Patient Leaflet Updated 28-Feb-2019 | Merck Sharp & Dohme Limited
Zoely 2.5 mg/1.5 mg film-coated tablets
Package leaflet: Information for the user
Zoely® 2.5 mg/1.5 mg film-coated tablets
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Important things to know about combined hormonal contraceptives (CHCs):
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Zoely is and what it is used for
2. What you need to know before you use 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 that is used to prevent pregnancy.
2. What you need to know before you use Zoely
Before you start using Zoely you should read the information on blood clots (thrombosis) in section 2. It is particularly important to read the symptoms of a blood clot – see section 2 “Blood clots”.
Before you can begin taking Zoely, your doctor will ask you some questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure and, depending upon your personal situation, may also carry out some other tests.
In this leaflet, several situations are described where you should stop taking the pill, or where the reliability of the pill may be decreased. In such situations you should not have sexual intercourse or you should take extra non-hormonal contraceptive precautions, e.g., use a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because the pill alters the usual changes in temperature and cervical mucus that occur during the menstrual cycle.
Zoely, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
When you should not use Zoely
You must not use Zoely if you have any of the conditions listed below. If you do have any of the conditions listed below, you must tell your doctor. Your doctor will discuss with you what other form of birth control would be more appropriate.
If any of these conditions appear for the first time while using Zoely, stop taking it at once and tell your doctor. In the meantime, use a non-hormonal contraceptive. See also ‘General Notes’ in section 2 above.
When to take special care with Zoely
When should you contact your doctor?
Seek urgent medical attention
For a description of the symptoms of these serious side effects please go to “How to recognise a blood clot”.
Tell your doctor if any of the following conditions apply to you.
If the condition develops, or gets worse while you are using Zoely, you should also tell your doctor.
Using a combined hormonal contraceptive such as Zoely increases your risk of developing a blood clot compared with not using one. In rare cases a blood clot can block blood vessels and cause serious problems.
Blood clots can develop
Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or, very rarely, they may be fatal.
It is important to remember that the overall risk of a harmful blood clot due to Zoely is small.
HOW TO RECOGNISE 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 are you possibly suffering from?
Deep vein thrombosis
If you are unsure, talk to a doctor as some of these symptoms such as coughing or being short of breath may be mistaken for a milder condition such as a respiratory tract infection (e.g., a ‘common cold’).
Symptoms most commonly occur in one eye:
Retinal vein thrombosis (blood clot in the eye)
Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.
Blood clots blocking other blood vessels
BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
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 product) after a break of 4 weeks or more.
After the first year, the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive.
When you stop Zoely your risk of 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 VTE and the type of combined hormonal contraceptive you are taking.
The overall risk of a blood clot in the leg or lung (DVT or PE) with Zoely is small.
Risk of developing a blood clot in a year
Women who are not using a combined hormonal pill and are not pregnant About 2 out of 10,000 women
Women using a combined hormonal contraceptive pill containing levonorgestrel, norethisterone or norgestimate About 5-7 out of 10,000 women
Women using Zoely Not yet known
Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Zoely is small but some conditions will increase the risk. Your risk is higher:
The risk of developing a blood clot increases the more conditions you have.
Air travel (> 4 hours) may temporarily increase your risk of a blood clot, particularly if you have some of the other factors listed.
It is important to tell your doctor if any of these conditions apply to you, even if you are unsure. Your doctor may decide that Zoely needs to be stopped.
If any of the above conditions change while you are using Zoely, for example a close family member experiences a thrombosis for no known reason or you gain a lot of weight, tell your doctor.
BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.
Factors that increase your risk of a blood clot in an artery
It is important to note that the risk of a heart attack or stroke from using Zoely is very small but can increase:
If you have more than one of these conditions or if any of them are particularly severe, the risk of developing a blood clot may be increased even more.
If any of the above conditions change while you are using Zoely, for example, you start smoking, a close family member experiences a thrombosis for no known reason or you gain a lot of weight, tell your doctor.
