Norethindrone; Ethinyl Estradiol Disintegrating Tablets

What is this medication?

NORETHINDRONE; ETHINYL ESTRADIOL (nor eth IN drone; ETH in il es tra DYE ole) prevents ovulation and pregnancy. It belongs to a group of medications called contraceptives. It is a combination of the hormones estrogen and progestin. It does not prevent HIV or other sexually transmitted infections (STIs).

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

COMMON BRAND NAME(S): Femlyv

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

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

• Blood clotting disorder
• Cancer, such as breast, cervical, or liver
• Diabetes
• Gallbladder disease
• Have had blood clots, a heart attack, or a stroke
• Have or have had depression
• Having surgery
• Heart or blood vessel conditions
• Hereditary angioedema, a genetic condition that causes episodes of severe swelling
• High blood pressure
• High cholesterol
• Liver disease
• Migraine or other severe headaches
• Tobacco use
• Vaginal bleeding between your periods
• An unusual or allergic reaction to estrogens, progestins, other medications, foods, dyes, or preservatives
• Pregnant, trying to get pregnant, or have recently been pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth. Take it at the same time every day and in the order directed on the package. Leave the tablet in the sealed pack until you are ready to take it. With dry hands, open the pack and gently remove the tablet. Place the tablet on the tongue and allow it to dissolve. Then, drink a glass of water. Do not cut, crush, or chew this medication. You can take it with or without food. If it upsets your stomach, take it with food. Do not take 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 1 pill. You may need to use back-up contraception.

What may interact with this medication?

Do not take this medication with the following:

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

This medication can increase the risk of serious blood clots, which can cause a heart attack or stroke. The risk increases if you are older than 35 years of age or use tobacco. Talk to your care team if you use tobacco products.

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.

This medication can cause dry eyes or a slight change in the shape of the eye. This can affect how contact lenses fit and feel. If you wear contact lenses, talk to your care team if you have eye discomfort or vision changes. They can help you find a solution, such as a change in contact lens or eye drops for dryness.

This medication may cause tender gums, which can cause swelling or bleeding. It is important to brush and floss your teeth to reduce the risk of side effects. Visit your dentist on a regular basis.

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

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 or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• 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 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, empty it out of the container. Mix it with cat litter, dirt, coffee grounds, or another unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.