Eileen 60mcgs + 13mcg / 24 hours. transdermal patch N3

It is used to prevent pregnancy.

Eileen 60 micrograms / 13 micrograms / 24 hours. transdermal patch

Gestodene / Ethinylestradiol

This product is subject to additional monitoring. This will help to quickly identify new safety information. We can help by reporting any you occurrence of side effects. For information on how to report side effects, see. End of section 4.

Important things you need to know about combined hormonal contraceptives (SHK):

• Correctly using, this is one of the most reliable reversible contraceptive methods.
• Combined hormonal contraceptives slightly increase the blood clots in the veins and arteries of the risks, especially in the first year, or re-introduction into use after 4 weeks or longer break.
• If you think you may get a blood clot symptoms, be vigilant and seek medical advice (see. Chapter 2, section "Blood clots").

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

- Keep this leaflet You may need to read it.

- If you have any further questions, ask your doctor, pharmacist or nurse.

- This medicine is only for you, so the others can not give. It may harm them.

- If you get side effects (even if it is not listed), talk to your doctor, pharmacist or nurse. See. Chapter 4.

What is in this leaflet?

1. What is Eileen and what it is used for
2. Before you Eileen
3. How Eileen
4. Possible side effects
5. How to store Eileen
6. Contents of the pack and other information

1. What is Eileen and what it is used for

Eileen is a patch used to prevent pregnancy.

Each patch contains two different female hormones, namely gestodene and ethinyl estradiol, which in small quantities continuously secreted by 7 days.

As Eileen contains two hormones, it belongs to the combined hormonal contraceptive group.

2. Before you Eileen

General comments

Before starting to Eileen, you must read Chapter 2 provides information about blood clots. In particular, it is important to read the symptoms of a blood clot (see. Chapter 2, section "Blood clots").

Before starting Eileen, the doctor will ask about your own and your immediate family health. In addition, the doctor will measure your blood pressure, and, depending on your state of health, may be carried out in other studies.

This leaflet describes some situations when you should stop taking or when Eileen Eileen reliability can be reduced. In such cases, you should avoid sex or use additional non-hormonal contraceptive precautions, eg., A condom or other barrier method. Do not use rhythm or temperature methods.These methods can be unreliable because Eileen changes the temperature and of the cervical mucus changes taking place during the menstrual cycle.

Eileen, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Eileen Do not

If you have any of the following apply to you, Eileen not be used. If you have any of the following apply to you, tell your doctor. The doctor will discuss with you what would be the appropriate method of contraception.

• If you have (or have ever had) a blood clot in the legs (deep vein thrombosis, or DVT), pulmonary (lung embolism, PE) or other organs of the blood vessels;
• If you know that you have a disorder that affects blood clotting, eg., Protein C deficiency, protein S deficiency, antithrombin III deficiency, Factor V Leiden or antiphospholipid antibodies;
• if you need surgery or a long time do not walk (see section. Blood clots');
• If you have ever had a heart attack (myocardial infarction) or stroke;
• If you have (or have ever had) angina (a condition that leads to severe chest pain and may be a first heart attack [myocardial infarction] character) or transient ischemic attack (TIA - transient stroke symptoms);
• If you have at least one of the following diseases that may increase the risk of clots in the arteries:

- Severe diabetes with blood vessel damage,

- Very high blood pressure,

- Very high levels of fat (cholesterol or triglycerides) in the blood,

- A condition called hyperhomocysteinemia;

• If you are (or ever was) a certain type of migraine called "migraine with aura";
• If you have (or have ever had) liver disease (the symptoms of which may be yellowing of the skin or itching all over the body) and liver function is still impaired;
• If you have (or have ever had) cancer, which can grow in the presence sex hormones (eg., Breast or genital organs);
• If you have (or have ever had) a benign or malignant liver tumors;
• If you have vaginal bleeding of unknown cause;
• If you are allergic to ethinylestradiol or any of the other ingredients of this medicine (listed in section 6). For example, it can cause itching, rash or swelling.

If you take Eileen experience any of these conditions, immediately remove the patch, stop taking it and contact your doctor. During this period, take non-hormonal contraceptive measures. See also. See "General remarks" in Section 2 above.

