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Revised MAY 2004

Cenestin®
(synthetic conjugated estrogens, A) Tablets

Read this PATIENT INFORMATION before you start taking Cenestin (synthetic conjugated estrogens) and read what you get each time you refill Cenestin (synthetic conjugated estrogens) . There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is Cenestin (synthetic conjugated estrogens) ?

Cenestin (synthetic conjugated estrogens) is a medicine that contains a mixture of synthetic estrogens made from a plant source.

What is Cenestin (synthetic conjugated estrogens) used for?

Cenestin (synthetic conjugated estrogens) 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 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 Cenestin (synthetic conjugated estrogens) .

•  treat moderate to severe dryness, itching, and burning in and around the vagina.
  You and your healthcare provider should talk regularly about whether you still need treatment with Cenestin (synthetic conjugated estrogens) to control these problems. If you use Cenestin (synthetic conjugated estrogens) only to treat your dryness, itching, and burning in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.

Who Should Not Take Cenestin (synthetic conjugated estrogens) ?

Do not start taking Cenestin (synthetic conjugated estrogens) 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 healthcare provider about whether you should take Cenestin (synthetic conjugated estrogens) .
•  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 Cenestin (synthetic conjugated estrogens) or any of its ingredients.
  See the end of this leaflet for a list of ingredients in Cenestin (synthetic conjugated estrogens) .
•  If you think you may be pregnant.

Tell your healthcare provider:

•  if you are breastfeeding.
  The synthetic estrogen hormones in Cenestin (synthetic conjugated estrogens) 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, 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 Cenestin (synthetic conjugated estrogens) works. Cenestin (synthetic conjugated estrogens) may also affect how your other medicines work.
•  if you are going to have surgery or will be on bedrest.
  You may need to stop taking estrogens.

How Should I Take Cenestin (synthetic conjugated estrogens) ?

Take one Cenestin (synthetic conjugated estrogens) tablet each day at about the same time. If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your normal schedule. Do not take 2 doses at the same time.

Start at the lowest dose and talk to your healthcare provider about how well that dose is working for you. Estrogens should be used only as long as needed. You and your healthcare provider should talk regularly (for example every 3 to 6 months) about whether you still need treatment with Cenestin (synthetic conjugated estrogens) .

What are the possible side effects of estrogens?

Less common but serious side effects include:

•  Breast cancer
•  Cancer of the uterus
•  Stroke
•  Heart attack
•  Blood clots
•  Dementia
•  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
•  Vomiting

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:

•  Headache
•  Breast pain
•  Irregular vaginal bleeding or spotting
•  Stomach/abdominal cramps, bloating
•  Nausea and vomiting
•  Hair loss

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

These are not all the possible side effects of Cenestin (synthetic conjugated estrogens) . For more information, ask your health care provider or pharmacist.

What can I do to lower my chances of a serious side effect with Cenestin (synthetic conjugated estrogens) ?

•  Talk with your healthcare provider regularly about whether you should continue taking Cenestin (synthetic conjugated estrogens) .
•  If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you.
•  See your healthcare provider right away if you get vaginal bleeding while taking Cenestin (synthetic conjugated estrogens) .
•  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 Cenestin (synthetic conjugated estrogens) .

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

Keep Cenestin (synthetic conjugated estrogens) out of the reach of children.

This leaflet provides a summary of the most important information about Cenestin (synthetic conjugated estrogens) . If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Cenestin (synthetic conjugated estrogens) that is written for health professionals. You can get more information by calling the toll free number 877-405-0369.

What are the ingredients in Cenestin (synthetic conjugated estrogens) ?

Tablets for oral administration, are available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg and 1.25 mg strengths of synthetic conjugated estrogens, A. Tablets also contain the following inactive ingredients: ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch, titanium dioxide, and triethyl citrate.

-0.3 mg tablets also contain: FD&C Blue No. 2 aluminum lake and D&C Yellow No. 10 aluminum lake.
-0.45 mg tablets also contain FD&C Yellow No. 6/Sunset Yellow FCF lake.
-0.625 mg tablets also contain: FD&C Red No. 40 aluminum lake.
-0.9 mg tablets do not contain any additional color additives.
-1.25 mg tablets also contain FD&C Blue No. 2 aluminum lake.

Last reviewed on RxList: 10/16/2008
This monograph has been modified to include the generic and brand name in many instances.