Read this PATIENT INFORMATION before you start taking DELESTROGEN and read what you get each time you refill DELESTROGEN. There may be new information. This information does not take the place of talking to your health care provider about your medical condition or your treatment.

DELESTROGEN is a medicine that contains estrogen hormones.

DELESTROGEN 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 in 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 feeling 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 health care provider should talk regularly about whether you still need treatment with DELESTROGEN.

· treat moderate to severe dryness, itching, and burning in or around the vagina. You and your health care provider should talk regularly about whether you still need treatment with DELESTROGEN to control these problems.

· help reduce your chances of getting osteoporosis (thin weak bones). Osteoporosis from menopause is a thinning of the bones that makes them weaker and easier to break. If you use DELESTROGEN only to prevent osteoporosis from menopause, talk with your health care provider about whether a different treatment or medicine without estrogens might be better for you. You and your health care provider should talk regularly about whether you should continue with DELESTROGEN.

Weight-bearing exercise, like walking or running, and taking calcium and vitamin D supplements may also lower your chances of getting postmenopausal osteoporosis. It is important to talk about exercise and supplements with your health care provider before starting them.

Do not start taking DELESTROGEN 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 had cancer, talk with your health care provider about whether you should take DELESTROGEN.

· had a stroke or heart attack in the past year. ï?·ï?  currently have or have had blood clots.

· are allergic to DELESTROGEN or any of its ingredients. See the end of this leaflet for a list of ingredients in DELESTROGEN.

·think you may be pregnant. Tell your health care provider:

· if you are breastfeeding. The hormone in DELESTROGEN can pass into your milk.

· about all of your medical problems. Your health care provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis, or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.

· about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how DELESTROGEN works. DELESTROGEN 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.

DELESTROGEN should be injected deeply into the upper, outer quadrant of the gluteal muscle following the usual precautions for intramuscular administration. By virtue of the low viscosity of the vehicles, the various preparations of DELESTROGEN (estradiol valerate injection, USP) may be administered with a small gauge needle. Since the 40 mg potency provides a high concentration in a small volume, particular care should be observed to administer the full dose.

DELESTROGEN should be visually inspected for particulate matter and color prior to administration; the solution is clear, colorless to pale yellow. Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on warming.

Note: A dry needle and syringe should be used. Use of a wet needle or syringe may cause the solution to become cloudy; however, this does not affect the potency of the material.

Estrogens should be used only as long as needed. You and your health care provider should talk regularly (for example, every 3 to 6 months) about whether you still need treatment with DELESTROGEN.

. Breast cancer

. Cancer of the uterus

. Stroke

. Heart attack

. Blood clots

. Gallbladder disease

· Ovarian cancer

. 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

. Vomiting

Call your health care provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

. Headache

. Breast pain

. Irregular vaginal bleeding or spotting

. Stomach/abdominal cramps, bloating

. Nausea and vomiting

. Hair loss

. High blood pressure

·Liver problems

· High blood sugar

. Fluid retention

. Enlargement of benign tumors of the uterus ("fibroids")

. Vaginal yeast infection

These are not all the possible side effects of DELESTROGEN. For more information, ask your health care provider or pharmacist.

· Talk with your health care provider regularly about whether you should continue taking DELESTROGEN.

. See your health care provider right away if you get vaginal bleeding while taking DELESTROGEN.

·Have a breast exam and mammogram (breast X-ray) every year unless your health care 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 health care provider for ways to lower your changes for getting heart disease.

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take DELESTROGEN for conditions for which it was not prescribed. Do not give DELESTROGEN to other people, even if they have the same symptoms you have. It may harm them.

This leaflet provides a summary of the most important information about DELESTROGEN. If you would like more information, talk with your health care provider or pharmacist. You can ask for information about DELESTROGEN that is written for health professionals. You can get more information by calling the toll free number 1-800-776-3637, select option 5.

DELESTROGEN is supplied in three 5 mL multiple dose vials; 10 mg/mL, 20 mg/mL, and 40 mg/mL strengths. The 10 mg/mL strength contains 10 mg estradiol valerate in a solution of chlorobutanol and sesame oil. The 20 mg/mL strength contains 20 mg estradiol valerate in a solution of benzyl benzoate, benzyl alcohol, and castor oil. The 40 mg/mL strength contains 40 mg estradiol valerate in a solution of benzyl benzoate, benzyl alcohol, and castor oil.

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