Breast cancer has been found slightly more often in women using combined pills, but it is not known whether this is caused by the combined pills. For example, it may be that tumours are found more in women on combined pills because they are examined by the doctor more often. After stopping the combined pill, the increased risk gradually reduces.
It is important to check your breasts regularly and you should contact your doctor if you feel any lump. You should also tell your doctor if a close relative has, or ever had breast cancer (see section 2 “When to take special care with Zoely”).
In rare cases, benign (noncancerous) liver tumours, and in even fewer cases malignant (cancerous) liver tumours have been reported in pill users. Contact your doctor if you have unusual severe abdominal pain.
Cervical cancer is caused by an infection with the human papilloma virus (HPV). It has been reported to occur more often in women using the pill for more than 5 years. It is unknown if this finding is due to the use of hormonal contraceptives or to other factors, such as difference in sexual behaviour.
Some women using hormonal contraceptives including Zoely have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.
If you are having any blood or urinary test, tell your doctor that you are using Zoely as it may affect the results of some tests.
Children and adolescents
No data on efficacy and safety are available in adolescents below 18 years.
Other medicines and Zoely
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal medicines.
Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you use Zoely.
Pregnancy and breast-feeding
Zoely must not be used by women who are pregnant, or who think they may be pregnant. If you get pregnant while using Zoely you should stop using Zoely and contact your doctor.
If you want to stop Zoely because you want to get pregnant, see in section 3 ‘If you stop taking Zoely’.
Zoely is not usually recommended for use during breast-feeding. If you wish to use the pill while breast-feeding, please seek the advice of your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Zoely has no or negligible effect on your ability to drive and use machines.
Zoely contains lactose
Zoely contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to use Zoely
When and how to take the tablets
The Zoely blister contains 28 tablets: 24 white tablets with the active substances (number 1-24) and 4 yellow tablets without active substances (number 25-28).
Each time you start a new blister of Zoely, take the number 1 white active tablet in the left-hand top corner (see ‘Start’). Choose from the 7 stickers with day indicators the one in the grey column that begins with your starting day. For example, if you start on a Wednesday, use the day label sticker that starts with ‘WED’. Stick it on the blister, just above the row of white active tablets where it reads ‘Place day label here’. This allows you to check whether you took your daily tablet.
Take one tablet each day at about the same time, with some water if necessary.
Follow the direction of the arrows on the blister, so use the white active tablets first and then the yellow placebo tablets.
Your period will start during the 4 days that you use the yellow placebo tablets (so-called withdrawal bleeding). Usually it will start 2-3 days after the last white active tablet and may not have finished before the next blister is started.
Start taking your next blister immediately after the last yellow tablet, even if your period hasn’t finished. This means that you will always start a new blister on the same day of the week, and also that you have your period on roughly the same days each month.
Some users may not have their period every month during the intake of the yellow tablets. If you have taken Zoely every day according to these directions, it is unlikely that you are pregnant (see also section 3 ‘If you have missed one or more periods’).
Starting your first pack of Zoely
When no hormonal contraceptive has been used in the past month
Start taking Zoely on the first day of your cycle (i.e. the first day of your menstrual bleeding). Zoely will work immediately. You do not need to use an additional contraceptive method.
When changing from another combined hormonal contraceptive (combined pill, vaginal ring, or transdermal patch)
You can start taking Zoely the day after you have taken the last tablet from your present pill blister (this means no tablet-free break). If your present pill blister also contains inactive (placebo) tablets you can start Zoely on the day after taking the last active tablet (if you are not sure which this is, ask your doctor or pharmacist). You can also start later, but never later than the day following the tablet-free break of your present pill (or the day after the last inactive tablet of your present pill). In case you use a vaginal ring or transdermal patch, it is best to start using Zoely on the day you remove the ring or patch. You can also start, at the latest, on the day you would have started using the next ring or patch. If you follow these instructions, it is not necessary to use an additional contraceptive method.
