Ethinyl estradiol is a form of estrogen. Estrogen is a female sex hormone necessary for many processes in the body.

Norethindrone is a form of progesterone. Progesterone is a female hormone important for the regulation of ovulation and menstruation.

Jevantique Lo (hormone replacement therapy) is a combination medicine used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to prevent osteoporosis.

Jevantique Lo may also be used for purposes not listed in this medication guide.

You should not use this medicine if you have: undiagnosed vaginal bleeding, liver disease, a bleeding disorder, if you will have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Do not use if you are pregnant.

This medicine may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.

Using this medicine can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, or ovaries. Jevantique Lo should not be used to prevent heart disease, stroke, or dementia.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Try to take this medicine at the same time each day.

Jevantique Lo may increase your risk of developing a condition that can lead to uterine cancer. To help lower this risk, your doctor may also want you to take a progestin. Report any unusual vaginal bleeding right away.

Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms.

If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using Jevantique Lo.

Store at room temperature away from moisture and heat.

You should not use Jevantique Lo if you are allergic to ethinyl estradiol or norethindrone, or if you have:

• unusual vaginal bleeding that has not been checked by a doctor;

• liver disease;

• a bleeding disorder;

• a history of heart attack, stroke, or blood clot; or

• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

Do not use if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Using this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Jevantique Lo should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

Tell your doctor if you have ever had:

• heart disease;

• liver problems, or jaundice caused by pregnancy or taking hormones;

• kidney disease;

• hereditary angioedema (an immune system disorder);

• bone cancer;

• lupus;

• asthma;

• epilepsy or other seizure disorder;

• migraines;

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

• gallbladder disease;

• endometriosis or uterine fibroid tumors;

• a thyroid disorder; or

• high or low levels of calcium in your blood.

Using Jevantique Lo may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.

This medicine can slow breast milk production. Tell your doctor if you are breast-feeding.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, or vaginal bleeding.

Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using Jevantique Lo.

Grapefruit may interact with Jevantique Lo and lead to unwanted side effects. Avoid the use of grapefruit products.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Jevantique Lo may cause serious side effects. Stop using Jevantique Lo and call your doctor at once if you have:

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed;

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;

• swelling or tenderness in your stomach;

• jaundice (yellowing of the skin or eyes);

• unusual vaginal bleeding, pelvic pain;

• a breast lump;

• memory problems, confusion, unusual behavior; or

• high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects of Jevantique Lo may include:

• stomach pain;

• bloating, swelling, weight gain;

• breast pain;

• light vaginal bleeding or spotting;

• thinning scalp hair; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect Jevantique Lo, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.