Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Climara (Estradiol-transdermal).

Note the following important information about estrogen replacement therapy:

The Women's Health Initiative (WHI) study results indicated an increased risk of heart attack, stroke, breast cancer, blood clots in the lungs, and blood clots in the leg veins in postmenopausal women during 5 years of treatment with 0.625 mg conjugated equine estrogens and 2.5 mg medroxyprogesterone compared to women receiving sugar tablets. Other combinations of estrogen and progestins were not studied. However, until additional data are available, the risks should be assumed to be similar for other hormone replacement products. Therefore,

• estrogens with or without progestins should be used at the lowest dose that relieves your menopausal symptoms for the shortest time period possible, as directed by your doctor
• estrogens with or without progestins should not be used to prevent heart disease, heart attacks, or strokes

Allergy: Contact allergy, such as itching and redness, is known to occur with the application of estrogen to the skin. Although this allergy is extremely rare, people who develop skin reactions or contact sensitization to any component of the medication are at risk of developing a severe allergic reaction with continued use. If you have a skin reaction to the patch, contact your doctor for advice.

Blood clotting disorders: Estrogens with or without progestins are associated with an increased risk of blood clots in the lungs (pulmonary Embolism) and legs (deep vein thrombosis). If you have or have had a heart attack, a stroke, heart disease, a blood clot in your leg, or have medical conditions that increase your risk of blood clots, you should not use this medication.

The risk of developing blood clots also increases with age, a personal or family history of blood clots, smoking, and Obesity. It is also increased if you are immobilized for prolonged periods and with major surgery.

If possible, Climara (Estradiol-transdermal) should be stopped 4 weeks before major surgery. Talk about the risk of blood clots with your doctor.

Blood pressure: Women may experience increased blood pressure when using estrogen replacement therapy. Your doctor should monitor your blood pressure or advise you on how often you should measure your blood pressure if you are using estrogen, especially if high doses are used. Regular checkups by your doctor are recommended. If you have high blood pressure, discuss with your doctor how Climara (Estradiol-transdermal) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Climara (Estradiol-transdermal), and whether any special monitoring is needed.

Bone disease: If you have bone disease due to cancer or a metabolic condition causing too much calcium in your body, discuss with your doctor how Climara (Estradiol-transdermal) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Climara (Estradiol-transdermal), and whether any special monitoring is needed.

Breast and Ovarian Cancer: Studies show there is an increased risk of breast and ovarian cancer with long-term use of estrogen replacement therapy. Women with a history of breast cancer should not use estrogens. Women who have breast nodules, fibrocystic disease, abnormal mammograms, or a strong family history of breast cancer should be closely monitored by their doctor.

Women taking estrogens should have regular breast examinations and should be instructed in breast self-examination. The estradiol patch must not be applied to the breasts, as it may have harmful effects on the breast tissue.

Dementia: Women over the age of 65 receiving combined hormone replacement therapy (estrogen and progestin) may be at increased risk of developing dementia (loss of memory and intellectual function). If you are over 65, talk to your doctor about whether you should be tested for dementia.

Diabetes: Estrogens can cause changes in blood glucose control for people who have diabetes or have risk factors for developing diabetes. If you have diabetes or are at risk for developing diabetes (e.g., have a family history of diabetes, have high blood pressure or High Cholesterol, or are obese), discuss with your doctor how Climara (Estradiol-transdermal) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Climara (Estradiol-transdermal), and whether any special monitoring is needed.

People who have diabetes (or a predisposition to diabetes) should monitor their blood glucose levels closely to detect changes in blood glucose.

Endometrial cancer: There is evidence from several studies that estrogen replacement therapy can increase the risk of cancer of the endometrium (lining of the uterus). Taking a progestin at the right time along with the estrogen reduces this risk of endometrial cancer to the same level as that of a woman who does not take estrogen. For this reason, all women who have not had their uterus removed should also take a progestin if they are using estrogens.

