Zoely 2.5 mg/1.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zoely 2.5 mg/1.5 mg film-coated tablets

nomegestrol acetate / estradiol

Important things you need to 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 a blood clot in veins and arteries, especially during the first year 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 be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Read the entire leaflet carefully before you start using 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if the side effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What Zoely is and what it is used for
2. What you need to know before 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 film-coated 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 known as "combined pills".
• Nomegestrol acetate (the progestogen in Zoely) and estradiol (the oestrogen in Zoely) work together to prevent ovulation (the release of an egg from the ovary) and reduce the chance of fertilisation of the released egg and pregnancy.

2. What you need to know before starting to use 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 about your personal and family medical history to provide you with individualized advice regarding treatment. Your doctor will also measure your blood pressure and, depending on your personal situation, may carry out other tests. This leaflet describes situations in which you should stop taking the pill or in which the pill's protection against pregnancy may be reduced. In such situations, you should not have sexual intercourse or you should use additional non-hormonal contraceptive precautions, for example, use of a condom or another barrier contraceptive method. Do not use rhythm or temperature methods. These methods may not protect against pregnancy 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 infection with the human immunodeficiency virus (HIV) (which can cause acquired immunodeficiency syndrome [AIDS]) or against any other sexually transmitted disease.

Do not use Zoely

You must 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 which 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 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 require 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 a stroke.

• If you have ever had angina pectoris (a condition causing severe chest pain and may be the first sign of blockage in the blood vessels of the heart, known as 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 blood 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 hyperhomocysteinaemia.

• If you have ever had a type of migraine called "migraine with aura".

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

• If you have ever had a serious liver disease and your liver and liver function are not yet normal.

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

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

• If you have a meningioma or have ever been diagnosed with a meningioma (a usually benign tumour of the tissue layer located between the brain and the skull).

• If you have any vaginal bleeding without an apparent cause.

• 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 develops 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.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Zoely.

When should you consult your doctor? Seek urgent medical assistance If you notice possible signs of a blood clot which may indicate that 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, particularly affecting any of the conditions mentioned in this leaflet (also see section 2, “Do not use Zoely”; do not forget changes in the health of your immediate family). If you notice a lump in the breast. If you experience symptoms of angioedema, such as swelling of the face, tongue or throat, difficulty swallowing, or hives, accompanied by breathing difficulties. If you are going to use other medications (see section 2, “Using Zoely with other medicines”). If you are going to be immobilized or undergo surgery (inform your doctor at least four weeks in advance). If you experience unusual and heavy vaginal bleeding. If you have missed taking one or more tablets during the first week of the pack and have had unprotected sex in the previous seven days (also see section 3, “If you have forgotten to take Zoely”). If you suffer from severe diarrhea or severe vomiting. If you stop having your period and suspect you are pregnant (do not start the next pack until your doctor tells you to; also see section 3, “If you have missed one or two periods”)

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

If any of these conditions develop or worsen while you are using Zoely, you must also inform your doctor if you have:

• hereditary or acquired angioedema. Seek immediate medical attention if you experience symptoms of angioedema such as swelling of the face, tongue, or throat, difficulty swallowing, or hives accompanied by difficulty breathing. Medicinal products containing estrogens may induce or worsen symptoms of angioedema;
• epilepsy (see section 2, “Use of Zoely with other medicines”);
• liver disease (e.g., jaundice) or gallbladder disease (e.g., gallstones);
• diabetes;
• depression;
• Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• systemic lupus erythematosus (SLE, a disease affecting your body’s natural defense system);
• haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• sickle cell anemia (an inherited red blood cell disorder);
• high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas);
• inflammation of veins beneath the skin (superficial thrombophlebitis);
• varicose veins;
• a condition that first occurred or worsened during pregnancy or with previous use of female hormones; for example: hearing loss, porphyria (a blood disorder), herpes gestationis (blistering skin rash during pregnancy), Sydenham’s chorea (a nervous system disorder causing sudden involuntary movements);
• have had or currently have chloasma (brownish-yellow pigmentation patches on the skin, known as “pregnancy mask,” especially on the face). In such cases, avoid excessive exposure to sunlight or ultraviolet light.

Also inform your doctor if:

• a close relative has or has had breast cancer;
• you require surgery or will be immobile for a prolonged period (see section 2 “Blood clots”);
• you have recently given birth and are at increased risk of blood clots. Ask your doctor how long you should wait after giving birth before starting Zoely.

BLOOD CLOTS

Using a combined hormonal contraceptive like 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 health 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. In rare cases, long-term serious effects may occur, and 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 notice any of the following signs or symptoms.

