Zoely 2.5 mg/1.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zoely 2.5mg/1.5mg film-coated tablets

Nomegestrol acetate / Estradiol

This medicinal product is subject to additional monitoring, which will allow for faster identification of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.

Important information you should know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 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 taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Zoely is and what it is used for
2. What you need to know before you start using Zoely
3. How to use Zoely
4. Possible side effects
5. How to store Zoely
6. Contents of the pack and other information

1. What Zoely is and what it is used for

Zoely is a contraceptive pill used to prevent pregnancy.

• The 24 white film-coated tablets are active tablets containing a small amount of two different female hormones: nomegestrol acetate (a progestogen) and estradiol (an oestrogen).
• The four yellow tablets are inactive tablets that do not contain hormones and are called placebo tablets.
• Contraceptive pills that contain two different hormones, such as Zoely, are called "combined pills".
• The estradiol in Zoely, the oestrogen, is identical to the hormone produced by your ovaries during a menstrual cycle.
• The nomegestrol acetate in Zoely, the progestogen, is derived from progesterone, a hormone produced by the ovaries during a menstrual cycle.

2. What you need to know before using Zoely

General considerations

Before starting to use Zoely, you must read the information about blood clots (thrombosis) in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).

Before you start taking Zoely, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out other tests.

This leaflet describes several situations in which you should stop taking the pill or in which the pill’s effectiveness may be reduced. In such situations, you should not have sexual intercourse or you should use additional non-hormonal contraceptive precautions, for example, using a condom or another barrier contraceptive method. Do not use rhythm or temperature methods. These methods may not be reliable because the pill alters the usual changes in body temperature and cervical mucus that occur during the menstrual cycle.

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

When not to use Zoely

Do not use Zoely if you have any of the conditions listed below. Inform 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 suitable.

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.

• If you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.

• If you need surgery or if you are going to be immobile for a long time (see section “Blood clots”).

• If you have ever had a heart attack or stroke.

• If you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).

• If you have any of the following conditions that may increase your risk of developing a clot in the arteries.

• severe diabetes with blood vessel damage;

• very high blood pressure;

• very high levels of fat in the blood (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 have had) pancreatitis (inflammation of the pancreas) related to high levels of fat in the blood.

• If you have (or have had) a serious liver disease and your liver is still not functioning normally.

• If you have (or have had) a benign or malignant liver tumour.

• If you have (or have had) or may have breast cancer or cancer of the genital organs.

• If you have any unexplained vaginal bleeding.

• If you are allergic to estradiol, nomegestrol acetate, or any of the other ingredients of this medicine (listed in section 6).

If any of these conditions occur for the first time while you are taking Zoely, stop taking it immediately and consult your doctor. In the meantime, use a non-hormonal contraceptive method. See also “General notes” in section 2 above.

When to be especially careful with Zoely

When should you consult your doctor?

Seek urgent medical help

• If you notice possible signs of a blood clot which may mean you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clot” below).

For a description of the symptoms of these serious adverse effects, see “How to recognize a blood clot”.

• If you notice any change in your health, especially affecting any of the conditions mentioned in this leaflet (see also section 2, “When not to use Zoely”; do not forget changes in your immediate family’s health).
• If you notice a lump in your breast.
• If you experience symptoms of angioedema, such as swelling of the face, tongue, or throat, difficulty swallowing, hives, accompanied by difficulty breathing.
• If you are going to use other medicines (see section 2, “Use of Zoely with other medicines”).
• If you are going to be immobile or undergo surgery (inform your doctor at least four weeks in advance).
• If you experience unusual and heavy vaginal bleeding.
• If you have missed one or more tablets in the first week of the blister pack and have had unprotected sex in the previous seven days (see also section 3, “If you forgot to take Zoely”).
• If you have severe diarrhoea or severe vomiting.
• If you miss your period and suspect you are pregnant (do not start the next pack until your doctor tells you to; see also section 3, “If you have missed one or two periods”).

Inform your doctor if you have any of the following conditions.

If the condition develops or worsens while you are using Zoely, you must also inform your doctor.

