CombiPatch Patch (Bi-weekly)Generic Name: Estradiol/Norethindrone
Estrogens have been reported to increase the chance of womb (endometrial) cancer. Estrogen-containing products should not be used to prevent heart disease or dementia. Estrogen given alone or in combination with another hormone (progestin) for replacement therapy may increase your risk for heart disease (eg, heart attacks), stroke, serious blood clots in the legs (deep vein thrombosis) or lungs (pulmonary embolism), dementia, or breast cancer. These risks appear to depend on the length of time CombiPatch Patch (Bi-weekly) is used and the amount of estrogen per dose. Therefore, CombiPatch Patch (Bi-weekly) should be used for the shortest possible length of time at the lowest effective dose, so that you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Consult your doctor or pharmacist for details.
CombiPatch Patch (Bi-weekly) is used for:
Treating certain symptoms (eg, hot flashes; vaginal itching, burning, or dryness) caused by menopause. It is also used to replace estrogen when your body does not produce enough.
CombiPatch Patch (Bi-weekly) is a combination of progestin and estrogen hormones. It works by replacing natural progestin and estrogen in women who do not produce enough of these hormones.
Do NOT use CombiPatch Patch (Bi-weekly) if:
- you are allergic to any ingredient in CombiPatch Patch (Bi-weekly)
- you are pregnant or suspect you may be pregnant, have recently given birth or are breast-feeding, have vaginal bleeding of abnormal or unknown cause, or have cancer of the uterus
- you have a history of serious blood clots (eg, in the legs, lungs, eyes), liver problems, or breast cancer; you may have breast cancer; or you have cancers that are estrogen-dependent
- you have had a recent heart attack or stroke
Contact your doctor or health care provider right away if any of these apply to you.
Before using CombiPatch Patch (Bi-weekly):
Some medical conditions may interact with CombiPatch Patch (Bi-weekly). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a family history of breast cancer, or you have breast lumps or disease or an abnormal mammogram
- if you have yellowing of the whites of the eyes or skin during pregnancy or with past estrogen use, or high blood pressure during pregnancy (toxemia)
- if you have a vaginal infection or womb problems (eg, uterine fibroids/endometriosis, abnormal vaginal bleeding, other uterine problems)
- if you have abnormal calcium levels in the blood, asthma, cancer, cholesterol or lipid problems, depression, diabetes, gallbladder disease, heart disease or other heart problems, circulation problems, high blood pressure, kidney or liver disease, low thyroid hormone levels, lupus, the blood disease porphyria, migraine headaches, pancreas disease, seizures, or yellowing of the skin or eyes
- if you smoke, are very overweight, or will be having surgery
- if you have had your uterus removed (hysterectomy)
Some MEDICINES MAY INTERACT with CombiPatch Patch (Bi-weekly). Tell your health care provider if you are taking any other medicines, especially any of the following:
- Azole antifungals (eg, ketoconazole), HIV protease inhibitors (eg, ritonavir), or macrolide antibiotics (eg, clarithromycin) because they may increase the risk of CombiPatch Patch (Bi-weekly)'s side effects
- Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), nevirapine, rifampin, or St. John's wort because they may decrease CombiPatch Patch (Bi-weekly)'s effectiveness
- Anticoagulants (eg, warfarin), corticosteroids (eg, prednisone), succinylcholine, or tacrine because the risk of their side effects may be increased by CombiPatch Patch (Bi-weekly)
- Anticoagulants (eg, warfarin) because their effectiveness may be decreased by CombiPatch Patch (Bi-weekly)
This may not be a complete list of all interactions that may occur. Ask your health care provider if CombiPatch Patch (Bi-weekly) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use CombiPatch Patch (Bi-weekly):
Use CombiPatch Patch (Bi-weekly) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with CombiPatch Patch (Bi-weekly). Talk to your pharmacist if you have questions about this information.
- The patch is usually replaced twice a week (about every 3 to 4 days), or as directed by your doctor. Follow the dosing schedule carefully.
- Do not open the sealed pouch containing the patch until ready to use. Open the pouch and remove the patch from the protective liner. Apply to an area of clean, dry skin on the lower stomach area below the belly button. Press the patch firmly against the skin for about 10 seconds to be sure the patch stays on. If the system lifts, press down to reapply. Wear only 1 system at any one time.
