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Femring®
(estradiol acetate) vaginal ring

Read this PATIENT INFORMATION before you start using Femring (estradiol acetate) and read what you get each time you refill your Femring (estradiol acetate) 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 Femring?

Femring (estradiol acetate vaginal ring) is an off-white, soft, flexible vaginal ring with a center that contains an estrogen. Femring (estradiol acetate) should be removed after 90 days of continuous use. If continuation of therapy is indicated, a new flexible ring should be replaced.

What is Femring (estradiol acetate) used for?

Femring (estradiol acetate) 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 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 Femring (estradiol acetate) .

• treat menopausal changes in and around the vagina

You and your healthcare provider should talk regularly about whether you still need treatment with Femring (estradiol acetate) to control these problems.

Who should not use Femring (estradiol acetate) ?

Do not start using Femring (estradiol acetate) 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 use Femring (estradiol acetate) .
• Had a stroke or heart attack
• Currently have or have had blood clots
• Currently have or have had liver problems
• Are allergic to any of the ingredients in Femring (estradiol acetate) . See the list of ingredients in Femring (estradiol acetate) at the end of this leaflet.
• Think you may be pregnant

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.
• 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), diabetes, migraine, endometriosis, lupus, or problems with your heart, liver, thyroid, 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 Femring (estradiol acetate) works. Femring (estradiol acetate) 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.
• If you are breastfeeding. The hormone in Femring (estradiol acetate) can pass into your milk.

How should I use Femring (estradiol acetate) ?

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 Femring (estradiol acetate) has not been determined. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are using and whether you still need treatment with Femring (estradiol acetate) .

• Femring (estradiol acetate) is inserted into your vagina by you or your healthcare provider.
• Femring (estradiol acetate) should stay in your vagina for 3 months.
• After 3 months Femring (estradiol acetate) should be removed and a new Femring (estradiol acetate) should be inserted.

To insert Femring (estradiol acetate) into your vagina:

1. Wash and dry your hands.

2. Remove Femring (estradiol acetate) from its pouch.

3. Choose the position that is most comfortable for you. For example, lying down or standing with one leg up (Diagrams 1a and 1b, respectively).

DIAGRAM 1a

DIAGRAM 1b

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 (estradiol acetate) if you twist it into a figure-of-eight shape (Diagram 2).

DIAGRAM 2

5. Use your other hand and hold open the folds of skin around your vagina (Diagram 3).

DIAGRAM 3

6. Place the tip of the ring in the vaginal opening and then 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 (Diagram 4).

DIAGRAM 4

If the ring feels uncomfortable, you probably did not push it into your vagina far enough. Use your index finger to push the ring as far as you can into your vagina (Diagram 5). There is no danger of Femring (estradiol acetate) being pushed too far up in the vagina or getting lost.

DIAGRAM 5

Femring (estradiol acetate) should now be in your upper vagina (Diagram 6). The exact position of Femring (estradiol acetate) in the vagina is not important for it to work.

DIAGRAM 6

7. Wash your hands when you are done.

After 3 months, Femring (estradiol acetate) may no longer release enough medicine to control your menopausal symptoms. To continue to have symptom relief your current Femring (estradiol acetate) should be removed and replaced with a new one if you and your healthcare provider have decided that you still need treatment with Femring (estradiol acetate) .

To remove Femring (estradiol acetate) :

1. Wash and dry your hands.
2. Choose the position that is most comfortable for you (see Diagrams 1a and 1b).
3. Put a finger into your vagina and hook it through the ring. (Diagram 7).

DIAGRAM 7

4. Gently pull downwards and forwards to remove Femring (estradiol acetate) .

5. Wrap the used ring in tissue or toilet paper and put it in a trash can.

6. Wash your hands.

Insert another ring now if your healthcare provider has told you to.

If your Femring (estradiol acetate) comes out of your vagina before 3 months, clean it with warm water and put it back in your vagina.

• Femring (estradiol acetate) can come out if it is not put in far enough.
• Femring (estradiol acetate) can come out when you are pushing hard during a bowel movement.
• Femring (estradiol acetate) can come out if your vaginal muscles are weak.

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

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

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

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

If you lose your Femring (estradiol acetate) , a new Femring (estradiol acetate) should be put in place for 3 months.

What are the possible side effects of vaginal rings?

A few cases of toxic shock syndrome (TSS) have been reported in women using vaginal rings. Toxic shock syndrome is a rare but serious illness caused by a bacterial infection. If you have fever, nausea, vomiting, diarrhea, muscle pain, dizziness, faintness, or a sunburn-rash on face and body, remove Femring (estradiol acetate) and contact your healthcare provider. A few cases of a vaginal ring becoming attached to the vaginal wall, making ring removal difficult, have been reported. Rare cases of a vaginal ring being inserted into the bladder, instead of the vagina, also have been reported.

What are the possible side effects of estrogens?

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:

• Breast cancer
• Cancer of the uterus
• Stroke
• Heart attack
• Blood clots
• Dementia
• Gallbladder disease
• Ovarian cancer
• High blood pressure
• Liver problems
• High blood sugar
• Enlargement of benign tumors of the uterus (“fibroids”)

Some of the warning signs of serious side effects include:

• 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
• Yellowing of the skin, eyes or nail beds

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

Less serious but common side effects include:

• Headache
• Breast pain
• Irregular vaginal bleeding or spotting
• Stomach/abdominal cramps, bloating
• Nausea and vomiting
• Hair loss
• Fluid retention
• Vaginal yeast infection
• Reactions from inserting Femring (estradiol acetate) such as burning, irritation, and itching

These are not all the possible side effects of Femring (estradiol acetate) . For more information, ask your healthcare provider or pharmacist.

What can I do to lower my chances of getting a serious side effect with Femring (estradiol acetate) ?

• Talk with your healthcare provider regularly about whether you should continue using Femring (estradiol acetate) .
• If you have a uterus, talk to 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. See your healthcare provider right away if you get vaginal bleeding while using Femring (estradiol acetate) .
• If you have fever, nausea, vomiting, diarrhea, muscle pain, dizziness, faintness, or a sunburn-rash on face and body, remove Femring (estradiol acetate) and contact your healthcare provider.
• Contact your healthcare provider right away if you have difficulty removing Femring (estradiol acetate) .
• 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 examinations 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 of 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 Femring (estradiol acetate) .

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

Keep Femring (estradiol acetate) out of the reach of children.

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

What are the ingredients in Femring?

Femring contains estradiol acetate, an estrogen. It also contains 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 (estradiol acetate) .

Last reviewed on RxList: 6/15/2009
This monograph has been modified to include the generic and brand name in many instances.