Zoely

Package leaflet: Information for the user

Zoely 2.5 mg/1.5 mg film-coated tablets

nomegestrol acetate/estradiol
Important things to know about combined hormonal contraceptives (CHCs):

• When used correctly, they are among the most reliable reversible methods of contraception.
• CHCs slightly increase the risk of developing a blood clot in veins and arteries, particularly during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be alert and contact your doctor if you think you may be experiencing symptoms of a blood clot (see section 2 "Blood clots").

Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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. These hormones are nomegestrol acetate (a progestogen) and estradiol (an oestrogen).
• The 4 yellow film-coated tablets are inactive tablets which do not contain hormones and are referred to as placebo tablets.
• Contraceptive pills that contain two different hormones, such as Zoely, are called "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 ovaries) and reduce the likelihood that any released egg will be fertilised and result in pregnancy.

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
paragraph 2. It is particularly important to read the section on symptoms related to a blood
clot – see paragraph 2 “Blood clots”.
Before you start taking Zoely, your doctor will ask about your medical history and that of your close
relatives to provide you with personalized advice regarding treatment. Your doctor will also measure
your blood pressure and, depending on your personal circumstances, may carry out additional tests.
This patient information leaflet describes situations in which you should stop using the pill, or in
which the pill's protection against pregnancy may be reduced. In these situations, you should refrain
from sexual intercourse or use additional non-hormonal contraceptive measures, such as a condom or
another barrier method. Do not use fertility awareness-based methods or temperature-based methods.
These methods may not protect you against pregnancy, because the pill alters the normal changes in
body temperature and cervical mucus that occur during the menstrual cycle.
Zoely, like other hormonal contraceptives, does not protect against infection with human
immunodeficiency virus (HIV) (which can cause acquired immunodeficiency syndrome, AIDS)
or other sexually transmitted diseases.
Do not use Zoely
You must not use Zoely if any of the conditions listed below apply to you. If any of the conditions
listed below apply to you, inform your doctor. Your doctor will discuss with you other more suitable
methods of birth control.

• if you have (or have had in the past) a blood clot in a blood vessel of the legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or other organs;
• if you suffer from a blood clotting disorder, for example protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are due to undergo surgery or will be confined to bed for a long time (see paragraph “Blood clots”);
• if you have previously had a heart attack or stroke;
• if you have previously had angina pectoris (a condition causing severe chest pain and may be an early sign of blockage of blood vessels around the heart, known as a heart attack) or a transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you suffer from any of the following conditions that may increase the risk of clots in the arteries:
  • severe diabetes with vascular damage
  • very high blood pressure
  • very high levels of certain fats in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinaemia
• if you have had a type of migraine called “migraine with aura”;
• if you have had pancreatitis (inflammation of the pancreas) associated with high levels of fats in the blood;
• if you have had severe liver disease and your liver is not yet functioning properly;
• if you have had a benign or malignant liver tumour;
• if you have had, or may have, cancer of the breast or genital organs;
• if you have a meningioma or have ever been diagnosed with a meningioma (a usually benign tumour of the tissue layer between the brain and the skull);
• if you have unexplained vaginal bleeding;
• if you are allergic to estradiol or nomegestrol acetate or to any of the other ingredients of this medicine (listed in paragraph 6).

If any of these conditions occurs for the first time while you are using Zoely, stop taking it
immediately and inform your doctor. In the meantime, use a non-hormonal contraceptive method.
See also “General considerations” in paragraph 2.
Warnings and precautions
Inform your doctor or pharmacist before using Zoely
When should you contact your doctor?
Seek urgent medical advice if:

• you notice possible signs of a blood clot which may indicate that you have a clot in the leg (i.e. deep vein thrombosis), a clot in the lung (i.e. pulmonary embolism), a heart attack or a stroke (see paragraph “Blood clots” below). For a description of the characteristic symptoms of these serious adverse effects, refer to “How to recognize a blood clot”.
• you notice any change in your health status, particularly regarding the aspects mentioned in this leaflet (see also paragraph 2 “Do not use Zoely”; do not forget changes in the health status of your close relatives);
• you notice a lump in your breast;
• you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with difficulty breathing;
• you need to take other medicines (see also paragraph 2 “Other medicines and Zoely”);
• you need to remain bedridden or undergo surgery (inform your doctor at least four weeks in advance);
• you have unusual and heavy vaginal bleeding;
• you missed one or more tablets in the first week of the blister pack and had unprotected sex in the previous seven days (see also paragraph 3 “If you forget to take Zoely”);
• you have severe diarrhoea or severe vomiting;
• you do not have your period and suspect you might be pregnant (do not start the next pack without consulting your doctor; see also paragraph 3 “If you have not had your period one or more times”).

