Euro Parches Transdérmicos

Please read this leaflet carefully before using this medicine.

– Keep this leaflet, You may need to read it again.

– If you have any questions, Consult your doctor or pharmacist.

– This medicine has been prescribed for you Do not pass it on to others, even if their symptoms, as yours.

– If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Leaflet:

1. What is EVRA and what it is used

2. Before using EVRA

3. Risks of using combined hormonal contraceptives

4. Using EVRA

5. Possible side effects

6. Conservation Evra

7. Additional information

1. EVRA WHAT IS AND WHAT IT IS USED

The name of this drug is EVRA transdermal patch. Call it "EVRA" in this prospectus.

It is used to prevent pregnancy. EVRA contains two types of hormones:

• norelgestromina

• etinilestradiol

Because it contains two hormones, EVRA is considered a "combined hormonal contraceptive".

2. BEFORE USING EVRA In use EVRA itself:

• Es alérgico (hypersensitive) a norelgestromina, ethinyl estradiol or any of the other ingredients of EVRA (listed in Section 7)

• Have you ever had a heart attack or a type of chest pain called "angina"

• Ever had a stroke, or symptoms that might warn of the, such as a mild cerebral attack, passenger, no after-effects

• have high blood pressure (160/100 mmHg or higher)

• Have diabetes with blood vessels affected

• have severe headaches with neurological symptoms such as changes in vision, numbness in any part of the body (Migraine with focal aura)

• Have you ever had a blood clot (thrombosis) leg (deep vein thrombosis or VTE) or lungs (pulmonary embolism) or other body part

• Have an inherited problem of blood clotting (such as "protein C deficiency" a "protein S deficiency")

• have high levels of blood fat (cholesterol or triglycerides)

• Have an inherited problem that affects blood fat levels (called dyslipoproteinemia)

• Have you ever had a tumor in the liver or other liver problem.

• Have you ever been told you can get breast cancer or uterine cancer, cervix (Cervical) the vagina

• Has unexplained vaginal bleeding.

EVRA should not use if you have some of the above conditions. If you are unsure, Ask your doctor or pharmacist before using EVRA.

Take special care with EVRA Screenings

Before using EVRA is necessary that your doctor will conduct a medical review.

Before using EVRA, Consult your doctor or pharmacist if you have or have had any of the following conditions, or if you develop or worsen during treatment with EVRA:

- Weight 90 Kg or more

- You, or someone in your family, have high levels of blood fat (cholesterol or triglyceride)

- Have high blood pressure or which tends to increase

- Has an alteration in the blood called porphyria

- Has an immune system disorder known as SLE (lupus erythematosus)

- Has an alteration in the blood that causes kidney damage known as "hemolytic uretic"

- Have hearing loss

- Has epilepsy or other seizure disorder problem

- Has a nervous disorder in which sudden body movements called occur

"Corea Sydenham"

- Have diabetes

- Has Depression

- Have Gallstones

- Have liver disorders, including yellowing of the skin and whites of the eye

(jaundice)

- You have an inflammatory bowel disease (Crohn's disease or ulcerative colitis)

- He had skin rash with blisters during pregnancy (“herpes gestacional”)

- Has "pregnancy patches" yellowish brown spots on the skin, especially in the face (called "chloasma")

- Think you may be pregnant

If you are unsure if you have any of the above conditions, Ask your doctor or pharmacist before using EVRA.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken other drugs or herbs, even those not prescribed.

Certain medications and herbal remedies can affect the operation of EVRA. If this happens, you can get pregnant.

Consult your doctor if you take:

• Medications for HIV infection (and ritonavir, nevirapina)

• Medicines for infections (como, rifampicin and griseofulvin)

• Medicines for epilepsy (as topiramate, barbiturates, phenytoin, carbamazepine, primidona, oxcarbazepine and felbamate)

• Used to treat high blood pressure in the blood vessels of the lungs Drugs

(bosentan)

• St. John's Wort or Hypericum, a medicinal herb used for depression.

If you are using some of the drugs listed above should use another method of birth control (as a preservative, the foam diaphragm). The effect of any of these medications can last up 28 days after stopping use.

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If you are using certain medications or drinking grapefruit juice, may increase blood levels of estrogen content EVRA.