Warnings and Precautions

Check with your doctor, pharmacist or nurse before taking Eileen.

In some cases, Eileen, or any other combination hormonal contraceptive should be used with extreme caution, and your doctor may need to regularly tested.

If any one of the following apply to you, tell your doctor. If this condition occurs, or difficulty taking Eileen, also you need to tell your doctor.

- If you smoke;

- If you have diabetes;

- If you are overweight;

- If you have high blood pressure;

- If you have a heart condition (valve disorder, a heart rhythm disorder);

- If someone else in your blood relatives ever had a blood clot (thrombosis in the leg, lung (pulmonary embolism) or other organs), heart attack (myocardial infarction) or stroke at an early age;

- If you suffer from migraines;

- If you have epilepsy (see. Section "Other medicines and Eileen" in Chapter 2);

- If a close relative in your blood is (or ever had) breast cancer;

- If you have liver or gallbladder disease;

- If you have depression;

- If you suffer from Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);

- If you suffer from systemic lupus erythematosus (SLE - disease that affects the body's natural defense system);

- If you have haemolytic uraemic syndrome (HUS - kidney failure resulting in blood clotting disorder);

- If you have sickle cell anemia (an inherited disease of red blood cells);

- If you have high blood fat levels (hypertriglyceridaemia) or a positive family history of this condition. Hypertriglyceridemia is associated with an increased risk of pancreatitis (inflammation of the pancreas) development risks;

- If you need surgery or a long time do not walk (see. Section 2 'Blood clots');

- If you have just given birth, you are at increased risk of blood clots. Ask your doctor how long after birth, you can start by Eileen;

- If you have inflammation of the subcutaneous vein (superficial thrombophlebitis);

- If your veins knotty and enlarged;

- If you have a condition that first appeared or worsened during pregnancy or previous use of sex hormones at the time (eg., Decreased hearing, metabolic disease called porphyria, a skin disease called herpes gestationis, or Sydenham's chorea - nerve disease causing sudden body movements;

- If you have (or ever was) yellow-brown pigmented spots (also known as "pregnancy patches"), especially on the face (chloasma) In this case, avoid direct exposure to sunlight or ultraviolet rays;

- If you have hereditary angioedema. If you experience symptoms of angioedema (swelling of the face, tongue, or (or) and throat (or) difficulty swallowing or hives together with difficulty in breathing), contact your doctor immediately. Medications containing estrogen may cause or exacerbate symptoms of angioedema.

Blood clots

Combination hormonal contraceptive, such as., Eileen, you have a higher blood clot risk than without using it. In rare cases, a blood clot can block the blood vessels and lead to serious disturbances.

Blood clots can occur

• veins (known as venous thrombosis, venous thromboembolism or VTE)
• arteries (called arterial thrombosis, arterial thromboembolism or ATE).

Blood clots are not always completely disappear. In rare cases, blood clots can cause serious long-term consequences, or in very rare cases, they can be fatal.

It is important to remember that the overall harmful blood clot due to Eileen consumption is low.

How to recognize a blood clot

If you notice any of these signs or symptoms, seek immediate medical attention.

Blood clots in a vein

What can happen if a blood clot in a vein?

• Combined hormonal contraceptive use is associated with an increased risk of blood clots in a vein (venous thrombosis). However, these side effects are rare. Most often it occurs in the first combined hormonal contraceptive use year.
• If the leg or foot vein blood clot, it can lead to deep vein thrombosis (DVT).
• If a blood clot from the legs to the lungs, it can cause a pulmonary embolism.

Very rarely, blood clots can form another body, for example., Eye vein (retinal vein thrombosis).

When a blood clot in a vein at highest risk?

The maximum blood clot in the vein, the risk is in the first year, the combined hormonal contraceptive is used for the first time. These risks may also be higher, if the re-start combined hormonal contraceptives (the same or a different medicine) after 4 weeks or longer break.

After the first year, this risk is decreasing, but is slightly higher than without the use of a combined hormonal contraceptive.

Upon termination of Eileen use you in the risk of blood clot returns to normal within a few weeks.

What is the risk of blood clots?

This risk depends on you the natural risk of VTE and used the combined hormonal contraceptive type.

