Zoely - Nomegestrol acetate/estradiol uses, dose and side effects

All 24 white film-coated tablets are active tablets containing a small amount of two different female sex hormones. These are nomegestrol acetate (a progestogen ) and estradiol (an estrogen ).
The 4 yellow film-coated tablets are inactive tablets that do not contain any hormones and are called placebo tablets.
Birth control pills that contain two different hormones , such as Zoely, are called combined birth control pills.
Nomegestrol acetate ( gestagen et in Zoely) and estradiol ( estrogen et in Zoely) work together to prevent ovulation (ovulation, when the egg is released from the ovary) and reduce the chance of the released egg being fertilized and getting pregnant.

What you need to know before you use Zoely 2.5 mg/1.5 mg film-coated tablets

Before you start using Zoely, you should read the information about blood clots ( thrombosis ) in section 2. It is especially important to read about the symptoms of blood clots – see section 2, “Blood clots”.

Before you can start taking Zoely, your doctor/midwife will ask you questions about your personal and your close relatives’ medical history to give you individual treatment advice.

The doctor/midwife will also measure your blood pressure and, depending on your situation, also carry out other examinations.

This leaflet describes situations that mean you should stop taking your birth control pills or mean that the birth control pill’s protection against pregnancy may be reduced. In such situations, you should either avoid having sex or use additional protection that does not contain hormones, such as a condom or another barrier method. Do not use safe periods or temperature methods. These methods may not protect against pregnancy because the pill interferes with normal changes in body temperature and cervical secretions that occur during the menstrual cycle.

Zoely, like other hormonal contraceptives, does not protect against infection with human immunodeficiency virus ( HIV ) (which can lead to acquired immunodeficiency syndrome, AIDS ) or other sexually transmitted diseases.

Do not use Zoely 2.5 mg/1.5 mg film-coated tablets

Do not use Zoely if you have any of the conditions listed below. If you have any of these conditions, you must inform your doctor/midwife. Your doctor/midwife will discuss what other type of contraception may be more appropriate.

if you have (or have ever had) a blood clot in a blood vessel in the legs (deep vein thrombosis, DVT), in the lungs ( pulmonary embolism ), or any other organ
if you have a disease that affects blood clotting – eg protein C deficiency, protein S deficiency, antithrombin III deficiency, Factor V Leiden or antiphospholipid antibodies
if you need to undergo an operation or if you will be bedridden for a long time (see section “Blood clots”)
if you have ever had or have had a heart attack or stroke
if you have ever had angina (a condition that causes severe chest pain and can be an early sign that the blood vessels around the heart have been blocked, a so-called heart attack) or transient ischemic attack ( TIA – transient stroke symptoms)
if you have any of the following diseases that can increase the risk of a blood clot in the arteries:
- severe diabetes with blood vessel damage
- very high blood pressure
- very high levels of certain blood fats (cholesterol and triglycerides )
- a condition called hyperhomocysteinemia.
if you have ever had a type of migraine called ‘migraine with aura’
if you have ever had inflammation of the pancreas ( pancreatitis ) and at the same time high levels of blood fats
if you have ever had severe liver disease and your liver function is not yet normal
if you have ever had a benign or malignant tumor in the liver
if you have ever had or if you think you may have breast or abdominal cancer
if you have or have had a meningioma (a usually benign tumor that occurs in the tissue between the brain and the skull). If you are unsure, ask your doctor.
if you have vaginal bleeding for no known reason
if you are allergic to estradiol or nomegestrol acetate or any of the other ingredients of this medicine (listed in section 6).

If any of these conditions appear for the first time while using Zoely, stop treatment immediately and contact your doctor. In the meantime, you must use a contraceptive that does not contain hormones. See also “General information” in section 2 above.

Warnings and precautions

Talk to your doctor or pharmacist before using Zoely.

When should you contact a doctor?

