Balcoltra is an oral contraceptive containing active ingredients levonorgestrel and ethinyl estradiol. It is formulated as a daily oral tablet regimen consisting of 21 active tablets and 7 inactive tablets. Key inactive ingredients in the active tablets include croscarmellose sodium, lactose monohydrate, and magnesium stearate. The tablets are designed to prevent pregnancy.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Do not use it more often than directed.

A patient package insert for the product will be given with each prescription and refill. Be sure to read this information carefully each time. The sheet may change often.

Talk to your care team about the use of this medication in children. Special care may be needed.

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 package insert for instruction. This medication may not work as well if you miss more than one pill. You may need to use back-up contraception.

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.

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.

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

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

• Breast, cervical, endometrial, ovarian, liver, or uterine cancer
• Depression
• Diabetes
• Have had a heart attack or stroke
• Have or have had blood clots
• Having surgery
• Heart disease
• High blood pressure
• High cholesterol
• Irregular heartbeat or rhythm
• Liver disease
• Migraine
• Tobacco use
• Unusual vaginal bleeding
• An unusual or allergic reaction to estrogens, progestins, iron, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

Do not take this medication with the following:

• Tranexamic acid

This medication may also interact with the following:

• Antibiotics, such as rifampin
• Bosentan
• Certain medications for breast cancer, such as anastrozole, exemestane, letrozole
• Certain medications for seizures, such as carbamazepine, phenytoin, phenobarbital, topiramate
• Colesevelam
• Cyclosporine
• Grapefruit juice
• Supplements, such as soy isoflavones or St. John's wort
• Steroid medications, such as prednisone or cortisone
• Theophylline
• Thyroid hormones

This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

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 health checks while on this medication.

You may need to use another form of contraception, such as a condom, during the first cycle of this medication.

If you may be pregnant, stop taking this medication right away and contact your care team.

Talk to your care team if you use tobacco products. Changes to your treatment plan may be needed. Tobacco increases the risk of getting a blood clot or having a stroke while you are taking this medication. This risk is higher if you are 35 years or older.

You may get dark patches on your face (chloasma) while taking this medication. If you noticed dark patches on your face during a pregnancy, your risk of getting it is higher. Keep out of the sun. If you cannot avoid the sun, wear protective clothing and use sunscreen. Do not use sun lamps, tanning beds, or tanning booths.

If you are going to need surgery or other procedure, tell your care team that you are using this medication.

What are the most serious risks of this medication?

This medication can increase the risk of serious blood clots, which can cause a heart attack or stroke. This risk increases if you are older than 35 years of age or use tobacco. You are strongly advised not to use tobacco.