Zoely

Este medicamento está sujeto a seguimiento adicional, lo que agilizará la detección de nueva información sobre su seguridad. Puede contribuir comunicando los efectos adversos que pudiera usted tener. La parte final de la sección 4 incluye información sobre cómo comunicar estos efectos adversos.

Important things to know about combined hormonal contraceptives (Way back):

 They are one of the most reliable reversible methods of contraception if used correctly.
 increase slightly the risk of a blood clot in the veins and arteries, especially in the first year or when the use of a combined hormonal contraceptive is restarted after a pause 4 weeks or more.
 Be alert and consult your doctor if you think you may have symptoms of a blood clot (see
section 2 "Blood clots").
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

– Keep this leaflet, You may need to read it again.
– If you have any questions, ask your doctor, pharmacist or nurse.
– Este medicamento se le ha recetado solamente a usted, Do not pass it on to others even if they have the same symptoms you, as yours.
– If you experience side effects, ask your doctor, pharmacist or nurse, even if it is side effects not listed in this leaflet. Ver sección 4.

1. What is Zoely and what it is used

Zoely mg / 1.5 mg film-coated tablets Acetate film Nomegestrol / Estradiol is a birth control pill used to prevent pregnancy.
 The 24 Film-coated tablets, white, They are active tablets containing a small amount of two different female hormones. These are nomegestrol acetate
(a progestogen) and estradiol (an estrogen).
 The four yellow tablets are inactive tablets that do not contain hormones and are called placebo tablets.
 Birth control pills that contain two different hormones, as Zoely, They are called "combined pills".
 Estradiol, estrogen Zoely, It is identical to the hormone produced by your ovaries during a menstrual cycle.
 nomegestrol acetate, progestogen in Zoely, derived from progesterone, a hormone, which is produced by the ovaries during a menstrual cycle.

The price is Zoely in Spain 13,89 euros PVP IVA.

2. Things to know before you start using Zoely

Considerations

Before you start using Zoely should read the information on blood clots (thrombosis) in the section 2. It is particularly important to read the symptoms of a blood clot (see
section 2 "Blood clots").
Before you start taking Zoely, the doctor will ask you questions about your personal health history and their close relatives. The doctor will also measure your blood pressure and,
depending on your personal situation, You can also perform other analyzes.

In this leaflet, several situations where you should stop taking the pill or where the reliability of the pill may be reduced are described. In such situations, you should not have sex or to use additional contraceptive precautions without hormones, por ejemplo, the use of a condom or other barrier method. Do not use the methods of rhythm or temperature. These methods may be unreliable because the pill alters the usual changes in temperature and cervical mucus the occurring during the menstrual cycle.

Zoely, like other hormonal contraceptives, It does not protect against HIV infection (PAGE) or against any other sexually transmitted disease.

When should you not use Zoely

Zoely should not use if you have any of the conditions listed below. Tell your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other
form of contraception would be more appropriate.

 If you have (or have ever had) a blood clot in a blood vessel of the legs (DVT, TVP), lung (pulmonary embolism, EP) or other organs.
 If you know you have a disorder that affects blood clotting: por ejemplo, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.
 If you need an operation or if a long time passes without stand (see section "Blood clots").
 If you have ever suffered a heart attack or stroke.
 If you have (or have ever had) angina (a condition that causes severe pain in the chest and may be the first sign of a heart attack) or a transient ischemic attack (AIT, temporary symptoms of stroke).
 If you have any of the following diseases that may increase your risk of clot formation in the arteries.
 severe diabetes with blood vessel damage;
 high blood pressure;
 very high levels of blood fat (cholesterol or triglycerides);
 a condition called hyperhomocysteinemia.
 If you have (or have ever had) a type of migraine called "migraine with aura".
 If you have (or had) Pancreatic inflammation (pancreatitis) related to high levels of blood fat.
 If you have (or had) a serious liver disease and your liver is not yet functioning normally.
 If you have (or had) a benign or malignant liver tumor.
 If you have (or had) or you may have a cancer of the breast or genital organs.
 If you have any bleeding in the vagina Unexplained.
 If you are allergic to estradiol, nomegestrol acetate or any of the other ingredients of this medicine (In section 6).