EVRA can reduce the effect of some drugs, como:

• medicines containing cyclosporin

the antiepileptic lamotrigine (This may increase the risk of attacks (seizures)). Consult your doctor or pharmacist before taking any medication.

EVRA with food and drinks

Not expected to affect food and drink to the efficacy of EVRA.

Pregnancy and lactation

• Do not use EVRA if you are pregnant or think you may be pregnant

• Do not use EVRA if you are breastfeeding or plan to breastfeed.

Consult your doctor or pharmacist before taking any medication during pregnancy or breast-feeding.

Driving and using machines

You can drive or operate machinery while wearing the patch EVRA.

Sexually Transmitted Diseases

EVRA does not protect against HIV infection (PAGE) or against any other sexually transmitted disease. This includes, Chlamydia, herpes genital, genital warts, gonorrhea, hepatitis B, syphilis. Use condoms to protect against these diseases.

Laboratory Tests

• If you make a blood or urine, tell your doctor or the person who will take the sample as EVRA may alter some analytical results.

3. RISKS OF USING COMBINED HORMONAL CONTRACEPTIVE

The following information is based on combined contraceptive pills. Since the EVRA transdermal patch contains hormones similar to those used in birth control pills combined, is likely to have the same risks. The use of any combined pill carries risks, which could lead to disability or death.

Has not been shown that as EVRA transdermal patch is safer than a combined contraceptive pill taken orally.

Combined hormonal contraceptives and blood clots (thrombosis)

The use of combined hormonal, incluido Euros, increases the risk of thrombosis (blood clots). It is possible that the risk of blood clots in the legs and / or lungs with EVRA is greater than the combined birth control pills. The risk of blood clots is not time dependent drug utilization. The risk decreases to normal levels within months after stopping the drug use.

Blood clots can block a vein or artery and can cause permanent disability or death.

• Blood clots can form in the leg veins (DVT or VTE) and go to the lungs, causing chest pain, difficulty breathing after collapse. This is known as "pulmonary embolism"

• Very rarely, blood clots occur in the arteries of the heart (causing a heart attack) or brain (cerebral thrombosis)

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• In extremely rare cases, Blood clots can form in the liver, intestines, kidney or eyes. In the latter case could result in loss of vision or double vision.

Consult your doctor immediately if you experience any signs of having a blood clot, as:

• Pain and / or swelling in the leg

• Chest pain with possible radiation to the arm

• breath sudden the sudden onset of cough

• unusual pain head, strong or long-term

• Vision problems

• Difficulty speaking

• Dizziness or fainting

• Weakness or numbness on one side or a body part

• Difficulty in walking or holding things

• Sudden stomach

Consult your doctor immediately if you think you have any of these symptoms.

The risk of developing a blood clot increases:

• With age

• If you have a family history of blood clots in the blood vessels (veins or arteries)

• Si fuma, especially if you have more than 35 años

• If you are in bed for many days

• If you are overweight

• If you have recently given birth or miscarriage or abortion

• If you have had a severe injury to the leg or hip

• If you have had or will undergo major surgery and / or need to stay in bed for a long time.

Normally you should not use EVRA during the two weeks before or two after surgery

• If you have or have had blood clots

• If you have high levels of blood fats (cholesterol or triglycerides)

• If you have high blood pressure

• If you have heart problems (problems with heart valves, abnormal heart rhythm).

Combined hormonal contraceptives and cancer: Breast cancer

There have been cases of breast cancer more often in women using

combined hormonal contraceptives. Nevertheless, is possible that combination hormonal contraceptives are not the cause that more women have breast cancer. This may be because

women using combined hormonal contraceptives are most frequently examined.

This would mean that there are more chances that breast cancer is detected. The increased risk of breast cancer decreases gradually after discontinuation of combination hormonal contraceptives. After ten years, the risk is equal to that of women who have never used combined hormonal contraceptives.

Cervical cancer (Cervical)

Cervical cancer (Cervical) also detected more frequently in women using combined hormonal contraceptives. Nevertheless, may be due to other causes. These include a high number of sexual partners and sexually transmitted diseases.

Liver Cancer

Have found rare cases of noncancerous tumors in the liver in women taking combined hormonal contraceptives. Even more rarely found in the liver cancer tumors. This can cause bleeding inside the body with a sharp pain in the stomach area. If you experience this symptom, should immediately contact your doctor.

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