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Drospirenone/ethinyl estradiol/levomefolate (By mouth)

Prevents pregnancy. Also treats premenstrual dysphoric disorder (PMDD) and acne. This medicine contains a folic acid supplement.

Brand Name(s):

Beyaz, Rajani, Safyral, Tydemy

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take your pills at the same time every day in the order they appear in the container. Birth control pills work best when there is no more than 24 hours between doses.
• Use a second form of birth control for the first 7 days of your first cycle of pills. Your body will need at least 7 days to adjust to the new medicine before a pregnancy will be prevented.
• If you vomit or have diarrhea within 3 to 4 hours of taking this medicine, treat this as a missed dose and follow the patient instructions or call your doctor.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose:
  • This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.
  • Use a second form of birth control for the next 7 days after you miss a dose.
  • If you miss a pill or change your schedule, you may not have a period that month. Tell your doctor if you miss your period 2 months in a row, because you may be pregnant.
  • You could have light bleeding or spotting if you do not take your pills on a regular schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
• Some foods and medicines can affect how this medicine works. Tell your doctor if you are using any of the following:
  • Acetaminophen, ascorbic acid (vitamin C), atorvastatin, bosentan, cholestyramine, heparin, methotrexate, omeprazole, St John's wort, sulfasalazine, theophylline, tizanidine
  • Diuretic (water pill)
  • Folate or potassium supplements
  • Medicine to lower blood pressure (including diltiazem, verapamil)
  • Medicine to treat HIV/AIDS
  • Medicine to treat infection (clarithromycin, erythromycin, fluconazole, griseofulvin, itraconazole, ketoconazole, pyrimethamine, rifampicin, voriconazole)
  • Medicine to treat seizures (including carbamazepine, felbamate, lamotrigine, oxcarbazepine, phenobarbital, phenytoin, primidone, topiramate, valproic acid)
  • NSAID pain or arthritis medicine (including aspirin, diclofenac, ibuprofen, naproxen)
  • Thyroid medicine replacement
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you had a baby within the last 4 weeks. Tell your doctor if you have hereditary angioedema, diabetes, high blood pressure, high cholesterol, or a history of depression or chloasma gravidarum. Tell your doctor if you had liver problems caused by pregnancy or birth control pills. Tell your doctor if you smoke or if you are having a surgery that requires inactivity for a long time.
• This medicine may cause the following problems:
  • Increased risk of heart attack, stroke, or blood clots
  • Increased risk of breast or cervical cancer
  • Liver problems (including liver tumor or cancer)
  • High blood pressure
  • Gallbladder disease
  • High cholesterol in the blood
• This medicine may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
• This medicine will not protect you from HIV/AIDS or other sexually transmitted diseases. Talk to your doctor if you have concerns about this.
• You may have light bleeding or spotting when you first take the pill.
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Breast lumps, pain, tenderness, swelling, or discharge
• Chest pain or tightness, trouble breathing, coughing up blood
• Confusion, weakness, uneven heartbeat, numbness in your hands, feet, or lips
• Dark urine or pale stools, loss of appetite, yellow skin or eyes
• Heavy vaginal bleeding, irregular or missed menstrual period
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Sudden and severe stomach pain, nausea, vomiting, lightheadedness
• Vision blurring or loss

If you notice these less serious side effects, talk with your doctor:

• Depression or mood changes
• Mild headache or stomach upset
• Vaginal spotting or light bleeding, itching, or discharge

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 9/6/2024