When changing from a progestogen-only pill (minipill)
You can stop taking the minipill any day and start taking Zoely the next day. But if you are having intercourse, make sure you also use a barrier method of contraception for the first 7 days that you are taking Zoely.
When changing from a progestogen-only injectable, implant or a hormone-medicated intrauterine system (IUS)
Start using Zoely when your next injection is due or on the day that your implant or IUS is removed. But if you are having intercourse, make sure you also use a barrier method of contraception for the first 7 days that you are taking Zoely.
After having a baby
You can start Zoely between 21 and 28 days after having a baby. If you start later than day 28, you should also use a barrier method of contraception during the first 7 days of Zoely use. If, after having a baby, you have had sexual intercourse before starting Zoely, be sure that you are not pregnant or wait until the next menstrual period. If you want to start Zoely after having a baby and are breast-feeding, see also section 2 ‘Pregnancy and Breast-feeding’.
Ask your doctor what to do if you are not sure when to start.
After a miscarriage or an abortion
Follow the advice of your doctor.
If you take more Zoely than you should
There have been no reports of serious harmful effects from taking too many Zoely tablets at one time. If you have taken several tablets at a time, you may have nausea, vomiting or vaginal bleeding. If you discover that a child has taken Zoely, ask your doctor for advice.
If you forget to take Zoely
The following advice only refers to missed white active tablets.
Day 1-7 of white active tablet intake (see picture and schedule)
Take the last white active missed 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. However, use a barrier method such as a condom as an extra precaution until you have taken your tablets correctly for 7 days in a row.
If you had sexual intercourse in the week before missing the tablets, there is a possibility of becoming or being pregnant. So contact your doctor immediately.
Day 8-17 of white active tablet intake (see picture and schedule)
Take the last missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. If you have taken your tablets correctly in the 7 days prior to the missed tablet, the protection against pregnancy is not reduced, and you do not need to use extra precautions. However, if you have missed more than 1 tablet, use a barrier method such as a condom as an extra precaution until you have taken your tablets correctly for 7 days in a row.
Day 18-24 of white active tablet intake (see picture and schedule)
There is a particularly high risk of becoming pregnant if you miss white active tablets close to the yellow placebo tablet interval. By adjusting your intake schedule this higher risk can be prevented.
The following two options can be followed. You do not need to use extra precautions if you have taken your tablets correctly in the 7 days prior to the missed tablet. If this is not the case, you should follow the first of these two options and use a barrier method such as a condom as an extra precaution until you have taken your tablets correctly for 7 days in a row.
Take the last missed white active tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. Start the next blister as soon as the white active tablets in the current blister are finished, so skip the yellow placebo tablets. You may not have your period until you take the yellow placebo tablets at the end of the second blister, but you may have spotting (drops or flecks of blood) or breakthrough bleeding while taking the white active tablets.
Stop taking the white active tablets and start taking the yellow placebo tablets for a maximum of 3 days so that the total number of placebo plus missed white active tablets is not more than 4. At the end of the placebo tablet interval, start the next blister.
If you cannot remember how many white active tablets you have missed, follow the first option, use a barrier method such as a condom as an extra precaution until you have taken your tablets correctly for 7 days in a row, and contact your doctor (as you may not have been protected from being pregnant).
If you have forgotten to take white active tablets in a blister, and you do not have the expected monthly period while taking the yellow placebo tablets from the same blister, you may be pregnant. Consult your doctor before you start with the next blister.
Yellow placebo tablets missed
The last 4 yellow tablets of the fourth row are placebo tablets which do not contain active substances. If you forgot to take one of these tablets the reliability of Zoely is maintained. Throw away the yellow placebo tablet(s) you missed and continue taking the next tablets at the usual time.
