Zoely

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

ZOELY contains the active ingredient nomegestrol acetate and estradiol. ZOELY is an oral contraceptive, used to prevent pregnancy.

For more information, see Section 1. Why am I using ZOELY? in the full CMI.

Do not use if you have ever had an allergic reaction to nomegestrol acetate, estradiol or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use ZOELY? in the full CMI.

Some medicines may interfere with ZOELY and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

More instructions can be found in Section 4. How do I use ZOELY? in the full CMI.

For more information, see Section 5. What should I know while using ZOELY? in the full CMI.

The most common side effects are changes in menstrual cycle, acne, mood changes and headaches. Serious side effects include blood clots in the veins or blood vessels and breast cancer. See more information under ‘The Pill and Thrombosis’ and ‘The Pill and Cancer’.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Active ingredient(s): Nomegestrol Acetate and Estradiol

This leaflet provides important information about using ZOELY. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using ZOELY.

Where to find information in this leaflet:

ZOELY contains the active ingredient nomegestrol acetate and estradiol. ZOELY is an oral contraceptive, commonly known as a "Birth Control Pill" or "The Pill" that has been prescribed to prevent you from getting pregnant.

ZOELY prevents pregnancy in several ways:

Oral contraceptives are an effective method of birth control. When taken correctly (without missing tablets) the chance of becoming pregnant is very low.

The following non-contraceptive health benefits have been associated with the combined Pill:

Do not use ZOELY if:

Some of the symptoms of an allergic reaction may include:

If you have any of the following conditions, tell your doctor before starting ZOELY. Your doctor may advise you to use a different type of Pill or an entirely different (non-hormonal) method of birth control.

If any of these conditions appear for the first time while using the Pill, stop taking it at once and tell your doctor. In the meantime, use non-hormonal contraceptive measures.

Do not take ZOELY if the expiry date printed on the pack has passed.

Do not take ZOELY if the packaging is torn or shows signs of tampering.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Tell your doctor immediately if you are pregnant or think you are pregnant while you are using ZOELY.

ZOELY must not be used during pregnancy.

ZOELY is not recommended for use during breastfeeding. If you wish to take the Pill while breastfeeding, please seek the advice of your doctor.

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 sex 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.

If you are concerned about contracting a sexually transmitted infection (STI), ask your partner to wear a condom when having sexual intercourse with you.

ZOELY will not protect you from HIV (AIDS) or any other sexually transmitted infections. To help protect yourself from STIs, you need to use a barrier contraceptive such as a condom, but even barrier contraceptives may not protect you against human papilloma virus (HPV).

You should have a thorough medical check-up, including a Pap smear, breast check, blood pressure check and urine check.

You must tell your doctor if you are allergic to any foods, dyes, preservatives or any other medicines.

You must tell your doctor if you smoke.

The risk of having a heart attack or stroke increases as you get older. It also increases the more you smoke. When using the Pill you should stop smoking, especially if you are older than about 35 years of age.

You must tell your doctor if you have any of the conditions listed below. You may need to be kept under close observation. Your doctor can explain this to you. Tell your doctor if:

Tell your doctor if any of the above conditions appear for the first time, recur, or worsen while using the Pill.

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins, or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Medicines that may reduce the effect of ZOELY include:

If you are taking medicines or herbal products that might make ZOELY less effective, a barrier contraceptive method should also be used. Since the effect of another medicine on ZOELY may last up to 28 days after stopping the medicine, it is necessary to use the additional barrier contraceptive method for that long.

ZOELY may also interfere with the working of other medicines - such as ciclosporin and the anti-epileptic lamotrigine.

The HCV combination drug regimen ombitasvir/paritaprevir/ritonavir with or without dasabuvir may cause increases in liver function blood test results (increase in ALT liver enzyme) in women using CHCs containing ethinylestradiol. ZOELY contains estradiol instead of ethinylestradiol. It is not known whether an increase in ALT liver enzyme can occur when using ZOELY with this HCV combination drug regimen. Your doctor will advise you.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect ZOELY.

Taking ZOELY at the same time each day will have the best effect. It will also help you remember when to take it.

A ZOELY pack contains strips of 28 tablets: 24 white tablets with active substances and 4 yellow tablets that do not contain active substances. Each time you start a new strip of ZOELY, take the first white active tablet in the left-hand top corner (see 'Start').