Inform your doctor if any of the following conditions apply to you.
You should also inform your doctor if any of these conditions develop or worsen during use of
Zoely if you have:

• hereditary or acquired angioedema. Contact your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with difficulty breathing. Medicines containing estrogens may induce or worsen angioedema symptoms;
• epilepsy (see paragraph 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 affecting the body’s immune system);
• haemolytic uraemic syndrome (HUS, a coagulation disorder causing kidney failure);
• sickle cell anaemia (an inherited red blood cell disorder);
• high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• inflammation of veins located under the skin (superficial thrombophlebitis);
• varicose veins;
• a condition that first occurred or worsened during pregnancy or during previous use of female hormones (e.g. hearing loss, porphyria [a blood disorder], herpes gestationis [blistering skin rash during pregnancy], Sydenham’s chorea [a nerve disorder causing sudden, involuntary movements]);

In addition, inform your doctor if:

• a close relative has or has had breast cancer;
• you are due to undergo surgery or remain bedridden for a long time (see paragraph 2 “Blood clots”);
• you have recently given birth, as the risk of blood clots is higher. Ask your doctor how long after delivery you can start taking Zoely.

BLOOD CLOTS
Using a hormonal contraceptive such as Zoely increases the risk of developing a blood clot compared
to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop

• in the veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in the arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE). Recovery after a blood clot is not always complete. Serious effects may persist rarely, and very rarely these may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to
Zoely is low.
HOW TO RECOGNIZE A BLOOD CLOT
Seek urgent medical advice if you notice any of the following signs or symptoms.
Do you notice any of these signs? What might you be experiencing?

• swelling in one leg or along a vein in the leg or foot, Deep vein thrombosis, especially if accompanied by:
• pain or tenderness in the leg, which may occur only when standing or walking
• excessive warmth in the affected leg
• change in skin colour of the leg, such as paleness, redness or a bluish tint

sudden unexplained shortness of breath or rapid breathing; •sudden cough without an obvious cause, even with coughing up blood; •sharp chest pain, which may worsen with deep breathing; •severe dizziness or lightheadedness; •rapid or irregular heartbeat; •severe stomach pain; If in doubt, consult your doctor, because some of these symptoms, such as cough or shortness of breath, may be mistaken for a less serious illness, for example a respiratory tract infection (such as a common cold).	Pulmonary embolism
Most commonly, symptoms affect only one eye: •sudden loss of vision or •blurred vision without pain, 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 oppression in the chest, arm, or under the breastbone; •feeling of fullness, indigestion, or choking; •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 trouble seeing in one or both eyes; •sudden difficulty walking, dizziness, loss of balance or coordination; •sudden, severe or prolonged headache without known cause; •loss of consciousness or fainting with or without seizure. Sometimes, stroke symptoms may be brief and recovery nearly complete and immediate, but you must still seek urgent medical attention as there may be a risk of another stroke.	Stroke
swelling and slight bluish discoloration in 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 side 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 highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same product or a different one) after an interruption of 4 weeks or more.
After the first year, the risk decreases, but remains slightly higher than the risk in women who do not use a combined hormonal contraceptive.
When you stop taking Zoely, the risk of blood clots returns to normal levels 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 on 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 low.

