"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Read this PATIENT INFORMATION before you start using ELESTRIN and read what you get each time you refill your ELESTRIN prescription. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.
- Patient Information:
Details with Side Effects
What is the most important information I should know about ELESTRIN (an estrogen hormone)?
- Using estrogen-alone may increase your chance of getting
cancer of the uterus (womb)
Report any unusual vaginal bleeding right away while you are using ELESTRIN. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
- Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function)
- Using estrogen-alone may increase your chances of getting strokes or blood clots
- Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older
- Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia
- Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
- Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older
- You and your healthcare provider should talk regularly about whether you still need treatment with ELESTRIN
What is ELESTRIN?
ELESTRIN is a medicine in a colorless gel that contains an estrogen hormone (estradiol) which is absorbed through the skin into the bloodstream.
What is ELESTRIN used for?
ELESTRIN is used after menopause to:
- Reduce moderate to severe hot flashes
Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 to 55 years old. This drop in body estrogen levels causes the “change of life” or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes “surgical menopause.”
When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (“hot flashes” or “hot flushes”). In some women, the symptoms are mild, and they will not need estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with ELESTRIN.
Who should not use ELESTRIN?
Do not start using ELESTRIN if you:
- Have unusual vaginal bleeding
- Currently have or have had certain cancers
Estrogens may increase the chance 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 ELESTRIN.
- Had a stroke or heart attack
- Currently have or have had blood clots
- Currently have or have had liver problems
- Have been diagnosed with a bleeding disorder
- Are allergic to ELESTRIN or any of its ingredients
See the list of ingredients in ELESTRIN at the end of this leaflet
- Think you may be pregnant
Tell your healthcare provider:
- If you have any unusual vaginal bleeding
Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
- 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), diabetes, migraine, endometriosis, lupus, or 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 ELESTRIN works. ELESTRIN 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 using ELESTRIN.
- If you are breastfeeding
The hormone in ELESTRIN can pass into your breast milk.
How should I use ELESTRIN?
- Start at the lowest dose and talk to your healthcare provider about how well that dose is working for you.
- ELESTRIN should be used at the lowest dose possible for your treatment and 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 ELESTRIN.
ELESTRIN comes in a metered-dose pump. One dose of ELESTRIN is released each time the pump is depressed (pressed down).
Use ELESTRIN exactly how your healthcare provider tells you.
The ELESTRIN pump contains enough of the medicine to let you prime the pump before you use it the first time (ten depressions) and then use the pump a total of 100 times (100 depressions) as prescribed by your healthcare provider.
After you have initially primed the pump with ten pump depressions and have used a total of 100 doses of ELESTRIN, you will need to throw the pump away and use a new one. The correct amount of medicine in each dose cannot be assured after 100 doses have been used, even though the pump container is not completely empty.
Important things to remember when using ELESTRIN
Wash your hands with soap and water after applying the gel to reduce the chance that the medicine will be spread from your hands to other people.
Allow the gel to dry for five minutes or more before dressing. Try to keep the area dry for as long as possible.
Do not allow others to come in contact with the area of skin where you applied the gel for at least two hours after you apply ELESTRIN.
Always move the spout into locked position and place the cap over the top of the pump after each use.
Never apply ELESTRIN to the breast. Never apply ELESTRIN in or around the vagina.
Do not allow others to apply the gel for you.
Do not apply sunscreen to the area where the gel was applied for at least 25 minutes.
Do not apply sunscreen to the area where the gel was applied for 7 or more consecutive days.
Avoid fire, flame or smoking until the gel has dried. ELESTRIN contains alcohol. Alcohol based gels are flammable.
It is important that you read and follow the detailed “Patient Instructions for Use” at the end of this leaflet on how to use the ELESTRIN pump and apply the dose.
What should I do if someone else is exposed to ELESTRIN?
If someone else is exposed to ELESTRIN by direct contact with the gel, that person should wash the area of contact with soap and water as soon as possible. The longer the gel is in contact with the skin before washing, the greater is the chance that the other person will absorb some of the estrogen hormone. This is especially important for men and children.