See a doctor immediately if you:

detect any signs of a blood clot that could mean you have a blood clot in the leg (so-called deep vein thrombosis ), a blood clot in the lung (so-called pulmonary embolism ), a heart attack, or a stroke (see section “Blood clots” below).

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

notice any change in your health, especially if it is linked to any of the conditions mentioned in this leaflet (see also section 2 “Do not use Zoely”, also do not forget changes in the health of your immediate family)
feel a lump in the chest
get symptoms of angioedema such as swelling of the face, tongue, or throat, get difficulty swallowing or hives along with breathing difficulties
must use other medicines (see also section 2 “Other medicines and Zoely”)
become temporarily immobile or have surgery (tell your doctor at least four weeks before surgery)
have unexpected, heavy abdominal bleeding
missed one or more tablets during the first tablet schedule and had unprotected sex during any of the previous 7 days (see also section 3 “If you forget to take Zoely”)
have severe diarrhea or severe vomiting
do not have a period and suspect that you are pregnant (do not start the next tablet chart before you have spoken to your doctor/midwife, see also section 3 “If you have missed one or more periods”).

Tell your doctor/midwife if any of the following conditions apply to you.

If the condition develops or worsens while using Zoely, you should also contact your doctor/midwife if you have:

hereditary and acquired angioedema. Consult your doctor immediately if you develop symptoms of angioedema, such as swelling of the face, tongue, or throat, difficulty swallowing, or hives along with difficulty breathing. Medicines that contain estrogen can induce or worsen the symptoms of angioedema.
epilepsy (see section 2 “Other medicines and Zoely”)
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 that affects your natural immune system)
hemolytic uremic syndrome (HUS, a disease that affects blood clotting and causes kidney failure )
sickle cell anemia (an inherited disease that affects the red blood cells )
elevated levels of blood fats ( hypertriglyceridemia ) or heredity for this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis ( inflammation of the pancreas).
inflammation of the veins under the skin (superficial thrombophlebitis )
varicose veins
a condition that first appeared, or worsened, during pregnancy or previous use of female hormones (eg hearing loss, porphyria [a blood disorder], herpes gestationis [blistering skin rash that occurs during pregnancy], Sydenham’s chorea [a neurological disorder in which involuntary sudden body movements occur])
or have ever had chloasma (yellow-brown pigment spots on the skin, so-called pregnancy spots, especially on the face). In that case, avoid too much sunlight or ultraviolet radiation.

Also tell your doctor if:

a close relative has, or has ever had, breast cancer
you need to undergo an operation or if you are bedridden for a long time (see section 2 “Blood clots”)
you have just given birth, as you are at increased risk of blood clots. Ask your doctor how soon after delivery you can start taking Zoely.

BLOOD CLOTS

If you use combined hormonal contraceptives such as Zoely, the risk of blood clots increases compared to not using these preparations. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form

in veins (called venous thrombosis, venous thromboembolism, or VTE)
in the arteries (so-called arterial thrombosis, arterial thromboembolism, or ATE).

Recovery from blood clots is not always complete. In rare cases, they can cause serious permanent effects and, in very rare cases, be life-threatening.

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

THIS IS HOW YOU RECOGNIZE A BLOOD CLOT

Seek medical attention immediately if you notice any of the following signs or symptoms.