• If you have hereditary angioedema. Seek immediate medical advice if you experience symptoms of angioedema, such as swelling of the face, tongue, or throat, difficulty swallowing, hives, accompanied by difficulty breathing. Medicines containing oestrogens may induce or worsen angioedema symptoms.

• If a close relative has or has ever had breast cancer.

• If you have epilepsy (see section 2, “Use of Zoely with other medicines”).

• If you have liver disease (e.g., jaundice) or gallbladder disease (e.g., gallstones).

• If you have diabetes.

• If you have depression.

• If you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease).

• If you have systemic lupus erythematosus (SLE, a disease affecting your body’s natural defence system).

• If you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure).

• If you have sickle cell anaemia (an inherited red blood cell disorder).

• If you have high levels of fat in the blood (hypertriglyceridaemia) or a known family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).

• If you need surgery or are immobile for long periods (see section 2 “Blood clots”).

• If you have recently given birth, you are at increased risk of blood clots. Ask your doctor when you can start taking Zoely after childbirth.

• If you have inflammation of veins beneath the skin (superficial thrombophlebitis).

• If you have varicose veins.

• If you have a condition that first occurred or worsened during pregnancy or previous use of sex hormones; for example: hearing loss, porphyria (a blood disorder), herpes gestationis (blistering skin rash during pregnancy), Sydenham’s chorea (a nerve disorder causing sudden, jerky movements), angioedema (hereditary). (See section 2, “When to consult your doctor”.)

• If you have (or have ever had) chloasma (brownish-yellow pigmentation, known as “pregnancy mask”, especially on the face). In this case, avoid excessive exposure to sunlight or ultraviolet light.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Zoely increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots may form:

• In veins (called “venous thrombosis,” “venous thromboembolism,” or VTE).
• In arteries (called “arterial thrombosis,” “arterial thromboembolism,” or ATE).

Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, or, very rarely, they may be fatal.

It is important to remember that the overall risk of developing a harmful blood clot due to Zoely is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you experience any of the following signs or symptoms.

Are you experiencing any of these signs?	What could you be suffering from?
Swelling in one leg or foot, or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticeable when standing or walking. Increased warmth in the affected leg. Change in skin color of the leg, e.g., turning pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing. Sudden cough without clear cause, possibly bringing up blood. Sharp chest pain that may worsen when breathing deeply. Severe dizziness or lightheadedness. Rapid 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, may be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision, or Painless blurred vision, which may 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 the sternum. Feeling of fullness, indigestion, or suffocation. Upper body discomfort spreading to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Extreme weakness, anxiety, or shortness of breath. Rapid or irregular heartbeat.	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 speech. Sudden vision problems in one or both eyes. Sudden difficulty walking, dizziness, loss of balance or coordination. Sudden, severe, and prolonged headache without known cause. Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of a limb. Severe stomach pain (acute abdomen).	Blood clots blocking other blood vessels

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 veins (venous thrombosis). However, these adverse effects are rare. They occur more frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in a vein of another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein higher?

The risk of developing a blood clot in a vein is higher during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be increased if you restart taking a combined hormonal contraceptive (the same product or a different one) after a break of 4 weeks or more.

After the first year, the risk decreases but remains somewhat higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Zoely, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive you are taking.

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Zoely is small.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
• It is not yet known how the risk of blood clot with Zoely compares to the risk with a combined hormonal contraceptive containing levonorgestrel.
• Your risk of developing a blood clot will vary depending on your personal medical history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal contraceptive pill and who are not pregnant	About 2 in 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5–7 in 10,000 women
Women who use Zoely	Not yet known

Factors that increase your risk of a blood clot in a vein

The risk of developing a blood clot with Zoely is small, but certain conditions increase this risk. Your risk is higher:

• If you are overweight (body mass index or BMI above 30 kg/m²).
• If any of your close relatives have had a blood clot in the leg, lung, or another organ at a young age (i.e., before the age of approximately 50). In this case, you may have an inherited blood clotting disorder.
• If you require surgery or will be immobile for a long time due to injury or illness, or if your leg is in a cast. You may need to stop taking Zoely several weeks before surgery or during periods of reduced mobility. If you need to stop taking Zoely, ask your doctor when you can start taking it again.
• With increasing age (especially over about 35 years).
• If you have given birth within the last few weeks.

