Do NOT use Vivelle Patch if:
- you are allergic to any ingredient in Vivelle Patch
- you are pregnant or suspect you may be pregnant
- you have undiagnosed, abnormal vaginal bleeding
- you have known or suspected abnormal estrogen-dependent growths, known or suspected breast cancer, or a history of breast cancer
- you have or have a history of blood clots in your legs, lungs, or other blood vessels
- you have had a heart attack or stroke within the past year or you have liver problems
Contact your doctor or health care provider right away if any of these apply to you.
Before using Vivelle Patch:
Some medical conditions may interact with Vivelle Patch. 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 breast lumps or disease, an abnormal mammogram, or a family history of breast cancer
- if you have yellowing of the whites of the eyes or skin during pregnancy or with past estrogen use, or if you have 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 asthma, cancer (eg, breast cancer), certain blood problems (eg, porphyria), cholesterol or lipid problems, depression, diabetes, epilepsy, excessive weight gain, gallbladder disease, heart disease or other heart problems (eg, heart attack, congestive heart failure), high blood pressure, kidney or liver disease, underactive thyroid, lupus, migraine headaches, pancreas disease, seizures, yellowing of the skin or eyes (jaundice), or a history of abnormal calcium levels in the blood, or if you are very overweight
- if you smoke or will be having surgery
Some MEDICINES MAY INTERACT with Vivelle Patch. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Clarithromycin, erythromycin, azole antifungals (eg, itraconazole, ketoconazole), or ritonavir because they may increase the risk of Vivelle Patch’s side effects
- Anticoagulants (eg, warfarin) because their actions and side effects may be increased by Vivelle Patch
- Carbamazepine, hydantoins (eg, phenytoin), barbiturates (eg, phenobarbital), rifampin, or St. John’s wort because they may decrease Vivelle Patch’s effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Vivelle Patch 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 Vivelle Patch:
Use Vivelle Patch as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Vivelle Patch. Talk to your pharmacist if you have questions about this information.
- If you are switching from oral estrogen to Vivelle Patch, stop taking the oral estrogen and wait 1 week before using Vivelle Patch. However, if your symptoms return, you may start using Vivelle Patch sooner.
- 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 the patch to a clean, dry, hairless area of the body, such as the lower abdomen or the upper part of the buttock, as described in the patient information leaflet or on the package. If you have any questions about where to apply the patch, contact your doctor or pharmacist for instructions. Press the patch firmly against the skin for about 10 seconds to be sure the patch stays on. If the system lifts off of your skin, 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 an area 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.
- When it is time to change the patch, remove it slowly. 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. It is best to rotate the areas where the patch is applied, allowing at least 1 week in between applications to the same site. 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 promptly.
- Grapefruit and grapefruit juice may increase the risk of Vivelle Patch’s side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Vivelle Patch.
- If you miss a dose of Vivelle Patch, use it as soon as possible. If a patch falls off, reapply it or apply a new patch and wear it for the rest of the scheduled period, then resume your usual dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Vivelle Patch.
Important safety information:
- Vivelle Patch may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Vivelle Patch with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Vivelle Patch may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker, and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
- Vivelle Patch may increase the risk of blood clots. The risk may be greater if you smoke (especially in women older than 35 years of age).
- Contact your health care provider if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.
- Contact your health care provider if vaginal discomfort occurs or if you suspect you have developed an infection while taking Vivelle Patch.
- 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 while you are taking Vivelle Patch.
- Nondrug 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.
- Vivelle Patch may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Vivelle Patch.
- Diabetes patients – Vivelle Patch may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Lab tests, including physical exams and blood pressure, may be performed while you use Vivelle Patch. 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. Be sure to keep all doctor and lab appointments.
- Use Vivelle Patch with caution in the ELDERLY; they may be more sensitive to its effects, especially dementia.
- Vivelle Patch should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Vivelle Patch if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Vivelle Patch may be found in breast milk. If you are or will be breast-feeding while you use Vivelle Patch, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Vivelle Patch:
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:
Bone or limb pain; breakthrough bleeding; breast tenderness; dizziness or lightheadedness; neck or back pain; nausea; skin redness/irritation at the application site; upset stomach; weight change.
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); abnormal vaginal bleeding; breast lumps; breast pain; changes in vaginal bleeding (eg, spotting, breakthrough bleeding, prolonged bleeding); changes in vision or speech (eg, change in contact lens fit, loss of vision); chest pain; coughing of blood; mental/mood changes (eg, severe depression, memory loss); one-sided weakness; pain or tenderness in calves or chest; pain, swelling, or tenderness in the stomach; severe headache or vomiting; sudden, severe headache, vomiting, dizziness, or fainting; 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.
If OVERDOSE is suspected:
Contact), your local poison control center, or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea; vomiting.
Proper storage of Vivelle Patch:
Store Vivelle Patch at room temperature, 59 to 86 degrees F (15 to 30 degrees C). Store in original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vivelle Patch out of the reach of children and away from pets.
- If you have any questions about Vivelle Patch, please talk with your doctor, pharmacist, or other health care provider.
- Vivelle Patch 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about Vivelle Patch. 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.