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|OrthoEvra Weekly Patch

OrthoEvra Weekly Patch

OrthoEvra Weekly Patch is used for:

Preventing pregnancy. It may also be used for certain conditions as determined by your doctor.

OrthoEvra Weekly Patch is an estrogen/progestin combination. It works by preventing the release of eggs from the ovaries and thereby preventing pregnancy.

Do NOT use OrthoEvra Weekly Patch if:

• you are allergic to any ingredient in OrthoEvra Weekly Patch
• you are pregnant or suspect you may be pregnant, have recently given birth, or are breast-feeding
• you have blood clots in the legs, lungs, or eyes; or a history of other blood clotting problems
• you have a history of blood vessel problems of the heart or brain, heart attack, chest pain, or stroke
• you have a history of yellowing of the eyes or skin during pregnancy or previous hormonal birth control use
• you have known or suspected breast cancer or cancer of the uterus, cervix, or vagina; known or suspected breast cancer or a past history of breast cancer; cancers that are estrogen-dependent; or you have unusual vaginal bleeding from an unknown cause
• you have a live tumor, liver cancer, or active liver disease; severe high blood pressure; blood vessel problems due to diabetes; certain heart valve problems; or the blood disease porphyria
• you have headaches with neurological symptoms or will be on bed rest for a long period following surgery

Contact your doctor or health care provider right away if any of these apply to you.

Before using OrthoEvra Weekly Patch:

Some medical conditions may interact with OrthoEvra Weekly Patch. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant
• 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 high blood pressure; high cholesterol, triglycerides, or calcium levels; or pancreatitis or gallbladder problems; or you are obese
• if you have breast nodules, fibrocystic disease of the breast, an abnormal breast x-ray or mammogram, endometriosis or endometrial carcinomas, uterine fibroids, or irregular or scanty menstrual periods
• if you have diabetes, headaches, migraine headaches, epilepsy, or a history of mental depression
• if you are having surgery
• if you are a heavy smoker (15 or more cigarettes per day), especially if you are older than 35 years

Some MEDICINES MAY INTERACT with OrthoEvra Weekly Patch. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Azole antifungals (eg, itraconazole), aprepitant, barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, penicillins (eg, amoxicillin), rifampin, St. John"s wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease OrthoEvra Weekly Patch"s effectiveness. Alternative forms of birth control are strongly recommended when taking any of these medicines along with this birth control medicine.
• Beta-blockers (eg, atenolol), selegiline, theophyllines (eg, aminophylline), or troleandomycin because the risk of their side effects may be increased by OrthoEvra Weekly Patch
• Lamotrigine because its effectiveness may be decreased by OrthoEvra Weekly Patch

This may not be a complete list of all interactions that may occur. Ask your health care provider if OrthoEvra Weekly 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 OrthoEvra Weekly Patch:

Use OrthoEvra Weekly Patch as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with OrthoEvra Weekly Patch. Talk to your pharmacist if you have questions about this information.
• One patch is usually applied to the skin and worn for 1 week and then replaced. 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 or where the skin is red, irritated, or cut. Do not use creams, oils, powder, or makeup on your skin where you will put a patch or near a patch you are using as it may cause the patch to become loose. Contact with water while bathing, showering, or swimming will not affect the patch.
• When it is time to change the patch, remove it slowly, fold in half (with the sticky sides together), and throw it away 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 promptly.
• If the patch has become loose or has fallen off for less than one day, try to reapply it or apply a new patch immediately. No other contraceptive measures are necessary.
• If the patch has become loose or has fallen off for more than one day or if you are not sure how long it has been off, apply a new patch to begin a new cycle. In this case, you may not be adequately protected from pregnancy. You must use an additional form of birth control (eg, male condoms, spermicide, diaphragm) until the patch has been in place for 7 days in a row.
• Do not try to reapply a patch if it is no longer sticky, if it has become stuck to itself or another surface, if it has other material stuck to it, or if it has previously come loose or fallen off. Do not use any tapes or wraps to keep the patch in place. If you cannot reapply a patch, apply a new patch immediately.
• Do not eat grapefruit or drink grapefruit juice while you use OrthoEvra Weekly Patch.
• If you forget to change the patch as scheduled, follow the directions in the additional patient leaflet that comes with this medicine or contact your doctor to establish a new schedule for OrthoEvra Weekly Patch.

Ask your health care provider any questions you may have about how to use OrthoEvra Weekly Patch.

Important safety information:

• OrthoEvra Weekly Patch may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use OrthoEvra Weekly Patch with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Limit alcoholic beverages.
• OrthoEvra Weekly Patch may cause dark skin patches on your face (melasma). Avoid the sun, sunlamps, or tanning booths until you know how you react to OrthoEvra Weekly Patch. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• OrthoEvra Weekly Patch 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).
• The risk of developing a blood clot may be greater with OrthoEvra Weekly Patch than with other forms of hormonal birth control (eg, birth control pill). Talk with your doctor about the benefits and risks of OrthoEvra Weekly Patch or other forms of hormonal birth control.
• OrthoEvra Weekly Patch may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke.
• 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 OrthoEvra Weekly 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 in these circumstances while you are using OrthoEvra Weekly Patch.
• 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.
• OrthoEvra Weekly Patch may increase the risk of breast and endometrial cancer.
• Diabetes patients - OrthoEvra Weekly Patch may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• OrthoEvra Weekly Patch may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using OrthoEvra Weekly Patch.
• Lab tests will be required to monitor therapy. You should have a complete physical examination, including blood pressure measurements, breast and pelvic examinations, 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.
• OrthoEvra Weekly Patch should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use OrthoEvra Weekly 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. OrthoEvra Weekly Patch may be found in breast milk. If you are or will be breast-feeding while you use OrthoEvra Weekly Patch, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of OrthoEvra Weekly 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:

Arthritis; back pain; bladder infection; bone and limb pain; breakthrough bleeding; breast tenderness; bronchitis; carpal tunnel syndrome; changes in sex drive; constipation; diarrhea; dizziness; ear infection; emotional disturbance; flu-like symptoms (fever, headache, sore throat); fungal infection; herpes; indigestion; joint and muscle strain; lightheadedness; muscle cramps, pain, and spasms; nausea; neck pain; nose and throat pain; sinus headache; skin redness/irritation or hair loss at the application site; sleeplessness; stomach bloating and upset; swelling of the legs and feet; tiredness; tooth abscess; toothache; upper respiratory tract infection; urinary tract infection; vaginal infection; vomiting; weight changes.

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; calf pain, swelling, or tenderness;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); pain, swelling, or tenderness in the stomach; severe headache or vomiting; 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 or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm), or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea; vomiting.

Store OrthoEvra Weekly Patch at 77 degrees F (25 degrees C) in the original sealed pouch. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep OrthoEvra Weekly Patch out of the reach of children and away from pets.

General information:

• If you have any questions about OrthoEvra Weekly Patch, please talk with your doctor, pharmacist, or other health care provider.
• OrthoEvra Weekly 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.

This information is a summary only. It does not contain all information about OrthoEvra Weekly 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.