The risk of developing a blood clot increases the more of these conditions you have.

Air travel (> 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed above.

It is important to inform your doctor if you have any of the conditions listed above, even if you are unsure. Your doctor may decide that you should stop taking Zoely.

If any of the conditions listed above change while you are using Zoely—for example, if a close relative experiences a thrombosis without a known cause, or if you gain significant weight—inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can lead to 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 while using Zoely is very small, but it may increase:

• With age (especially over about 35 years).
• If you smoke. You are advised to stop smoking when using a combined hormonal contraceptive such as Zoely. If you are unable to stop smoking and are over 35 years old, your doctor may recommend that you use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you suffer from migraines, especially migraines with aura.
• If you have a heart condition (valve disorder, a heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

If you have one or more of these conditions, or if any of them are particularly severe, your risk of developing a blood clot may be further increased.

If any of the conditions listed above change while you are using Zoely—for example, if you start smoking, a close relative experiences a thrombosis without a known cause, or you gain significant weight—inform your doctor.

Cancer

Cases of breast cancer have been observed at a slightly increased frequency in women taking combined oral contraceptives, but it is not known whether this is caused by the combined pills. For example, more tumors may be detected in women taking combined oral contraceptives because they are examined more frequently by their doctor. After stopping the combined oral contraceptive, the increased risk gradually decreases.

It is important to regularly examine your breasts and consult your doctor if you notice any lump. You should also inform your doctor if a close relative has or has ever had breast cancer (see section 2, "When you must be cautious with Zoely").

Rarely, benign (non-cancerous) liver tumors have been reported in women taking oral contraceptives, and even more rarely, malignant (cancerous) liver tumors. Contact your doctor if you experience unusually severe abdominal pain.

Cervical cancer is caused by infection with human papillomavirus (HPV). It has been reported to occur more frequently in women who use oral contraceptives for more than 5 years. It is not known whether this observation is due to the use of hormonal contraceptives or to other factors, such as differences in sexual behavior.

Laboratory tests

If you are undergoing any blood or urine tests, inform your doctor that you are taking Zoely, as it may affect the results of certain laboratory tests.

Children and adolescents

There are no data available on safety and efficacy in adolescents under 18 years of age.

Use of Zoely with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription and herbal medicines.

Likewise, inform any other doctor or dentist who prescribes you another medicine (or the pharmacist dispensing the medicine) that you are taking Zoely. They can advise you whether you need to use additional contraceptive precautions (barrier method), and if so, for how long.

• Some medicines may reduce the effectiveness of Zoely in preventing pregnancy or may cause unexpected bleeding. These include medicines used to treat the following conditions:

• epilepsy (e.g., primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate);

• tuberculosis (e.g., rifampicin);

• HIV infection (e.g., ritonavir, nevirapine, nelfinavir, efavirenz);

• other infectious diseases (e.g., griseofulvin);

• high blood pressure in the blood vessels of the lungs (bosentan).

• The herbal remedy called St. John’s wort (Hypericum perforatum) may also cause Zoely to stop working properly. If you wish to use herbal products containing St. John’s wort while using Zoely, you must consult your doctor first.

• Some medicines may increase blood levels of the active substances in Zoely. The contraceptive efficacy remains, but inform your doctor if you are taking antifungal medicines containing ketoconazole.

• Zoely may also interfere with the action of other medicines, such as the antiepileptic lamotrigine.

Pregnancy and breastfeeding

Women who are pregnant or think they might be pregnant should not use Zoely. If you become pregnant while taking Zoely, you must stop taking it and contact your doctor.

If you wish to stop taking Zoely because you want to become pregnant, refer to section 3, “If you stop taking Zoely”.