General blood clot in the leg or lung (DVT or PE) risk associated with Eileen is low.

- Approximately 2 out of 10 000 women who are not receiving the SHK is not pregnant within a year the blood clots.

- Approximately 5-7 per 10 000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone or norgestimate, during the year, the blood clots.

- Approximately 9-12 per 10 000 women who use combined hormonal contraceptives containing gestodene, eg., Eileen, during the year, the blood clots.

- Is not yet known what the risk of blood clots taking Eileen, compared to the risk associated with combined hormonal contraceptive containing levonorgestrel and combined oral contraceptives containing gestodene.

- Risk of blood clots is varied and depends on the individual medical history (see. "Factors that increase the risk of blood clot" below).

Factors that increase the risk of blood clots in the veins

Blood clot risk associated with Eileen is small, but some condition that increases the risk. This risk is higher:

• If you have a lot of excess weight (body mass index (BMI) over 30 kg / m ² );
• If any of your blood relatives had a blood clot in the leg, lung or other organ at an early age (eg., Up to about 50 years). In this case, you may have an inherited blood clotting disorder;
• If you need surgery or do not walk for a long time due to injury, illness or legs in plaster. A few weeks before surgery or until your mobility is limited, you may need to stop taking Eileen. If you need to stop treatment with Eileen, ask your doctor when you can start again to use it;
• With age (especially if you have more than about 35 years old);
• Have given birth less than a few weeks.

The more of these conditions apply to you, at the risk of blood clots is higher.

Travelling by air (> 4 hours) may temporarily increase the risk of blood clots, especially if you have other risk factors listed.

It is important to tell your doctor if you fit any of these conditions, even if you are not sure. Your doctor may decide that Eileen should be discontinued.

If you take Eileen changed any of the conditions listed above, eg., Blood relative thrombosis occurred without a known cause or gain a lot of weight, tell your doctor.

Blood clots in arteries

What can happen if a blood clot in an artery?

Arteries, as well as vein, a blood clot can lead to serious complications. For example, it can cause a heart attack (myocardial infarction) or stroke.

Factors that increase the risk of a blood clot in an artery

It is important to note that the risk of heart attack (myocardial infarction) or stroke for Eileen consumer risk is very small, but it can be increased:

• Age (over about 35 years of age);
• If you smoke. The use of combined hormonal contraceptives, eg., Eileen, it is advisable not to smoke. If you are unable to quit smoking, and you are more than 35 years old, your doctor may advise you to use another method of contraception;
• If you are overweight;
• If your blood pressure is elevated;
• If any of your blood relatives had a heart attack (myocardial infarction) or stroke at an early age (around 50 years). In this case, you can also be higher heart attack (myocardial infarction), or stroke;
• If you or anyone in your immediate family, found high levels of fat (cholesterol or triglycerides) in the blood;
• If you suffer from migraine, particularly migraine with aura;
• If you have a heart condition (valve disorder or arrhythmia called atrial fibrillation);
• If you have diabetes.

If you to more than one of the following conditions, or any of these conditions is a serious risk of blood clots may be even greater.

If you take Eileen changed any of the conditions listed above, eg., Started smoking, blood relative thrombosis occurred without a known cause or gain a lot of weight, tell your doctor.

Combined hormonal contraceptives and cancer

Combined hormonal contraceptives in women taking a little more determined breast cancer, but is not known whether it is caused by the same treatment. Eg., Maybe women who take combined hormonal contraceptives are often the doctor examined so tumors diagnosed more frequently. Upon termination of the combined hormonal contraceptive, the risk of breast tumors diminishing. It is important to regularly check the breasts and deducing any lump, contact your doctor.

In rare cases in users of combined hormonal contraceptives for women to identify benign liver tumors, and even more rarely - malignant liver tumors. In isolated cases, these tumors have led to life-threatening internal bleeding. If you have unusual severe abdominal pain, see your doctor.

The primary cervical cancer risk factor is the Persistent human papillomavirus (HPV) infection. Some studies suggest that long-term use of combined hormonal contraceptives increase the risk of developing cervical cancer. Still, it is unclear how much this increases the risk of sexual lifestyle or other factors, for example., The human papilloma virus.

