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Here is the essential safety information for Tri-Lo-Sprintec (norgestimate / ethinyl estradiol), a combined oral contraceptive (COC). This information highlights significant risks, precautions, and special considerations when using this medication.

• Smoking and Heart Risks: If you smoke, particularly if you are a female over 35 years old, using Tri-Lo-Sprintec can significantly increase your risk of serious heart-related issues such as strokes, heart attacks, and blood clots. Consider discussing alternatives with your healthcare provider if you smoke.

• Blood Clots and Stroke: Tri-Lo-Sprintec may elevate the risk of blood clots, which can occur in various parts of the body, including the lungs, legs, brain, and heart. Emergency attention is necessary if you experience symptoms like unexplained swelling, chest pain, or difficulty breathing.

• Cancer Risks: There is a potential association between the use of Tri-Lo-Sprintec and an increased risk of breast and cervical cancers. Individuals with a history of breast cancer should avoid this medication.

• Liver and Gallbladder Issues: Although rare, Tri-Lo-Sprintec can lead to liver problems or gallbladder disease. If you have pre-existing liver problems or a history of gallbladder disease, consult with your healthcare provider before using this medication.

• Blood Sugar and Triglycerides: This medication can elevate blood sugar and triglyceride levels, posing additional risks for individuals with diabetes or prediabetes. Monitoring and consultation with your healthcare provider are recommended.

• Blood Pressure: Tri-Lo-Sprintec may increase blood pressure. Regular monitoring is advised, and those with uncontrolled hypertension should seek alternative contraceptive options.

• Headaches and Mood Changes: While headaches are a common side effect, severe or new migraines should be reported to your healthcare provider. Additionally, report any symptoms of depression.

• Drug Interactions: Several medications can affect how Tri-Lo-Sprintec works, either reducing its effectiveness or increasing side effects. It's crucial to inform your healthcare provider about all medications you are taking.

• Allergic Reactions: Some individuals may be allergic to ingredients in the medication, such as FD&C Yellow No. 5 (tartrazine). Seek medical help if you experience signs of an allergic reaction.

In case of overdose or concerning symptoms, immediate medical attention is vital. This medication is contraindicated for individuals with certain conditions, including active or history of blood clots, stroke, or liver disease, and those taking specific hepatitis C treatments. Always consult with a healthcare provider to ensure Tri-Lo-Sprintec is appropriate for your health needs.

When taking this medication, you may notice some common side effects, which are generally mild and manageable. These include headaches or migraines, nausea, vomiting, breast changes such as tenderness, stomach pain or bloating, and changes in your menstrual cycle, including spotting or irregular periods. Some individuals may also experience mood changes, weight gain, acne, vaginal infections, and a feeling of tiredness. It's important to monitor these symptoms, and if they persist or worsen, consult your healthcare provider for advice.

Although less common, this medication can have serious side effects that require immediate medical attention. These include lumps in the breast, severe stomach or abdominal pain, continuous spotting or sudden heavy bleeding, dark urine, or yellowing of the eyes and skin, which can indicate liver problems. In rare instances, serious blood clots may occur, leading to conditions such as a heart attack, stroke, deep vein thrombosis, or pulmonary embolism. Symptoms to watch for include chest pain, confusion, sudden dizziness, pain or swelling in the legs, trouble speaking, shortness of breath, rapid breathing, severe headaches, and sudden vision changes. If you notice any of these symptoms, seek urgent medical care.

An allergic reaction to this medication is also rare but serious. Symptoms include rash, itching, swelling, severe dizziness, and trouble breathing. If these occur, seek emergency medical help. Always keep track of any unusual effects and contact your healthcare provider if you have concerns.

Certain medications can interact with this drug, potentially affecting its effectiveness. Medications such as aromatase inhibitors (like anastrozole and exemestane), fezolinetant, ospemifene, tamoxifen, tizanidine, and tranexamic acid may have interactions. Additionally, some drugs can reduce the effectiveness of hormonal birth control by lowering hormone levels in your body, which might increase the risk of pregnancy. These include griseofulvin, modafinil, certain antibiotics like rifamycins (for instance, rifampin and rifabutin), ritonavir, St. John's wort, epilepsy medications (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), and certain HIV medications (like nelfinavir and nevirapine).

It’s important to inform your healthcare provider when you begin any new medication and discuss whether additional birth control methods are necessary. Pay attention to any new spotting or irregular bleeding, as these could indicate that your birth control is not functioning effectively. Additionally, this medication might interfere with specific laboratory tests, including those for blood clotting factors and thyroid function, potentially leading to inaccurate results. Ensure that all medical personnel and your doctors are aware that you are taking this medication.