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Generic Name: Estradiol Vaginal Tablets (ES-tra-DYE-ol)
Brand Name: Vagifem
Vagifem should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens have been shown to increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use Vagifem . Talk with your doctor if you have questions about the benefits and risks of using Vagifem .
Vagifem should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use this
Vagifem is used for:
Treating itching, burning, and dryness in or around the vaginal area in women past menopause.
Vagifem is vaginal female hormone tablet. It works by replacing female hormones in women who are no longer able to produce the proper amount of hormone.
Do NOT use Vagifem if:
- you are allergic to any ingredient in Vagifem
- you are pregnant or suspect you may be pregnant, have recently given birth or are breast-feeding, have vaginal bleeding of abnormal or unknown cause, or have cancer of the uterus
- you have known or suspected breast cancer (unless directed by your doctor)
or you have cancers that are estrogen-dependent
- you have blood clots or circulation disorders
Contact your doctor or health care provider right away if any
of these apply to you.
Before using Vagifem :
Some medical conditions may interact with Vagifem . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are planning to become pregnant
- 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 (eg, breast), certain blood disorder (porphyria), 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 Vagifem . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Blood thinners (eg, warfarin), corticosteroids (eg, prednisone), succinylcholine, tacrine or because their actions and the risk of their side effects may be increased by Vagifem
thinners (eg, warfarin) because their effectiveness may be decreased by Vagifem
- Barbiturates (eg, phenobarbital), hydantoins (eg, phenytoin), or rifampin because they may decrease Vagifem "s effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Vagifem 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 Vagifem :
Use Vagifem as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Vagifem . Talk to your pharmacist if you have questions about this information.
- To use, tear off a single applicator, separate the plastic wrap, and remove the applicator from the plastic wrap.
- Select the position for vaginal
insertion that is most comfortable for you (lying on the bed, squatting, or standing with one leg on a stool).
- Use the finger of one hand to press the applicator plunger. Use the other hand to gently and comfortably guide the applicator into the vagina. If the tablet falls out of the applicator before inserting the filled applicator, use a new applicator with a fresh tablet.
- Insert the tablet as far into the vagina as it can comfortably go without force.
- After inserting the filled applicator, gently press the plunger until you hear a click and the plunger is fully depressed. This will eject the tablet inside your vagina. The tablet will dissolve slowly over several hours.
- After depressing the plunger, gently remove the applicator and throw it away. Do not reuse the applicator.
- You may insert the tablet-filled applicator any time of day. You should use the applicator at the same time each day.
- Grapefruit and grapefruit juice may increase the risk of Vagifem "s side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Vagifem .
- If you miss a dose of Vagifem , use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Vagifem .
Important safety information:
- Vagifem may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Vagifem 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 Vagifem .
- Vagifem 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.
- Vagifem may increase the risk of blood clots. The risk may be greater if you smoke (especially in women older than 35 years of age).
- Contact your doctor if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.
- Contact your doctor if vaginal discomfort occurs or if you suspect you have developed an infection while taking Vagifem .
- 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 Vagifem .
- Vagifem may increase the risk of breast and endometrial cancer. Your doctor may prescribe another hormone
(progestin) to decrease this risk.
- Vagifem may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Vagifem .
- Your doctor should reevaluate you every 3 to 6 months to determine whether or not you need to continue taking Vagifem .
- Diabetes patients - Vagifem 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 Vagifem . 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.
- Vagifem should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Vagifem if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Vagifem is found in breast milk. If you are or will be breast-feeding while you use Vagifem , check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Vagifem :
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Breast pain or tenderness; headache; hair loss; mild nausea or vomiting; spotting or breakthrough bleeding; stomach cramps or bloating.
Severe allergic reactions (rash; hives; itching; difficulty breathing;
tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain;breast discharge or lump in the breast; calf or leg pain or swelling; chest pain; coughing up blood; dark urine; depression;
dizziness; fainting; fever; memory problems; mental or mood changes; muscle pain; one-sided weakness; painful or difficult urination; persistent or severe breast pain or tenderness; persistent or severe headache, nausea, or vomiting;
severe stomach pain or swelling; slurred speech; sudden shortness of
sunburn-like rash; swelling of hands, legs, or feet; unusual vaginal bleeding, discharge, itching, or odor; vision changes;
vomiting; 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.
Proper storage of Vagifem :
Vagifem at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vagifem out of the reach of children and away from pets.
- If you have any questions about Vagifem , please talk with your doctor, pharmacist, or other health care provider.
- Vagifem 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 Vagifem . 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.
Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.
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