The use of Zoely during breastfeeding is generally not recommended. If you wish to use the pill while breastfeeding, consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Zoely contains lactose

Zoely contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to use Zoely

When and how to take the tablets

The Zoely blister pack contains 28 tablets: 24 white active tablets (numbered 1 to 24) and four yellow inactive tablets (numbered 25 to 28).

Each time you start a new Zoely blister pack, take the active white tablet marked number 1 in the upper left corner (see "Starting"). Select from the seven day-of-the-week stickers the one in the grey column that starts with your chosen starting day. For example, if you start on a Wednesday, use the sticker showing “WED”. Apply it to the blister pack, directly above the row of active white tablets, where it says “Place day-of-the-week label here”. This helps you keep track of whether you have taken your daily tablet.

Take one tablet every day, approximately at the same time; if necessary, with a little water.

Follow the direction of the arrows on the blister pack, using first the active white tablets, followed by the yellow placebo tablets.

Your period will start during the four days you take the yellow placebo tablets (this bleeding is called withdrawal bleeding). It usually begins two to three days after the last active white tablet, and may not have finished before you start the next pack.

Start the next pack immediately after taking the last yellow tablet, even if your period has not ended. This means you will always start a new pack on the same day of the week, and your period will occur approximately on the same days each month.

Some users may not have a period every month while taking the yellow placebo tablets. If you have taken Zoely every day as instructed, it is unlikely that you are pregnant (see also section 3, “If you have missed one or two periods”).

Starting your first pack of Zoely

If you have not used any hormonal contraceptive in the previous month

Start taking Zoely on the first day of your cycle (i.e., the first day of your period). Zoely will work immediately. You do not need to use an additional contraceptive method.

If switching from another combined hormonal contraceptive (combined pill, vaginal ring, or transdermal patch)

You may start taking Zoely the day after taking the last tablet of your current pill pack (meaning there is no break between pill packs). If your current pill pack also contains inactive (placebo) tablets, you may start Zoely the day after taking the last active tablet (if you are unsure which one this is, consult your doctor or pharmacist). You may also start later, but never later than the day after the break from your current pills (or the day after the last inactive tablet of your current pill pack). If you are using a vaginal ring or transdermal patch, it is best to start Zoely on the day you remove the ring or patch. You may also start, at the latest, on the day you would have started the next ring or patch.

If you follow these instructions, you do not need to use an additional contraceptive method.

If switching from a progestogen-only pill (mini-pill)

You may stop taking the mini-pill on any day and start taking Zoely the following day. However, if you have sexual intercourse, make sure to also use a barrier contraceptive method during the first seven days of taking Zoely.

If switching from a progestogen-only injectable, implant, or hormone-releasing intrauterine system

Start using Zoely on the day your next injection is due, or on the day your implant or intrauterine system is removed. However, if you have sexual intercourse, make sure to also use a barrier contraceptive method during the first seven days of taking Zoely.

After childbirth

You may start taking Zoely between 21 and 28 days after giving birth. If you start after the 28th day, you must also use a barrier contraceptive method during the first seven days of taking Zoely. If you have had sexual intercourse after childbirth before starting Zoely, ensure you are not pregnant or wait until your next period. If you wish to start taking Zoely after childbirth and are breastfeeding, also read section 2 “Pregnancy and breastfeeding”.

If you are unsure when to start, consult your doctor.

After a spontaneous or induced abortion

Follow your doctor’s advice.

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 once, you may experience nausea, vomiting, or vaginal bleeding. If you find that a child has taken Zoely, seek advice from your doctor.

If you forget to take Zoely

The following advice applies only to forgotten active white tablets.

• If less than 24 hours have passed since you missed a tablet, contraceptive reliability remains intact. Take the missed tablet as soon as you remember, then take the following tablets at your usual time.
• If 24 hours or more have passed since you missed a tablet, contraceptive reliability may be reduced. The more consecutive tablets you miss, the greater the risk of reduced contraceptive effectiveness. The risk of pregnancy is especially high if you miss white active tablets at the beginning or end of the pack. Therefore, follow the instructions below.

