Combination hormone replacement therapy (estrogen and progestin) may increase the risk of heart attack, stroke, blood clots in the lungs and legs, and breast cancer. Tell your doctor if you smoke and if you have or have ever had a breast lump; breast cancer; a heart attack; a stroke; blood clots or blood clotting problems; high blood pressure; high blood levels of cholesterol or fats; lupus (an autoimmune disease in which the immune system attacks healthy parts of the body such as joints, skin, blood vessels, and organs); or diabetes. If you are having surgery or will be on bedrest, talk to your doctor about stopping estrogen and progestin at least 4 to 6 weeks before the surgery or bedrest.
If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: sudden, severe headache; sudden, severe vomiting; sudden partial or complete loss of vision; speech problems; dizziness or faintness; weakness or numbness of an arm or a leg; a lump in your breast; crushing chest pain or chest heaviness; coughing up blood; sudden shortness of breath; or calf pain.
Combination hormone replacement therapy also may increase the risk of dementia (decrease in thinking, remembering, and reasoning).
Talk to your doctor about the risk(s) and benefits of taking estrogen and progestin.
Why is this medicine prescribed?
Estrogen and progestin transdermal patches are used to treat certain symptoms of menopause. Estrogen and progestin patches are also used to treat certain conditions in women before they reach menopause if they are not making these hormones naturally. Estrogen and progestin patches are also used to prevent thinning of the bones (osteoporosis) in menopausal women. Your doctor will select the product that is best to treat your condition. Estrogen and progestin are two sex hormones. Hormone replacement therapy works by replacing hormones that are no longer being made by the body. Estrogen reduces hot flashes (feelings of warmth in the upper body and periods of sweating and heat), vaginal symptoms (itching, burning, and dryness) and difficulty with urination. Progestin is added to estrogen in hormone replacement therapy to reduce the risk of uterine cancer when the uterus is still present.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Transdermal estrogen and progestin come as a patch to apply to the skin. Patches are usually applied either once or twice weekly, depending on the product being used. Certain patients may also be told to only apply the patch during the last two weeks of their cycle. Always apply your patch on the same day(s) of the week. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Do not use more or less of it or apply it more often than prescribed by your doctor. Apply estrogen and progestin patches exactly as directed.
To treat the symptoms of menopause, your doctor will probably start you on a low dose of estrogen and progestin and gradually increase your dose, not more than once every 3 to 6 months.
Each brand of estrogen and progestin patches should be applied following the specific directions given in the manufacturer's information for the patient. Read this information carefully before you start using estrogen and progestin patches and each time you refill your prescription. Ask your doctor or pharmacist if you have any questions. The following general instructions can help you remember some important things to do when you apply an estrogen and progestin patch:
- Select a placement area of clean, dry area of skin on the lower abdomen (or upper part of the buttock if using the Climara® patch). Do not apply the patch to or near the breasts or near your waistline. The area should not have oily, damaged, or irritated skin or have skin with birth marks, tattoos, or that is very hairy. Rotate the areas used with an interval of at least a week for use of the same site.
- Open the pouch and remove the patch carefully. Remove the protective liner as directed being careful to not touch the adhesive part of the patch with your fingers.
- Apply the patch to the selected site immediately after opening the pouch and removing the protective lining according to the instructions. Press the patch firmly in place and hold for at least 10 seconds making sure there is good contact around the edges.
- When changing the patch, carefully and slowly remove the patch to avoid irritation of the skin. If any adhesive remains on the skin after removal, allow the area to dry for 15 minutes. Then gently rub the area with an oil-based cream or lotion to remove the adhesive residue.
- Used patches may still contain some medication. Carefully fold each patch in half so that it sticks together and dispose of it so that it is out of the reach of children and pets. Do not flush used patches in a toilet.
Check your patch every day to make sure it is sticking. If the patch falls off, try to reapply it in the same place immediately. If you can not reapply the patch, apply a new patch in another area. Then continue to follow your original placement schedule. If you stop using your patch or forget to apply a new patch as scheduled you may have spotting, or bleeding, and your symptoms may come back.
Once in place, the patch should not be exposed to the sun for prolonged periods of time.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
What special precautions should I follow?
Before using estrogen and progestin patches,
- tell your doctor and pharmacist if you are allergic to estrogen or progestin, any other medications, or any of the ingredients in the transdermal patches. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while using estrogen and progestin patches. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- the following nonprescription or herbal products may interact with estrogen and progestin patches: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start using estrogen and progestin patches. Do not start any of these medications while using estrogen and progestin patches without discussing with your healthcare provider.
- in addition to the conditions listed in the IMPORTANT WARNING section, tell your doctor if you have or have ever had unusual vaginal bleeding, any type of cancer, or liver disease. Your doctor may tell you not to use estrogen and progestin patches.
- tell your doctor if you have or have ever had a hysterectomy (surgery to remove your uterus), asthma, seizures, migraine, endometriosis (condition in which tissue similar to the lining of the uterus grows outside the uterus), high levels of calcium in your blood, or gallbladder, thyroid, or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using estrogen and progestin patches, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist you are using estrogen and progestin patches.
- tell your doctor if you use tobacco products. Smoking while taking this medication may increase your risk of serious side effects such as blood clots and stroke.
What special dietary instructions should I follow?
Do not drink grapefruit juice while taking this medication.
What should I do if I forget to take a dose?
Apply the missed dose as soon as you remember it. Do not apply extra patches to make up for a missed dose.
What should I do in case of overdose?
If someone swallows estrogen and progestin patches or applies multiple patches, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and vaginal bleeding
What side effects can this medicine cause?
Estrogen and progestin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- redness or irritation where the patch is placed
- headache
- breast pain
- nausea
- back pain
- swelling of the hands, legs, and feet
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:
- hives, rash, itching, difficulty breathing or swallowing
- swelling of the face, throat, tongue, lips, and eyes
- changes in vision
- extreme thirst, frequent urination and pain in the stomach area
- unusual vaginal bleeding
- nausea, vomiting, pain in the upper right side of abdomen
- severe pain in the upper abdomen that may spread to the back or chest
- itchy skin, dark urine, yellowing of your skin or eyes, flu-like symptoms pain in the upper right part of your stomach.
Estrogen and progestin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone (
1-800-332-1088).What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store Combipatch in a refrigerator. Climara Pro may be stored at room temperature.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( https://goo.gl/c4Rm4p ) for more information if you do not have access to a take-back program.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to estrogen and progestin.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are using estrogen and progestin patches.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.