Evra

Follow the instructions in the package insert or those given to you by your doctor.

A patch is worn every day for 3 weeks. The patch is changed each week and is worn for 7 days. During the 4th week, no patch is worn and menstruation will occur. Always change the patch on the same day of the week. Never be without a patch for longer than 7 days at a time – you may not be protected against pregnancy.

Only one patch should be worn at a time. Apply the patch to clean, dry, healthy skin. It should be applied to the buttock, abdomen, upper outer arm, or upper torso in a spot that will not be rubbed by clothing. Do not apply it to the breast. Do not apply the patch on red, irritated, or cut skin. Do not use creams or other skin products on the area where the patch is currently applied or where you will be soon placing the patch.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones given here, do not change the way you are using the medication without consulting your doctor.

It is important to use Evra exactly as prescribed by your doctor. If you make a dosing error (e.g., forget to change your patch), or if your patch becomes loose or falls off, check the instructions that came with the medication. If you are not sure what to do, contact your doctor and use a backup method of birth control.

Store Evra at room temperature. Each patch should be stored in its protective pouch inside the original box. Keep Evra out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause nausea or, rarely, vomiting; it could cause water retention and swelling; it may make your skin more sensitive to UV rays (e.g., sunlight, tanning lamps) - avoid exposure to UV rays as much as possible and protect yourself when out in the sun; it may cause your breasts to feel swollen and tender; it may cause a reaction at the application site. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Each transdermal system sealed within a protective pouch and heat-stamped "EVRA™" contains 6 mg of norelgestromin and 0.60 mg of ethinyl estradiol in the middle layer, releasing approximately 200 µg of norelgestromin and 35 µg of ethinyl estradiol every 24 hours. Nonmedicinal ingredients: backing layer: low-density pigmented polyethylene outer layer and a polyester inner layer; middle layer inactive components: polyisobutylene/polybutene adhesive, crospovidone, non-woven polyester fabric, lauryl lactate; release liner: polyethylene terephthalate film with polydimethylsiloxane coating on one side. The EVRA transdermal system does not contain any metal components.

Do not use norelgestromin - ethinyl estradiol if you:

• are allergic to norelgestromin or ethinyl estradiol or any other ingredients of the medication
• are immobilized for prolonged periods
• are known or suspected to be pregnant
• have or have had Blood Clots (in the legs, lungs, eyes, or anywhere else) or have severe or multiple risk factors for them
• have or have had a Stroke or TIA ("mini-stroke")
• have or have had a Heart Attack or chest pain (Angina)
• have or have had valvular heart disease with complications
• have severe high blood pressure (always >160/100 mmHg)
• have Diabetes with blood vessel involvement
• have very High Cholesterol
• have health conditions that increase the risk of blood clots (such as certain inherited blood clotting diseases; talk to your doctor for more information)
• smoke and are over the age of 35
• have active liver disease
• have or have had liver tumours (benign or malignant)
• have or are suspected to have Breast Cancer
• have or are suspected to have cancer of the reproductive organs (e.g., endometrium)
• have undiagnosed abnormal vaginal bleeding
• have yellowing of the skin (jaundice) due to steroids or blocked bile ducts
• have yellowing of the eyes or skin during pregnancy
• have vision problems due to vascular eye disease
• have migraine with focal aura
• have had major surgery associated with an increased risk of blood clots
• are taking the following medication combination used to treat Hepatitis C: paritaprevir, ritonavir, ombitasvir with or without dasabuvir

There may be an interaction between norelgestromin - ethinyl estradiol patch and any of the following:

• Anastrozole
• antibiotics (e.g., ampicillin, Metronidazole, penicillin, rifampin, neomycin, tetracyclines)
• anticonvulsants (e.g., Carbamazepine, , Phenobarbital, Phenytoin, primidone, Topiramate, Lamotrigine)
• Aprepitant
• "azole" antifungals (e.g., fluconazole, ketoconazole, Voriconazole)
• barbiturates (e.g., phenobarbital)
• benzodiazepines (e.g., Lorazepam, Clonazepam, Diazepam)
• blood pressure medications (e.g., Metoprolol, , methyldopa)
• Bosentan
• Celecoxib
• Cholestyramine
• Clozapine
• Cobicistat
• Colesevelam
• Colestipol
• corticosteroids (e.g., Dexamethasone, Prednisone)
• Cyclosporine
• dabigatran
• diabetes medications (e.g., Glyburide, Gliclazide, insulin)
• Edoxaban
• folic acid
• grapefruit juice
• Heparin
• Hepatitis C antivirals (e.g., dasabuvir, ombitasvir, paritaprevir, ritonavir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hyaluronidase
• Levothyroxine
• low molecular weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• lumacaftor
• mifepristone
• Modafinil
• mycophenolate
• rifabutin
• rifampin
• Rivaroxaban
• Ropinirole
• St. John's wort
• Selegiline
• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)
• Tizanidine
• Tocilizumab
• tretinoin
• Tranexamic acid
• tretinoin
• Ursodiol
• vitamin B12
• vitamin C (ascorbic acid)
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Evra. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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 Evra.