Days 1 to 7 of taking active white tablets (see figure and diagram)

Take the last missed active white tablet as soon as you remember (even if this means taking two tablets at once), and take the next tablet at your usual time. However, use a barrier contraceptive method, for example, a condom, as an additional precaution until you have taken tablets correctly for seven consecutive days.

If you had sexual intercourse in the week before missing tablets, there is a possibility you may be or become pregnant. Consult your doctor immediately.

Days 8 to 17 of taking active white tablets (see figure and diagram)

Take the last missed tablet as soon as you remember (even if this means taking two tablets at once), and take the following tablets at your usual time. If you have taken tablets correctly for the previous seven days before the missed tablet, pregnancy protection is not reduced, and you do not need additional precautions. However, if you have missed more than one tablet, use a barrier contraceptive method, for example, a condom, as an additional precaution until you have taken tablets correctly for seven consecutive days.

Days 18 to 24 of taking active white tablets (see figure and diagram)

There is a particularly high risk of pregnancy if you miss active white tablets close to the placebo tablet interval. This increased risk can be avoided by adjusting your tablet-taking schedule.

You may follow either of the two options below. You do not need additional precautions if you have taken tablets correctly during the seven days before the missed tablet. If not, you must follow the first option and use a barrier contraceptive method, for example, a condom, as an additional precaution until you have taken tablets correctly for seven consecutive days.

1st option:

Take the last missed active white tablet as soon as you remember (even if this means taking two tablets at once), and take the following tablets at your usual time. Start the next pack immediately after finishing the active white tablets in the current pack, i.e., skip the yellow placebo tablets. You may not have your period until you take the placebo tablets at the end of the second pack, but you may experience breakthrough bleeding (spotting or light bleeding) or intermenstrual bleeding (bleeding between periods) while taking the active white tablets.

2nd option:

Stop taking the active white tablets and start taking the yellow placebo tablets for up to three days, so that the total number of placebo tablets plus active white tablets taken is not more than four. At the end of this interval, start the next pack.

If you cannot remember how many active white tablets you have missed, follow the first option, use a barrier contraceptive method, for example, a condom, as an additional precaution until you have taken tablets correctly for seven consecutive days, and consult your doctor (as you may not have been protected against pregnancy).

If you have missed active white tablets from a pack and do not have your expected monthly period while taking the yellow placebo tablets of the same pack, you may be pregnant. Consult your doctor before starting the next pack.

If you forget the yellow placebo tablets

The last four yellow tablets in the fourth row are placebo tablets that do not contain active ingredients. If you forget to take one of these tablets, the reliability of Zoely remains unchanged. Discard the missed yellow placebo tablet(s) and continue taking the following tablets at your usual time.

Figure

Calendar: If 24 hours or more have passed since you were due to take the white tablets

If you vomit or have severe diarrhoea

If you vomit within three to four hours after taking an active white tablet, or if you have severe diarrhoea, the active ingredients in your Zoely tablet may not have been fully absorbed. This situation is similar to missing an active white tablet. After vomiting or having severe diarrhoea, take an active white tablet from a spare pack as soon as possible. If possible, take it within 24 hours of your usual pill-taking time. Take the next tablet at your usual time. If this is not possible or if more than 24 hours have passed, follow the advice under “If you forget to take Zoely”. If you have severe diarrhoea, consult your doctor.

The yellow tablets are placebos and do not contain active ingredients. If you vomit or have severe diarrhoea within three to four hours after taking a yellow tablet, the reliability of Zoely remains unchanged.

If you wish to delay your period

You can delay your period by not taking the yellow placebo tablets and moving directly to a new Zoely pack. You may experience light bleeding or period-like bleeding while using this second pack. When you want your period to start during the second pack, stop taking the active white tablets and start taking the yellow placebo tablets. After finishing the four yellow placebo tablets of the second pack, start the next (third) pack.