Are you experiencing any of these signs?	What could you possibly be suffering from?
• swelling of a leg or along a blood vessel in the leg or foot, especially if you also get: • pain or tenderness in the leg that is felt only when standing or walking• increased heat in the affected leg • color change of the skin on the leg eg pale, red, or blue	Deep vein thrombosis
• sudden unexplained shortness of breath or rapid breathing• sudden coughing for no apparent reason which could lead to you coughing up blood• severe chest pain that may increase with deep breaths• strong feeling of unsteadiness or dizziness• fast or irregular heartbeats• severe pain in the stomach. If you are unsure, consult a doctor as some of these symptoms eg cough and shortness of breath can be misinterpreted as a milder condition such as a respiratory infection (eg a common cold).	Pulmonary embolism
Symptoms that usually occur in one eye: • immediate vision loss or• blurred vision without pain that can develop into vision loss.	Retinal vein thrombosis (blood clot in the eye)
• chest pain, discomfort, pressure, heaviness• feeling of pressure or fullness in the chest, arm, or under the sternum• feeling of fullness, indigestion, or feeling of suffocation• discomfort in the upper body that radiates to the back, jaw, neck, arm, and stomach• sweating, nausea, vomiting or dizziness• extreme weakness, anxiety or shortness of breath• fast or irregular heartbeats.	Myocardial infarction
• sudden weakness or numbness in the face, arms, or legs, especially on one side of the body• sudden confusion, difficulty speaking or understanding• sudden difficulty seeing with one or both eyes• sudden difficulty walking, dizziness, loss of balance or coordination• sudden, severe or prolonged headache with no known cause• unconsciousness or fainting with or without seizures. Sometimes the symptoms of a stroke can be short-lived with almost immediate or complete recovery, but you should still seek medical attention immediately because you are at risk of another stroke.	Stroke
• swelling and slight blue discoloration of the leg or arm• severe abdominal pain ( acute abdomen).	Blood clots that block 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 a vein (venous thrombosis ). However, these side effects are rare. They most often occur during the first year of using a combined hormonal contraceptive.
If a blood clot forms in a vein in a leg or foot, it can cause a deep vein thrombosis (DVT).
If a blood clot travels from the leg and lodges in the lung, it can cause a pulmonary embolism.
In very rare cases, a blood clot can form in a vein in another organ, such as the eye ( retinal vein thrombosis ).

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

The risk of developing a blood clot in a vein is greatest during the first year and the first time you use combined hormonal contraceptives. The risk may also be higher if you start again with a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or longer.

After the first year, the risk decreases but is always slightly higher than if you do not use a combined hormonal contraceptive.

When you stop using Zoely, the risk of a blood clot returns to normal within a few weeks.

How big is the risk of developing a blood clot?

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

The overall risk of a blood clot in a leg or lung with Zoely is small.

Out of 10,000 women who are not using a combined hormonal contraceptive and are not pregnant, about 2 develop a blood clot within a year.
Out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate, about 5-7 develop a blood clot during one year.
The risk of blood clots with Zoely compared to a combined hormonal contraceptive containing levonorgestrel is about the same.
The risk of a blood clot varies depending on your personal medical history (see “Factors that increase the risk of a blood clot” below).

	Risk of developing a blood clot over a year
Women who do not use combined hormonal contraceptives and who are not pregnant	About 2 in 10,000 women
Women using a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate	About 5-7 out of 10,000 women
Women using Zoely	Much the same as with other combined hormonal contraceptives, including contraceptives containing levonorgestrel

Factors that can increase the risk of a blood clot in a vein

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

if you are very overweight (body mass index or BMI over 30 kg/m ² )
if a close relative has had a blood clot in the leg, lung, or other organs at a young age (e.g. younger than about 50 years). If so, you may have an inherited blood clotting disorder.
if you need to undergo an operation or are bedridden for a long time due to an injury or illness, or if you have a leg cast. The use of Zoely may need to be stopped for several weeks before an operation or while you are less mobile. If you have to stop using Zoely, ask your doctor when you can start using it again.
with increasing age (especially if you are over about 35)
if you have given birth a few weeks ago.

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

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

You must tell your doctor if you have any of these conditions, even if you are not sure. Your doctor may decide that you need to stop using Zoely.

If any of the above conditions change while you are using Zoely, for example, a close relative gets a blood clot for no known reason or if you gain a lot of weight, talk to your doctor.

BLOOD CLOTS IN AN ARTERY

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

Similar to a blood clot in a vein, a blood clot in an artery can lead to serious problems. It can, for example, cause a heart attack or stroke.