If any of these conditions appear for the first time while taking Zoely, stop taking it immediately and consult your doctor. While, use a non-hormonal contraceptive. See also "General Notes" section 2, higher.

When to take special care with Zoely

When should you consult your doctor?
Seek emergency medical attention

 If possible note signs of a blood clot that may mean you are suffering a blood clot in the leg (ie, DVT), a blood clot in the
lung (ie, pulmonary embolism), a heart attack or stroke (see section "blood clot" below).
For a description of the symptoms of these serious side effects, see "How to recognize a blood clot".

 If you notice any changes in your health, which especially affects any of the items mentioned in this leaflet (see also section 2, "When should you not use Zoely"; do not forget to changes in the health of your immediate family).
 If you notice a lump in the breast.
 If you have symptoms of angioedema, as swelling of the face, tongue or throat, or difficulty swallowing, or hives, accompanied by difficulty breathing.
 If you are using other medicines (see section 2, "Using Zoely with other medicines").
 If you will be immobilized or are to have surgery (tell your doctor at least four weeks in advance).
 If you have an unusual and heavy vaginal bleeding.
 If you forget to take two tablets or more in the first week of the blister and has had sex in the previous seven days (see also section 3, "If you forget to take Zoely").
 If you have severe diarrhea or have severe vomiting.
 If you stop having periods and suspect you are pregnant (do not start the next blister until the doctor tells; see also section 3, "If you have stopped having one or two periods").

Tell your doctor if you experience any of the following conditions.

If the condition develops or worsens while using Zoely, You should also tell your doctor.

 Si tiene angioedema hereditario. Consult your doctor immediately if symptoms of angioedema, as swelling of the face, tongue or throat, or difficulty swallowing, or hives, accompanied by difficulty breathing. Medicines containing estrogens may induce or worsen symptoms of angioedema.

 If a close relative has or ever had breast cancer.
 Si tiene epilepsia (see section 2, "Using Zoely with other medicines").
 If you have a liver disease (por ejemplo, jaundice) or gallbladder (por ejemplo,calculations).
 If you have diabetes.
 Si tiene depresión.
 If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
 If you have systemic lupus erythematosus (THE, a disease affecting your natural defense system).
 If you have HUS (SUH, a disorder of the blood clotting causing failure in the kidney).

 If you have sickle cell anemia (an inherited disease of RBCs).
 If you have high levels of blood fat (hypertriglyceridemia) or known family history of this condition. Hypertriglyceridemia has been associated with increased risk of pancreatitis (inflammation of the pancreas).
 If you need surgery or spend much time without standing (see section 2 "Blood clots").
 If you have just given birth are at higher risk of blood clots. You should ask your doctor when you can start taking Zoely after childbirth.
 If you have an inflammation of the veins beneath the skin (tromboflebitis superficial).
 If you have varicose veins.
 If you have a condition that occurred for the first time or worsened during pregnancy or previous use of sex hormones; por ejemplo: hearing loss, porphyria (a blood disease), herpes gestationis (rash with blisters during pregnancy), Sydenham chorea (a disease of the nerves in which sudden movements of the body occur), angioedema (hereditary). (See section 2, "When should you contact your doctor".)
 If you have (or have ever had) cloasma (pigmented stains golden brown, called
"Pregnancy patches", especially in the face). Then, avoid excessive exposure to sun or ultraviolet light.

BLOOD CLOTS

Using a combined hormonal contraceptive like Zoely increases your risk of a blood clot compared with not using. In rare cases a blood clot can block blood vessels and cause serious problems.

