Generic Name: estradiol (ES-tra-DYE-ol)
Brand Name: Examples include Estrace and Gynodiol
Gynodiol 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 Gynodiol. Talk with your doctor if you have questions about the benefits and risks of using Gynodiol.
Gynodiol 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 Gynodiol.
Gynodiol is used for:
Treating conditions due to menopause (eg, hot flashes; vaginal itching, burning, or dryness), treating vulval or vaginal atrophy, and preventing osteoporosis (brittle bones). It is also used for estrogen replacement therapy after failure of the ovaries and to relieve the symptoms of breast cancer.
Treating advanced prostate cancer. It is also used to relieve symptoms of breast cancer.
Gynodiol is a female estrogen hormone. It works by replacing natural estrogens in a woman who can no longer produce enough estrogen.It works for advanced prostate cancer by antagonizing male hormones.
Do NOT use Gynodiol if:
- you are allergic to any ingredient in Gynodiol
- you are pregnant or suspect you may be pregnant, have recently given birth or are breast-feeding, or have vaginal bleeding of abnormal or unknown cause
- you have known or suspected breast cancer (unless directed by your doctor) or you have cancers that are estrogen-dependent
- you have blood clots, vein inflammation, or liver disease
- you have had a recent stroke or heart attack
Contact your doctor or health care provider right away if any of these apply to you.
Before using Gynodiol:
Some medical conditions may interact with Gynodiol. 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)
- if you have abnormal calcium levels in the blood, asthma, cancer, 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 Gynodiol. 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, or tacrine because their actions and the risk of their side effects may be increased by Gynodiol
- Blood thinners (eg, warfarin) because their effectiveness may be decreased by Gynodiol
- Barbiturates (eg, phenobarbital), hydantoins (eg, phenytoin), or rifampin because they may decrease Gynodiol's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Gynodiol 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 Gynodiol:
Use Gynodiol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Gynodiol. Talk to your pharmacist if you have questions about this information.
- Take Gynodiol by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Grapefruit and grapefruit juice may increase the risk of Gynodiol's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Gynodiol.
- If you miss a dose of Gynodiol, take 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 take 2 doses at once.
Ask your health care provider any questions you may have about how to use Gynodiol.
Important safety information:
- Gynodiol may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Gynodiol 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 taking Gynodiol.
- Gynodiol 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.
- Gynodiol 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 Gynodiol.
- Follow your doctor's instructions for examining your breasts and report any lumps immediately.
- Additional monitoring of your dose or condition may be necessary if you are presently taking an azole antifungal (eg, itraconazole), carbamazepine, a macrolide antibiotic (eg, erythromycin), ritonavir, cimetidine, or St. John's wort.
- 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 Gynodiol.
- 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.
- Some of these products may contain the dye tartrazine (FD&C Yellow No. 5), which can cause allergic reactions in certain patients. Consult your doctor or pharmacist. If you previously had allergic reactions to the dye tartrazine, contact your doctor or pharmacist to determine if the product you are taking contains the dye tartrazine.
- Gynodiol may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Gynodiol.
- Diabetes patients - Gynodiol 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 Gynodiol. 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.
- Gynodiol should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Gynodiol if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Gynodiol may be found in breast milk. If you are or will be breast-feeding while you use Gynodiol, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Gynodiol:
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 breath; 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 about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea; vomiting.Proper storage of Gynodiol:
Store Gynodiol at room temperature, 59 to 86 degrees F (15 to 30 degrees C), in a tight, light-resistant container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Gynodiol out of the reach of children and away from pets.
- If you have any questions about Gynodiol, please talk with your doctor, pharmacist, or other health care provider.
- Gynodiol 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Gynodiol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Gynodiol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Gynodiol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Gynodiol.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.