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

You must know that the risk of a heart attack or stroke as a result of using Zoely is very small but may increase:

with increasing age (after about age 35)
if you smoke. If you are using a combined hormonal contraceptive such as Zoely, you should stop smoking. If you cannot stop smoking and are over 35, your doctor may advise you to use another type of birth control.
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 (younger than about 50 years). In that case, you may also be at greater risk of a heart attack or stroke.
if you or a close relative have a high level of blood fats ( cholesterol or triglycerides )
if you get migraines, especially migraines with aura
if you have problems with your heart (flutter, heart rhythm disorder called atrial fibrillation )
if you have diabetes.

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

If any of the above conditions change while you are using Zoely, for example, if you start smoking, a close relative has a blood clot for no known reason or if you gain a lot of weight, talk to your doctor.

Cancer

Breast cancer has been detected slightly more often in women using combined contraceptives, but it is not clear whether it is caused by combined oral contraceptives. For example, it may be that tumors are detected more often in women who use combined oral contraceptives because they undergo more breast examinations with their doctor. When combined oral contraceptives are discontinued, the increased risk gradually disappears.

You must examine your breasts regularly and contact your doctor if you feel a lump. You should also tell your doctor if a close relative has or has had breast cancer (see section 2 “Warnings and precautions”).

In rare cases, benign liver tumors (not cancer), and in even rarer cases, malignant liver tumors (cancer), have occurred among women using birth control pills. Contact a doctor immediately if you experience unusually severe abdominal pain.

Cervical cancer is caused by an infection with the human papillomavirus (HPV). Cervical cancer has been reported more often in women using combined oral contraceptives for more than 5 years. It is not clear whether this is due to the use of contraceptives that contain hormones or to other factors, such as differences in sexual habits.

Meningioma

Cases of meningioma (a usually benign brain tumor) have been reported with long-term use (many years) of nomegestrol alone (without estradiol) at high doses of at least 3.75 mg or 5 mg and above (see section “Do not use Zoely”). If a meningioma is diagnosed, treatment with Zoely should be discontinued.

Mental disorders

Some women using hormonal birth control, including Zoely, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If you experience mood changes and symptoms of depression, you should contact a doctor for advice as soon as possible.

Laboratory examinations

If you need to give a blood or urine sample, tell your doctor that you are using Zoely as it may affect some test results.

Children and young people

No data are available regarding safety and efficacy in adolescents under 18 years of age.

Other medicines and Zoely 2.5 mg/1.5 mg film-coated tablets

Tell your doctor/midwife or pharmacist if you are taking, have recently taken, or might be taking other medicines. Also, tell other healthcare professionals who prescribe or dispense medicines to you that you are using Zoely.

Some medicines can reduce the contraceptive effect of Zoely or that can cause unexpected bleeding. It applies to medicines used in the treatment of:
- epilepsy (eg primidone, phenytoin , phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate)
- tuberculosis (eg rifampicin)
- HIV infection (eg rifabutin , ritonavir, efavirenz)
- hepatitis C virus ( HCV ) infection (e.g. protease inhibitors )
- other infectious diseases (eg griseofulvin)
- high blood pressure in the blood vessels of the lungs, so-called pulmonary arterial hypertension ( bosentan ).
The herbal remedy St. John’s wort ( Hypericum perforatum ), can also prevent Zoely from functioning properly. If you want to use herbal remedies containing St. John’s wort when you are already using Zoely, you should first consult your doctor.
If you use drugs or herbal remedies that can make Zoely less effective, a barrier method should be used. Because the effect of another medicine on Zoely can remain for up to 28 days after you stop using the medicine, it is necessary to use a barrier method throughout this time.
Some medicines can increase the amount of active substances from Zoely in the blood. The effect of the birth control pill remains, but tell your doctor if you are using any medicine against fungal infection that contains ketoconazole.
Zoely can also interfere with the effect of other medicines – such as the epilepsy medicine lamotrigine.
The hepatitis C virus ( HCV ) combination treatment ombitasvir/paritaprevir/ritonavir with or without dasabuvir, as well as the treatment glecaprevir/pibrentasvir, may cause elevated liver function values in blood test results (increase in ALT liver enzyme) in women using combined hormonal contraceptives containing ethinylestradiol. Zoely contains estradiol instead of ethinylestradiol. It is not known whether an increase in ALT liver enzyme may occur when using Zoely together with this HCV combination therapy. Your doctor will advise you.