They may form blood clots:
 In the veins (what is called "venous thrombosis", “tromboembolia venosa” o TEV).
 In the arteries (what is called "arterial thrombosis", “tromboembolia arterial” o TEA).
The recovery of blood clots is not always complete. In rare cases there can be serious or lasting effects, very rarely, They can be deadly.
It is important to remember that the overall risk of a harmful blood clot due to Zoely is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek emergency medical attention if you notice any of the following signs or symptoms.
Do you experience any of these signs? What you may be suffering?
 swelling of a leg or foot or along a vein in the leg or
pie, especially when it is accompanied by:

  • Pain or tenderness in the leg, maybe it is noticed only when standing or walking.
  • Increased temperature in the affected leg.
  • Change skin color leg, p. not. if it gets pale, red or blue.
  • deep vein thrombosis

 Sudden shortness of breath with no known cause or rapid breathing.
 sudden coughing without a clear cause, you can drag blood.
 sharp chest pain that can increase deep breathing.
 intense lightheaded or dizzy.
 fast or irregular heartbeat.
 severe stomach pain.
If you are unsure, consult a doctor, as some of these symptoms such as cough or shortness of breath can be confused with a milder condition such as a respiratory infection (p. not. a "common cold").

pulmonary embolism

Symptoms that occur more often in one eye:

 immediate loss of vision, or
Painless  Blurred vision, which can progress to vision loss.

Retinal vein thrombosis (blood clot in the eye)

 Pain, discomfort, Pressure, heaviness in the chest.
 feeling of tightness or fullness in the chest, arm or below
breastbone.
 Feeling of fullness, indigestion or choking.
 Discomfort upper body radiating to the back, the jaw, throat, the arm and stomach.
 Sweating, nausea, vomiting or dizziness.
 Extreme weakness, anxiety or shortness of breath.
 Fast heartbeat or irregular.

Heart attack

 Sudden weakness or numbness of the face, arm or leg,
especially on one side of the body.
 Sudden confusion, difficulty speaking or understanding.
 Sudden trouble seeing in one or both eyes.
 Sudden trouble walking, dizziness, loss of balance or coordination.
 Sudden headache, intense and prolonged with no known cause.
 Loss of consciousness or fainting, with or without seizures.

Sometimes the symptoms of stroke can be brief, with an almost immediate and full recovery, but anyway should seek immediate medical attention as it may run the risk of having another stroke.

 Swelling and light blue coloration of a limb.
 severe stomach pain (acute abdomen).
Blood clots which block blood vessels other

Blood clots in A VEIN

What can happen if a blood clot forms in a vein?
 The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. They occur most frequently in the first year of use of a combined hormonal contraceptive.
 If a blood clot forms in a vein in the leg or foot, can cause deep vein thrombosis (TVP).
 If a blood clot travels from the leg and lodges in the lung can cause a pulmonary embolism.
 Very rarely can form a clot in a vein in another organ, as the eye
(Retinal vein thrombosis).
When is the greater the risk of a blood clot in a vein?
The risk of a blood clot in a vein is highest during the first year in which a combined hormonal contraceptive is taken for the first time. The risk may be greater if you re also start taking a combined hormonal contraceptive (the same product or a different product) after an interruption 4 weeks or more.
After the first year, the risk decreases, but it is always something greater than if you were not taking a combined hormonal contraceptive.
When you stop taking Zoely, your risk of a blood clot returns to normal within a few weeks.
What is the risk of a blood clot?
The risk depends on their natural risk of VTE and the type of combined hormonal contraceptive are taking.
The overall risk of developing a blood clot in the leg or in the lung (TVP of the EP) with Zoely is small.
 From each 10.000 women not using any combined hormonal contraceptive and are not pregnant, some 2 will present a blood clot in a year.
 From each 10.000 Women using a combined hormonal contraceptive containing levonorgestrel, norethindrone o norgestimato, some 5-7 will present a blood clot in a
year.
 It is not known yet how the risk of a blood clot with Zoely with risk compared with a combined hormonal contraceptive containing levonorgestrel.
 The risk of having a blood clot vary depending on your personal medical history (see "Factors that increase your risk of a blood clot" below).

