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Femring

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Femring

PATIENT INFORMATION

Femring
(fem-ring)
(estradiol acetate) Vaginal Ring

Read this Patient Information before you start using Femring and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.

What is the most important information I should know about Femring (an estrogen hormone)?

  • Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using Femring. Vaginal bleeding after menopause may be a warning s ign of cancer of the uterus (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 Femring.

What is Femring?

Femring is a prescription vaginal ring that contains estradiol (an estrogen hormone). Femring should be removed after 90 days of continuous use. If you and your healthcare provider decide you should continue using Femring, a new ring can be inserted in your vagina.

What is Femring used for?

Femring is used after menopause to:

  • reduce moderate to severe hot flushes
    Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 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 estrogen levels begin dropping, some women get very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden intense episodes 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.
  • treat moderate to severe menopausal changes in and around the vagina
    You and your healthcare provider should talk regularly about whether you still need treatment with Femring to control these problems. If you use Femring 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.
    You and your healthcare provider should talk regularly about whether you still need treatment with Femring.

Who should not use Femring?

Do not start using Femring if you:

  • have 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.
  • currently have or have had certain cancers
    Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast and uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use Femring.
  • had a stroke or heart attack
  • currently have or have had blood clots
  • currently have or have had liver problems
  • have been diagnosed with a bleeding disorder
  • are allergic to Femring or any of its ingredients
    See the list of ingredients in Femring at the end of this leaflet.
  • think you may be pregnant

Femring 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 Femring if the test is positive and talk to your healthcare provider.

What should I tell my healthcare provider before I use Femring?

Before you use Femring, tell your healthcare provider 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.
  • have any problems with your vagina or cervix (lower end of your womb)
    Your healthcare provider may need to check you more carefully if your cervix, bladder, or rectum have fallen out of their normal position and into the vagina or through the opening of the vagina. This may make it more difficult for you to keep Femring in place in your vagina.
  • have any other medical conditions
    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, angioedema (swelling of face and tongue) or problems with your heart, liver, thyroid, kidneys, or have high calcium levels 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 using Femring.
  • are breastfeeding
    The hormones in Femring 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 Femring works. Femring may also affect how your other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use Femring?

For detailed instructions, see the step-by-step instructions for using Femring at the end of this Patient Information.

  • Use Femring exactly as your healthcare provider tells you to use it.
  • Femring is inserted into your vagina by you.
  • Femring should stay in your vagina for 90 days.
  • After 90 days Femring should be removed. If you and your healthcare provider decide you should continue using Femring, a new Femring can be inserted.
  • You and your healthcare provider should talk regularly (every 3 to 6 months) about the dose of medicine you are using and whether you still need treatment with Femring.

What are the possible problems you may have when using Femring?

  • toxic shock syndrome (TSS)
    Toxic shock syndrome is a rare but serious illness caused by a bacterial infection that may cause death. Remove your Femring immediately and call your healthcare provider right away if you have any of the following symptoms:
    • fever o dizziness
    • nausea or vomiting
    • feel faint
    • diarrhea
    • a sunburn rash on your face or body
    • muscle pain
  • attachment to your vaginal wall
    Contact your healthcare provider right away if you have difficulty removing Femring.
  • accidental placement in your bladder

What are the possible side effects of Femring?

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 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 or speech
  • sudden new severe headaches
  • severe pains in your chest or legs with or without shortness of breath, weakness and fatigue

Less serious, but common side effects include:

  • headache
  • breast tenderness or pain
  • irregular vaginal bleeding or spotting
  • stomach or abdominal cramps, bloating
  • nausea and vomiting
  • hair loss
  • fluid retention
  • vaginal yeast infection
  • reactions from inserting Femring such as burning, irritation, and itching

These are not all the possible side effects of Femring. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects that bother you or does not go away.

You may report side effects to Warner Chilcott at 1-800-521-8813 or to FDA at 1800-FDA-1088.