Bleeding between menstrual

As with all combined hormonal contraceptives, the first few months may be irregular vaginal bleeding (spotting or cause Bleeding between periods) between menstruation. You may need to hygiene measures, but continue to take Eileen as usual.

The body adapts to Eileen, irregular vaginal bleeding usually disappear (usually after about 3 cycles of treatment). If it persists, abundant, or starts again, tell your doctor.

What to do if no bleeding

If Eileen taken properly and not taken any other drugs are not likely to become pregnant. Take Eileen continue as usual.

If Eileen taken improperly or if Eileen taken properly, but the bleeding does not happen twice in a row, you may be pregnant. Contact your doctor immediately. Do not start the next patch until you are sure that you are not pregnant. During this period, take non-hormonal contraceptive measures. See also. See "General remarks", above, in Section 2.

Children and adolescents

Eileen safety and efficacy of adolescents under 18 years of age have not been established.

Other medicines and Eileen

If you are taking or have recently taken any other medicines or herbal products, including medicines obtained without a prescription, or because you are not sure, talk to your doctor or pharmacist. Also tell any other doctor or dentist who prescribes another medicine (or the medicines issued the pharmacist) that you are taking Eileen. They will be able to tell you if you need to use an additional contraceptive method (eg., A condom) and, if appropriate, of the time to use them, or to advise whether it is necessary to change the other medicines you may require.

Some medicines can act Eileen blood and weaken its effectiveness in protecting against pregnancy, or can cause unexpected bleeding. These include:

and drugs used to treat these conditions:

- Epilepsy (eg., Primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine,
eslicarbazepine, topiramate, felbamate);

- Tuberculosis (eg., Rifampicin, rifabutin)

- Sleep disorder narcolepsy (modafinil);

- High blood pressure in the lungs (bosentan);

- HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors), other infections (griseofulvin);

and herbal preparation St. John's wort.

Combined hormonal contraceptives may have an effect on other medicines, eg., Anti-epileptic lamotrigine.

Labaratory tests

If you need a blood test or other laboratory tests, tell your doctor or laboratory staff that you are taking Eileen, because hormonal contraceptives can affect the results of some tests.

Eileen with food, drink and alcohol

It is unlikely that food, beverages or alcohol would affect the functioning of Eileen.

Pregnancy and breast-feeding

If you are pregnant or think you may be pregnant, Eileen not be used. If you become pregnant while taking Eileen, immediately remove the patch and call your doctor.

If you want to get pregnant, you can stop by Eileen use at any time (see also. See "If you stop taking Eileen" in Chapter 3).

Usually Eileen breast-feeding is not recommended. If you want to use Eileen breast-feeding, you should seek medical advice.

Driving and using machines

Taking Eileen can drive or operate machinery.

3. How Eileen

Always take this medicine exactly as directed by your doctor or pharmacist. If in doubt, talk to your doctor or pharmacist.

Eileen prevents you from getting pregnant, because through the skin into your body falls hormones.For the patch to work properly, it must be good to stick to the skin.

Eileen effectiveness depends on how you are following the instructions for use of the patch. The more closely you follow these instructions, the less likely that you are pregnant.

So Eileen always exactly as described in the brochure. Failure to follow these instructions may increase the chances of pregnancy.

When did you first start taking Eileen

Mark the day of the week stuck on the first patch. The day of the week will be your patch change day every week (see also. See "patch" Change Day "in Section 3 below).

Follow the rules as to the use of Eileen, or how to replace the previous method of Eileen consumption.Last month, the contraceptive method used to select the left column of the table below:

Rules as to the use of Eileen, or how to replace the previous method of use Eileen

After a miscarriage

Follow your doctor's advice.

After giving birth

If you just had a baby, your doctor may tell you to wait for the first normal menstrual period and then start Eileen. Sometimes it is possible to start sooner. Your doctor will advise you.

If after the birth before taking Eileen already had sex before užsiklijuodama patch, you must make sure you are not pregnant or wait for the first normal menstruation.

If, after giving birth to begin the use of Eileen and breast-feeding, discuss this with your doctor.

If you are not sure when to start Eileen, talk with your doctor what to do.