If you wish to change the day your period starts

If you take the tablets as instructed, your period will start during the days you take the placebo tablets. If you need to change this day, shorten the number of days you take the placebo tablets (i.e., when you take the yellow placebo tablets), but never extend it (maximum is four days). For example, if you usually start the placebo tablets on Friday and wish to change to Tuesday (three days earlier), you should start a new pack three days earlier than usual. You may not have bleeding during the shortened placebo interval. While using the next pack, you may experience some breakthrough bleeding (spotting or light bleeding) or intermenstrual bleeding on the days you take the active white tablets.

If you are unsure what to do, consult your doctor.

If you have unexpected bleeding

With all combined pills, during the first few months, you may experience some irregular vaginal bleeding (breakthrough bleeding or intermenstrual bleeding) between periods. You may need to use sanitary protection, but continue taking the tablets as usual. Irregular vaginal bleeding usually stops once your body adjusts to the pill (usually after about three months). If bleeding continues, becomes heavy, or starts again, consult your doctor.

If you have missed one or more periods

In clinical studies with Zoely, it has been observed that occasionally you may not have your regular monthly period after day 24.

• If you have taken all tablets correctly, have not experienced vomiting or severe diarrhoea, and have not taken any other medication, it is very unlikely that you are pregnant. Continue taking Zoely as usual. Also refer to section 3, “If you vomit or have severe diarrhoea” or section 2, “Use of Zoely with other medicines”.
• If you did not take the tablets correctly or if your expected period is missed twice in a row, you may be pregnant. Contact your doctor immediately. Do not start the next Zoely pack until your doctor has confirmed you are not pregnant.

If you stop taking Zoely

You may stop taking Zoely at any time. If you do not wish to become pregnant, consult your doctor about other contraceptive methods first.

If you have stopped taking Zoely because you wish to become pregnant, it is recommended that you wait until you have had a natural period before trying to conceive. This will help you determine your due date.

If you have any other questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in your health that you think may be due to Zoely, consult your doctor.

All women who take combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism [VTE]) or blood clots in the arteries (arterial thromboembolism [ATE]). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2, “What you need to know before starting to use Zoely”.

The following adverse effects have been reported with the use of Zoely:

Very common (may affect more than 1 in 10 people):

• acne;
• changes in menstruation (e.g., absence or irregularity);

Common (may affect up to 1 in 10 people):

• decreased sexual desire, depression or depressed mood, mood changes;
• headache or migraine;
• feeling sick (nausea);
• heavy menstrual bleeding, breast pain, pelvic pain;
• weight gain.

Uncommon (may affect up to 1 in 100 people):

• increased appetite, fluid retention (oedema);
• hot flushes;
• abdominal bloating;
• increased sweating, hair loss, itching, dry skin, oily skin;
• heaviness in the limbs;
• regular but scanty periods, breast enlargement, breast lump, milk production while not pregnant, premenstrual syndrome, pain during sexual intercourse, dryness of the vagina or vulva, uterine spasm;
• irritability;
• increased liver enzymes.

Rare (may affect up to 1 in 1,000 people):

• harmful blood clots in a vein or artery, for example:
  • in a leg or foot (i.e., DVT);
  • in a lung (i.e., PE);
  • heart attack;
  • stroke;
  • mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA);
  • blood clots in the liver, stomach/intestines, kidneys or eye.

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

• decreased appetite;
• increased sexual desire;
• attention disorder;
• dry eyes, intolerance to contact lenses;
• dry mouth;
• brownish-yellow pigmented spots, especially on the face; excessive hair growth;
• vaginal odour, vaginal or vulval discomfort;
• hunger;
• gallbladder disease.

Allergic reactions (hypersensitivity) have been reported in users of Zoely, but their frequency cannot be estimated from the available data.