• Among 10,000 women who do not use any combined hormonal contraceptive and 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.
• The risk of blood clots associated with Zoely is comparable to the risk associated with a combined hormonal contraceptive containing levonorgestrel.
• The risk of developing 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 in one year
Women who are not using 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	About the same as other combined hormonal contraceptives including contraceptives containing levonorgestrel

Factors that increase the risk of a blood clot in a vein
The risk of developing a blood clot with Zoely is low, but it increases in the presence of certain conditions. The risk is higher:

• if you are overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in the leg, lung, or another organ at a young age (e.g. before approximately 50 years). In this case, you may have an inherited blood clotting disorder;
• if you are scheduled for surgery or must remain bedridden for a long time due to an accident or illness, or if you have a leg in a cast. It may be necessary 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 resume taking it.
• with increasing age (especially after about 35 years);
• if you have given birth less than a few weeks ago.

The risk of developing a blood clot increases the more of these conditions apply to you.
Air travel (lasting more than 4 hours) may temporarily increase the risk of developing a clot, particularly if you have other risk factors as listed.
It is important to inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide that you should stop using Zoely.
If any of the conditions listed above change while you are using Zoely, for example if a close relative develops 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 may lead to a heart attack or stroke.

Factors that increase the risk of a blood clot in an artery
It is important to note that the risk of heart attack or stroke due to the use of Zoely is very low, but it may increase:

• with increasing age (after about 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Zoely, you should stop smoking. If you cannot 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 (before approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart disease (a heart valve disorder, a rhythm disorder called atrial fibrillation);
• if you have diabetes.

If more than one of these conditions applies to you, or if one of them is particularly severe, the risk of developing a blood clot may be even higher.
If any of the conditions listed above change while you are using Zoely, for example if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight, inform your doctor.

Cancer
Breast cancer has been detected slightly more frequently in women using combined contraceptives, but it is not known whether this is caused by the combined pills. For example, breast tumours may be diagnosed more often in women taking combined pills because these women may undergo more frequent breast examinations. After stopping the combined pill, the increased risk gradually decreases.
It is important to examine your breasts regularly and contact your doctor if you notice lumps. Also inform your doctor if a close relative has or has previously had breast cancer (see section 2 “Warnings and precautions”).
In rare cases, benign (non-cancerous) liver tumours have occurred in women using oral contraceptives, and even more rarely, malignant (cancerous) liver tumours. Contact your doctor if you experience unusual, particularly severe abdominal pain.
Cervical cancer is caused by infection with the human papillomavirus (HPV). This cancer is more common in women who use the pill for more than 5 years. It is not known whether this is due to the use of hormonal contraceptives or other factors, such as differences in sexual behaviour.

Meningiomas
The use of nomegestrol acetate has been linked to the development of generally benign tumours of the tissue layer between the brain and the skull (meningioma). The risk increases particularly with high-dose and long-term use (several years). If you have been diagnosed with a meningioma, your doctor will discontinue treatment with Zoely (see section “Do not use Zoely”). If you experience 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 or legs, you must inform your doctor immediately.

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

Diagnostic tests
If you need to undergo any blood or urine tests, inform your doctor that you are taking Zoely, as it may alter the results of certain tests.

Children and adolescents
Efficacy and safety data are not available for adolescents under 18 years of age.

Other medicines and Zoely
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Also inform healthcare professionals who prescribe or dispense other medicines that you are using Zoely.

• Some medicines may reduce the effectiveness of Zoely in preventing pregnancy or cause unexpected bleeding. These include medicines used to treat:
  • epilepsy (e.g. primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate);
  • tuberculosis (e.g. rifampicin);
  • HIV infections (e.g. rifabutin, ritonavir, efavirenz);
  • hepatitis C virus infections (e.g. protease inhibitors);
  • other infectious diseases (e.g. griseofulvin);
  • high blood pressure in the blood vessels of the lungs, also known as pulmonary arterial hypertension (bosentan).
• The herbal product St John’s wort (Hypericum perforatum) may also prevent Zoely from working properly. If you wish to use herbal products containing St John’s wort while using Zoely, you must first consult your doctor.
• If you are taking medicines or herbal products that may reduce the effectiveness of Zoely, you should also use a barrier contraceptive method. Since the effects of another medicine on Zoely may persist for up to 28 days after stopping that medicine, you must continue to use a barrier contraceptive method during this entire period.
• Some medicines may increase blood levels of the active ingredients in Zoely. The effectiveness of the pill is preserved, 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.
• The hepatitis C virus (HCV) treatment regimen consisting of ombitasvir/paritaprevir/ritonavir with or without dasabuvir, as well as the regimen based on glecaprevir/pibrentasvir, may cause increases in blood test results related to liver function (increase in liver enzyme ALT) in women using COCs containing ethinylestradiol. Zoely contains estradiol instead of ethinylestradiol. It is not known whether an increase in liver ALT enzyme may occur when using Zoely with this HCV combination regimen. Your doctor will provide you with necessary instructions.