Where to stick the patch

Apply Eileen only in these areas: the abdomen, buttocks or upper part of the upper arm, where the patch will not be rubbed by tight clothing (see. Fig. Below). For example, attach the patch at the waist clothes.

Make sure that the skin at the application site is intact, sound, clean, dry and - preferably - hairless.Do not stick the patch on the breast, on the cut, red or irritated skin or in the same place where it glued the last time.

In the area of ​​the skin where there is or will be sealed Eileen, do not use lotions, creams, oils, powders or powder, make-up or other topical products. This could keep the patch from sticking or part of it may become loose.

Change the patch application, using the same bonding different field locations. For example. You can change the application site from the left side of the abdomen to the right or left side of the buttocks or upper arm to the right.

In addition, you can stick every week in a different location (eg., One week in the outer part of the upper arm, next week - on the stomach).

Every day and check that the patch firmly stuck to the skin.

Please note

• At the same time, take only one patch.
• If the patch is worn properly, you can bathe or shower as usual.
• If the patch remains properly adhering, no restrictions, eg., You can swim, sunbathe sauna and sports.
• A clear patch is protected from ultraviolet radiation of sun light so it can be exposed to solar radiation and need not be covered by clothing.

What do you receive in a pharmacy

Eileen pharmacy received a box containing the leaflet and 3, 9 or 18 sealed sachets, each containing one Eileen patch.

Sachets depends on the prescription that you get the prescription the doctor.

Each sealed sachet contains one patch to stick to the skin. The patch is round and clear:

• The adhesive side of the patch is covered with two pieces of square-glossy, transparent protective film.

• On the opposite side of the patch is covered with a white, square-shaped coating, which prevents the patch from sticking to the internal sachet.

How to prepare a patch

1. Use your fingers to tear the top of the sachet. Where looting indicates notches.
   Do not use scissors. Do not cut, not to damage or otherwise alter the patch, as this may weaken its contraceptive effect.

2. Round contraceptive patch is between the two parts of the square-shaped shiny, transparent protective films and a white square of the cladding layer. It is important to remove the patch from the sachet together with a transparent protective film and a white coating. Do not discard the sachet. Sachet need to stay pavartotam patch handle (see. Section patch management "in Chapter 5).

3. After opening the sachet, the patch should be applied immediately stick, as described below.

• First of all, from the upper part of the patch remove one part white square covering layer.

After removing from the patch of white square covering layer, which prevents the patch from the inside sticking to the sachet, this layer should be discarded.

Two-piece square glossy transparent protective film covers a round, transparent patch bottom (adhesive) part. Adhesive side are active drugs. Avoid touching the sticky surface of the patch that he remained sticky.

• Then peel off the side of a transparent protective film.

• Hold the patch at the edge, which still covers the second part of the protective film, cuddle it to the skin in the place where it will be glued.
• Half of the patch application site prispaudusi gently, remove the protective film.

• 30 seconds to hold the patch firmly prispaudusi palm of your hand. Make sure the edges stick well.

Do not forget that the sachet can not be discarded because of its need to manage pavartotam patch (see. Section patch management "in Chapter 5).

The further application instructions

Each patch should be used as follows: three patches (each is used for 1 week) and 7-day break without the patch consists of a 4-week cycle.

• 3 weeks in a row on the same day of the week (the patch change day - see. See "patch" Change Day "later in this chapter 3) užsiklijuokite new patch.
• Before applying a new patch, be sure to remove the old patch, because at the same time can be only one patch.
• A new patch every time you stick a different place.
• 4-week patch to attach. Make sure that you have removed the old patch. This week should begin menstruation. If your period does not start, see. See "What to do if no bleeding" in Chapter 2.The exact scheme, when sealed, and (or) removal of the patch, please consult the "patch" Change Day "later in this chapter 3.
• The next day after the end of the 4th week, the same day of the week (the patch change day) start a new 4-week cycle, stick the new patch, regardless of whether the monthly continues or ends.

• Repeat the same steps every 4 weeks.

Patch Change Day

Each new patch on the same day of the week. This day will be your "Patch Change Day. Eg., If the first patch was sealed on Sunday, with all other patches must also be glued on Sundays. At the same time, take only one patch.