Risk of a blood clot in a year

Women not using a combined hormonal pill and are not pregnant
Nail 2 each 10.000 women Women using a combined hormonal contraceptive pill containing levonorgestrel, norethindrone o norgestimato
Nail 5-7 each 10.000 women women using Zoely not yet known .

Factors that increase your risk of a blood clot in a vein
The risk of having a blood clot with Zoely is small, but some conditions increase the risk. Your risk is higher:
 If you are overweight (of body mass index or BMI over 30 kg / m
 If any of your close relatives has had a blood clot in the leg, lung or other body at an early age (ie, before 50 years approximately). In this case you may have an inherited disorder of blood clotting.
 If you need surgery or if a long time passes without standing due to injury or illness, or if you have leg cast. Perhaps you have to stop using Zoely several weeks before surgery or while you have less mobility. If you need to stop using Zoely ask your doctor when you can start using it again.
 With increasing age (especially above about 35 años).
 If you have given birth less than a few weeks ago.

The risk of a blood clot increases the more conditions have.
Air travel (> 4 hours) They can temporarily increase the risk of a blood clot, especially if any of the other risk factors listed.
It is important to tell your doctor if you experience any of the above conditions, although it is not safe. Your doctor may decide you need to stop using Zoely.
If any of the above conditions change while you are using Zoely, for example a close relative experiences a thrombosis with no known cause, or you gain a lot of weight, tell your
doctor.

Blood clots in an artery

What can happen if a blood clot forms in an artery?
As a blood clot in a vein, a clot in an artery can cause serious problems. Por ejemplo, it can cause a heart attack or stroke.
Factors that increase your risk of a blood clot in an artery
It is important to note that the risk of a heart attack or stroke by using Zoely is very
little, but can increase:
• With the age (above about 35 años).
• And smoke. When you use a combined hormonal contraceptive like Zoely you are advised to stop smoking. If not able to quit smoking and has more than 35 años, your doctor may advise you to use a different type of contraception.
• If you are overweight.
• If you have high blood pressure.
• If a close relative has had a heart attack or stroke at a young age (less than about 50 años). In this case you may also have increased risk of heart attack or stroke.
• If you or any of your close relatives has a high level of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (disorder valves, altered heart rhythm called atrial fibrillation).
• If you have diabetes.
If you have one or more of these conditions or if any of them is particularly serious, the risk of a blood clot may be increased even more.
If any of the above conditions change while you are using Zoely, for example start smoking, a close relative experiences a thrombosis with no known cause, or you gain a lot of
weight, tell your doctor.

Cancer

There have been cases of breast cancer slightly more often in women taking combination pills, but it is not known if this is caused by the combined pills. Por
example, it may be that more tumors are detected in women taking combined pills because they are examined more frequently by the doctor. After stopping the combined pill, el
increased risk gradually decreases.

It is important to regularly check the breasts and consult your doctor if you notice any lumps.
You should also tell your doctor if a close relative has or has ever had breast cancer (see section 2, "When to take special care with Zoely").
In rare cases, in women taking pills, Benign tumors have been reported (noncancerous) liver and, even more exceptional cases, malignant tumors (cancerous) liver. Contact
with your doctor if you have an exceptionally severe abdominal pain.
Cervical cancer is caused by infection with the human papillomavirus (HPV). It has been reported that occurs more often in women using the pill for more than 5 años. It is not known whether this observation is due to the use of hormonal contraceptives or to other factors, as the difference in sexual behavior.

Laboratory analysis

If you do any blood or urine, tell your doctor that you are taking Zoely, because it can affect the results of some tests.

Children and adolescents

There are no data on safety and efficacy in adolescents under 18 años.
Zoely use with other medicines Tell your doctor or pharmacist if you are taking, ha tomado recientemente o podría tener que tomar cualquier otro medicamento, even those without a prescription and herbal medicines.

