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Levonorgestrel/ethinyl estradiol/ferrous bisglycinate (By mouth)

Prevents pregnancy. This medicine contains an iron supplement.

Brand Name(s):

Balcoltra

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. Do not use it if you had an allergic reaction to levonorgestrel, ethinyl estradiol, or ferrous bisglycinate, or if you are pregnant. Do not use it if you have unusual vaginal bleeding, liver disease (including liver cancer), breast cancer, blood clotting problems, certain heart problems, or headaches.

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.
  • Follow your doctor's instructions carefully about when to start taking your medicine. You may begin taking the pills on the first day of your menstrual period or on the Sunday after your period begins.
  • You should also use a second form of birth control (including condoms, diaphragms, or contraceptive foams and jellies) when you first start using this medicine.
  • If you vomit or have diarrhea within 3 to 4 hours of taking this medicine, treat this 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.
    • If you miss one active pill, take it as soon as you can. Then take your next pill at the regular time. This means you may take two pills in one day.
    • If you miss two active pills in week 1 or 2, take two pills as soon as you can and two more pills the next day. Continue taking one pill a day until you finish the pack. Use another kind of birth control for seven days after you miss 2 doses.
    • If you miss two active pills in week 3 or three or more active pills in a row in weeks 1, 2, or 3:
      • Day 1 start - Throw out the rest of your pills and start a new pack on the same day.
      • Sunday start - Continue taking one pill a day until Sunday, then throw out the rest of the pack and start a new pack that same day.
      • Use a second form of birth control (including condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy.
    • You could have light bleeding or spotting any time you do not take a pill on schedule. The more pills you miss, the more likely you are to have bleeding.
    • If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills.
  • 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 medicines can affect how levonorgestrel/ethinyl estradiol/ferrous bisglycinate works. Tell your doctor if you are using any of the following:
    • Acetaminophen, aprepitant, ascorbic acid, bosentan, carbamazepine, clofibric acid, cyclosporine, felbamate, fluconazole, griseofulvin, itraconazole, ketoconazole, lamotrigine, morphine, oxcarbazepine, phenobarbital, phenytoin, prednisolone, rifabutin, rifampicin, rufinamide, salicylic acid, St John's wort, temazepam, theophylline, tizanidine, topiramate, voriconazole
    • Medicine to treat HIV/AIDS (including amprenavir/ritonavir, atazanavir/ritonavir, boceprevir, darunavir/ritonavir, efavirenz, etravirine, fosamprenavir/ritonavir, indinavir, lopinavir/ritonavir, nelfinavir, nevirapine, ritonavir, telaprevir, tipranavir/ritonavir)
    • Thyroid medicines
  • If you are also taking colesevelam, take it 4 hours before or after you use this medicine.
  • Do not 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 given birth within 4 weeks before you start using this medicine. Tell your doctor if you have kidney disease, diabetes, gallbladder disease, hereditary angioedema, high blood pressure, high cholesterol, migraines, or a history of breast cancer, cervical cancer, depression, or chloasma gravidarum or jaundice during pregnancy. 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
    • Liver problems (including liver tumor or cancer)
    • High blood pressure
    • Gallbladder disease
    • High cholesterol in the blood
    • Possible increased risk of breast or cervical cancer
  • This medicine will not protect you from getting HIV/AIDS or other sexually transmitted infections.
  • This medicine may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
  • This medicine contains a food, drug, and cosmetic dye, called tartrazine, which may cause unwanted effects in some people. Tell your doctor if you have asthma or an allergy to aspirin.
  • 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, tenderness, pain, swelling, or discharge
  • Chest pain that may spread, trouble breathing, unusual sweating, fainting
  • Dark urine or pale stools, loss of appetite, yellow skin or eyes
  • Heavy vaginal bleeding, irregular or missed menstrual period
  • Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg (calf), sudden or severe headache, problems with vision, speech, or walking
  • Sudden and severe stomach pain, nausea, vomiting, lightheadedness
  • Vision loss, double vision

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

  • Mood changes, depression, nervousness
  • 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: 3/19/2020

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