Mimvey

PATIENT INFORMATION

Read this Patient Information leaflet before you start taking Estradiol and Norethindrone Acetate Tablets and read what you get each time you refill. 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 Mimvey (estradiol and norethindrone acetate tablets , USP) (a combination of estrogen and progestin hormones )?

  • Estrogens increase the chance of getting cancer of the uterus.
    Report any unusual vaginal bleeding right away while you are taking estrogens. 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.
  • Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes.
    Using estrogens with or without progestins may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots.
  • Do not use estrogens with or without progestins to prevent dementia.

Using estrogens with or without progestins may increase your risk of dementia.

You and your healthcare provider should talk regularly about whether you still need treatment with Estradiol and Norethindrone Acetate Tablets.

What are Mimvey Tablets ?

Mimvey Tablets are a medicine that contains estrogen and progestin hormones.

What are Mimvey Tablets used for?

Mimvey Tablets are 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 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 estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with Estradiol and Norethindrone Acetate Tablets.
  • 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 estradiol and norethindrone acetate tablets only to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you. You and your healthcare provider should talk regularly about whether you should continue with estradiol and norethindrone acetate tablets.
    Weight-bearing exercises, like walking or running, and taking calcium and vitamin D 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.

Mimvey Tablets are also used after menopause to:

  • Treat moderate to s evere drynes s , itching, and burning in or around the vagina
    You and your healthcare provider should talk regularly about whether you still need treatment with estradiol and norethindrone acetate tablets 1 mg/0.5 mg to control these problems. If you use estradiol and norethindrone acetate tablets 1 mg/0.5 mg 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.

Who should not take Mimvey Tablets ?

Do Not Take Mimvey Tablets If You Have Had Your Uterus Removed (hysterectomy)

Mimvey Tablets contain a progestin to decrease the chances of getting cancer of the uterus. If you do not have a uterus, you do not need a progestin and you should not take estradiol and norethindrone acetate tablets.

Do not start taking Mimvey Tablets if you:

  • Have unusual vaginal bleeding
  • Currently have or have had certain cancers

Estrogens may increase the chance 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 estradiol and norethindrone acetate tablets 1 mg/0.5 mg.

  • Had a stroke or heart attack in the pas t year
  • Currently have or have had blood clots
  • Currently have or have had liver problems
  • Are allergic to Estradiol and Norethindrone Acetate Tablets 1 mg/0.5 mg or any of their ingredients

See section entitled, “What are the ingredients in Mimvey (estradiol and norethindrone acetate tablets , USP) 1 mg/0.5 mg?” for a list of ingredients.

  • Think you may be pregnant

Tell your healthcare provider:

  • If you are breast-feeding

The hormones in Estradiol and Norethindrone Acetate Tablets 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, or kidneys; or have high calcium levels in your blood.

  • About all the medicines you take

This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how estradiol and norethindrone acetate tablets work. Estradiol and norethindrone acetate tablets may also affect how your other medicines work.

  • If you are going to have surgery or will be on bed res t

You may need to stop taking estrogens.

How s hould I take Mimvey Tablets ?

  1. Take one tablet once a day.
  2. Estrogens should be used at the lowest dose possible for your treatment only as long as needed. You and your healthcare provider should talk regularly (e.g., every 3 to 6 months) about the dose you are taking and whether you still need treatment with estradiol and norethindrone acetate tablets.

What are the possible side effects of estrogens ?

Less common but serious side effects include:

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

Some of the warning signs of serious side effects include:

  • Breast lumps
  • Dizziness and faintness
  • Severe headaches
  • Shortness of breath
  • Changes in vision
  • Unusual vaginal bleeding
  • Changes in speech
  • Chest pain
  • Pains in your legs
  • 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
  • Irregular vaginal bleeding or s potting
  • Nausea and vomiting
  • Back pain
  • Hair loss
  • Breast pain
  • Stomach/abdominal cramps , bloating
  • Mental depression
  • Weight increase

Other side effects include:

  • High blood pres sure
  • High blood sugar
  • Enlargement of benign tumors of the uterus (“fibroids ”)
  • Hirsutism
  • Weight decrease
  • Allergic reactions
  • Mental depression
  • Liver problems
  • Fluid retention
  • Vaginal yeast infection
  • Acne
  • Sleep disturbances
  • Nervousness

These are not all the possible side effects of Mimvey (estradiol and norethindrone acetate tablets, USP) 1 mg/0.5 mg. For more information, ask your healthcare provider or pharmacist.

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

  • Talk with your healthcare provider regularly about whether you should continue taking Mimvey (estradiol and norethindrone acetate tablets, USP).
  • See your healthcare provider right away if you get vaginal bleeding while taking Mimvey Tablets.
  • Have a breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you otherwise. 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.

Have an annual gynecologic exam

General information about the safe and effective use of Mimvey Tablets

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

Keep Mimvey Tablets out of the reach of children

This leaflet provides a summary of the most important information about estradiol and norethindrone acetate tablets. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about estradiol and norethindrone acetate tablets that is written for health professionals. You can get more information by calling the toll free number 1-800-BARRLAB (227- 7522).

What are the ingredients in Mimvey (estradiol and norethindrone acetate tablets , USP) 1 mg/0.5 mg?

Mimvey is a single tablet for oral administration containing 1 mg of estradiol and 0.5 mg of norethindrone acetate and the following inactive ingredients: lactose, colloidal silicon dioxide, copovidone, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, starch and titanium dioxide.

Last reviewed on RxList: 4/1/2014
This monograph has been modified to include the generic and brand name in many instances.

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