On the patch-change day, the patch can be changed at any time.

The next cycle start on the same patch change day, within 7 days without a patch (22-28 days).

Days without using the patch

4th week (from 22 th to 28 th day of the cycle) Do not use the patch.

Never do not be neprisiklijavusi patch for more than 7 consecutive days.

If the patch without the break lasts longer than 7 days, you can be protected from pregnancy.

If, during this longer break without the patch had sex, you can already be pregnant. Use an additional method of contraception, eg., Condoms (see also. See "What you need to do your patch becomes loose, timely neužklijavus his or changing?" Later in this chapter 3).

Memo and reminder stickers

To make it easier to remember the patch change day, you might find this booklet concludes with a nuplėšiamoji memory and reminder stickers.

The memo can possess a 4-week cycle patch change day. In addition, you can use a reminder stickers for your personal calendar or diary.

Reminder sticker with a checkmark symbol should be applied on the date of
the affix 1st patch 1 week - this is your patch Change Day.

Two reminder stickers with arrow symbols need to stick
the patch-change day, the 2nd and 3rd week.

Label with the cross symbol should stick
the patch change day 4th week. 4-week patch to attach.

After the 4-week cycle, repeat the above steps again.

If you take a large dose of Eileen?

It is unlikely that Eileen will lead to overdose because the patch releases the same hormones. At the same time, do not take more than one patch. An inadvertent administration of high doses of hormonal contraceptives, serious side effects have been identified.

At the same time, the use of multiple patches may cause nausea or vomiting.

Young girls may have bleeding from the vagina. In case of overdose, contact your doctor or pharmacist.

If you forget to Eileen

What you need to do your patch becomes loose, timely neužklijavus his or changing?

If all or part of the patch has been detached

• Less than a day (no more than 24 hours)

You must try to immediately re-affix it in the same place or replaced with a new patch. Additional contraceptive method is required. Your patch Change Day "will remain the same.

• More than a day (24 hours or more) or if you are not sure when the patch becomes loose

You may be protected from pregnancy. Stop the current contraceptive cycle and start a new cycle immediately, užsiklijuodama new patch. It will now be a new Day 1 and a new Patch Change Day. The first week of the new cycle you have to use an additional method of contraception, such as., Condoms, spermicides or diaphragm.

If the patch is no longer sticky, if it stuck together or stuck to any surface, provided it sticks to your skin other material or if they have previously been part of his detached, or it was dropped, re-attach the patch. If the post fails re-affix the patch immediately užsiklijuokite new patch. Do not use glue or other films to keep the patch application site.

Forget to change your patch

• Any patch beginning of the cycle

(1st week / Day 1):

You may be protected from pregnancy. The first of the new cycle užsiklijuokite patch as soon as you remember. It will now be a new patch "Change Day" and new Day 1. The first week of the new cycle you have to use an additional method of contraception, such as., Condoms, spermicides or diaphragm.

• In the middle of the patch cycle

(Second week / Day 8 or Week Three / Day 15):

- If you are late by one or two days (less than 48 hours)

užsiklijuokite new patch immediately. The next patch užsiklijuokite usual patch change day. Additional contraceptive method is required.

- If you are delayed over two days (48 hours or more)

You may be protected from pregnancy. Stop the current contraceptive cycle and immediately start a new 4-week cycle, užsiklijuodama new patch. It will now be a new patch "Change Day" and new Day 1. Once a week, use an additional contraceptive method.

• At the end of the patch cycle

(Week 4/22-Day):

If you forget to remove the patch, remove it as soon as you remember (at least 28 minutes a day). Start the next cycle of the normal Patch Change Day ", the day after the 28th day.Additional contraceptive method is required.

Consequences patch becomes loose, timely neužklijavus his or changing and what to do in such cases, indicated in the table below:

Consequences patch becomes loose, timely or changing its neužsiklijavus and necessary actions

Timely ask for another prescription package, before taking the last patch package to ensure that the patches on your way.

What to do in case of skin irritation?

If you use the patch causes unpleasant irritation of the patch on the spot, remove the patch and elsewhere sealed with a new one. The new patch to take another in a scheduled patch change day.

