Evra 18 Patches

Weeks 1, 2 & 3: Put on one patch and leave it on for exactly seven days

Week 4: Do not put on a patch this week

Choose a place on your body to put the patch:

• Always put your patch on clean, dry, hairless skin

• Put it on the buttock, abdomen, upper outer arm or upper back - places where it won’t be rubbed by tight clothing.

• Never put the patch on your breasts

Consult your Patient Information Leaflet for detailed instructions on how to place the Evra patches.

Important information to follow when using the patch:

• Change Evra on the same day of each week. This is because it is designed to work over 7 days

• Never go without wearing a patch for more than 7 days in a row

• Only wear one patch at a time

• Do not cut or tamper with the patch

• Do not put the patch on skin that is red, irritated or cut

• To work properly the patch must stick firmly to your skin

• Press the patch down firmly until the edges stick well

• Do not use creams, oils, lotions, powder or makeup on the skin where you are placing a patch or near a patch you are wearing. This may make the patch come loose

• Do not put a new patch on the same area of skin as the old patch. If you do you are more likely to cause irritation

• Check each day to make sure the patch has not fallen off

• Keep using the patches even if you do not have sex very often

The active substances are norelgestromin and ethinyl estradiol. Each 20 cm2 transdermal patch

contains 6 mg norelgestromin and 600 micrograms ethinyl estradiol. The active substances are

released over 7 days with an average of 203 micrograms norelgestromin and 34 micrograms ethinyl estradiol being released each 24 hours.

The other ingredients are: backing layer: low-density pigmented polyethylene outer layer, polyesterinner layer; middle layer: polyisobutylene/polybutene adhesive, crospovidone, non-woven polyester fabric, lauryl lactate; third layer: polyethylene terephthalate (PET) film, polydimethylsiloxane coating.

Before you start using Evra read the Patient Information Leaflet.  It is particularly important to read the blood clot symptoms.

You should not use Evra if you have any of the conditions listed below, consult with your doctor:

• if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis,

• DVT), your lungs (pulmonary embolus, PE) or other organs

• if you know you have a disorder affecting your blood clotting - for instance, protein C

• deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or

• antiphospholipid antibodies

• if you need an operation or if you are off your feet for a long time

• if you have ever had a heart attack or a stroke

• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack (TIA – temporary stroke symptoms

• if you have a disease that may increase your risk of a clot in the arteries:

  • severe diabetes with blood vessel damage

  • very high blood pressure

  • a very high level of fat in the blood (cholesterol or triglycerides);

  • a condition known as hyper homocysteinaemia

• if you have (or have ever had) a type of migraine called ‘migraine with aura’

• if you are allergic to norelgestromin, ethinyl estradiol or any of the other ingredients of this medicine

• if you have ever been told you might have breast cancer or cancer of the womb, cervix or vagina

• if you have ever had liver tumours or a liver disease because of which your liver does not function properly

• if you have unexplained vaginal bleeding

• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);

• if you have SLE (systemic lupus erythematosus; a disease affecting your natural defence system)

• if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing failure of the kidneys)

• if you have sickle cell anaemia (an inherited disease of the red blood cells)

• if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition

• if you need an operation, or you are off your feet for a long time

• if you have just given birth you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you can start taking Evra

• if you have an inflammation in the veins under the skin (superficial thrombophlebitis);

• if you have varicose veins

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other

medicines.  Certain medicines and herbal therapies may stop Evra from working properly. If this happens you could get pregnant.

Tell your doctor if you are taking:

• some antiretroviral medicines used to treat HIV/AIDS (such as nelfinavir, ritonavir, nevirapine, efavirenz)

• medicines for infection (such as rifampicin, rifabutin and griseofulvin, penicillins and tetracycline)

• anti-seizure medicines (such as topiramate, phenobarbital, phenytoin, carbamazepine, primidone, oxcarbamazepine, felbamate, eslicarbazepine acetate and rufinamide are some examples)

• (fos)aprepitant (a medicine to treat nausea)

• bosentan (a medicine for high blood pressure in the blood vessels in the lungs)

• St. John’s wort (an herbal therapy used for depression). St. John’s wort should not be taken when you are using Evra

• medicines containing ciclosporin

• lamotrigine used for epilepsy (this can increase the risk of seizures).

Consult the Patient Information Leaflet for more information on possible risks and side effects.