PATIENT INFORMATION

Menest ®

(esterified estrogens tablets, USP)

Read this PATIENT INFORMATION before you start taking Menest and read what you get each time you refill Menest. 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 Menest?

Menest is a medicine that contains estrogen hormones.

What is Menest used for?

Menest is used after menopause to:

• reduce moderate to 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 the 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. This 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 estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with Menest.

• treat moderate to severe dryness, itching, and burning in and around the vagina. You and your healthcare provider should talk regularly about whether you still need treatment with Menest to control these problems. If you use Menest only to treat your dryness, itching, and burning in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.
• treat certain conditions in women before menopause if their ovaries do not make enough estrogen naturally.
• ease symptoms of certain cancers that have spread through the body, in men and women.

Who should not take Menest?

Do not start taking Menest if you:

• have unusual vaginal bleeding.
• 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 had cancer, talk with your healthcare provider about whether you should take Menest.
• had a stroke or heart attack in the past year.
• currently have or have had blood clots.
• currently have or have had liver problems.
• are allergic to Menest or any of its ingredients. See the end of this leaflet for a list of ingredients in Menest.
• think you may be pregnant.

Tell your healthcare provider:

• if you are breastfeeding. The hormone in Menest can pass into your milk.
• about all of your medical problems. Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
• about all of the medicines you take. This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Menest works. Menest may also affect how your other medicines work.
• if you are going to have surgery or will be on bed rest. You may need to stop taking estrogens.

How should I take Menest?

Your healthcare provider will select the lowest appropriate dose of Menest, determine how frequently it will be taken, and determine the length of time you will be treated, depending on your condition.

For treatment of postmenopausal symptoms, the lowest dose that will control symptoms will be selected and used for the shortest amount of time.

In general, you will take Menest for several weeks, skip a week, and then begin taking Menest again. Again, your healthcare provider will discuss with you the instructions for taking Menest.

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose, and go back to your normal schedule. Do not take 2 doses at the same time.

Estrogens should be used only as long as needed. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about whether you still need treatment with Menest.

What are the possible side effects of estrogens?

Less common but serious side effects include:

• Breast cancer
• Cancer of the uterus
• Stroke
• Heart attack
• Blood clots
• Dementia
• Gallbladder disease
• Ovarian cancer

These are some of the warning signs of serious side effects:

• Breast lumps
• Unusual vaginal bleeding
• Dizziness and faintness
• Changes in speech
• Severe headaches
• Chest pain
• Shortness of breath
• Pains in your legs
• Changes in vision
• Vomiting

Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

Common side effects include:

• Headache
• Breast pain
• Irregular vaginal bleeding or spotting
• Stomach/abdominal cramps, bloating
• Nausea and vomiting
• Hair loss

Other side effects include:

• High blood pressure
• Liver problems
• High blood sugar
• Fluid retention
• Enlargement of benign tumors of the uterus ("fibroids")
• Vaginal yeast infection

These are not all the possible side effects of Menest. For more information, ask your healthcare provider or pharmacist.

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

• Talk with your healthcare provider regularly about whether you should continue taking Menest. If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you.
• See your healthcare provider right away if you get vaginal bleeding while taking Menest.
• Have a 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 exams more often.
• 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 Menest.

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

This leaflet provides a summary of the most important information about Menest. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for more information about Menest that is written for health professionals.

What are the ingredients in Menest?

Menest is a mixture of esterified estrogens that are of the type excreted by pregnant mares. Menest also contains ethyl cellulose, fragrances, hydroxypropyl cellulose, hypromellose 2910, lactose, magnesium stearate, methylcellulose, polyethylene glycol, sodium bicarbonate, shellac, starch, stearic acid, titanium dioxide, and vanillin. The tablets come in different strengths; the color ingredients for each strength are:

0.3 mg Tablet: FD&C Yellow No. 6, D&C Yellow No. 10.

0.625 mg Tablet: FD&C Yellow No. 6, D&C Yellow No. 10.

1.25 mg Tablet: FD&C Yellow No. 6, D&C Yellow No. 10, and FD&C Blue No. 1.

2.5 mg Tablet: D&C Red No. 30.

How should I store Menest?

Do not store above 25°C (77°F).

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

LAB 1139-1.0

Revised: 4/2019