How to change the patch-change day, the next day

If you want to change your patch change day to finish your current cycle and remove the third patch the day. This week, when not using the patch, you can be brought forward (by no means delay) of the patch-change day, užsiklijuodama new patch preferred day. In no way can not be longer than 7 days without a break in the patch.

What to do if you are sick or very diarrhea?

Vomiting or diarrhea should not operate from Eileen your body entering drug content.

If you stop taking Eileen

You can stop taking Eileen at any time. If you do not want to become pregnant, talk to your doctor about other reliable methods of contraception. If you want to become pregnant, discontinue use and Eileen, before trying to become pregnant, wait menstruation. It will be easier to calculate the expected date of birth.

Upon termination of Eileen consumption periods may be irregular, scanty or may not be, especially if the periods were not regular before taking Eileen.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Eileen, like other medicines, can cause side effects, although not everybody gets them. If you get side effects, especially if it is severe and persistent, or develop health status change, which, in your opinion, could lead to Eileen, tell your doctor.

All women who use combined hormonal contraceptives and blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) have an increased risk. For more information on the various risks associated with combined hormonal contraceptives are listed in section 2 "Before you Eileen.

Serious side effects

Side effects, including severe reactions associated with combined hormonal contraceptives are listed in section 2 "Warnings and precautions", "Blood clots, combined hormonal contraceptives and cancer" and "Do not Eileen. Please read the following sections and, if necessary, contact your doctor immediately.

Eileen User-defined the following side effects.

Very common: may affect more than 1 in 10 women:

• Reactions at the application site.

Common: may affect up to 1 in 10 women:

• Emotional lability,
• migraine,
• Nausea,
• Bleeding from the genital tract,
• Chest pain.

Uncommon: may affect up to 1 in 100 women:

• Depression or depressed mood,
• Decreased libido and disappeared.

Rare: may affect up to 1 in 1 000 women:

• Harmful blood clots in a vein or artery.

Some side effects description

Side effects, which are often very small, or the symptoms of late is considered to be associated with combined hormonal contraceptives group are listed below (see also. In section 2 "Do not Eileen" and "Warnings and Precautions").

Blood clots

• Hazardous blood clot in a vein or artery, eg .:

and the leg or foot (ie DVT);

and lungs (ie, PE);

and heart attack (myocardial infarction);

and stroke;

and the mini-stroke or transient stroke-like symptoms, called praeinančiuoju ischemic attack (TIA);

and blood clots in the liver, stomach, intestine, kidney or eye.

Blood clots may be greater if there are other factors that increase the risk (for more information about the factors that increase the risk of blood clots, and symptoms of a blood clot in Chapter 2).

tumors

• Combined hormonal contraceptives in women taking a bit more often diagnosed with breast cancer.Since up to 40 years for women are rarely diagnosed with breast cancer, the excess number is small compared to the overall risk of breast cancer. It is not known whether there is a direct link with combined hormonal contraceptive use.
• Liver tumors (benign and malignant).

Other conditions

• Skin condition characterized by itchy red spots or swollen skin patches (erythema multiforme).
• Skin condition characterized by tender red nodules (erythema nodosum).
• Increased fat in the blood (hypertriglyceridemia, which increases the risk of inflammation of the pancreas, resulting in the use of combined hormonal contraceptives).
• Increased blood pressure.
• Conditions where a direct link with combined hormonal contraceptives are not clear, the emergence or worsening jaundice and (or) itching associated with bile secretion disorder (cholestasis), gallstones, porphyria, systemic lupus erythematosus (an immune system disease), hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure), nerve disease causing sudden movements of the body called Sydenham's chorea, herpes prenatal (pregnancy accompanying skin condition), hearing impairment.
• In women with hereditary angioedema (characterized, eg., A sharp face, tongue or throat), external estrogens may induce or exacerbate symptoms of angioedema.
• Impaired liver function.
• Glucose tolerance or effect on peripheral insulin resistance changes.
• Inflammatory bowel disease (Crohn's disease, ulcerative colitis), difficulty breathing.
• Worsening of epilepsy.
• Yellow-brown pigment spots (also known as "pregnancy patches", especially on the face).