Pregnancy, breastfeeding, and fertility

Zoely should not be used by women who are pregnant, or who think they may be pregnant.

If you become pregnant while using Zoely, stop treatment with Zoely immediately and contact your doctor/midwife.

If you want to stop treatment with Zoely because you want to get pregnant, see section 3 “If you stop taking Zoely”.

In general, Zoely is not recommended for use during breastfeeding. If you want to use birth control pills while breastfeeding, you should consult your doctor/midwife.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving ability and use of machinery

Zoely has no or negligible effect on the ability to drive and use machines.

Zoely 2.5 mg/1.5 mg film-coated tablets contain excipients

Zoely contains lactose

If you have an intolerance to certain sugars, you should contact your doctor/midwife before taking this medicine.
How to use Zoely 2.5 mg/1.5 mg film-coated tablets

Always use this medicine as directed by your doctor or pharmacist. Consult a doctor/midwife or pharmacist if you are unsure.

When and how to take the tablets

The Zoely tablet chart contains 28 film-coated tablets: 24 white tablets with active substances (numbers 1-24) and 4 yellow tablets without active substances (numbers 25-28).

Each time you start a new tablet map with Zoely, take the white active, number 1 tablet in the upper left corner of the tablet map (see “Start”). Then, from the 7 sticky strips with the days of the week, select the strip in the gray column that starts with your “start day”. For example, if you start on a Wednesday, use the sticky strip that starts with “WED.” Place it on the tablet chart, just above the row of white active tablets where it says “Place weekday label here”. This will help you keep track of whether you have taken your daily tablet.

Take one tablet a day at about the same time, with a little water if needed.

Take the tablets in the order shown by the arrows on the tablet chart, take the white active tablets first and then the yellow (inactive) placebo tablets.

Your period will start during the 4 days when you take the yellow placebo tablets (a so-called withdrawal bleed). It usually starts 2-3 days after you have taken the last white active tablet and does not need to have stopped before you start the next tablet chart.

Start the next tablet chart immediately after taking the last yellow placebo tablet, even if the period has not stopped. This means that you will always start on a new tablet chart on the same day of the week and that your period will come on roughly the same days of the week each month.

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

How to start taking the first pack of Zoely

If you have not taken any hormonal contraception during the previous month

Start taking Zoely on the first day of the natural menstrual cycle (ie on the first day of your period). If you start Zoely on the first day of your period, you will be protected against pregnancy immediately. You do not need to use any additional contraceptive method.

Changing from another contraceptive method with combined hormones (combined birth control pills, birth control ring, or birth control patch )

You can advantageously start Zoely the day after you have taken the last active tablet (the last tablet containing active substances) on your current tablet chart (no tablet break). If your current tablet chart also contains inactive placebo tablets, you can start taking Zoely the day after you have taken the last active tablet (if you are not sure which the active tablets are, ask your doctor/midwife or pharmacist). You can also start Zoely later but never later than the day after the tablet-free period of your current pill (or the day after the last inactive tablet of your current pill ). If you change from a birth control ring or birth control patch is best to start Zoely on the day the patch or ring is removed. You can also start at the latest on the day you would have started with a new ring or a new patch.

If you follow the instructions, you do not need to use any additional protection. If you are unsure whether you are protected or not, consult your doctor/midwife.