Are you experiencing any of these signs?	What might 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 a clear cause, possibly bringing up blood. Sharp chest pain that may worsen upon deep breathing. 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 beneath the sternum. Feeling of fullness, indigestion, or suffocation. Upper body discomfort radiating 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 difficulty 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 first-time use of a combined hormonal contraceptive. 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 it remains slightly 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 to 7 will develop a blood clot in one year.
• The risk of a blood clot with Zoely compared to the risk with a combined hormonal contraceptive containing levonorgestrel.
• Your risk of having 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 pill and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone, or norgestimate	About 5-7 out of 10,000 women
Women who use Zoely	Almost the same as with other combined hormonal contraceptives, including those containing levonorgestrel

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

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

• If you are overweight (body mass index or BMI above 30 kg/m²).
• If any of your close relatives has had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or will be immobile for a long time due to injury or illness, or if you have a plaster cast on your leg. You may need to stop using Zoely several weeks before surgery or while you are less mobile. If you need to stop using Zoely, ask your doctor when you can start taking it again.
• As you get older (especially over about 35 years of age).
• 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 (for more than 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 mentioned above, even if you are uncertain. Your doctor may decide that you need to stop using Zoely.

If any of the conditions listed above change while you are using Zoely—for example, a close relative has a thrombosis without a known cause, or you gain a lot of 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 heart attack or stroke while using Zoely is very small, but it may increase:

• With age (especially over about 35 years).
• If you smoke. When using a combined hormonal contraceptive such as Zoely, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• 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 (under about 50 years). In this case, you may also be at increased risk of heart attack or stroke.
• If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart condition (valve disorders, 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 is 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, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a lot of weight—inform your doctor.

Cancer

Breast cancer has been detected slightly more frequently in women taking combined oral contraceptives, but it is not known whether this is caused by the combined pills. For example, more tumours may be detected in women taking combined pills because their breasts are examined more often by their doctor. After stopping the combined pill, the increased risk gradually decreases.

It is important to regularly examine your breasts and to consult your doctor if you notice a lump. You should also inform your doctor if a close family member has or has ever had breast cancer (see section 2, “Warnings and precautions”).

In rare cases, benign (non-cancerous) liver tumours have occurred in women taking oral contraceptives, and even more rarely, malignant (cancerous) liver tumours. 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 the pill for more than 5 years. It is unknown whether this is due to the use of hormonal contraceptives or to other factors, such as differences in sexual behaviour.

Meningiomas

The use of nomegestrol acetate has been associated with the development of a usually benign tumour of the tissue layer located between the brain and the skull (meningioma). The risk increases especially when administered at high doses over a prolonged period (several years). If you are diagnosed with a meningioma, your doctor will stop treatment with Zoely (see section “Do not use Zoely”). If you notice any symptoms such as changes in vision (e.g., double or blurred vision), hearing loss or ringing in the ears, loss of smell, headaches that worsen over time, memory loss, seizures, or weakness in the arms and legs, you should inform your doctor immediately.

Psychiatric disorders

Some women using hormonal contraceptives such as Zoely have reported depression or a depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor for further medical advice as soon as possible.

Laboratory tests

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

Children and adolescents

There are no data 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.

Also, inform any other healthcare professional who prescribes or dispenses medicine to you that you are taking Zoely.

• Some medicines may make Zoely less effective 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., rifabutin, ritonavir, efavirenz);

• Hepatitis C virus (HCV) infection (e.g., protease inhibitors);

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

• High blood pressure in the blood vessels of the lungs known as pulmonary arterial hypertension (bosentan).

• The herbal remedy St John’s wort (Hypericum perforatum) may also reduce the effectiveness of Zoely. If you wish to use herbal products containing St John’s wort while using Zoely, you should consult your doctor first.

• If you are taking medicines or herbal products that could reduce the effectiveness of Zoely, you should also use a barrier contraceptive method. Since the effect of other medicines on Zoely may last up to 28 days after stopping the medicine, a barrier contraceptive method should be used during this time.

• Some medicines may increase blood levels of the active ingredients in Zoely. The contraceptive efficacy remains, but inform your doctor if you are using medicines for fungal infections containing ketoconazole.

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

• Combination regimens for hepatitis C virus (HCV) infection—ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirine, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir—may cause elevations in blood tests of liver function (increase in liver enzyme ALT) in women using combined hormonal contraceptives (CHCs) containing ethinylestradiol. Zoely contains estradiol instead of ethinylestradiol. It is unknown whether an increase in liver enzyme ALT may occur when using Zoely with these HCV combination regimens. Your doctor will advise you accordingly.

