Ethinyl Estradiol; Levonorgestrel; Ferrous Bisglycinate Tablets

What is this medication?

ETHINYL ESTRADIOL; LEVONORGESTREL; FERROUS BISGLYCINATE (ETH in il es tra DYE ole; LEE voh nor jes trel; FER us bis GLY sin ate) prevents ovulation and pregnancy. It belongs to a group of medications called oral contraceptives. It is a combination of the hormones estrogen and progestin.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Balcoltra

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Abnormal vaginal bleeding
• Blood vessel disease
• Breast, cervical, endometrial, ovarian, liver, or uterine cancer
• Diabetes
• Gallbladder disease
• Heart disease or recent heart attack
• High blood pressure
• High cholesterol
• History of blood clots
• Kidney disease
• Liver disease
• Migraine headaches
• Smoke tobacco
• Stroke
• Systemic lupus erythematosus (SLE)
• An unusual or allergic reaction to estrogens, progestins, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. To reduce nausea, this medication may be taken with food. Follow the directions on the prescription label. Take this medication at the same time each day and in the order directed on the package. Do not take your medication more often than directed.

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Contact your care team regarding the use of this medication in children. Special care may be needed. This medication has been used in female children who have started having menstrual periods.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, refer to the patient information sheet you received with your medication for direction. If you miss more than one pill, this medication may not be as effective and you may need to use another form of birth control.

What may interact with this medication?

Do not take this medication with the following:

• Dasabuvir; ombitasvir; paritaprevir; ritonavir
• Ombitasvir; paritaprevir; ritonavir

This medication may also interact with the following:

• Acetaminophen
• Antibiotics or medications for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin, and possibly penicillins or tetracyclines
• Aprepitant
• Ascorbic acid (vitamin C)
• Atorvastatin
• Barbiturate medications, such as phenobarbital
• Bosentan
• Caffeine
• Carbamazepine
• Clofibrate
• Cyclosporine
• Dantrolene
• Doxercalciferol
• Felbamate
• Grapefruit juice
• Hydrocortisone
• Medications for anxiety or sleeping problems, such as diazepam or temazepam
• Medications for diabetes, including pioglitazone
• Mineral oil
• Modafinil
• Mycophenolate
• Nefazodone
• Oxcarbazepine
• Phenytoin
• Prednisolone
• Ritonavir or other medications for HIV infection or AIDS
• Rosuvastatin
• Selegiline
• Soy isoflavones supplements
• St. John's wort
• Tamoxifen or raloxifene
• Theophylline
• Thyroid hormones
• Topiramate
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medication.

Use an additional method of contraception during the first cycle that you take these tablets.

If you have any reason to think you are pregnant, stop taking this medication right away and contact your care team.

If you are taking this medication for hormone related problems, it may take several cycles of use to see improvement in your condition.

Smoking increases the risk of getting a blood clot or having a stroke while you are taking birth control pills, especially if you are more than 35 years old. You are strongly advised not to smoke.

This medication can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your care team if you feel you are retaining fluid.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye care specialist.

In some women, tenderness, swelling, or minor bleeding of the gums may occur. Notify your dentist if this happens. Brushing and flossing your teeth regularly may help limit this. See your dentist regularly and inform your dentist of the medications you are taking.

If you are going to have elective surgery, you may need to stop taking this medication before the surgery. Consult your care team for advice.

This medication does not protect you against HIV infection (AIDS) or any other sexually transmitted infections.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Increase in blood pressure
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• New or worsening migraines or headaches
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Unusual vaginal discharge, itching, or odor
• Worsening mood, feelings of depression

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Breast pain or tenderness
• Dark patches of skin on the face or other sun-exposed areas
• Irregular menstrual cycles or spotting
• Nausea
• Weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.