Switching from a birth control pill with only progestogen hormone ( minipill )

You can switch from the progestagen-only pill any day to start Zoely the next day, but you must use a barrier method of birth control (such as a condom) for the first seven days of taking Zoely.

When switching from injections, implants, or hormone coils with only progestin

Start Zoely on the day you would have had your next injection or on the day your implant or IUD is removed. If you have intercourse, use a barrier method of contraception for the first seven days of taking Zoely.

After giving birth

You can start Zoely between 21 and 28 days after giving birth. If you start after day 28, you must use a barrier method of contraception (such as a condom) for the first seven days of taking Zoely. If after giving birth you have had sex before starting Zoely, you must first make sure you are not pregnant or you will have to wait for your next period. If you are breastfeeding and want to start Zoely after you have had a baby, see section 2 ‘Pregnancy and breastfeeding.

Consult a doctor/midwife or pharmacist if you are unsure.

After miscarriage or abortion

Follow the doctor’s/midwife’s advice.

If you have used too much Zoely 2.5 mg/1.5 mg film-coated tablets

There are no reports of serious damage from taking too many Zoely tablets. If you have taken several tablets at the same time, you may feel sick, vomit, and have bleeding from the abdomen. If you have taken too many Zoely tablets or if you discover that a child has swallowed some, a doctor or pharmacist should be contacted for advice.

If you forget to use Zoely 2.5 mg/1.5 mg film-coated tablets

The following advice only applies to forgotten white active tablets.

If it has been less than 24 hours since you should have taken your tablet, you are still protected against pregnancy. Take the tablet as soon as you can and then take the next tablet at the usual time.
If it has been 24 hours or more than 24 hours since you should have taken a tablet, protection against pregnancy may be reduced. The more tablets you have forgotten, the greater the risk of you becoming pregnant. The risk of becoming pregnant is particularly high if you forget white active tablets at the beginning or the end of the tablet map. Therefore, you should always follow the instructions given below.

Day 1-7 with the intake of white active tablets (see picture and schedule)

Take the forgotten white active tablet as soon as you can, even if it means taking two tablets at the same time, and then take the next tablet at the usual time. Use a barrier method of contraception (such as a condom) for additional protection until you have taken your tablets correctly for 7 consecutive days.

If you have had sex in the week before the forgotten tablets, there is a risk that you could become or are pregnant. In this case, contact your doctor/midwife immediately.

Day 8-17 with the intake of white active tablets (see picture and schedule)

Take the last forgotten white tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablet at the usual time. If you have taken your tablets correctly in the previous 7 days before the forgotten tablet, the protection against pregnancy is not reduced and you do not need to use an additional protection. If you have forgotten more than 1 tablet, use a barrier method such as a condom for additional protection until you have taken your tablets correctly during

7 consecutive days.

Day 18-24 with the intake of white active tablets (see picture and schedule)

The risk of you becoming pregnant is particularly high if you forget a white active tablet in connection with the period of yellow inactive placebo tablets. By adopting the tablet intake, the increased risk can be prevented.

You can choose between the following two options. You do not need to use a supplemental barrier method if you have taken your tablets correctly in the previous 7 days before the missed tablet. If this is not the case, follow the first option and use a barrier method of contraception (to

for example a condom) for additional protection until you have taken your tablets correctly for 7 consecutive days.

Option 1: Take the last missed white active tablet as soon as you can (even if this means you have to take two tablets at the same time) and then take the next tablet at the usual time. Start on the next tablet chart immediately after the white active tablets in the current tablet chart are finished, skip the yellow placebo tablets. You may not have a period until you take the yellow tablets at the end of the next tablet chart, but you may have light or period-like bleeding while taking the white active tablets.

Option 2. Stop taking the white active tablets. Start taking the yellow placebo tablets for a maximum of 3 days so that the total number of placebo tablets including forgotten white active tablets does not exceed 4. Once the yellow placebo tablets have been taken, start the next tablet chart.