Hypersensitivity (including symptoms such as rash, urticaria).

interaction

On the other drug interactions with combined hormonal contraceptives (eg., Herbal preparation St. John's wort or drugs for epilepsy, tuberculosis, HIV and hepatitis C virus infections) may experience unexpected bleeding and (or) the ineffectiveness of contraception. See. Chapter 2, section "Other medicines and Eileen.

Notification of side effects

If you experience side effects, including not listed, please tell your doctor or pharmacist. The side effects can also inform the State Medicines Control Agency under the Lithuanian Ministry of Health toll-free phone 8 800 73568 or a complete web site www.vvkt.lt the form and submit it to the State Medicines Control Agency under the Lithuanian Ministry of Health in the following ways : writing (address Žirmūnų g. 139A, LT-09120 Vilnius), toll-free fax number 8 800 20131, e-mail.NepageidaujamaR@vvkt.lt mail, as well as through the State Medicines Control Agency under the Lithuanian Ministry of Health website (at http://www.vvkt.lt). When reporting side effects you can help us to get more information about the safety of the medicine.

5. How to store Eileen

Keep this medicine out of the sight and reach of children place.

Keep the sachet in order to protect from light and moisture. Do not freeze.

The folding carton and sachet label after "EXP" or "EXP" after the expiry date, Eileen not be used. The expiry refers to the last day of the month.

Patches handling and preparation

Once removed from the protective sachet, the patch should be applied immediately stick.

In the area of ​​the skin where there is or will be sealed Eileen, do not use make-up, creams, lotions, powders or powders or other topical products.

The active substance gestodene and ethinyl estradiol cause risk to the environment, in particular fish.In addition, gestodene and ethinylestradiol is long in the environment. Used patches should not be thrown into the toilet or placed in liquid waste management systems.

The used patch should be discarded carefully in accordance with the following instructions:

• The manufacturer sachet keep pavartotam patch management.
• Administered patch, fold it in half, adhesive side inwards.
• Put the original sachet.
• Fold the open edge of the sachet.
• On the sachet is a two-leaf label.
• Remove the first label leaflet and use užlenktam sealed sachet edge.
• After the first leaflet at the second leaflet can be found in the processing instructions.

Safely dispose of children or pets reach. Administered or unused patches should be disposed of in accordance with local requirements. If in doubt, ask your pharmacist. These measures will help to protect the environment.

6. Contents of the pack and other information Eileen composition

The active substances are gestodene and ethinyl estradiol. Each 11 cm ² area of the transdermal patch contains 2.10 mg of gestodene and 550 micrograms ethinyl estradiol.

One transdermal patch over 24 hours releases 60 micrograms gestodene and 13 micrograms ethinyl estradiol (equivalent to 20 micrograms of oral dose).

The other patch incorporating materials

The protective layer: low-density polyethylene (PE) outer layer.

Adhesive layer: adhesive containing a hydrogenated rosin ester, polybutene, polyisobutylene, Pentaerythritol (3- (3,5-di-tert-butyl-4-hydroxyphenyl) propionate) bemotrizinolio.

Distinctive foil: polyethylene terephthalate (PET) film.

Adhesive matrix adhesive containing a hydrogenated rosin ester, polybutene, polyisobutylene, Pentaerythritol (3- (3,5-di-tert-butyl-4-hydroxyphenyl) propionate).

Release liner: siliconized polyethylene terephthalate (PET) film.

Eileen appearance and contents of the pack

Eileen is a folding box, the leaflet (including memory and reminder stickers) and 3, 9 or 18 sealed sachets, each sachet contains one transdermal patch.

It may not be available in all packs.

Thin transdermal patch is a circular, transparent, and its area is 11 cm ² .

• The adhesive side of the patch is covered with a two-piece, square-shaped, glossy, transparent protective film.
• On the opposite side of the patch is covered with a white, square-shaped coating, which prevents the patch stick sachet.

The registrant and manufacturer

The registrant

Gedeon Richter Plc.

Gyömrői út 19-21

1103 Budapest

Hungary

Manufacturers

Bayer Weimar GmbH und Co. KG
Döbereinerstrasse 20

99427 Weimar,
Germany

Gedeon Richter Plc.

Gyömrői út 19-21

1103 Budapest

Hungary