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The safety and warning information for this medication is crucial and should be reviewed thoroughly. Please discuss any concerns with your healthcare provider.

• Heart Problems and Strokes: Smoking while using Trivora can significantly increase the risk of serious heart issues, especially in women over 35 who smoke 15 or more cigarettes daily. It is highly recommended that women using oral contraceptives like Trivora avoid smoking. Risk factors include age over 35, heavy smoking, high blood pressure, high cholesterol, obesity, and diabetes.

• Blood Clots: The use of Trivora may increase the risk of developing blood clots, irrespective of how long the medication is taken. The risk can be heightened by surgical procedures, prolonged immobility, or recent childbirth. Consult your healthcare provider about discontinuing Trivora at least four weeks before and two weeks after surgery or during extended bed rest. Postpartum women should wait four to six weeks before starting Trivora if not breastfeeding. Seek immediate medical attention if you experience symptoms such as sharp chest pain, coughing up blood, difficulty breathing, or leg pain.

• High Blood Pressure: Trivora can cause elevated blood pressure, particularly in older individuals and those using birth control over an extended period. Regular monitoring of blood pressure is advised. Consult your healthcare provider if you have high blood pressure, as an alternative contraceptive method may be more appropriate.

• High Blood Sugar and Cholesterol: Trivora may increase blood sugar and cholesterol levels. Individuals with diabetes, prediabetes, or high cholesterol should consult their healthcare provider before starting Trivora, as regular monitoring will be necessary.

• Irregular Bleeding: Users of Trivora may experience irregular bleeding or spotting, particularly in the first three months. While often temporary, persistent issues should be discussed with your healthcare provider, who may suggest an alternative contraceptive. If you miss periods, a pregnancy test is recommended to ensure you are not pregnant.

• Headache: Report any new or worsening headaches or migraines to your healthcare provider. Persistent or severe headaches may require discontinuation of the medication.

• Breast and Cervical Cancer: Trivora is not recommended for individuals with a current or past history of breast cancer, as some breast cancers are hormone-sensitive. The risk of breast cancer is slightly elevated in current or recent users of combined oral contraceptives. Regular breast examinations are advised.

• Liver Problems: Though uncommon, Trivora can cause liver issues, including liver damage or tumors. Those with existing liver conditions should not use this medication. Seek immediate medical advice if you notice symptoms like fatigue, abdominal pain, or yellowing of the skin or eyes.

• Drug Interactions: Certain medications may decrease the effectiveness of Trivora, potentially leading to pregnancy, while others might increase its side effects. Inform your healthcare provider about all medications you are taking to avoid interactions.

Contraindications:

Trivora should not be used if you have:

• A current or past history of blood clots.
• A history of heart attack or stroke.
• Current or past breast cancer.
• Tumors that grow in the presence of estrogen.
• Undiagnosed vaginal bleeding.
• Jaundice during pregnancy or previous birth control use.
• Liver tumors or liver cancer.
• Pregnancy.
• Are taking certain hepatitis C medications.

Always consult your healthcare provider for guidance specific to your health condition and medication regimen.

Common side effects:

• Nausea
• Vomiting
• Stomach cramps
• Bloating
• Bleeding between periods
• Spotting
• Changes in menstrual flow
• Missed periods

Less common but important to monitor:

• Temporary infertility after stopping the medication
• Swelling
• Skin changes such as brown spots or patches
• Breast tenderness or enlargement
• Weight fluctuations
• Headaches
• Allergic rashes
• Mental depression
• Vaginal yeast infections
• Discomfort when wearing contact lenses

Serious side effects:

• Blood clots symptoms such as sharp chest pain, coughing up blood, sudden shortness of breath, and calf pain
• Heart attack signs like crushing chest pain and dizziness
• Stroke symptoms such as severe headache, dizziness, and weakness in limbs
• Pulmonary embolism indicators like cough and chest pain
• Liver issues manifested by yellowing of the skin or eyes and stomach pain

When taking Trivora-28, it's important to be aware of potential interactions with other medications, supplements, and certain foods, as these can affect the effectiveness of the contraceptive or increase the risk of side effects.

Medications That May Reduce Trivora-28's Effectiveness:

Some drugs can decrease the levels of ethinyl estradiol and levonorgestrel in your body, potentially making Trivora-28 less effective at preventing pregnancy. These include:

• Antibiotics: Certain antibiotics, such as Ampicillin and tetracyclines, may reduce the effectiveness of Trivora-28 by altering gut flora and decreasing the reabsorption of estrogens.

• Antiepileptic Drugs: Medications like Carbamazepine, Phenytoin, and barbiturates can enhance the metabolism of contraceptive hormones, leading to reduced efficacy.

• Antifungal Agents: Griseofulvin has been noted to decrease plasma concentrations of contraceptive hormones.

• HIV Medications: Some protease inhibitors and non-nucleoside reverse transcriptase inhibitors may lower contraceptive hormone levels.

• Herbal Supplements: St. John's wort can decrease the effectiveness of hormonal contraceptives.

If you're prescribed any of these medications, consult your healthcare provider. They may recommend using an additional non-hormonal contraceptive method, such as condoms, during the course of treatment and for a period after discontinuation.

Medications That May Increase Hormone Levels:

Other substances can increase the levels of contraceptive hormones, potentially leading to more pronounced side effects. These include:

• Vitamin C (Ascorbic Acid): High doses may elevate ethinyl estradiol levels.

• Acetaminophen: Commonly known as paracetamol, it can increase hormone levels when taken in large amounts.

• Antifungal Medications: Drugs like Fluconazole may raise ethinyl estradiol concentrations.

Food Interactions:

• Grapefruit Juice: Consuming grapefruit or grapefruit juice can increase the blood levels of ethinyl estradiol, potentially leading to enhanced side effects. It's advisable to limit grapefruit intake while on Trivora-28.

Other Considerations:

• Smoking: Combining smoking with Trivora-28, especially in women over 35, significantly increases the risk of serious cardiovascular events like blood clots, heart attacks, and strokes. It's strongly recommended to avoid smoking while using this contraceptive.

• Laboratory Tests: Trivora-28 may interfere with certain lab tests, including those measuring blood clotting factors and thyroid function. Inform your healthcare provider and lab personnel that you're taking this medication to ensure accurate test results.

Always inform your healthcare provider about all medications, supplements, and herbal products you're currently using. This will help them assess potential interactions and provide guidance on how to manage them effectively.