If you are not sure how many white active tablets you have missed, follow option 1, use a barrier method such as a condom for additional protection until you have taken your tablets correctly for 7 consecutive days, and contact your doctor/midwife (as you may not have been protected from getting pregnant). If you have forgotten to take white active tablets in a tablet map and the bleeding expected to come when you take the yellow placebo tablets does not occur, you may be pregnant. You must speak to your doctor/midwife before starting the next tablet chart.

The following advice only applies to forgotten yellow placebo tablets

The last four yellow tablets on the fourth row of the tablet chart are placebo tablets that do not contain any active substance. If you forget to take one of these tablets, Zoely still protects against pregnancy. Throw away the yellow tablets that you forgot and start taking the tablets on the next tablet chart at the usual time.

Picture

Schedule if you are 24 hours or more than 24 hours late taking a white active tablet

If you vomit or have severe diarrhea

If you vomit within 3-4 hours after taking a white active tablet or have severe diarrhea, there is a risk that the active substances in the Zoely tablets are not fully absorbed in your body. The situation is equivalent if you forget a white active tablet. After vomiting or diarrhea, you must take a new white active tablet from a reserve tablet chart as soon as possible. If possible, take it within 24 hours of when you normally take your tablet. Take the next tablet at the usual time. If this is not possible or if 24 hours or more have passed, follow the advice given under ‘If you forget to take Zoely’. If you have severe diarrhea, contact your doctor/midwife.

The yellow tablets are placebo tablets that do not contain any active substances. If you vomit or have severe diarrhea within 3-4 hours of taking a yellow placebo tablet, Zoey’s protection against pregnancy remains.

If you want to postpone your period

Although not recommended, you can delay your period by skipping the yellow placebo tablets from the fourth row and immediately starting the next tablet chart with Zoely. You may experience light or menstrual-like bleeding while using the second tablet chart. When you want menstruation to start, during the second tablet map, stop taking the white active tablets and start taking the yellow placebo tablets. Finish this second tablet chart by taking the 4 yellow placebo tablets and then start the next tablet chart (the third). If you are not sure how to proceed, ask your doctor/midwife or pharmacist.

If you want to change the start day of your period

If you take your tablets correctly, you will have your period during the placebo interval. If you want to change the start day, you can reduce the days in the placebo interval – when you take the yellow placebo tablets – but never extend it (4 is the maximum number). For example, if you start with the yellow placebo tablets on a Friday and you want to change this to a Tuesday (3 days earlier), you must start on a new tablet chart 3 days earlier than usual. You may not get any

menstruation during the shortened placebo interval. You may have light or menstrual-like bleeding while taking the white active tablets in the next tablet chart.

If you are not sure how to proceed, ask your doctor/midwife or pharmacist.

If you have unexpected bleeding

During the first few months of using combined oral contraceptives, you may have irregular bleeding (breakthrough bleeding or spotting). You may need to use menstrual protection, but still, continue to take your tablets as usual. The irregular bleeding usually disappears when the body has adapted to the pill (usually after about three months). Talk to your doctor/midwife if the bleeding continues after three months, if it gets heavier or if it recurs.

If you have missed your period one or more times

In clinical studies with Zoely, it has been seen that menstruation can sometimes not occur after Day 24.

If you have taken all your tablets correctly, and you have not vomited, had severe diarrhea, or used other medicines at the same time, it is unlikely that you are pregnant. Continue taking Zoely as usual. See also section 3 “If you vomit or have severe diarrhea” or section 2 “Other medicines and Zoely”.
If you have not taken all the tablets correctly or if you miss your period twice in a row, you may be pregnant. Contact your doctor/midwife immediately. Do not start your next tablet chart with Zoely until it has been checked that you are not pregnant.

If you stop using Zoely 2.5 mg/1.5 mg film-coated tablets

You can unsubscribe from Zoely at any time. If you do not want to get pregnant, you should consult your doctor/midwife about another contraceptive method.