Pregnancy and breastfeeding
Zoely must not be used by women who are pregnant or suspect they may be pregnant. If you become pregnant while using Zoely, stop taking Zoely 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”.
The use of Zoely is generally not recommended during breastfeeding. If you wish to use the pill while breastfeeding, you must consult your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Zoely has no effect or has a negligible effect on the ability to drive vehicles or use machines.

Zoely contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to use Zoely

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

When and how to take the tablets

The Zoely blister pack contains 28 film-coated tablets: 24 white active tablets (numbers 1–24) and 4 yellow placebo tablets without active ingredients (numbers 25–28).
Each time you start a new Zoely blister pack, take the first white active tablet marked "1" in the top left corner (see “Starting”). In the grey column, select the adhesive label corresponding to your starting day from the 7 available adhesive labels. For example, if you start on a Wednesday, use the label beginning with “WED”. Apply it to the blister pack immediately above the row of white active tablets, aligning it with the text “Stick day-of-the-week label here”. This will help you track whether you have taken your daily tablet.

Take one tablet every day, approximately at the same time each day, with some water if necessary.
Follow the direction of the arrows on the blister pack: take the white active tablets first, followed by the yellow placebo tablets.

Your menstrual period will usually start during the 4 days when you take the yellow placebo tablets (this is known as withdrawal bleeding). Withdrawal bleeding typically begins 2–3 days after taking the last white active tablet and may not have finished when you start the next blister pack.

Start the new blister pack immediately after the last yellow placebo tablet, even if your menstrual bleeding has not yet stopped. This means you should always start a new blister pack on the same day of the week, and your periods should occur approximately every month on similar days.

Some women may not experience a menstrual 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 more periods”).

Starting the first pack of Zoely

If you have not used hormonal contraceptives in the previous month
Start taking Zoely on the first day of your cycle (i.e. the first day of menstrual bleeding). If you start Zoely on the first day of your cycle, you will be immediately protected against pregnancy. You do not need to use an additional contraceptive method.

Switching from another combined hormonal contraceptive (combined oral pill, vaginal ring, or transdermal patch)
You may start Zoely preferably the day after taking the last active tablet (the last tablet containing active ingredients) of your current contraceptive (i.e. without any break). If your current contraceptive blister 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 tablet-free interval of your current contraceptive (or the day after the last inactive tablet).

If switching from a vaginal ring or transdermal patch, start Zoely preferably on the day of removal of the ring or patch. You may also start, at the latest, on the day you would have used 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 your protection, consult your doctor.

Switching from a progestogen-only pill (mini-pill)
You may switch from a progestogen-only pill to Zoely on any day, but you must use a barrier contraceptive method (e.g. condom) during the first 7 days of taking Zoely.

If you previously used a progestogen injection, implant, or hormonal intrauterine system (IUS)
Start using Zoely on the day when your next injection would have been due, or on the day of removal of the implant or intrauterine device. If you have sexual intercourse, remember to use a barrier contraceptive method (e.g. condom) during the first 7 days of taking Zoely.

After childbirth
You may start taking Zoely between 21 and 28 days after childbirth. If you start after day 28, you must also use a barrier contraceptive method (e.g. condom) during the first 7 days of taking Zoely. If, after childbirth, you have had sexual intercourse before starting Zoely, you should first ensure that you are not pregnant or wait for the onset of your next menstrual period.

If you are breastfeeding and wish to start taking Zoely after childbirth, read section 2 “Pregnancy and breastfeeding”. Consult your doctor or pharmacist if you are unsure about when to start.

After a pregnancy termination or miscarriage
Follow your doctor’s instructions.

If you take more Zoely than you should
No serious harm has been reported in cases of overdose with 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 if you notice that a child has taken them, consult your doctor or pharmacist.