Likewise, inform any other doctor or dentist who prescribes another medicine (or farmacéutico this the pantry and medicine) that you take Zoely. They can tell if you have to take some other additional contraceptive precautions (barrier method) and, if so, how long.
 There are medicines that can make Zoely less effective in preventing pregnancy, or can cause unexpected bleeding. These include drugs to treat the following diseases:

  1. epilepsy (por ejemplo, primidona, phenytoin, phenobarbital, carbamazepine, oxcarbamazepina, topiramate, felbamato);
    tuberculosis (por ejemplo, rifampicin);
  2. HIV infection (por ejemplo, ritonavir, nevirapina, nelfinavir, efavirenz);
  3. other infectious diseases (por ejemplo, griseofulvina);
  4. high pressure in the blood vessels of the lungs (bosentan).

 The medicinal plant called Hypericum or St. John's wort can also make Zoely stop working properly. If you want to use herbal products that containing hypericum while you are using Zoely, you should consult with your doctor.
 Some medications can increase levels of the active ingredients of Zoely in the blood. The effectiveness of the pill remains, but tell your doctor if you are using medicine to treat fungal infections containing ketoconazole.
 Zoely may also interfere with the function of other medications, as antiepileptic lamotrigine called.

Pregnancy and lactation

Women who are pregnant or who believe they may be pregnant should not use Zoely. If pregnant while using Zoely stays, You stop taking it and contact your doctor.
If you want to stop taking Zoely because you want to get pregnant, see section 3, "If you stop taking Zoely".
generally it not recommended the use of Zoely during lactation. If you want to use the pill while breastfeeding, ask your doctor.
Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Zoely influence on the ability to drive or operate machinery has no or negligible.

Zoely contains lactose

Zoely contains lactose. If your doctor has told you have an intolerance to some sugars,
Consult your doctor before taking this medicine.

3. Using Zoely

When and how to take the tablets

The Zoely blister contains 28 tablets: 24 white tablets with active ingredients (numbers 1 a,en 24) and four yellow tablets without active ingredients (numbers 25 a,en 28).
Each time you start a new blister of Zoely, take white active tablet, identified by the number 1, in the top left-hand corner (see "Home"). Choose from seven stickers with day indicators, the gray column that begins with your starting day.

Por ejemplo, if you start on a Wednesday, use sticker weekdays indicating "WED". Paste it into the blister, just above the row of white active tablets, where it says "Place day label here
of the week". This allows you to check whether he took his daily tablet.
Take one tablet each day, approximately the same time; if required, with a little water. Follow the direction of the arrows on the blister, so use the white active tablets first, and
after, yellow placebo tablets.
Your period will begin during the four days of taking the yellow placebo tablets (this period is called withdrawal bleeding). Generally, will start two to three days
after the last white active tablet and you may not have finished before the next blister.
Start taking the next blister immediately after the last yellow tablet, even if your period has not finished. This means you will always start a new blister on the same day of the week, and also have approximately the same menstruation days, each month.

Some users may not have menstruation every month while taking the yellow tablets. If you have taken Zoely every day according to these instructions, It is unlikely to be pregnant (see also section 3, "If you have stopped having one or two periods").

Beginning of its first container of Zoely

If you have not used any hormonal contraceptive in the past month Start taking Zoely on the first day of your cycle (ie, the first day of your period). Zoely will act immediately. No need to use an additional contraceptive method.
Changing from another combined hormonal contraceptive (combined pill, vaginal ring or transdermal patch)

You can start taking Zoely the day after taking the last tablet in the current blister pills (this means that no interruption in making tablets). If the current blister pills also contains inactive tablets (placebo), you can start Zoely the day after you take the last active tablet (if you are not sure what is, ask your doctor or pharmacist). You can also start later, but not later than the day following the disruption of the pills you are taking now (or the day after the last inactive tablet its current pill). In case you use a vaginal ring or transdermal patch, it is best to start using Zoely the day remove the ring or patch.

You can also start, later than, the day had started using the next ring or patch.
If you follow these instructions, You do not need to use an additional contraceptive method.

You are changing from a progestogen-only pill containing (minipíldora)

You can stop taking the minipill any day and start taking Zoely the next day. But if you have sex, make sure you also use a barrier method of contraception during
the first seven days you are taking Zoely.