Further information about changes in menstruation (e.g., absent or irregular) as a possible adverse effect during use of Zoely can be found in section 3, “When and how to take the tablets”, “If you have unexpected bleeding” and “If you have missed one or more periods”.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zoely

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

Do not use this medicine after the expiry date stated on the blister and the carton, after EXP/EXP DATE. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Combined oral contraceptive pills (including Zoely tablets) that are no longer needed should not be disposed of via wastewater or municipal sewage systems. The hormonal active substances in the tablet may have harmful effects if they enter the aquatic environment. Return them to a pharmacy or dispose of them in another safe manner, in accordance with local regulations. In this way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Zoely

• The active ingredient(s): nomegestrol acetate and estradiol.
  Active film-coated white tablets: each tablet contains 2.5 mg of nomegestrol acetate and 1.5 mg of estradiol (as hemihydrate).
  Yellow placebo film-coated tablets: the tablet contains no active ingredients.

• Other components:
  Tablet core (active white film-coated tablets and yellow placebo film-coated tablets):
  lactose monohydrate (see section 2, “Zoely contains lactose”), microcrystalline cellulose (E460), crospovidone (E1201), talc (E553b), magnesium stearate (E572) and colloidal anhydrous silica.

Tablet coating (active white film-coated tablets):
polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 and talc (E553b).

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

Presentation of the product and contents of the pack

The active film-coated tablets are white, round, and marked with the code “ne” on both sides.

The placebo film-coated tablets are yellow, round, and marked with the code “p” on both sides.

Zoely is available in blisters of 28 film-coated tablets (24 active white film-coated tablets and 4 yellow placebo film-coated tablets), packaged in a cardboard box.

Pack sizes: 28, 84, 168 and 364 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturers

Organon (Ireland) Limited
Drynam Road
Swords
Co. Dublin
Ireland

Delpharm Lille S.A.S.
Parc d’Activités Roubaix-Est
22 Rue de Toufflers
CS 50070
59452 LYS-LEZ-LANNOY
France

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Krakow
Poland

N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgium/Belgium/Belgien Teva Pharma Belgium N.V./S.A./AG Tel/Tél: + 32 (0)38 20 73 73	Lithuania UAB Merck Sharp & Dohme Tel: + 370 5 2780247 [email protected]
Bulgaria Actavis EAD Tel: +359 2 489 95 85	Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Tel/Tél: + 32 (0)38 20 73 73
Czech Republic Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111 [email protected]	Hungary MSD Pharma Hungary Kft. Tel.: + 36 1 888-5300 [email protected]
Denmark MSD Danmark ApS Tlf: + 45 4482 4000 [email protected]	Malta Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) [email protected]
Germany MSD SHARP & DOHME GMBH Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) [email protected]	Netherlands Merck Sharp & Dohme BV Tel: 0800 9999 000 (+ 31 23 515 3153) [email protected]
Estonia Merck Sharp & Dohme OÜ Tel: + 372 6144 200 [email protected]	Norway MSD (Norge) AS Tlf: + 47 32 20 73 00 [email protected]
Greece Specifar ABEE Tel: +30 210 5401500	Austria Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 [email protected]
Spain Teva Pharma S.L.U Tel: +34 91 387 32 80	Poland MSD Polska Sp. z o.o. Tel.: +48 22 549 51 00 [email protected]
France TEVA SANTÉ Tél: + 33 1 55 91 78 00	Portugal Merck Sharp & Dohme, Lda Tel: + 351 21 4465700 [email protected]
Croatia Pliva Hrvatska d.o.o. Tel: +385 1 37 20 000	Romania Teva Pharmaceuticals S.R.L. Tel: + 4021 230 65 24
Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700 [email protected]	Slovenia Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390
Iceland Vistor hf. Tel: + 354 535 7000	Slovakia Merck Sharp & Dohme, s.r.o. Tel: + 421 (2) 58282010 [email protected]
Italy Teva Italia S.r.l. Tel: +39 02 8917981	Finland MSD Finland Oy Puh/Tel: + 358 (0)9 804650 [email protected]
Cyprus Specifar ABEE, Greece Tel: +30 210 5401500	Sweden Merck Sharp & Dohme (Sweden) AB Tfn: + 46 (0)77 570 04 88 [email protected]
Latvia SIA Merck Sharp & Dohme Latvija Tel: + 371 67 364224 [email protected]	United Kingdom Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 [email protected]

Date of the latest review of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.