Schedule: if you are 24 or more hours late taking white tablets
If you vomit or have severe diarrhoea
If you vomit within 3-4 hours of taking a white active tablet, or you have severe diarrhoea, the active ingredients of your Zoely tablet may not have been completely absorbed into your body. The situation is similar to if you forget a white active tablet. After vomiting or diarrhoea, you must take another white active tablet from a reserve blister as soon as possible. If possible take it within 24 hours of when you normally take your pill. Take the next tablet at the usual time. If this is not possible or 24 or more hours have passed, you should follow the advice given under "If you forget to take Zoely". If you have severe diarrhoea, please tell your doctor.
The yellow tablets are placebo tablets which do not contain active substances. If you vomit or have severe diarrhoea within 3-4 hours of taking a yellow tablet, the reliability of Zoely is maintained.
If you want to delay your period
You can delay your period by not taking the yellow placebo tablets and going straight to a new blister of Zoely. You may experience light or menstruation-like bleeding while using this second blister. When you wish your period to begin during the second blister, stop taking the white active tablets and start taking the yellow placebo tablets. After finishing the 4 yellow placebo tablets from the second blister, start with the next (third) blister.
If you want to change the starting day of your period
If you take the tablets according to the instructions, then your period will begin during the placebo days. If you have to change this day, reduce the number of placebo days – when you take the yellow placebo tablets – (but never increase them – 4 is the maximum). For example, if you start taking the placebo tablets on Friday, and you want to change this to a Tuesday (3 days earlier) you must start a new blister 3 days earlier than usual. You may not have any bleeding during the shortened period of yellow placebo tablet intake. While using the next blister you may have some spotting (drops or flecks of blood) or breakthrough bleeding on white active tablet-taking days.
If you are not sure what to do, consult your doctor.
If you have unexpected bleeding
With all combined pills, for the first few months, you can have some irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods. You may need to use sanitary protection, but keep taking your tablets as usual. Irregular vaginal bleeding usually stops once your body has adjusted to the pill (usually after about 3 months). If bleeding continues, becomes heavy or starts again, contact your doctor.
If you have missed one or more periods
Clinical trials with Zoely have shown that you may occasionally miss your regular monthly period after Day 24.
If you stop taking Zoely
You can stop taking Zoely at any time. If you do not want to become pregnant, first ask your doctor about other methods of birth control.
If you stop taking Zoely because you want to get pregnant, you are recommended to wait until you have had a natural period before trying to conceive. This will help you to determine when the baby will be due.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any side effect, particularly if severe or persistent, or have any change to your health that you think may be due to Zoely, please talk to your doctor.
An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives. For more detailed information on the different risks from taking combined hormonal contraceptives, please see section 2, “What you need to know before you use Zoely”.
The following side effects have been linked with the use of Zoely:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
The chance of having a blood clot may be higher if you have any other conditions that increase this risk. (See section 2 for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot.)
Allergic (hypersensitive) reactions have been reported in users of Zoely, but the frequency cannot be estimated from the available data.
Further information on the possible side effect changes to menstrual periods (e.g. absence or irregular) during the use of Zoely is described in section 3 ‘When and how to take the tablets’, ‘If you have unexpected bleeding’ and ‘If you have missed one or more periods’).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Combined pills (including Zoely tablets) no longer required should not be disposed via wastewater or the municipal sewage system. The hormonal active ingredients in the tablet may have harmful effects if they reach the aquatic environment. Return them to a pharmacy or dispose them in another safe way according to local requirements. These measures will help to protect the environment.
6. Contents of the pack and other information
What Zoely contains
What Zoely looks like and contents of the pack
The active film-coated tablets (tablets) are white and round. They are coded ‘ne’ on both sides.
The placebo film-coated tablets are yellow and round. They are coded ‘p’ on both sides.
Zoely comes in blisters of 28 film-coated tablets (24 white active film-coated tablets and 4 yellow placebo film-coated tablets) packed in a ply carton. Pack sizes: 28, 84, 168 and 364 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in January 2019.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
© Merck Sharp & Dohme Limited, 2019. All rights reserved.
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