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

  • Talk with your healthcare provider regularly about whether you should continue using Femring.
  • If you have a uterus, talk with 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). See your healthcare provider right away if you develop vaginal bleeding while using Femring.
  • 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 (breast x-ray), 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 for getting heart disease.

Ask your healthcare provider for ways of lowering your chances for getting heart disease.

How should I store Femring?

  • Store at room temperature 68° F to 77° F (20° C to 25° C).

KEEP FEMRING and all other medicines out of the reach of children.

General information about safe and effective use of Femring.

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

This leaflet summarizes the most important information about Femring. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Femring that is written for health professionals. You can get more information by calling the toll free number 1-800-521-8813.

What are the ingredients in Femring?

Active ingredient: estradiol

Inactive ingredients: cured silicone elastomer composed of dimethyl polysiloxane silanol, silica (diatomaceous earth), normal propyl orthosilicate, stannous octoate; and barium sulfate. There are no coloring agents in Femring.

Instructions for Use

Femring
(fem-ring)
(estradiol acetate) vaginal ring

Inserting Femring into your vagina:

Step 1. Wash and dry your hands.

Step 2. Remove Femring from the pouch it comes in.

Step 3. Choose the position that is most comfortable for you. For example, lying down or standing with 1 leg up (See Figures A and B).

Figure A

Choose the position that is most comfortable for you - Illustration

Figure B

Choose the position that is most comfortable for you - Illustration

Step 4. Use your thumb and index finger (pointer finger) to press the sides of the ring together. You may find it easier to insert Femring if you twist it into a figure-eight shape (See Figure C).

Figure C

Twist the ring into a figure-eight shape - Illustration

Step 5. Use your other hand and hold open the folds of skin around your vagina (See Figure D).

Figure D

Open the folds of skin around your vagina - Illustration

Step 6. Place the tip of the ring in the vaginal opening. Use your index finger to push the folded ring gently into your vagina. Push it up towards your lower back as far as you can (See Figure E)

Figure E

Push the folded ring gently into your vagina - Illustration

  • If the ring feels uncomfortable, you may not have pushed the ring into your vagina far enough. Use your index finger to push the ring as far as you can into your vagina (See Figure F).

Figure F

Push the ring as far as you can - Illustration

  • Femring should now be in your upper vagina (See Figure G). The exact Position of Femring in the vagina is not important for it to work

Figure G

Femring should now be in your upper vagina - Illustration

Step 7. Wash your hands when you are done.

Note: After 90 days, Femring may no longer release enough medicine to control your menopausal symptoms. Your Femring should be removed and replaced with a new one after 90 days of continuous use if you and your healthcare provider have decided that you still need treatment with Femring.

Removing Femring from your vagina:

  • Wash and dry your hands.
  • Choose the position that is most comfortable for you (See Figures A and B).
  • Put a finger into your vagina and hook it through the ring (See Figure H).

Figure H

Put a finger into your vagina and hook it through the ring - Illustration

  • Gently pull downwards and forwards to remove Femring.
  • Wrap the used ring in tissue or toilet paper and put it in a trash can.
  • Wash your hands.
  • Insert another ring now if your healthcare provider has told you to (See Step 1 through Step 7 above under “Inserting Femring into your vagina”).
  • If your Femring comes out of your vagina before 90 days, clean it with warm water and put it back in your vagina.
  • Femring can come out if:
    • it is not put in far enough
    • you are pushing hard during a bowel movement
    • your vaginal muscles are weak

If Femring comes out often, tell your healthcare provider. Femring may not be right for you.

Call your healthcare provider if you have any problems putting Femring in your vagina or taking it out.

You may leave Femring in place if you need to use medicine for a vaginal infection.

You may leave Femring in place during sex (intercourse). If you take Femring out during intercourse or it comes out, clean it with warm water and put it back in your vagina.

If you lose your Femring, a new Femring should be put in place for 90 days.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 6/12/2014
This monograph has been modified to include the generic and brand name in many instances.

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Femring - User Reviews

Femring User Reviews

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