The information provided here results from studies of combination oral contraceptives; the patch contraceptive is thought to have similar risks. Oral combination contraceptives increase the risk of the following serious conditions:

• blood clots
• gallbladder disease
• heart attack
• liver tumours
• stroke

The risk of disease or death from these conditions greatly increases if a woman has other risk factors such as high blood pressure, high cholesterol, Obesity, or diabetes.

Smoking while taking oral contraceptives increases the risk of side effects that affect the heart and blood vessels (e.g., blood clots). This risk is greatest for women 35 years and older. You should not take Evra if you smoke and are 35 years or older.

You should stop using the patch immediately if you develop any of the following:

• blood clot disorders and cardiovascular disorders (e.g., inflammation of a vein due to blood clot, blood clot in your lung)
• a condition that makes you immobile for a long period of time (e.g., recovering from major surgery, being bedridden due to a long-term illness)
• vision or eye problems (e.g., double vision, certain eye conditions) – check with your doctor
• severe headache without known cause, or worsening of preexisting migraine

Body weight: For women weighing 90 kg (198 lbs.) or more, the patch may be less effective. Check with your doctor for more information.

Breast self-exam and physical exams: Women taking Evra should do regular breast self-exams and have yearly physical exams done by their doctor.

Depression: Hormones, such as estrogen, have been known to cause mood swings and symptoms of depression. If you have had clinical depression in the past, you may be more likely to experience it again while taking Evra. If you have depression or a history of depression, discuss with your doctor how Evra may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Evra, and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking Evra contact your doctor as soon as possible.

Heat sources: Do not expose the patch area to heat sources such as heating pads, electric blankets, saunas, hot tubs, or heat lamps. This may increase the amount of medication that enters your body through the skin.

Sexually transmitted infections: Birth control patches do not protect against sexually transmitted infections, including HIV/AIDS. For protection against these, use latex condoms.

Pregnancy: Evra should not be taken during pregnancy. You should stop using Evra if you become pregnant and contact your doctor.

Breast-feeding: Evra passes into breast milk and may affect your baby. Adverse effects on the baby, such as jaundice and breast enlargement, have been reported. Talk to your doctor about whether you should continue breast-feeding.

Children: Evra is not recommended for use before the start of menstruation in puberty.

This medication is contained in a patch that is to be applied to your skin. It must be placed on a hairless area, preferably on the abdomen or buttocks. Avoid touching the sticky side when handling the patch. To apply: thoroughly clean and dry the area, then apply the patch and press firmly. When you change patches, apply the new one at a different location. Wait a week before applying a patch at the same location. The patch may cause itching or a rash where it has been applied. If such a reaction persists, consult your pharmacist.<br/><br/>Usually, this contraceptive method is based on a 28-day cycle; 3 weeks on, 1 week off. Wear each patch for 7 days, replacing it with a fresh one on the same day each week. After wearing a patch for 3 weeks, take 1 week off, then restart the cycle. If you forget to change your patch or if you start a cycle late, contact your pharmacist who can help advise you on what to do next. Your health care professional may have suggested a different schedule that is more appropriate for you.<br/><br/>Patches are waterproof; you may swim or take a shower. If a patch peels off, partially or completely, its contraceptive effectiveness could be reduced. If you can't stick it back naturally (without tape), replace it with a fresh one. If the patch remains even partly detached for more than 24 hours or if you are not sure how long the patch has been detached, contact your pharmacist. Heat may increase drug absorption. Avoid heat sources such as heating pads, electric blankets, saunas, heated waterbeds, hot baths or sun bathe. Call your health care professional if you get a fever.