Femring

• Warner Chilcott (US), LLC

Serious side effects have been reported with Femring. See the “Femring Precautions” section.

Common side effects of Femring include the following:

• headache
• breast pain or tenderness
• nausea
• vomiting
• constipation
• gas
• heartburn
• weight gain or loss
• hair loss
• swelling, redness, burning, irritation or itching of the vagina
• vaginal discharge
• painful menstrual periods
• anxiety
• depression
• changes in mood
• change in sexual desire
• back, neck, or muscle pain
• runny nose or congestion
• cough
• unwanted hair growth

This is not a complete list of Femring side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Grapefruit and grapefruit juice may interact with Femring and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Use Femring exactly as prescribed.

This medication is available as a vaginal ring and is usually inserted for a 3 month period (90 days).

Instructions for Use

Hands should be thoroughly washed before and after ring insertion.

Femring Insertion

Insert upon removal from the protective pouch.

The opposite sides of the vaginal ring should be pressed together and inserted into the vagina. The exact position is not critical to its function. When Femring is in place, the patient should not feel anything. If the patient feels discomfort, the vaginal ring is probably not far enough inside the vagina. Gently push Femring further into the vagina.

Femring Use

Femring should remain in place for 3 months and then be replaced by a new Femring.

The patient should not feel Femring when it is in place and it should not interfere with sexual intercourse. Straining upon bowel movement may make Femring move down in the lower part of the vagina. If so, it may be repositioned with a finger.

If Femring is expelled totally from the vagina, it should be rinsed in lukewarm water and reinserted by the patient (or healthcare provider if necessary).

Femring Removal

Femring may be removed by looping a finger through the ring and pulling it out.

Estradiol can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

You should not use this medication if you have any of the following conditions: liver disease, a bleeding disorder, unusual vaginal bleeding, a history of breast or uterine cancer, or if you have ever had a heart attack, stroke, or a blood clot.

Long-term use of estradiol may increase your risk of breast cancer, uterine cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using estradiol vaginal long term.

Estradiol vaginal should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

Remove the vaginal ring and insert a new one as soon as you remember. Do not use an extra vaginal ring to make up the missed wearing time.

If a vaginal ring falls out, rinse it with warm water and reinsert it. If it slides down into the lower part of the vagina, use your finger to push it in farther.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Chest pain or pressure.
• Shortness of breath.
• Coughing up blood.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Very bad headache.
• Very bad dizziness or passing out.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Very upset stomach or throwing up.
• Very bad belly pain.
• Back pain.
• Bulging eyes.
• Change in how contact lenses feel in the eyes.
• Loss of eyesight.
• Change in eyesight.
• A lump in the breast, breast soreness, or nipple discharge.
• Breast pain.
• Vaginal itching or discharge.
• Vaginal bleeding that is not normal.
• Low mood (depression).
• Mood changes.
• Memory problems or loss.
• Fever.
• Not able to pass urine or change in how much urine is passed.
• Pain when passing urine.
• Swelling.
• Toxic shock syndrome (TSS) has happened in a few patients using vaginal rings. TSS is rare, but can be very bad and sometimes deadly. Tell your doctor right away if you have loose stools (diarrhea), dizziness or light-headedness, passing out, fever, muscle pain, upset stomach, throwing up, or a sunburn-like rash.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

No drug interaction studies have been conducted for Femring.

7.1       Metabolic Interactions

In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St. John’s wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine and rifampin may decrease the plasma concentration of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase the plasma concentration of estrogens and may result in side effects.

Applies to estradiol: vaginal cream, vaginal insert extended release, vaginal tablet

Other dosage forms:

• transdermal emulsion, transdermal gel/jelly, transdermal patch extended release, transdermal spray

Along with its needed effects, estradiol (the active ingredient contained in Femring) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking estradiol:

• Vaginal yeast infection

• Change in vaginal discharge
• clear or bloody discharge from the nipple
• decrease in the amount of urine
• dimpling of the breast skin
• fast heartbeat
• fever
• hives, itching, or rash
• hoarseness
• inverted nipple
• irritation
• joint pain, stiffness, or swelling
• lump in the breast or under the arm
• noisy, rattling breathing
• pain or feeling of pressure in the pelvis
• pain, redness, or swelling in the arm or leg
• persistent crusting or scaling of the nipple
• redness of the skin
• redness or swelling of the breast
• sore on the skin of the breast that does not heal
• swelling of the eyelids, face, fingers, lips, hands, feet, or lower legs
• tightness in the chest
• troubled breathing at rest
• troubled breathing or swallowing
• vaginal bleeding

Get emergency help immediately if any of the following symptoms of overdose occur while taking estradiol:

• Abdominal or stomach pain
• dizziness
• drowsiness
• nausea or vomiting
• tenderness of the breasts
• unusual tiredness or weakness

Some side effects of estradiol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• headache
• itching or pain of the vagina or genital area
• thick, white vaginal discharge with mild or no odor
• weight gain

• Body aches or pain
• chills
• cough
• diarrhea
• ear congestion
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat

• Feeling sad or empty
• headache, severe and throbbing
• irritability
• lack of appetite
• tiredness
• trouble concentrating
• trouble sleeping
• welts