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Climara Pro®
(Estradiol/Levonorgestrel Transdermal System)

Read this Patient Information leaflet before you start taking Climara Pro (estradiol, levonorgestrel transdermal) and read what you get each time you refill Climara Pro (estradiol, levonorgestrel transdermal) . 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 Climara Pro (estradiol, levonorgestrel transdermal) ?

Climara Pro (estradiol, levonorgestrel transdermal) is a medicine that contains two kinds of hormones, estrogen and a progestin.

What is Climara Pro (estradiol, levonorgestrel transdermal) used for?

Climara Pro (estradiol, levonorgestrel transdermal) 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 Climara Pro (estradiol, levonorgestrel transdermal) .
• 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 Climara Pro (estradiol, levonorgestrel transdermal) only to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you. You and your healthcare provider should talk regularly about whether you should continue with Climara Pro.

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.

Who should not use Climara Pro (estradiol, levonorgestrel transdermal) ?

Do not use Climara Pro (estradiol, levonorgestrel transdermal) if you have had your uterus removed (hysterectomy).

Climara Pro (estradiol, levonorgestrel transdermal) contains a progestin to decrease the chances of getting cancer of the uterus. If you do not have a uterus, you do not need a progestin and you should not use Climara Pro (estradiol, levonorgestrel transdermal) .

Do not start using Climara Pro (estradiol, levonorgestrel transdermal) if you:

• have unusual vaginal bleeding
• currently have or have had certain cancers. Estrogens may increase the chancesofgetting certain typesofcancers, including cancerofthe breastoruterus.Ifyou haveorhad cancer, talk with your healthcare provider about whether you should use Climara Pro (estradiol, levonorgestrel transdermal) .
• 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 Climara Pro (estradiol, levonorgestrel transdermal) or any of its ingredients. See the end of this leaflet for a list of ingredients in Climara Pro (estradiol, levonorgestrel transdermal) .
• think you may be pregnant

Tell your healthcare provider:

• if you are breastfeeding. The hormones in Climara Pro (estradiol, levonorgestrel transdermal) 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, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Climara Pro (estradiol, levonorgestrel transdermal) works. Climara Pro (estradiol, levonorgestrel transdermal) 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 estrogens.

How should I use Climara Pro (estradiol, levonorgestrel transdermal) ?

Climara Pro (estradiol, levonorgestrel transdermal) isapatch that you wearonyour skin. The Climara Pro (estradiol, levonorgestrel transdermal) patch releases two hormones, estradiol and levonorgestrel. See the end of this leaflet for complete instructionsonhowtouse Climara Pro (estradiol, levonorgestrel transdermal) .

1. Start at the lowest dose and talk to your healthcare provider about how well that dose is working for you.
2. Estrogens 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 using and whether you still need treatment with Climara Pro (estradiol, levonorgestrel transdermal) .

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 Climara Pro (estradiol, levonorgestrel transdermal) . For more information, ask your healthcare provider or pharmacist.

What can I do to lower my chances of a serious side effect with Climara Pro?

• Talk with your healthcare provider regularly about whether you should continue using Climara Pro (estradiol, levonorgestrel transdermal) .
• See your healthcare provider right away if you get vaginal bleeding while using Climara Pro (estradiol, levonorgestrel transdermal) .
• 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.

Have an annual gynecologic exam

General information about safe and effective use of Climara Pro (estradiol, levonorgestrel transdermal)

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Climara Pro (estradiol, levonorgestrel transdermal) for conditions for which it was not prescribed. Do not give Climara Pro (estradiol, levonorgestrel transdermal) to other people, even if they have the same symptoms you have. It may harm them.

Keep Climara Pro (estradiol, levonorgestrel transdermal) out of the reach of children

This leaflet provides a summary of the most important information about Climara Pro. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Climara Pro (estradiol, levonorgestrel transdermal) that is written for health professionals. You can get more information by calling the toll free number (1-888-84-BAYER).

What are the ingredients in Climara Pro (estradiol, levonorgestrel transdermal) ?

The active ingredients in Climara Pro (estradiol, levonorgestrel transdermal) are estradiol and levonorgestrel. Climara Pro also contains acrylate copolymer adhesive and polyvinylpyrrolidone/vinyl acetate copolymer.

Do not store above 86°F (30°C).

Do not store unpouched.

Instructions for Use

How and Where do I apply the Climara Pro (estradiol, levonorgestrel transdermal) Patch

• Talk to your healthcare provider or pharmacist if you have questions about applying the Climara Pro (estradiol, levonorgestrel transdermal) patch.
• Each Climara Pro (estradiol, levonorgestrel transdermal) patchisindividually sealedinaprotective pouch. To open the pouch, hold itup with the Climara Pro (estradiol, levonorgestrel transdermal) name facing you. Tear left to right using the top tear notch. Tear from bottom to top using the side tear notch. Pull the pouch open. Carefully remove the Climara Pro (estradiol, levonorgestrel transdermal) patch. You will notice that the patchisattached to a thicker, hard-plastic liner and that the patch itself is oval.

• Apply the adhesive side of the Climara Pro (estradiol, levonorgestrel transdermal) patch to a clean, dry area of the lower abdomen. Do not apply the Climara Pro (estradiol, levonorgestrel transdermal) patch to your breasts. The sites of application must be rotated, with an interval of at least 1 week allowed between applications to a particular site. The area selected should not be oily, damaged, or irritated. Avoid the waistline, since tight clothing may rub and remove the patch. Application to areas where sitting would dislodge the patch should also be avoided. Apply the patch immediately after opening the pouch and removing the protective liner. Press the patch firmly in place with the fingers for about 10 seconds, making sure there is good contact, especially around the edges.

• The Climara Pro (estradiol, levonorgestrel transdermal) patch should be worn continuously for one week. You may wish to experiment with different locations when applying a new patch, to find ones that are most comfortable for you and where clothing will not rub on the patch.
• The Climara Pro (estradiol, levonorgestrel transdermal) patch should be changed once weekly. Remove the used patch. Carefully fold it in half so that it sticks to itself because used patches still contain active hormones and discard it. Any adhesive that might remain on your skin can be easily rubbed off. Then place the new Climara Pro (estradiol, levonorgestrel transdermal) patch on a different skin site. (The same skin site should not be used again for at least 1 week after removal of the patch.)
• Contact with water when you are bathing, swimming, or showering may affect the patch. If the patch falls off, the same patch may be reapplied to another area of the lower abdomen. Make sure that there is good contact, especially around the edges. If the patch will not stick completely to your skin, put a new patch on a different area of the lower abdomen. Do not apply two patches at the same time.
• Once in place, the transdermal system should not be exposed to the sun for prolonged periods of time.

Last reviewed on RxList: 2/19/2009
This monograph has been modified to include the generic and brand name in many instances.