If you forget to take Zoely
The following recommendations apply only to forgetting the white active tablets.

• If you are less than 24 hours late in taking a tablet, contraceptive protection remains. Take the missed tablet as soon as possible and continue taking the following tablets at your usual time.
• If you are 24 hours or more late in taking a tablet, contraceptive protection may be reduced. The more tablets you miss, the higher the risk of pregnancy. The risk of pregnancy is particularly high if you miss white active tablets at the beginning or end of the pack. Follow the instructions below.

Days 1–7 of taking white active tablets (see figure and scheme)
Take the missed white active 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. However, use a barrier contraceptive method (e.g. a condom) as an additional precaution until you have taken tablets correctly for 7 consecutive days.
If you had sexual intercourse in the week before missing the tablets, there is a possibility of pregnancy. In this case, contact your doctor immediately.

Days 8–17 of taking white active tablets (see figure and scheme)
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 took the tablets correctly in the 7 days before the missed tablet, contraceptive protection is not reduced, and no additional precautions are needed.
However, if you missed more than one tablet, use a barrier method (e.g. a condom) as an additional precaution until you have taken tablets correctly for 7 consecutive days.

Days 18–24 of taking white active tablets (see figure and scheme)
The risk of pregnancy is particularly high if you miss white active tablets just before the yellow placebo tablet interval. This risk can be avoided by modifying the dosing schedule.

You have two options as described below. You do not need additional precautions if you took the tablets correctly in the 7 days before the missed tablet. Otherwise, follow Option 1 and use a barrier contraceptive method (e.g. a condom) as an additional precaution until you have taken tablets correctly for 7 consecutive days.

Option 1:
Take the last missed white active 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 white active tablets of the current pack, without taking the yellow placebo tablets. Your period may not occur until after taking the yellow placebo tablets at the end of the second pack, but you may experience light bleeding or spotting during the intake of the white active tablets.

Option 2:
Stop taking the white active tablets and start taking the yellow placebo tablets for up to 3 days, so that the total number of missed white active tablets plus the yellow placebo tablets taken does not exceed 4. After finishing the yellow placebo tablets, start the next blister pack.

If you do not remember how many white active tablets you missed, follow Option 1, use a barrier method (e.g. a condom) as an additional precaution until you have taken tablets correctly for 7 consecutive days, and contact your doctor (as you may not have been protected against pregnancy).

If you missed white active tablets from one pack and do not have your expected period during the yellow placebo tablet phase of the same pack, you may be pregnant. Consult your doctor before starting a new pack.

The following applies only to forgetting yellow placebo tablets
The last 4 yellow tablets in the fourth row are placebo tablets and do not contain active ingredients. If you forget one of these tablets, contraceptive protection with Zoely remains. Discard the missed yellow placebo tablet(s) and start the next pack at your usual time.

Figure

Dosing schedule: in case of a delay of 24 hours or more in taking white active tablets

In case of vomiting or severe diarrhoea
If you vomit within 3–4 hours after taking a white active tablet or have severe diarrhoea, there is a risk that the active substances in Zoely tablets are not fully absorbed. This situation is similar to missing a white active tablet. After vomiting or severe diarrhoea, take another white active tablet from a spare blister 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 instructions under “If you forget to take Zoely”. If you have severe diarrhoea, inform your doctor.

The yellow tablets are placebo tablets and do not contain active ingredients. If you vomit or have diarrhoea within 3–4 hours after taking a yellow placebo tablet, contraceptive protection with Zoely remains.

If you wish to delay your period
Although not recommended, you may delay your period by skipping the yellow placebo tablets of the fourth row and starting directly with a new blister pack of Zoely. While using this second pack, you may experience light bleeding or spotting. If you wish your period to start while using the second pack, stop taking the white active tablets and start taking the yellow placebo tablets. Complete this second pack by taking the 4 yellow placebo tablets, then start the next (third) pack. 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 directed, your menstrual cycle will begin during the placebo tablet days. To change the day your period starts, reduce the number of placebo days (i.e. the days you take yellow placebo tablets), but never increase it (4 is the maximum). For example, if you usually start the yellow placebo tablets on Friday and wish to start on Tuesday (3 days earlier), you should start the new pack 3 days earlier than usual. You may not have any bleeding during this shortened placebo phase. During the next pack, you may experience light bleeding or spotting while taking the white active tablets.