If you develop any abnormal vaginal bleeding while using Climara (Estradiol-transdermal), contact your doctor. If you have or have had endometrial cancer, you should not use Climara (Estradiol-transdermal).

Endometriosis: Estrogen replacement therapy can cause endometriosis to reappear or get worse. If you have or have had endometriosis, discuss with your doctor how Climara (Estradiol-transdermal) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Fibroids: Climara (Estradiol-transdermal) may worsen fibroids by causing sudden enlargement, pain, or tenderness. If you notice these effects, contact your doctor.

Fluid retention: Estrogen may cause sodium (salt) and fluid retention. This can be dangerous for women with heart or kidney dysfunction or Asthma. If you have any of these conditions, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Climara (Estradiol-transdermal), and whether any special monitoring is needed.

If you notice the symptoms of any of these conditions getting worse, contact your doctor.

Follow-up examinations: It is important to have a follow-up examination 3 to 6 months after starting Climara (Estradiol-transdermal) to assess your response to treatment. Examinations should be done at least once a year after the first one.

Gallbladder disease: Climara (Estradiol-transdermal) can aggravate gallbladder disease or increase the risk of developing it. If you have gallbladder disease, discuss with your doctor how Climara (Estradiol-transdermal) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart disease and stroke: Studies indicate an increased risk of heart disease and stroke with estrogen (with or without progestin) for postmenopausal women. If you experience symptoms of a heart attack (chest pain, tightness or pressure, sweating, nausea, feeling of impending doom) or stroke (sudden dizziness, headache, loss of speech, changes in vision, weakness or numbness in the arms and legs) while taking Climara (Estradiol-transdermal), get immediate medical attention.

High cholesterol or triglycerides: Estrogen may increase triglyceride levels for those who already have high levels. This has been observed particularly when estrogen is taken orally – the risk is reduced with use of the patch. Your doctor will monitor your cholesterol and triglyceride levels while you are taking this medication.

Kidney function: Estrogen can affect how calcium and phosphorus are used by your body. If you have Kidney Disease, this may be a concern and you should discuss with your doctor how Climara (Estradiol-transdermal) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Climara (Estradiol-transdermal), and whether any special monitoring is needed.

Liver function: If you have reduced liver function, you may require special monitoring by your doctor while you use Climara (Estradiol-transdermal). Make sure to tell your doctor if you have ever had liver problems. People with active liver disease or liver tumours should not use the estradiol patch.

If you experience symptoms of liver problems (e.g., yellowing of the skin or eyes, abdominal pain, loss of appetite, dark urine, pale stools, nausea, or vomiting), contact your doctor immediately.

Migraine headaches: If you have migraines with aura (headache is associated with symptoms such as flashes of light, tingling sensations, blind spots, muscle weakness, difficulty speaking either before or during the headache), you should not use Climara (Estradiol-transdermal).

For some people who experience migraine headaches, estrogen can make the condition worse. Talk to your doctor if you notice any change in your migraine pattern while using estrogen.

Seizures: Estrogens may increase your risk of having a seizure. If you have a seizure disorder or a history of seizures, discuss with your doctor how Climara (Estradiol-transdermal) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Climara (Estradiol-transdermal), and whether any special monitoring is needed.

Thyroid disease: Estrogen may affect how thyroid hormone is used by the body. If you are taking thyroid medication to supplement an underactive thyroid gland, discuss with your doctor how Climara (Estradiol-transdermal) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Climara (Estradiol-transdermal), and whether any special monitoring is needed.

Pregnancy: Estrogen should not be used during pregnancy. If you become pregnant while taking Climara (Estradiol-transdermal), contact your doctor immediately.

Breast-feeding: Climara (Estradiol-transdermal) passes into breast milk. If you are a breast-feeding mother and are taking estrogen, it may affect your baby. Climara (Estradiol-transdermal) is not recommended for breast-feeding women.

Children: The safety and effectiveness of using this medication have not been established for children.