Evra patches

• Contraceptive patch
• Use new patch every week
• Not suitable for women who are breastfeeding

Evra transdermal contraceptive patch is a safe and convenient birth control method. EVRA contains two types of female sex hormones, a progestogen called norelgestromin and an oestrogen called ethinyl estradiol, which are absorbed into the bloodstream via the skin.

The hormones in EVRA prevent ovulation and change the lining of the uterus to prevent pregnancy. Because it contains two hormones, EVRA is called a combined hormonal contraceptive.

Apply your first patch and wear it for seven days. On day 8, change the patch to a new one. Change it like this every week for three weeks, and then have a patch-free week (like the pill-free week with contraceptive pills). During this week you will get a mild withdrawal bleed. You'll be protected from pregnancy during this week, provided the patch is used correctly and changed on time.

The package leaflet contains detailed instructions on how to use and remove the patches. Follow these instructions closely. The general guidelines for use are:

• Do not put the patch on skin that is red, irritated or cut.
• Press the patch down firmly until the edges stick well. Do not use skincare products or makeup on the skin where you are placing a patch or near a patch you are wearing.
• 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.
• 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.
• Wear the patch for seven days (one week). On the first 'patch change day', day 8, take off the used patch. Put on a new patch immediately. Change the patch on the same day of each week.
• Normal activities such as having a bath or shower, using a sauna and exercising should not
• affect how well the patch works. However, you should check that the patch has not fallen off after doing these activities.

Check the package leaflet to see when to apply the first EVRA patch. The package leaflet also tells you what to do if your patch becomes loose, you forget to change your patch or use too many patches.

EVRA patches are not suitable for everyone. Do not use these contraceptive patches if:

• You are allergic to any of the ingredients in EVRA (see section ‘What EVRA contains').
• You have ever had a heart attack or angina pectoris (chest pain).
• You have ever had a stroke or symptoms of stroke, including mild, temporary paralysis without permanent consequences.
• You have high blood pressure (160/100 mmHg or higher).
• You have diabetes with blood vessel damage.
• You get migraines with symptoms involving the nervous system, such as visual disturbances or numbness in certain parts of the body (migraine with aura).
• You have, or have ever had, a blood clot in a blood vessel of your legs (deep vein thrombosis), your lungs (pulmonary embolus) or other organs.
• You have a genetic disorder affecting your blood clotting (e.g., protein C deficiency or protein S deficiency).
• You have high cholesterol or raised levels of triglycerides in your blood.
• You have a genetic disorder that is characterised by abnormally elevated or decreased levels of lipoproteins in your blood (dyslipidemia).
• You have ever had liver tumours or a liver disease because of which your liver does not function properly.
• You have ever been told you might have breast cancer or cancer of the womb, cervix or vagina.
• You have vaginal bleeding of unknown cause.

When should this medicine be used with caution?

Consult your doctor or pharmacist before using EVRA if you have any of the following or they happen or get worse while using EVRA:

• You weigh 90 kg or more.
• You, or anyone in your immediate family, has high cholesterol or raised levels of triglycerides in the blood.
• You have high blood pressure or your blood pressure gets higher.
• You have a blood problem called porphyria.
• You have systemic lupus erythematosus (SLE).
• You have haemolytic uraemic syndrome (HUS).
• You have a hearing loss.
• You have epilepsy or any other problem that can cause fits (convulsions).
• You have a neurological disease called Sydenham’s chorea.
• You have diabetes.
• You suffer from depression.
• You have gallstones.
• You have liver problems including yellowing of the skin and whites of the eye (jaundice).
• You have Crohn’s disease or ulcerative colitis.
• You had a skin rash with blisters during pregnancy (herpes gestationis).
• You have, or have had, ‘pregnancy spots’. These are yellowish-brown patches or spots, especially on your face (chloasma).
• You are pregnant or think you may be pregnant.

Pregnancy and breastfeeding

Do not use EVRA patches if you are pregnant or breastfeeding.

Other medicines and EVRA

Certain medicines and herbal therapies may stop EVRA from working properly.

These include:

• Some antiretroviral medicines used to treat HIV (e.g., ritonavir, nevirapine).
• Medicines for infection (e.g., rifampicin and griseofulvin).
• Anti-seizure medicines (e.g., barbiturates, topiramate, phenytoin, carbamazepine, primidone, oxcarbazepine, felbamate).
• Bosentan (a medicine for high blood pressure in the blood vessels in the lungs).
• St John’s wort (herbal therapy used for depression).

If you take any of these medicines, you may need to use another method of birth control (such as a

condom, diaphragm or foam). The interfering effect of some of these medicines can last for up to 28 days after you have stopped taking them.

EVRA may make some other medicines less effective, such as:

• Medicines containing ciclosporin.
• Lamotrigine used for epilepsy. This can increase the risk of fits (seizures).

For more information, see the package leaflet. Ask your doctor or pharmacist for advice before taking any medicines. Always tell your doctor that you are using EVRA patches or any other medicines, including herbal remedies.

EVRA patches are generally well tolerated. Like all hormonal contraceptive medicines, EVRA can cause side effects. The following side effects are very common:

• Headache.
• Nausea.
• Sensitive breasts.

Other common side effects include:

• Vaginal yeast infection (thrush).
• Mood problems such as depression, change in mood or mood swings.
• Dizziness.
• Problems affecting the stomach and intestines.
• Migraine.
• Acne, skin rash, skin itching or skin irritation.
• Muscle spasms.
• Changes in menstrual bleeding pattern, painful or heavy periods, uterine cramps, bleeding in between menstrual periods, vaginal discharge.
• Problems where the patch has been on the skin such as redness, irritation, itching or rash.
• Feeling tired or generally unwell.
• Weight gain.

For a list of less common side effects, please see the package leaflet.

Hormonal contraceptives slightly increase the risk of having a blood clot in the veins and arteries (thrombosis) or certain types of cancer. For more detailed information, see the package leaflet.

Consult a doctor if the side effects are severe or if you experience side effects that are not listed in the package leaflet.

The active substances in EVRA are norelgestromin (6 mg) and ethinyl estradiol (600 mcg). The active substances are released over seven days with an average of 203 micrograms norelgestromin and 34 micrograms ethinyl estradiol being released each 24 hours.

The other ingredients are: polyisobutylene/polybutene adhesive, crospovidone, non-woven polyester fabric, lauryl lactate.

The manufacturer of EVRA is:

Janssen Pharmaceutica NV Turnhoutseweg 30
Beerse B-2340
Belgium

Read the package leaflet before use. The official package leaflet of EVRA patches is available for download here.