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

If you have unexpected bleeding
With all combined oral contraceptives, irregular vaginal bleeding (light or heavy spotting) between periods may occur during the first few months. 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 3 months). If bleeding continues, increases in intensity, or recurs, contact your doctor.

If you have missed one or more periods
Clinical studies with Zoely have shown that periods occasionally do not occur after day 24.

• If you took all tablets correctly, did not vomit or have severe diarrhoea, and did not take other medicines, it is highly unlikely that you are pregnant. Continue taking Zoely as usual. See also section 3 “In case of vomiting or severe diarrhoea” or section 2 “Other medicines and Zoely”.
• If you did not take all tablets correctly or if you miss two periods in a row, you may be pregnant. Contact your doctor immediately. Do not start the next blister pack of Zoely until your doctor confirms that you are not pregnant.

If you stop taking Zoely
You may stop taking Zoely at any time. If you do not want a pregnancy, consult your doctor about other birth control methods. If you stop taking Zoely because you wish to become pregnant, it is advisable to wait for a natural menstrual period before trying to conceive. This will make it easier to determine the expected date of delivery.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health status and think it may be due to Zoely, consult your doctor.
All women who take combined hormonal contraceptives have an increased risk of blood clots in veins (venous thromboembolism, VTE) or in 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 taking Zoely".
The following side effects have been reported with the use of Zoely:

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

• acne
• menstrual disorders (e.g. absent or irregular periods)

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

• reduced interest in sexual activity, depression/depressed mood, mood changes
• headache or migraine
• nausea
• heavy menstrual bleeding; breast tenderness; pelvic pain (abdomen)
• weight gain

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

• increased appetite; fluid retention (oedema)
• hot flushes
• bloated abdomen (bloating)
• increased sweating, hair loss, itching; dry skin, oily skin
• heaviness in limbs
• regular but scanty menstrual bleeding; breast enlargement; breast lump; lactation in absence of pregnancy; premenstrual syndrome; pain during sexual intercourse; vaginal or vulvar dryness; uterine spasm
• irritability
• increased liver enzymes

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

• harmful blood clots in a vein or an artery, for example: in a leg or foot (i.e. DVT), or in a lung (i.e. PE), or heart attack, or stroke, or mini-stroke, or temporary stroke-like symptoms known as transient ischaemic attacks (transient ischaemic attack, TIA), or 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 the risk (see section 2 for further information on conditions that increase the risk of blood clots and symptoms related to a clot).
• decreased appetite
• increased interest in sexual activity
• attention disorders
• dry eyes, intolerance to contact lenses
• dry mouth
• yellow-brown pigmented spots, especially on the face, excessive hair growth
• vaginal odour, vaginal or vulvar discomfort
• hunger
• gallbladder disease

Allergic reactions (hypersensitivity) have been reported in women using Zoely, but the frequency cannot be determined from the available data.
Further information on possible menstrual-related side effects (e.g. absent or irregular periods) during use of Zoely is provided in section 3, "When and how to take the tablets", under "If you have unexpected bleeding" and "If you have missed one or more periods".

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Unused combined pills (including Zoely tablets) must not be disposed of via wastewater or household waste. The hormonal active substances contained in the tablet may have harmful effects if they enter the aquatic environment. Return the tablets to your pharmacy or dispose of them safely in accordance with local regulations. This will help protect the environment.

6. Package contents and other information

What Zoely contains

• The active substances are: 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 placebo tablets with film coating: the tablet does not contain any active substances.
• 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 colloidal anhydrous 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).

Description of the appearance of Zoely and contents of the pack
The film-coated active tablets are white and round. The inscription “ne” is printed on both sides.
The film-coated placebo tablets are yellow and round. The inscription “p” is printed on both sides.
Zoely is available in 28-tablet blister packs of film-coated tablets (24 white active film-coated tablets and 4 yellow placebo film-coated tablets), packed in a carton box. Pack sizes: 28, 84, 168 and 364 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Theramex Ireland Limited
3 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

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.