Estradiol Valerate; Dienogest Tablets

What is this medication?

ESTRADIOL VALERATE; DIENOGEST (es tra DYE ol val er rate; dye EN oh jest) prevents ovulation and pregnancy. It may also be used to treat heavy periods. 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): Natazia

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 or blood clots
• Breast, cervical, endometrial, ovarian, liver, or uterine cancer
• Diabetes (high blood sugar)
• Gallbladder disease
• Heart disease or recent heart attack
• High blood pressure
• High cholesterol
• Kidney disease
• Liver disease or liver cancer
• Mental illness
• Migraine headaches
• Stroke
• Swelling of the face or tongue
• Systemic lupus erythematosus (SLE)
• Tobacco smoker
• An unusual or allergic reaction to estrogens, progestins, or 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. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. 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.

Talk to your care team about the use of this medication in children. Special care may be needed. This medication has been used in adolescents 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 contraception.

What may interact with this medication?

• Antibiotics or medications for infections, especially rifampin, rifabutin, rifapentine, griseofulvin, and possibly penicillins, tetracyclines, or macrolides like erythromycin
• Barbiturate medications, such as phenobarbital
• Bosentan
• Carbamazepine
• Certain antidepressants
• Certain medications for blood pressure like diltiazem, verapamil
• Certain medications for fungal infections like ketoconazole and itraconazole
• Cimetidine
• Felbamate
• Grapefruit juice
• Ketoconazole
• Lamotrigine
• Oxcarbazepine
• Phenytoin
• Ritonavir or other medications for HIV infection or AIDS
• Soy isoflavones supplements
• St. John's wort
• 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.

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 contraceptives, 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 care team.

Tenderness, swelling, or minor bleeding of the gums may occur. Talk to your dentist if this happens. Brushing and flossing your teeth regularly may reduce the risk of side effects. Visit your dentist on a regular basis. Tell your dentist about any 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 diseases.

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
• Breast tissue changes, new lumps, redness, pain, or discharge from the nipple
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• 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
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• 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):

• Acne
• 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.