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|Zovia

Zovia

Zovia is used for:

Preventing pregnancy. It may also be used for other conditions as determined by your doctor.

Zovia is an estrogen/progestin combination. It works by preventing the release of eggs from the ovaries and thereby preventing pregnancy.

Do NOT use Zovia if:

• you are allergic to any ingredient in Zovia
• you are pregnant or think you may be pregnant
• you have blood clots in the legs, lungs, or eyes; or a history of heart attack, chest pain, or stroke
• you have known or suspected breast cancer or cancer of the lining of the uterus, cervix, or vagina, or have had vaginal bleeding of unknown causes
• you have a liver tumor or active liver disease, or a history of yellowing of the eyes or skin during pregnancy or previous birth control use
• you have headaches with neurological symptoms or will be on bed rest for a long period following surgery

Contact your doctor or health care provider right away if any of these apply to you.

Before using Zovia :

Some medical conditions may interact with Zovia . Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have high blood pressure; high cholesterol, triglycerides, or calcium levels; have pancreatitis or gallbladder problems; or are obese
• if you have breast nodules, fibrocystic disease of the breast, an abnormal breast x-ray or mammogram, endometriosis or endometrial carcinomas, uterine fibroids, or irregular or scanty menstrual periods
• if you have diabetes, headaches, migraine headaches, epilepsy, or a history of mental depression
• if you are having surgery
• if you are a heavy smoker (15 or more cigarettes per day), especially if you are older than 35 years of age

Some MEDICINES MAY INTERACT with Zovia . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Azole antifungals (eg, itraconazole), aprepitant, bosentan, barbiturates (eg, phenobarbital), carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, penicillins (eg, amoxicillin), rifampin, St. John"s wort, tetracyclines (eg, doxycycline), topiramate, and troglitazone because they may decrease Zovia "s effectiveness. Alternative forms of birth control are strongly recommended when taking any of these medicines along with this birth control medicine.
• Beta-blockers (eg, atenolol), selegiline, theophyllines (eg, aminophylline), and troleandomycin because the risk of their side effects may be increased by Zovia
• Lamotrigine because its effectiveness may be decreased by Zovia

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zovia may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zovia :

Use Zovia as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Zovia . Talk to your pharmacist if you have questions about this information.
• Take Zovia by mouth with or without food.
• To achieve maximum effectiveness of Zovia , it must be taken every day (every 24 hours) and at the same time each day.
• Remember to take all of the pills in the pack. Do not skip any doses.
• Be sure to have an extra full pack of this medication available at all times.
• If you miss 1 tablet during the first 3 weeks of the pack, take the tablet as soon as you remember. If you miss 2 tablets during the first or second week of the pack, take 2 tablets the day you remember and 2 tablets the next day; then continue to take 1 pill every day until you finish the pack. You should use a backup method (additional type) of birth control if you have sex in the 7 days after missing a pill. If you miss 2 pills during the third week of the pack or you miss 3 pills in a row during any of the first 3 weeks of the pack, you should continue to take a pill every day until Sunday. On Sunday, you should throw away the rest of the pack and start a new pack that same day. If you do not start your pack on Sunday, take a pill every day until the day you start your packs and start a new pack on that day. Be sure to use a backup method (additional type) of birth control if you have sex in the 7 days after missing a pill. If you have any questions, contact your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Zovia .

Important safety information:

• Zovia may cause dizziness or changes in vision. These effects may be worse if you take it with alcohol or certain medicines. Use Zovia with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• If you miss your period during the week of inactive pills, call your doctor immediately. A missed period may indicate that you are pregnant.
• Zovia may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths.
• Follow your doctor"s instructions for examining your own breasts, and report any lumps immediately.
• Zovia may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Zovia .
• If you will be having surgery or will be confined to a chair or bed for a long period of time (such as a long plane flight), notify your doctor 3 to 4 weeks beforehand. Special precautions may need to be taken in these circumstances while you are taking Zovia .
• Bleeding or spotting may occur while taking Zovia . Do not stop taking Zovia if this occurs. If bleeding or spotting continues for more than 7 days or is heavy, contact your doctor.
• Smoking cigarettes while using Zovia may increase your risk of stroke, heart attack, blood clots, high blood pressure, or other diseases of the heart and blood vessels.
• Taking certain antibiotics or anticonvulsants while you are using Zovia , or vomiting or diarrhea may decrease the effectiveness of Zovia . To prevent pregnancy, use an additional form of birth control (such as condoms, spermicide, diaphragm) until your next period. If you have any questions, contact your doctor or pharmacist.
• If you wear contact lenses and you develop problems with them, contact your doctor.
• Use of Zovia will not prevent the spread of sexually transmitted diseases (STDs).
• Lab tests will be required while you are taking Zovia . You will need to have follow-up exams at least once per year. Be sure to keep all doctor and lab appointments.
• Zovia should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use this medicine if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Continue to use another method of birth control (such as condoms). Zovia is found in breast milk. Do not breast-feed while you are taking Zovia . Do not take Zovia soon after delivery of a baby even if you are not breast-feeding. You should wait 4 weeks after delivery if you are not breast-feeding or 4 weeks after a second trimester abortion.

Possible side effects of Zovia :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Change in appetite; brief, minor spotting between menstrual periods; change in menstrual flow; headache; nausea; reduction of breast milk when given right after childbirth; spotty darkening of the skin, especially the face; stomach cramps or bloating; weight change.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; breast lumps; breast tenderness; calf/leg pain or swelling; changes in vision; chest pain or heaviness in the chest; coughing up blood; difficulty wearing contact lenses; dark urine or light-colored bowel movements; dizziness or fainting; fever; loss of appetite; loss of scalp hair; missed menstrual period; mood/mental changes; numbness of an arm or leg; persistent or recurrent abnormal vaginal bleeding; severe pain or tenderness in the stomach area; shortness of breath; sleeplessness; slurred speech; sudden severe headache (migraine); sudden shortness of breath; swelling of fingers or ankles; vaginal infection; vomiting; weakness or fatigue; weakness or numbness in the arm or leg; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include nausea or vomiting; vaginal bleeding.

Store Zovia at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zovia out of the reach of children and away from pets.

General information:

• If you have any questions about Zovia , please talk with your doctor, pharmacist, or other health care provider.
• Zovia is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Zovia . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.