If you change from an injectable that contains only progestin, implant or hormone medicated intrauterine system

Start using Zoely when you play the next shot or the day you remove the implant or intrauterine system. But if you have sex, be sure to use a method
barrier contraceptive during the first seven days you are taking Zoely.

He is having had a child

You can start taking Zoely between 21 and 28 days after giving birth. If you start after the 28th day, You should also use a barrier method of contraception during the first seven days of Zoely use.
Yes, after giving birth, He has had sex before you start taking Zoely, make sure you are not pregnant or wait until the next menstruation. If you want to start taking Zoely
after giving birth and breastfeeding, Also read the section 2 "Pregnancy and lactation".

If you are not sure when to start, ask your doctor.

After spontaneous or induced abortion

Follow the advice of your doctor.

If you take more Zoely than you should

There have been no reports of serious harmful effects from taking too many Zoely tablets at once. If you have taken several tablets at a time, You may have nausea, vomiting or vaginal bleeding.
If you discover that a child has taken Zoely, seek advice from your doctor.

If you forget to take Zoely

The following advice only refers to white active tablets have forgotten to take.
 If you have been less than 24 hours from the time you forget to take a tablet, the reliability of the pill remains. Take the tablet barely remember and, then, take the
next tablets at the usual time.

 If it has been more than 24 hours from the time you forget to take a tablet, the reliability of the pill may be reduced. The more consecutive tablets have forgotten, the greater the risk that the contraceptive efficacy is reduced. There is a particularly high risk of becoming pregnant if you miss white active tablets take the start or the end of the blister. Therefore, You should follow the instructions.
Day 1 a,en 7 of taking the white active tablets (see Figure and schema)
Take the last white tablet Active forget to take barely remember (although this
means taking two tablets at once) and take the next tablet at the usual time. Without
embargo, use a barrier method, as an additional precautionary measure, over the next seven
days.
If you have had sex in the previous week to forget to take your tablets,
there is a possibility of becoming pregnant. Consult your doctor immediately.
Day 8 a,en 17 of taking the white active tablets (see Figure and schema)
Take the last tablet forget to take barely remember (even if this means taking two
tablets at once) and take these tablets at the usual time. Protection against
pregnancy is not reduced, and not have to take extra precautions more. Nevertheless, if has
I forgot to take more than one tablet, should adopt additional precautions for seven days.
Day 18 a,en 24 of taking the white active tablets (see Figure and schema)
There is a particularly high risk of becoming pregnant if you miss taking white tablets
active near the range of the yellow placebo tablets. This higher risk may be
if you set your calendar to avoid making tablets.

You can continue two options:

First option:Take the last white active tablet forgotten to take, barely remember (even if this means taking two tablets at once) and take these tablets at the usual time.
Start the next blister just white active tablets in the current blister are completed, ie, skip the yellow placebo tablets. You may not have your period until you take
yellow placebo tablets at the end of the second blister, but may have spotting (drops or spotting) a metrorragia Intermenstrual (bleeding between two rules) while taking
white active tablet.

Second option:
Immediately stop taking the white active tablet and go directly to the range of yellow placebo tablets. At the end of this interval, start with the next blister.

If you can not remember how many white active tablets you have forgotten to take, follow the first option, use a barrier method as a precaution for the next seven days, and
ask your doctor.

If you have forgotten to take white active tablets in a blister pack and no monthly menstruation expected while taking the yellow placebo tablets from the same blister, you may be pregnant. Consult your doctor before starting the next blister.

If you forget the yellow placebo tablets

The last four yellow tablets of the fourth row are placebo tablets not containing active substances. If you forget to take one of these tablets, reliability is maintained Zoely. pull (the) compressed(s,en) yellow placebo have forgotten to take and continue to take the next tablets at the usual time.

