OGEN- estropipate tablet 
Pharmacia and Upjohn Company LLC

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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 THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT OGEN (AN ESTROGEN HORMONE)?
  • Using estrogen-alone increases your chance of getting cancer of the uterus (womb)
    Report any unusual vaginal bleeding right away while you are taking OGEN. Vaginal bleeding after menopause may be a warning sign of cancer of the uterine (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
  • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function)
  • Using estrogen-alone may increase your chances of getting strokes or blood clots
  • Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia
  • Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
  • Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • You and your healthcare provider should talk regularly about whether you still need treatment with OGEN

What is OGEN?

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

What is OGEN used for?

OGEN is used after menopause to:

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.

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.

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:

Who should not take OGEN?

Do not start taking OGEN if you:

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.

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

Tell your healthcare provider:

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.

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

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.

You may need to stop taking OGEN.

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:

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

Less serious, but common side effects include:

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?

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.

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LAB-0090-5.0
November 2015

Revised: 7/2016
Document Id: 04a84612-42a8-4ed8-b4f4-430dceea8aaf
Set id: 5c1b620b-9e16-472a-a450-969e19530ea2
Version: 6
Effective Time: 20160713
 
Pharmacia and Upjohn Company LLC