Pregnancy and breastfeeding

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

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

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

The influence of Zoely on the ability to drive or use machines is negligible or none.

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

Follow exactly the instructions for taking this medicine given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

When and how to take the tablets

The Zoely blister pack contains 28 tablets: 24 white active tablets (numbers 1 to 24) and four yellow placebo tablets without active ingredients (numbers 25 to 28).

Each time you start a new Zoely blister pack, take the white active tablet marked with the number 1 in the top left corner (see "Starting"). Choose from the seven day-of-the-week stickers the one that starts with your starting day. For example, if you start on a Wednesday, use the weekly day sticker indicating "WED". Place it on the blister pack, directly above the row of active white tablets, where it says "Place the day-of-the-week label here". This allows you to check whether you have taken your daily tablet.

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

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

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

Start the next pack immediately after taking the last yellow placebo tablet, even if your menstruation has not yet ended. This means you will always start a new pack on the same day of the week and will also have your period approximately on the same days each month. Some women 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 Zoely on the first day of your cycle (i.e., the first day of your menstruation). If you start Zoely on the first day of your period, you will be protected against pregnancy immediately. You do not need to use an additional contraceptive method.

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

You may preferably start Zoely the day after taking the last active tablet (the last tablet containing active ingredients) of your current pill pack (meaning there is no break in tablet-taking). 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, ask your doctor or pharmacist). You may also start later, but never later than the day after the break from taking your current pills (or the day after the last inactive tablet of your current pill). If you have been 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 using the next ring or patch.

If you follow these instructions, you do not need to use an additional contraceptive method. If you have any doubts about whether you are protected, ask your doctor.

Switching from a progestogen-only pill (mini-pill)

You may switch from the progestogen-only pill to start Zoely the next day, on any day. However, you must also use a barrier contraceptive method (e.g., a condom) during the first seven days of taking Zoely.

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 hormone-releasing 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 day 28, you must also use a barrier contraceptive method (e.g., a condom) during the first seven days of taking Zoely. If you have had sexual intercourse after childbirth and before starting Zoely, you must first ensure that you are not pregnant or wait until your next menstruation.

If you are breastfeeding and wish to start taking Zoely after childbirth, see section 2 "Pregnancy and breastfeeding".

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

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 harm from taking too many Zoely tablets. If you have taken several tablets at once, you may experience nausea, vomiting, or vaginal bleeding. If you have taken too many Zoely tablets or discover that a child has taken some, seek advice from your doctor or pharmacist.

If you forget to take Zoely

The following advice applies only to the missed active white tablets. If less than 24 hours have passed since you took a tablet, the contraceptive protection of the pill remains effective. Take the missed tablet as soon as possible, and then continue taking the following tablets at your usual time. If 24 hours or more have passed since you took a tablet, the contraceptive protection may be reduced. The more tablets you have missed, the higher the risk of becoming pregnant. The risk of pregnancy is particularly high if you miss active white tablets at the beginning or end of the blister pack. Therefore, you should follow the instructions below. Days 1 to 7 of taking the active white tablets (see figure and diagram) Take the missed active white tablet as soon as possible, even if this means taking two tablets at the same time, and then take the next tablet at your usual time. However, use a barrier contraceptive method, for example, a condom, as an additional precautionary measure until you have taken the tablets correctly for seven consecutive days. If you had sexual intercourse during the week before missing the tablets, there is a possibility that you may be or become pregnant. In this case, consult your doctor immediately. Days 8 to 17 of taking the 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 the same time) and continue taking the following tablets at your usual time. If you have taken the tablets correctly during the seven days prior to the missed tablet, contraceptive protection is not reduced, and no additional precautions are necessary. 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 the tablets correctly for seven consecutive days. Days 18 to 24 of taking the active white tablets (see figure and diagram) The risk of becoming pregnant is particularly high if you miss active white tablets close to the yellow placebo tablet interval. This increased risk can be avoided by adjusting your tablet-taking schedule. Either of the two options below may be followed. You do not need to use additional precautionary measures if you have taken the tablets correctly during the seven days before the missed tablet. If this is not the case, you must follow the first option and use a barrier contraceptive method, for example, a condom, as an additional precaution until you have taken the tablets correctly for seven consecutive days. Option 1: Take the last missed active white tablet as soon as possible, even if this means taking two tablets at the same time, and continue taking the following tablets at your usual time. Start the next blister pack immediately after finishing the active white tablets of the current pack, i.e., skip the yellow placebo tablets. You may not have your period until you take the yellow placebo tablets at the end of the second pack, but you may experience light bleeding or breakthrough bleeding during the active white tablets. Option 2: Stop taking the active white tablets and begin taking the yellow placebo tablets for up to three days, ensuring that the total number of placebo tablets plus active white tablets does not exceed four. At the end of the placebo tablet intake, start the next blister pack. If you cannot remember how many active white tablets you have missed, follow Option 1, use a barrier contraceptive method, for example, a condom, as an additional precaution until you have taken the tablets correctly for seven consecutive days, and consult your doctor (since 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. You should consult your doctor before starting the next pack. The following recommendation applies only to missed yellow placebo tablets. The last four yellow tablets in the fourth row are placebo tablets that do not contain active ingredients. If you have missed one of these tablets, the contraceptive protection of Zoely remains effective. Discard the missed yellow placebo tablet(s) and start taking tablets from the next pack at your usual time. Figure

