PATIENT INFORMATION

Medroxyprogesterone Acetate Tablets, USP

Read this Patient Information before you start taking medroxyprogesterone acetate tablets and read what you get each time you refill your medroxyprogesterone acetate tablets 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 are medroxyprogesterone acetate tablets?

Medroxyprogesterone acetate tablets are a medicine that contains medroxyprogesterone acetate, a progestin hormone.

What are medroxyprogesterone acetate tablets used for?

Medroxyprogesterone acetate tablets are used to:

• Treat menstrual periods that have stopped or to treat abnormal uterine bleeding. Women with a uterus who are not pregnant, who stop having regular menstrual periods or who begin to have irregular menstrual periods may have a drop in their progesterone level. Talk with your healthcare provider about whether medroxyprogesterone acetate tablets are right for you.
• Reduce your chances of getting cancer of the uterus (womb). In postmenopausal women with a uterus who use estrogens, taking progestin in combination with estrogen will reduce your chance of getting cancer of the uterus (womb).

Who should not take medroxyprogesterone acetate tablets?

Do not start taking medroxyprogesterone acetate tablets if you:

• have unusual vaginal bleeding
• currently have or have had certain cancers.
  Estrogen plus progestin may increase your chance of getting certain types of cancers, including cancer of the breast. If you have or have had cancer, talk with your healthcare provider about whether you should use medroxyprogesterone acetate tablets.
• had a stroke or heart attack
• currently have or have had blood clots
• currently have or have had liver problems
• are allergic to MPA or any of its ingredients
  See the list of ingredients in MPA at the end of this leaflet.
• think you may be pregnant
  MPA is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not use MPA if the test is positive and talk to your healthcare provider. There may be an increased risk of minor birth defects in children whose mothers take MPA during the first 4 months of pregnancy.
  Medroxyprogesterone acetate tablets should not be used as a test for pregnancy.

What should I tell my healthcare provider before taking MPA? Before you take MPA, tell your healthcare provider if you:

• have any other medical problems
  Your healthcare provider may need to check you more carefully if you have certain conditions such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis (severe pelvic pain), lupus, or problems with your heart, liver, thyroid, kidneys, or have high calcium in your blood.
• are going to have surgery or will be on bed rest
  Your healthcare provider will let you know if you need to stop taking MPA
• are breast feeding
  The hormone in MPA can pass into your breast milk.

Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how MPA works. MPA may also affect how other medicines work.

How should I take medroxyprogesterone acetate tablets?

Start at the lowest dose and talk to your healthcare provider about how well that dose is working for you. The lowest effective dose of medroxyprogesterone acetate has not been determined. You and your healthcare provider should talk regularly (every 3 to 6 months) about the dose you are taking and whether you still need treatment with medroxyprogesterone acetate tablets.

1. Absence of menstrual period: Medroxyprogesterone acetate tablets may be given in doses ranging from 5 to 10 mg daily for 5 to 10 days.
2. Abnormal Uterine Bleeding: Medroxyprogesterone acetate tablets may be given in doses ranging from 5 to 10 mg daily for 5 to 10 days.
3. Overgrowth of the lining of the uterus: When used in combination with oral conjugated estrogens in postmenopausal women with a uterus, medroxyprogesterone acetate tablets may be given in doses ranging from 5 or 10 mg daily for 12 to 14 straight days per month.

What are the possible side effects of medroxyprogesterone acetate tablets?

The following side effects have been reported with the use of medroxyprogesterone acetate tablets alone:

• breast tenderness
• breast milk secretion
• breakthrough bleeding
• spotting (minor vaginal bleeding)
• irregular periods
• amenorrhea (absence of menstrual periods)
• vaginal secretions
• headaches
• nervousness
• dizziness
• depression
• insomnia, sleepiness, fatigue
• premenstrual syndrome-like symptoms
• thrombophlebitis (inflamed veins)
• blood clot
• itching, hives, skin rash
• acne
• hair loss, hair growth
• abdominal discomfort
• nausea
• bloating
• fever
• increase in weight
• swelling
• changes in vision and sensitivity to contact lenses

Call your healthcare provider right away if you get hives, problems breathing, swelling of the face, mouth, tongue or neck

The following side effects have been reported with the use of medroxyprogesterone acetate tablets with an estrogen.

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:

• heart attack
• stroke
• blood clots
• dementia
• breast cancer
• cancer of the uterus
• cancer of the ovary
• high blood pressure
• high blood sugar
• gallbladder disease
• liver problems
• changes in your thyroid hormone levels
• enlargements of benign tumors ("fibroids")

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

• new breast lumps
• unusual vaginal bleeding
• changes in vision and speech
• sudden new severe headaches
• severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
• memory loss or confusion

Less serious but common side effects include:

• headache
• breast pain
• irregular vaginal bleeding or spotting
• stomach/or abdominal cramps, bloating
• nausea and vomiting
• hair loss
• fluid retention
• vaginal yeast infection

These are not all the possible side effects of medroxyprogesterone acetate tablets with or without estrogen. For more information, ask your healthcare provider or pharmacist for advice about side effects. Tell your healthcare provider if you have side effect that bothers you or does not go away. You may report side effects to Greenstone LLC at 1-800-438-1985 or FDA at 1-800-FDA-1088.

What can I do to lower my chances of a serious side effect with medroxyprogesterone acetate tablets?

• Talk with your healthcare provider regularly about whether you should continue taking medroxyprogesterone acetate tablets. The addition of a progestin is generally recommended for women with a uterus to reduce the chance of getting cancer of the uterus (womb).
• See your healthcare provider right away if you get vaginal bleeding while taking medroxyprogesterone acetate tablets.
• 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 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 a higher chance of getting heart disease. Ask your healthcare provider for ways to lower your chance of getting heart disease.

General information about safe and effective use of medroxyprogesterone acetate tablets

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

Keep medroxyprogesterone acetate tablets out of the reach of children.

This leaflet provides a summary of the most important information about medroxyprogesterone acetate tablets. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about medroxyprogesterone acetate tablets that is written for health professionals. You can get more information by calling the toll-free number, 1-800-438-1985.

What are the ingredients in medroxyprogesterone acetate tablets?

Each medroxyprogesterone acetate tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate.

Inactive ingredients:

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

LAB-0147-6.0
January 2018