Jencycla contains the active ingredient norethindrone in a form of 0.35 mg per tablet. The formulation is a yellow oral tablet intended for continuous oral contraceptive use. Key inactive ingredients include D&C Yellow No. 10, FD&C Yellow No. 6, lactose anhydrous, lactose monohydrate, corn starch, povidone, and magnesium stearate.

How should I use this medication?

Take this medication by mouth with a glass of water. You may take it with or without 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.

Contact your care team about 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.

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.

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.

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 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:

• Blood vessel disease or blood clots
• Breast, cervical, or vaginal cancer
• Diabetes
• Heart disease
• Kidney disease
• Liver disease
• Mental depression
• Migraine
• Seizures
• Stroke
• Vaginal bleeding
• An unusual or allergic reaction to norethindrone, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Amprenavir or fosamprenavir
• Bosentan

This medication may also interact with the following:

• Antibiotics or medications for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin, and possibly penicillins or tetracyclines
• Aprepitant
• Barbiturate medications, such as phenobarbital
• Carbamazepine
• Felbamate
• Modafinil
• Oxcarbazepine
• Phenytoin
• Ritonavir or other medications for HIV infection or AIDS
• St. John's wort
• Topiramate

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.