If you stop taking Zoely because you want to get pregnant, it is best to wait until you have had a natural period before trying to get pregnant. This will help you calculate when the baby will be born.

If you have further questions about this medicine, contact your doctor, pharmacist, or nurse.

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 they are severe or do not go away, or if your health changes and you think it may be due to Zoely, talk to your doctor.

An increased risk of blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries ( arterial thromboembolism (ATE)) exists in all women using combined hormonal contraceptives. For more detailed information about the different risks of using combined hormonal contraceptives, see section 2, “What you need to know before you use Zoely”.

The following side effects have been associated with Zoely:

Very common (may affect more than 1 in 10 users)

acne
menstrual disorders (e.g. missed or irregular menstruation)

Common (may affect up to 1 in 10 users)

decreased interest in sex, depression/low mood, mood changes headache or migraine
nausea
heavy periods, breast pain, pelvic pain
weight gain.

Uncommon (may affect up to 1 in 100 users)

increased appetite, fluid retention ( edema )
hot flashes
distended abdomen (stomach)
increased sweating, hair loss, itching, dry skin, oily skin
heaviness in arms and legs
regular but sparse bleeding, larger breasts, lumps in the breasts, milk production despite not being pregnant, premenstrual syndrome, pain during sex, dryness in the vagina or around the labia, uterine spasms
irritability
elevated liver enzymes.

Rare (may affect up to 1 in 1,000 users)

harmful blood clots in a vein or an artery, eg:
- in a leg or foot (so-called DVT)
- in the lungs
- myocardial infarction
- stroke
- mini-stroke or transient stroke-like symptoms called transient ischemic attack ( TIA )
- blood clots in the liver, stomach/intestines, kidneys, or eyes.

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

decreased appetite
increased sexual desire
disturbances in attention
dry eyes, difficulty using contact lenses
dry mouth
golden brown pigment spots, mostly on the face, increased hair growth
the odor from the vagina, discomfort from the vagina or around the labia
hunger
the disease of the gallbladder.

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

More information about menstrual disorders (eg missed or irregular periods) when using Zoely can be found under section 3 “When and how to take the tablets”, “If you have unexpected bleeding” and “If you have missed one or more periods”.

How to store Zoely 2.5 mg/1.5 mg film-coated tablets

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

Use before the expiry date stated on the tablet map and carton after “EXP” and “Expiry Date”. The expiration date is the last day of the specified month.

This medicine does not require any special storage instructions.

Leftover combined birth control pills (including Zoely) should not be thrown down the drain or through municipal waste disposal. The hormonally active substances in the tablet can have harmful effects if they reach the aquatic environment. The tablets should be returned to the pharmacy or disposed of in another safe manner by local requirements. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

– The active substances are: nomegestrol acetate and estradiol

White active film-coated tablets: one tablet contains 2.5 mg nomegestrol acetate and 1.5 mg estradiol as hemihydrate.

The yellow film-coated placebo tablets: tablets contain no active substances.

– Other ingredients are:

Tablet core (white active film-coated 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 colloidal anhydrous silica.

Tablet casing (white active film-coated tablets):

Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 and talc (E553b).

Tablet casing (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 and package sizes of the medicine

The active film-coated tablets are white, round, and marked with “no” on both sides. The placebo tablets are yellow, round, and marked with “p” on both sides.

Zoely is available in packs containing tablet charts of 28 film-coated tablets (24 white active film-coated tablets and 4 yellow placebo film-coated tablets) packed in a carton. Pack sizes: 28, 84, 168, and 364 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Theramex Ireland Limited

3rd Floor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Manufacturer

Delpharm Lille SAS

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 Cracow

Poland

NV Organon

Kloosterstraat 6

5349 AB Us

Netherlands

Merck Sharp & Dohme BV

Waarderweg 39

2031 BN Haarlem