while less frequent, should be monitored. These include acne, vaginal infections, and feelings of fatigue. While these effects are not typically severe, they can be bothersome, and consulting a healthcare provider can help manage them effectively.

In rare cases, the medication can cause serious side effects requiring immediate medical attention. These include symptoms of heart attacks such as chest pain and dizziness, signs of a stroke like sudden weakness or difficulty speaking, and blood clots indicated by swelling or pain in the legs or trouble breathing. Serious liver issues may also occur, signaled by yellowing of the skin or eyes. Additionally, a severe allergic reaction might happen, identified by rash, swelling, severe dizziness, or trouble breathing. If any of these severe symptoms occur, seek urgent medical care without delay.