To use the Gynovel vaginal cream:
Using the marked applicator provided, measure the prescribed dose of cream.
Lie on your back with your knees drawn up, sit, or stand in a position that allows you comfortable access to the vaginal area. To deliver the medication, gently insert the applicator deep into your vagina and press the plunger downward to its original position.
Clean the applicator by pulling the plunger from the barrel. Wash it with mild soap and warm water.
Have yearly physical exams and examine your breasts for lumps on a monthly basis while using Gynovel.
What special precautions should I follow?
Tell your doctor if you have any of the following: high blood pressure, angina, or heart disease; high levels of cholesterol or triglycerides in your blood; liver disease; kidney disease; asthma; epilepsy; migraines; diabetes; depression; gallbladder disease; uterine fibroids; had a hysterectomy (uterus removed); a narrow, short, or prolapsed vagina; vaginal irritation; or a vaginal infection.
Do not use Gynovel without first talking to your doctor if you have a circulation, bleeding, or blood-clotting disorder; undiagnosed, abnormal vaginal bleeding; or any type of breast, uterine, or hormone-dependent cancer. Using Gynovel may be dangerous in some cases if you have any of the conditions listed above.
You may not be able to use Gynovel, or you may require a dosage adjustment or special monitoring during treatment, if you have any of the conditions listed above.
Long-term treatment with Gynovel may increase the risk of a stroke. Because of this risk, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking Gynovel during a long-term cycle. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.
The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50-79 years of age) during 5 years of treatment with oral conjugated estrogens combined with medroxyprogesterone acetate.
The WHIMS study found that postmenopausal women 65 years of age or older who were treated with oral conjugated estrogens plus medroxyprogesterone acetate had an increased risk of developing dementia. It is unknown whether this finding applies to younger postmenopausal women or to women using estrogen only therapy.
Gynovel is in the FDA pregnancy category X. This means that Gynovel will cause birth defects in an unborn baby. Do not use Gynovel if you are pregnant or are planning a pregnancy.
Gynovel may decrease milk flow and have other effects on milk composition. Do not use Gynovel without first talking to your doctor if you are breast-feeding a baby.
What should I do if I forget a dose?
Insert the next dose of cream or ring as soon as you remember. Continue to follow your regular schedule. Do not use two doses simultaneously unless your doctor directs otherwise.
If at any time the ring falls out, rinse it with warm water and reinsert it. If it slides down into the lower part of the vagina, use a finger to reinsert it.
What side effects can this medication cause?
An Gynovel test measures the amount of a hormone called Gynovel in the blood. Gynovel is one of the main types of estrogens.
What is the most important information I should know about Gynovel (Estrace, Gynodiol)?
You should not use this medicine if you have: undiagnosed vaginal bleeding, liver disease, a bleeding disorder, if you will have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.
Do not use if you are pregnant.
Gynovel may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.
Using this medicine can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, or ovaries. Gynovel should not be used to prevent heart disease, stroke, or dementia.
What Are Side Effects Associated with Using Gynovel?
Side effects associated with use of Gynovel, include the following:
- Abdominal cramping
- Breakthrough bleeding
- Breast enlargement
- Breast tenderness/pain/swelling
- Freckles or darkening of facial skin (melasma)
- Changes in menstrual periods
- Delayed ejaculation
- Dry mouth
- Excessive thirst
- Fainting or lightheadedness
- High blood pressure (hypertension)
- Loss of scalp hair
- Missed menstrual periods
- Muscle cramps
- Skin irritation and redness at application site (transdermal)
- Stomach cramps
- Stomach upset
- Swelling of extremities
- Vaginal discharge
- Vaginal discomfort, vaginal erosion, vaginal ulceration, adherence of the vaginal ring to the vaginal wall (Estring)
- Weight changes
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
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Gynovel is a female sex hormone necessary for many processes in the body. Gynovel vaginal products release estrogen that is absorbed directly through the skin of the vaginal wall.