If you vomit or have severe diarrhea

If you vomit within three or four hours following the time it took a white active tablet, or you have severe diarrhea, perhaps the active ingredients of the tablet not been absorbed Zoely
completely in the body. This situation is similar to if you forget to take a white active tablet. After vomiting or diarrhea, You must take, as soon as possible, an active white tablet blister reserve.

If possible, Take it in 24 after hours when it normally takes the pill. Take the next tablet at the usual time. If this is not possible or if it has been 24 hours, You should follow the recommendation under "If you forget to take Zoely".

If you have severe diarrhea, see the doctor.

The yellow tablets are placebo and contain active principles. If you vomit or have severe diarrhea in three to four hours of the time it took a yellow tablet, the
reliability is maintained Zoely.

If you want to delay your period

You can delay your period not taking the yellow placebo tablets and going straight to a new blister of Zoely. It may be slightly or bleeding similar to that of the
menstruation while using this second blister. When you want to start menstruation during the second blister, stop taking the white active tablets and start taking the tablets
yellow placebo. After finishing the four yellow placebo tablets from the second blister, start with the next blister (the third).

To change the starting day of your period

If you take the tablets according to the instructions, menstruation starts during the days of taking the placebo. If you have to change this day, reduce the number taking placebo, ie, when you take the yellow placebo tablets (No never increase; the maximum is four). Por ejemplo, if you start taking the placebo tablets on Friday, and you want to change to Tuesday (Three days before), You should start a new blister three days earlier than usual. Perhaps not present bleeding during the shortened period taking the yellow placebo tablets.
While using the next blister, may present some spotting (drops or spotting) or breakthrough bleeding on days take white active tablet.
If you are not sure what to do, see the doctor.

If you have unexpected bleeding

With all combined pills, during the first months, You can have some irregular vaginal bleeding (oligometrorragia o metrorragia intermenstrual) between periods. You may need to use a sanitary protection, but keep taking the tablets as usual. Irregular vaginal bleeding usually stops once the body has adjusted to the pill (usually, after about three months).

If bleeding continues, It becomes heavy or starts again, ask your doctor.

If you have stopped having one or more periods

In clinical studies it has been observed Zoely that may, sometimes, not have regular monthly menstruation after the 24th day.
 If you have taken all tablets correctly, He has not been vomiting or severe diarrhea, and has not taken any other medicines, then it is very unlikely to be pregnant.
Keep taking Zoely as usual. See also section 3, "If you vomit or have severe diarrhea 'or, the section 2, "Using Zoely with other medicines".
 If you have not taken the tablets correctly or if menstruation takes two consecutive expected, you may be pregnant. Contact your doctor immediately. No
start the next blister of Zoely until your doctor has checked you are not pregnant.

If you stop taking Zoely

You can stop taking Zoely at any time. If you do not want to get pregnant, ask your doctor first about other contraceptive methods.
If you have stopped taking Zoely because you want to get pregnant, It is advised to wait until you have had a natural period before trying to conceive. This will help you determine
when the child will be born.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effects, especially if severe and persistent, or have any health change thought to be due to Zoely, ask your doctor.
All women taking combined hormonal contraceptives are at increased risk of blood clots in the veins (VTE [TEV]) or blood clots in the
arteries (tromboembolia arterial [TEA]). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 "What you need to know before
start using Zoely ".

The following adverse effects have been associated with the use of Zoely:
Very common (may affect more than 1 each 10 people):
 acne;
 menstrual changes (por ejemplo, absence or irregularity);
FAQ (may affect up 1 each 10 people):
 decreased sexual desire, depression or depressed mood, mood swings;
 headache or migraine;
 feeling sick (nausea);
 heavy menstruation, breast pain, pelvic pain;
 weight gain.
Uncommon (may affect up 1 each 100 people):
 increased appetite, fluid retention (edema);
 hot flushes;
 swelling of the abdomen;
 increased sweating, Hair loss, itching, dry skin, oily skin;
 heavy limbs;
 regular but scanty menses, larger breasts, breast lump, production
milk when not pregnant, premenstrual syndrome, pain during intercourse
sexual, dryness of the vagina or vulva, uterine spasm;
 irritability;
 increased liver enzymes.
Rare (may affect up 1 each 1.000 people):
 harmful blood clots in a vein or artery, por ejemplo:
or a leg or foot (ie, TVP);
or a lung (ie, EP);
or heart attack;
or stroke;
or mild stroke or temporary symptoms similar to those of a stroke, what it is called a transient ischemic attack (AIT); or blood clots in the liver, stomach / intestine, kidney or eye.