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, there is a risk that the active ingredients from the Zoely tablets have not been completely absorbed into your body. This situation is similar to forgetting to take an active white tablet. After vomiting or having severe diarrhoea, you should take an active white tablet from a spare blister pack as soon as possible. If possible, take it within 24 hours of your usual time of taking the pill. Take the next tablet at your usual time. If this is not possible or if 24 hours or more have passed, you must follow the advice under “If you forget to take Zoely”. If you have severe diarrhoea, consult your doctor.

The yellow tablets are placebo tablets and do not contain active ingredients. If you vomit or have severe diarrhoea within three to four hours after taking a yellow placebo tablet, the contraceptive protection provided by Zoely remains effective.

If you wish to delay your period

Although not recommended, you may delay your period by not taking the yellow placebo tablets in the fourth row, and instead starting directly with a new blister pack of Zoely. You may experience light bleeding or breakthrough bleeding while using this second blister pack. When you wish for your period to start during the second blister pack, stop taking the active white tablets and start taking the yellow placebo tablets. Complete the four yellow placebo tablets from the second blister pack, then start with the next blister pack (the third). If you are unsure what to do, consult your doctor or pharmacist.

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. If you need to change this day, reduce the number of days you take the placebo, i.e., when taking the yellow placebo tablets, but never extend it (the maximum is four days). For example, if you usually start taking the yellow placebo tablets on Friday and wish to change it to Tuesday (three days earlier), you should start a new blister pack three days earlier than usual. You may not have bleeding during the shortened placebo period.

While using the next blister pack, you may experience light bleeding or breakthrough bleeding on the days you take the active white tablets.

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

If you have unexpected bleeding

With all combined oral contraceptives, during the first few months, you may experience some irregular vaginal bleeding (oligometrorrhagia or intermenstrual metrorrhagia) between periods. You may need to use sanitary protection, but continue taking the tablets as usual. Irregular vaginal bleeding usually stops once your body has adjusted to the pill (typically after about three months). If the 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 medicines, 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 have not taken the tablets correctly, or if you miss two consecutive expected periods, you may be pregnant. Contact your doctor immediately. Do not start the next blister pack of Zoely until your doctor has confirmed that 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 first about other contraceptive methods.

If you have stopped taking Zoely because you wish to become pregnant, wait until you have had a natural period before trying to conceive. This will help you determine the baby’s expected delivery date.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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 associated 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 menstruation, breast pain, pelvic pain;
• weight gain.

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

• increased appetite, fluid retention (oedema);
• hot flushes;
• abdominal swelling (bloating);
• increased sweating, hair loss, itching, dry skin, oily skin;
• heaviness in the limbs;
• regular but scanty menstruation, enlarged breasts, 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 the 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 stopped having one or more periods”.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Zoely Storage

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

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

No special storage conditions are required.

Combined oral contraceptives (including Zoely tablets) that are no longer needed should not be disposed of via drains or the municipal sewage system. The hormonal active substances in the tablet may have harmful effects if they enter aquatic environments. Return them to the pharmacy or dispose of them safely in another manner, in accordance with local regulations. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zoely

• The active ingredient(s): nomegestrol acetate and estradiol.

White film-coated active tablets: each tablet contains 2.5 mg of nomegestrol acetate and 1.5 mg of estradiol (as hemihydrate).

Yellow film-coated placebo tablets: the tablet does not contain active ingredients.

• Other components are:

Tablet core (white film-coated active tablets and yellow film-coated placebo tablets):

lactose monohydrate (see section 2, “Zoely contains lactose”), microcrystalline cellulose (E460), crospovidone (E1201), talc (E553b), magnesium stearate (E572), and anhydrous colloidal silica.

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

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

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Theramex Ireland Limited
3rd Floor, Kilmore House,
Park Lane, Spencer Dock
Dublin 1
D01 YE64
Ireland

Manufacturer

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

Date of the most recent revision of this leaflet: 02/2025

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