- Do not place the patch on the breast. Make sure the application site is not oily, damaged, or irritated. Avoid applying to the waistline because tight clothing may rub the patch off. Do not put the patch on areas where sitting may loosen it. Do not apply to a site that is exposed to sunlight. Contact with water while bathing, showering, or swimming will not affect the patch.
- After removing the used patch, fold it in half with the sticky sides together. Discard the patch out of the reach of children and away from pets.
- Apply a new patch to a different area to prevent skin irritation. Use a different site when replacing the patch and do not repeat the same site for at least 1 week. If the area around the patch becomes red, itchy, or irritated, try a new site. If the irritation continues or becomes worse, notify your doctor right away.
- Grapefruit and grapefruit juice may increase the risk of side effects from CombiPatch Patch (Bi-weekly). Talk with your doctor before including grapefruit or grapefruit juice in your diet while taking CombiPatch Patch (Bi-weekly).
- If you forget to change the patch as scheduled, change it as soon as possible and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use CombiPatch Patch (Bi-weekly).
Important safety information:
- CombiPatch Patch (Bi-weekly) may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use CombiPatch Patch (Bi-weekly) with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Limit alcoholic beverages.
- CombiPatch Patch (Bi-weekly) may cause dark skin patches on your face. Avoid the sun, sunlamps, or tanning booths until you know how you react to CombiPatch Patch (Bi-weekly). Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- CombiPatch Patch (Bi-weekly) may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke (especially in women older than 35 years old).
- Contact your doctor if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.
- Contact your doctor if vaginal discomfort occurs or if you suspect you have developed an infection while using CombiPatch Patch (Bi-weekly).
- Follow your doctor's instructions for examining your breasts, and report any lumps immediately.
- If you wear contact lenses and you develop problems with them, contact your doctor.
- If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are using CombiPatch Patch (Bi-weekly).
- Nonprescription therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.
- CombiPatch Patch (Bi-weekly) may increase the risk of breast and endometrial cancer.
- Diabetes patients - CombiPatch Patch (Bi-weekly) may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- CombiPatch Patch (Bi-weekly) may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using CombiPatch Patch (Bi-weekly).
- Lab tests, including physical exams and blood pressure, may be performed while you use CombiPatch Patch (Bi-weekly). You should have breast and pelvic exams and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- CombiPatch Patch (Bi-weekly) should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use CombiPatch Patch (Bi-weekly) if you are pregnant. Avoid becoming pregnant while you are using it. If you think you may be pregnant, contact your doctor right away. It is not known if CombiPatch Patch (Bi-weekly) is found in breast milk after topical use. If you are or will be breast-feeding while you use CombiPatch Patch (Bi-weekly), check with your doctor. Discuss any possible risks to your baby.
Possible side effects of CombiPatch Patch (Bi-weekly):
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Back pain; diarrhea; headache; irregular vaginal bleeding or spotting; mild breast pain; mild hair loss; nausea; runny or stuffy nose; stomach pain, cramps, or bloating; vomiting; weakness.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps; calf pain or tenderness; changes in vision or speech (eg, loss of vision); chest pain; coughing of blood; mental/mood changes (eg, depression, memory loss); pain, swelling, or tenderness in the stomach; severe headache or vomiting; severe or persistent breast pain; severe or unusual vaginal bleeding; sudden shortness of breath; swelling of hands or feet; unusual vaginal discharge, itching, or odor; weakness or numbness of an arm or leg; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea; vomiting.Proper storage of CombiPatch Patch (Bi-weekly):
Store CombiPatch Patch (Bi-weekly) at room temperature, below 77 degrees F (25 degrees C), in the original sealed pouch. Store away from heat, moisture, and light. Do not store in the bathroom. Keep CombiPatch Patch (Bi-weekly) out of the reach of children and away from pets.
- If you have any questions about CombiPatch Patch (Bi-weekly), please talk with your doctor, pharmacist, or other health care provider.
- CombiPatch Patch (Bi-weekly) is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about CombiPatch Patch (Bi-weekly). If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.