Estrace Cream – Consumer Medicine Information
|Manufacture:||Warner Chilcott , LLC|
|Condition:||Vaginal Atrophy (Atrophic Vaginitis), Vaginal Thrush (Vaginal Yeast Infection)|
|Form:||Cream, gel, liniment or balm, lotion, ointment, etc, Vaginal (e.g., douche, pessary, etc.)|
|Ingredients:||estradiol, purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate di-sodium and tertiary-butylhydroquinone|
NOTE: The number of doses per tube will vary with dosage requirements and patient handling.
Read this PATIENT INFORMATION before you start using ESTRACE® Vaginal Cream and read what you get each time you refill ESTRACE Vaginal Cream. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is Estrace Vaginal Cream?
ESTRACE Vaginal Cream is a medicine that contains estrogen hormones.
What is Estrace Vaginal Cream used for?
ESTRACE Vaginal Cream is used to:
- treat moderate to severe dryness, itching, and burning in and around the vagina due to menopause. You and your healthcare provider should talk regularly about whether you still need treatment with ESTRACE Vaginal Cream to control these problems.
Who should not use Estrace Vaginal Cream?
Do not start using ESTRACE Vaginal Cream if you:
- have unusual vaginal bleeding
- currently have or have had certain cancers
Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use ESTRACE Vaginal Cream.
- had a stroke or heart attack in the past year
- currently have or have had blood clots
- currently have or have had liver problems
- are allergic to ESTRACE Vaginal Cream or any of its ingredients
See the end of this leaflet for a list of ingredients in ESTRACE Vaginal Cream
- think you may be pregnant
Tell your healthcare provider:
- if you are breastfeeding
The hormone in ESTRACE Vaginal Cream can pass into your milk.
- about all of your medical problems
Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
- about all the medicines you take
This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how ESTRACE Vaginal Cream works. ESTRACE Vaginal Cream may also affect how your other medicines work.
- if you are going to have surgery or will be on bed rest.
You may need to stop taking estrogens.
How should I use Estrace Vaginal Cream?
- Remove cap from tube. (There is no seal on tube)
- Do not separate plunger from applicator.
- Screw threaded end of applicator onto the opened tube until secure.
- Position upright in order to view the calibrated gram amounts.
- Gently squeeze tube from the bottom to expel the prescribed amount of ESTRACE Vaginal Cream into the applicator. As cream is squeezed out, plunger will rise to indicate amount of grams.
- Unscrew applicator from tube.
- Replace cap onto tube.
- Lie on back with knees drawn up. To deliver medication, gently insert applicator deeply into the vagina and press plunger downward to its original position.
- To cleanse applicator: Pull plunger to remove it from barrel. Wash with mild soap and warm water. DO NOT BOIL OR USE HOT WATER.
ESTRACE Vaginal Cream should be used at the lowest dose possible for your treatment only as long as needed. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with ESTRACE Vaginal Cream.
What are the possible side effects of Estrace Vaginal Cream?
Although ESTRACE Vaginal Cream is only used in and around the vagina, the risks associated with oral estrogens should be taken into account.
Less common but serious side effects include:
- Breast cancer
- Cancer of the uterus
- Heart attack
- Blood clots
- Gallbladder disease
- Ovarian cancer
These are some of the warning signs of serious side effects:
- Breast lumps
- Unusual vaginal bleeding
- Dizziness and faintness
- Changes in speech
- Severe headaches
- Chest pain
- Shortness of breath
- Pains in your legs
- Changes in vision
Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.
Common side effects include:
- Breast tenderness
- Irregular vaginal bleeding or spotting
- Stomach/abdominal cramps, bloating
- Nausea and vomiting
- Hair loss
- Vaginal burning, irritation, and itching
Other side effects include:
- High blood pressure
- Liver problems
- High blood sugar
- Fluid retention
- Enlargement of benign tumors of the uterus (“fibroids”)
- Vaginal yeast infection
- Allergic Reactions
These are not all the possible side effects of ESTRACE Vaginal Cream. For more information, ask your healthcare provider or pharmacist.
What can I do to lower my chances of a serious side effect with Estrace Vaginal Cream?
Talk with your healthcare provider regularly about whether you should continue using ESTRACE Vaginal Cream. See your healthcare provider right away if you get vaginal bleeding while using ESTRACE Vaginal Cream. Have a breast exam and mammogram (breast x-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often. If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.
General information about safe and effective use of Estrace Vaginal Cream
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use ESTRACE Vaginal Cream for conditions for which it was not prescribed. Do not give ESTRACE Vaginal Cream to other people, even if they have the same symptoms you have. It may harm them.
Keep ESTRACE Vaginal Cream out of the reach of children.
This leaflet provides a summary of the most important information about ESTRACE Vaginal Cream. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about ESTRACE Vaginal Cream that is written for health professionals. You can get more information by calling the toll free number 1- 800-521-8813.
What are the ingredients in Estrace Vaginal Cream?
Each gram of ESTRACE Vaginal Cream contains 0.1 mg estradiol in a nonliquefying base containing purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate di-sodium and tertiary-butylhydroquinone.