PATIENT INFORMATION

OGEN®
estropipate tablets, USP

Read this PATIENT INFORMATION before you start taking OGEN and read what you get each time you refill your OGEN prescription. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is OGEN?

OGEN is a medicine that contains estropipate, an estrogen hormone.

What is OGEN used for?

OGEN is used after menopause to:

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Reduce moderate or severe hot flashes

Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 to 55 years old. This drop in body estrogen levels causes the "change of life" or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes "surgical menopause".

When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating ("hot flashes" or "hot flushes"). In some women, the symptoms are mild, and they will not need to take estrogens. In other women, symptoms can be more severe.

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Treat menopausal changes in and around the vagina

You and your healthcare provider should talk regularly about whether you still need treatment with OGEN to control these problems. If you use OGEN only to treat your menopausal changes in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.

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Help reduce your chances of getting osteoporosis (thin weak bones)

Osteoporosis from menopause is a thinning of the bones that makes them weaker and easier to break. If you use OGEN only to prevent osteoporosis due to menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you.

Weight-bearing exercise, like walking or running, and taking calcium (1500 mg per day of elemental calcium) and vitamin D (400–800 IU per day) supplements may also lower your chances of getting postmenopausal osteoporosis. It is important to talk about exercise and supplements with your healthcare provider before starting them.

You and your healthcare provider should talk regularly about whether you still need treatment with OGEN.

OGEN is also used to:

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Treat certain conditions in women before menopause if their ovaries do not make enough estrogen naturally

Who should not take OGEN?

Do not start taking OGEN if you:

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Have unusual vaginal bleeding

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Currently have or have had certain cancers

Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take OGEN.

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Had a stroke or heart attack

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Currently have or have had blood clots

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Currently have or have had liver problems

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Have been diagnosed with a bleeding disorder

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Are allergic to OGEN tablets or any of its ingredients

See the list of ingredients at the end of this leaflet.

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Think you may be pregnant

Tell your healthcare provider:

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If you have any unusual vaginal bleeding

Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.

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About all of your medical problems

Your healthcare provider may need to check you more carefully if you have certain medical conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), hypertension (high blood pressure), problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.

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About all the medicines you take

This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how OGEN works. OGEN may also affect how your other medicines work.

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If you are going to have surgery or will be on bed rest

You may need to stop taking OGEN.

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If you are breast feeding

The hormone in OGEN can pass into your breast milk.

How should I take OGEN?

Take OGEN as directed by your healthcare provider. OGEN comes in three strengths. Check with your healthcare provider periodically to make sure you are using the appropriate dose.

1.

Start at the lowest dose and talk to your healthcare provider about how well that dose is working for you.

2.

Estrogens should be used at the lowest dose possible for your treatment only as long as needed. The lowest effective dose of OGEN has not been determined. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with OGEN.

What are the possible side effects of OGEN?

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious, but less common side effects include:

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Heart attack

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Stroke

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Blood clots

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Dementia

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Breast cancer

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Cancer of the lining of the uterus (womb)

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Cancer of the ovary

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High blood pressure

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High blood sugar

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Gallbladder disease

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Liver problems

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Enlargement of benign tumors of the uterus ("fibroids")

Call you healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

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New breast lumps

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Unusual vaginal bleeding

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Changes in vision or speech

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Sudden new severe headaches

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Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue

Less serious, but common side effects include:

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Headache

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Breast pain

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Irregular vaginal bleeding or spotting

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Stomach or abdominal cramps, bloating

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Nausea and vomiting

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Hair loss

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Fluid retention

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Vaginal yeast infection

These are not all the possible side effects of OGEN. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What can I do to lower my chances of getting a serious side effect with OGEN?

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Talk with your healthcare provider regularly about whether you should continue taking OGEN

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If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you. The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus (womb)

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See your healthcare provider right away if you get vaginal bleeding while taking OGEN

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Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast examinations more often

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If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease

General information about safe and effective use of OGEN

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take OGEN for conditions for which it was not prescribed. Do not give OGEN to other people, even if they have the same symptoms you have. It may harm them.

Keep OGEN out of the reach of children.

This leaflet provides a summary of the most important information about OGEN. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about OGEN that is written for health professionals. You can get more information by calling the toll free number 1-888-691-6813.

What are the ingredients in OGEN?

OGEN contains estropipate as the active ingredient. OGEN also contains colloidal silicon dioxide, dibasic potassium phosphate, hydrogenated vegetable oil wax, hydroxypropyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and tromethamine.

The color ingredients are:

OGEN .625 (yellow tablet): D&C Yellow No. 10 and FD&C Yellow No. 6.

OGEN 1.25 (peach tablet): FD&C Yellow No. 6.

OGEN 2.5 (blue tablet): FD&C Blue No. 2.

LAB-0090-6.0
Revised May 2019