The chances of having a blood clot may be higher if you have any condition that increases the risk (see section 2 for more information about conditions that increase the risk of blood clots and the symptoms of a blood clot).

 decreased appetite;
 increased sex drive;
 attention disorder;
 dry eyes, intolerance to contact lenses;
 dry mouth;
 pigmented spots golden brown, especially in the face; excessive hair growth
 vaginal odor, discomfort in the vagina or vulva;
 hunger;
 gallbladder disease.

Allergic reactions have been reported (hypersensitivity) in users of Zoely, but their frequency can not be estimated from available data.
You can find more information about changes in menstrual periods (por ejemplo, absent or irregular) as a possible side effect while using Zoely in section 3, "When and how to take the tablets", "If you have unexpected bleeding 'and' If you have stopped having one or more periods".

Communication adverse effects

If you experience any adverse effect, ask your doctor, pharmacist or nurse, even if it is possible side effects not listed in this leaflet. also can
communicate directly via the national reporting system listed in Appendix V. By communicating adverse effects you can help provide more information
on the safety of this drug.

5. Conservation Zoely

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date on the blister and carton, after EXP / CAD. The expiry date is the last day of that month.
It does not require any special storage conditions.
Combination pills (including tablets Zoely) which are no longer required should not be disposed of via wastewater or the municipal sewage system. The hormonal active ingredients of the tablet may have harmful effects if they reach the aquatic environment. Return them to a pharmacy or dispose of otherwise safe, according to local regulations. Thus, help protect the environment.

6. Package contents and additional information

Composition of Zoely

– The (the) beginning(s,en) active(s,en) this is (its): nomegestrol acetate and estradiol.
Coated tablets white active film: Each tablet contains 2,5 mg of nomegestrol acetate and 1,5 mg estradiol (como hemihidrato).
Yellow film-coated tablets with placebo: the tablet does not contain active ingredients.
– The other ingredients are: Tablet core (white film coated active and yellow placebo tablets): lactose monohydrate (see section 2, "Zoely contains lactose"), microcrystalline cellulose (E460), crospovidona (E1201), talc (E553b), magnesium stearate (E572) and colloidal anhydrous silica.

Tablet coating (coated tablets white active film): polivinil alcohol (E1203), titanium dioxide (E171), macrogol 3350 and talc (E553b).
Tablet coating (yellow film-coated tablets placebo): polivinil alcohol (E1203), titanium dioxide (E171), macrogol 3350, talc (E553b), yellow iron oxide (E172) and black iron oxide (E172).

Looks like and contents of container

Film-coated tablets assets (tablets) They are white and round, and have the code "ne" on both sides.
The placebo film-coated tablets are yellow and round, and have the code "p" on both sides.
Zoely comes in blister packs of 28 Film-coated tablets (24 film coated tablets white active and 4 yellow film-coated tablets
placebo), packed in a cardboard box.

Package sizes: 28, 84, 168 and 364 Film-coated tablets.
Can be marketed pack sizes.
Holder of the authorizing responsible for placing and manfacture
Holder of the marketing authorization
Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Responsible for manufacturing
Organon (Ireland) Limited
Drynam Road
Swords
What. Dublin
Ireland
Delpharm Lille S.A.S.
Z.I. Roubaix East
Rue de Toufflers
59390 Lys-lez-Lannoy
France

Teva Operations Poland Sp. with o.o..
the. Mogilska 80
31-546 Krakow
Polonia
NV. Organon
Kloosterstraat 6
5349 AB Oss
Netherlands

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Netherlands

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