What should I do if I get ELESTRIN in my eyes?
If you get ELESTRIN in your eyes, rinse your eyes right away with warm clean water to flush out any ELESTRIN. Seek medical attention if needed.
What should I do if I miss a dose?
If you miss a dose, do not double the dose on the next day to catch up. If your next dose is less than 12 hours away, it is best just to wait and apply your normal dose the next day. If it is more than 12 hours until the next dose, apply the dose you missed and resume your normal dosing the next day.
What are the possible side effects of ELESTRIN?
Side effects are grouped by how serious they are and how often they happen when you are treated.
Serious, but less common side effects include:
- Heart attack
- Blood clots
- Breast cancer
- Cancer of the lining of the uterus (womb)
- Cancer of the ovary
- High blood pressure
- High blood sugar
- Gallbladder disease
- Liver problems
Enlargement of benign tumors of the uterus (“fibroids”)
Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:
- New breast lumps
- Unusual vaginal bleeding
- Changes in vision or speech
- Sudden new severe headaches
- Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
Less serious, but common side effects include:
- Breast pain
- Irregular vaginal bleeding or spotting
- Stomach or abdominal cramps, bloating
- Nausea and vomiting
- Hair loss
- Fluid retention
- Vaginal yeast infection
These are not all the possible side effects of ELESTRIN. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to Azur Pharma at 1-800-890-3098 or to FDA at 1-800-FDA-1088.
What can I do to lower my chances of a serious side effect with ELESTRIN?
- Talk with your healthcare provider regularly about whether you should continue using ELESTRIN
- If you have a uterus, talk to your healthcare provider about
whether the addition of a progestin is right for you
The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus. See your healthcare provider right away if you get vaginal bleeding while using ELESTRIN.
- Have a pelvic exam, 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 a higher chance for getting heart disease
Ask your healthcare provider for ways to lower your chances of getting heart disease.
General information about the safe and effective use of ELESTRIN
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use ELESTRIN for conditions for which it was not prescribed. Do not give ELESTRIN to other people, even if they have the same symptoms you have. It may harm them.
Keep ELESTRIN out of the reach of children
This leaflet provides a summary of the most important information about ELESTRIN. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about ELESTRIN that is written for health professionals. You can get more information by calling 1-800-890-3098 (toll free).
Patient Instructions for Use.
1. Remove the cap.
2. Activate the pump.
- Unlock the pump by turning the spout on top of the bottle a quarter turn to the left or the right
3. Prime the pump before using the pump for the first time.
- Prime the pump by fully depressing the spout ten times
- Throw away the unused gel by placing it in the trash to avoid another person or pet from accidental contact with the gel or, eating or drinking it
- After priming, the pump is ready to use
- One complete pump depression will dispense the same amount of ELESTRIN each time. After each daily dose, return the spout to the locked position and replace the cap before you put it away
4. Apply ELESTRIN.
- Dry skin completely before applying ELESTRIN
You should apply your daily dose of gel to clean, dry, unbroken skin. If you take a bath or shower or use a sauna, apply ELESTRIN after your bath, shower, or sauna. If you go swimming, try to leave as much time as possible, at least 2 hours, between applying your ELESTRIN dose and going into the water.
- Apply ELESTRIN at the same time each day
To apply the dose, hold the pump with the tip facing the application area of the arm. For each pump depression needed, press the pump firmly and fully with a continuous motion without hesitation.
Gently spread the gel using only 2 fingers. Spread and gently rub in the gel over the entire area of your upper arm and shoulder area, as illustrated.
5. Wash your hands with soap and water.
ELESTRIN should not be used after the date printed on the container (expiration date).
What are the ingredients in ELESTRIN?
Active ingredient: estradiol.
Inactive ingredients: purified water, ethanol, propylene glycol, diethylene glycol monoethyl ether, carbomer 940, triethanolamine, and edetate disodium. ELESTRIN™ is a trademark of Azur Pharma International II Limited
Last reviewed on RxList: 3/9/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Elestrin Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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