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|Femring Ring

Femring Ring

Femring Ring is used for:

Treating itching, burning, and dryness in or around the vaginal area and treating lower urinary tract symptoms (eg, difficulty urinating, burning during urination) in postmenopausal women.

Femring Ring is a vaginal synthetic female hormone. It works topically to replace hormone levels in women who cannot produce enough hormones.

Do NOT use Femring Ring if:

• you are allergic to any ingredient in Femring Ring
• you are pregnant or suspect you may be pregnant, have recently given birth, or are breast-feeding
• you have unexplained, abnormal vaginal bleeding, known or suspected cancer of the breast or uterus, or tumors that are estrogen-dependent
• you have had a heart attack or stroke within the last year
• you have a history of blood clots (especially in the legs or lungs) or circulation disorders

Contact your doctor or health care provider right away if any of these apply to you.

Before using Femring Ring:

Some medical conditions may interact with Femring Ring. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a family history of breast cancer, or you have breast lumps or disease or an abnormal mammogram
• if you have yellowing of the whites of the eyes or skin during pregnancy or with past estrogen use, or high blood pressure during pregnancy (toxemia)
• if you have a vaginal infection or womb problems (eg, uterine fibroids/endometriosis, abnormal vaginal bleeding, other uterine problems) or vaginal conditions (eg, recurring vaginal infections, prolapse, stenosis)
• if you have abnormal calcium levels in the blood, asthma, cancer, cholesterol or lipid problems, depression, diabetes, epilepsy, excessive weight gain, gallbladder disease, heart disease or other heart problems, high blood pressure, kidney or liver disease, low thyroid hormone levels, lupus, migraine headaches, pancreas disease, seizures, or yellowing of the skin or eyes
• if you smoke or will be having surgery

Some MEDICINES MAY INTERACT with Femring Ring. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin), azole antifungals (eg, ketoconazole), corticosteroids (eg, prednisone), macrolide antibiotics (eg, erythromycin), ritonavir, succinylcholine, or tacrine because their actions and side effects may be increased by Femring Ring
• Hydantoins (eg, phenytoin), barbiturates (eg, phenobarbital), or rifampin because they may decrease Femring Ring"s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Femring Ring may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Femring Ring:

Use Femring Ring as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Femring Ring. Talk to your pharmacist if you have questions about this information.
• Wash and dry your hands before removing the ring from the pouch. The ring becomes slippery when wet, so make sure your hands are dry.
• To insert the ring, choose a comfortable position, such as lying down, squatting, or standing with one leg up.
• Hold the ring between your thumb and index finger and press the opposite sides of the ring together.
• Gently push the folded ring into your vagina. Insert the ring into your vagina as deeply as possible into the upper one third of the vaginal vault. The exact position of the ring in the vagina is not important for it to work.
• You may not feel the ring once it is in place. If you feel discomfort, the ring is probably not inserted far enough in your vagina. Use your finger to gently push the ring further into your vagina. There is no danger in the ring being pushed too far up the vagina or getting lost. It can be inserted only as far as the end of the vagina. The cervix will block it from going any further.
• The ring should not interfere with sexual intercourse.
• Generally, the ring is left in place for 90 days and then removed and replaced with a new ring if therapy is continued. Do not leave the ring in place for longer than 90 days. Follow the dosing schedule carefully.
• Some women have experienced moving or gliding of the ring within the vagina due to bowel movements, straining, constipation, or coughing. If this occurs, push it back into place with your finger. If the ring is removed or falls out of the vagina, rinse the ring with lukewarm water and reinsert.
• To remove the ring, wash and dry your hands thoroughly. Find a comfortable position, either standing, squatting, or lying down. Loop your finger through the ring and gently pull it out. Discard the used ring in the trash container. Do not flush it down the toilet.
• It is recommended that the ring be removed during treatment with other vaginal medicines. If you develop a vaginal infection while using the ring, it is recommended that you remove the ring and resume therapy after the infection has been treated. Consult your doctor or pharmacist for more information.
• It may take 2 to 3 weeks for Femring Ring to work. If your symptoms persist, contact your doctor.
• If you forget and have not inserted a new ring after 90 days, contact your doctor to establish a new schedule for Femring Ring.

Ask your health care provider any questions you may have about how to use Femring Ring.

Important safety information:

• Femring Ring may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Femring Ring with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Limit alcoholic beverages while you are using Femring Ring.
• Femring Ring may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
• Femring Ring may increase the risk blood clots (especially in women older than 35 years of age). The risk may be greater if you smoke.
• Contact your health care provider if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.
• Contact your health care provider if vaginal discomfort occurs or if you suspect you have developed an infection while taking Femring Ring.
• Follow your doctor"s instructions for examining your breasts, and report any lumps immediately.
• If you wear contact lenses and you develop problems with them, contact your doctor.
• If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Femring Ring.
• Nonprescription therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.
• Femring Ring may increase the risk of breast and endometrial cancer. Your doctor may prescribe another hormone (progestin) to decrease this risk.
• Your doctor should reevaluate you every 3 to 6 months to determine whether or not you need to continue taking Femring Ring.
• Femring Ring may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Femring Ring.
• Diabetes patients - Femring Ring may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including physical exams and blood pressure, may be performed while you use Femring Ring. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. Be sure to keep all doctor and lab appointments.
• Femring Ring should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Femring Ring if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Femring Ring is found in breast milk. If you are or will be breast-feeding while you are taking Femring Ring, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Femring Ring:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Arthritis; back pain; bladder infection; bone and limb pain; breakthrough bleeding; breast tenderness; bronchitis; carpal tunnel syndrome; changes in sex drive; constipation; diarrhea; dizziness; ear infection; emotional disturbance; flu-like symptoms (fever, headache, sore throat); fungal infection; herpes; increased vaginal discharge; indigestion; joint and muscle strain; lightheadedness; muscle cramps, pain, and spasms; nausea; neck pain; nose and throat pain; sinus headache; sleeplessness; stomach bloating and upset; swelling of the legs and feet; tiredness; tooth abscess; toothache; unusual vaginal discharge, itching, or odor; upper respiratory tract infection; urinary tract infection; vaginal discomfort, infection, or irritation; vomiting; weight changes.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; breast lumps; breast pain; changes in vaginal bleeding (eg, spotting, breakthrough bleeding, prolonged bleeding); changes in vision or speech (eg, change in contact lens fit, loss of vision); chest pain; coughing up blood; dizziness; fainting; mental/mood changes (eg, severe depression, memory loss); pain in calves or chest; pain, swelling, or tenderness in the stomach; severe headache or vomiting; sudden shortness of breath; swelling of hands or feet; unusual vaginal discharge, itching, or odor; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea; vomiting.

Store Femring Ring at room temperature at 59 to 86 degrees F (15 to 30 degrees C). Store in original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Femring Ring out of the reach of children and away from pets.

General information:

• If you have any questions about Femring Ring, please talk with your doctor, pharmacist, or other health care provider.
• Femring Ring is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Femring Ring. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.