Ogen 1.25 is a form of estrogen, a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Ogen 1.25 is used to treat menopause symptoms such as hot flashes and vaginal changes, and to prevent osteoporosis (bone loss) in menopausal women. This medicine is also used to replace estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body.

Ogen 1.25 may also be used for purposes not listed in this medication guide.

You should not use Ogen 1.25 if you have: undiagnosed vaginal bleeding, liver disease, 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.

Ogen 1.25 may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.

Using Ogen 1.25 can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, or ovaries. Ogen 1.25 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. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Ogen 1.25 may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to help lower this risk. Report any unusual vaginal bleeding right away.

Your doctor should check your progress on a regular basis to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms while using Ogen 1.25.

If you need major surgery or will be on long-term bed rest, you may need to stop using Ogen 1.25 for a short time. Any doctor or surgeon who treats you should know that you are using Ogen 1.25.

Store this medication at room temperature away from moisture and heat.

You should not use Ogen 1.25 if you are allergic to it, or if you have:

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

• liver disease;

• 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 Ogen 1.25 if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Using Ogen 1.25 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.

Ogen 1.25 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:

• a hysterectomy;

• heart disease;

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

• a thyroid disorder;

• gallbladder disease;

• kidney disease;

• asthma;

• epilepsy or other seizure disorder;

• migraine headaches;

• lupus;

• endometriosis or uterine fibroid tumors;

• high levels of calcium in your blood; or

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

Using Ogen 1.25 may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.

Ogen 1.25 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.

Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using Ogen 1.25.

Grapefruit may interact with Ogen 1.25 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.

Ogen 1.25 may cause serious side effects. Call your doctor at once if you have:

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

• 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);

• memory problems, confusion, unusual behavior;

• unusual vaginal bleeding, pelvic pain;

• a lump in your breast; 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 Ogen 1.25 may include:

• headache;

• vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding;

• bloating, stomach cramps, nausea, vomiting;

• breast pain;

• thinning scalp hair; or

• fluid retention (swelling, rapid weight gain).

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 Ogen 1.25, 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.