Choose from the 7 stickers with day indicators the one that begins with your starting day, e.g. if you start on a Wednesday, use the day label sticker that starts 'WED'. Stick it on the strip, 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 liquid if necessary.

Follow the direction of the arrows on the pack taking the white active tablets first followed by the yellow inactive tablets.

A period should begin during the 4 days that you use the yellow inactive tablets (the withdrawal bleed). Usually it will start on day 2-3 after the last white tablet and may not have finished before the next strip is started.

Start taking your next pack immediately after the last yellow inactive tablet, even if your period hasn't finished. This means you will always start new packs on the same day of the week, and also means that you have your period on about the same days, each month.

When no hormonal contraception has been used in the past month

Start taking ZOELY on the first day of your cycle, i.e. the first day of menstrual bleeding. ZOELY will work immediately, it is not necessary to use an additional contraceptive method.

You may also start on days 2-5 of your cycle, but in that case make sure you also use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking in the first cycle.

When changing from another combined hormonal contraceptive (combined oral contraceptive (COC), no problem vaginal ring, or transdermal patch)

You can start taking ZOELY the day after you take the last tablet from your present Pill pack. If your present Pill pack contains inactive tablets (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 the present Pill (or the day after the last inactive tablet of your present Pill).

In case you use a vaginal ring or transdermal patch, you should start using ZOELY preferably on the day of removal, but at latest when the next ring or patch would have been applied.

If you have used the Pill, patch or ring consistently and correctly and if you are sure that you are not pregnant, you can stop taking the Pill or remove the ring or patch on any day and start using ZOELY immediately.

If you follow these instructions, it is not necessary to use an additional contraceptive method.

When changing from a progestogen-only method (minipill)

You can stop taking the minipill any day and start taking ZOELY the next day, at the same time. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet-taking.

When changing from an injectable, an implant or a progestogen-releasing intrauterine device (IUD)

Start using ZOELY when your next injection is due or on the day that your implant or your IUD is removed. Make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet-taking.

After having a baby

If you have just had a baby, your doctor may tell you to wait until after your first normal period before you start taking ZOELY. Sometimes it is possible to start sooner. Your doctor will advise you. If you are breast-feeding and want to take ZOELY, you should discuss this first with your doctor.

After a miscarriage or abortion

Your doctor will advise you.

Additional contraceptive precautions

When additional contraceptive precautions are required you should either abstain from vaginal sex, or use a barrier method of contraception, a condom, or a cap (diaphragm) plus spermicide. Rhythm methods are not advised as the Pill disrupts the cyclical changes associated with the natural menstrual cycle e.g., changes in temperature and cervical mucus.

The following advice only refers to missed white active tablets

If you are less than 24 hours late in taking a tablet,

If you are 24 or more hours late in taking any tablet,

Picture 1

 

Day 1-7 (the first 7 days of white active tablet intake, see picture 1 and the schedule at the end of this leaflet)

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 tablets at the usual time. 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 pregnant. So tell your doctor immediately.

Days 8 to 17 from the first white active tablet intake (see picture 1 and the schedule at the end of this leaflet)

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 (the last 7 days of white active tablet intake, see picture 1 and the schedule at the end of this leaflet)

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.

Option 1

Take the last missed white active tablet as soon as you remember (even if this means taking 2 tablets at the same time) and take the next tablets at the usual time. Start the next strip as soon as the white active tablets in the current strip 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 strip, but you may have spotting (drops or flecks of blood) or breakthrough bleeding while taking the white active tablets.

Option 2

Stop taking the active white tablets and start taking the placebo yellow tablets so that the total number of placebo plus missed active white tablets is not more than 4. At the end of this interval, start the next blister. For example, if you missed one active white tablet, you should take 3 days of the placebo yellow tablets; if you missed 2 active white tablets, you should take 2 days of the placebo yellow tablets; and if you missed 3 active white tablets, you should take only 1 day of the placebo yellow tablets.

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 becoming pregnant).

If you have forgotten to take white active tablets in a strip and you do not have the expected monthly period while taking the yellow placebo tablets from the same strip, you may be pregnant. Consult your doctor before you start with the next strip.

Yellow 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 tablet that you missed and continue taking the next tablets at the usual time.

You want to delay your period

You can delay your period if you continue with the white active tablets in your next pack of ZOELY immediately after finishing the white tablets in your current pack. You can continue with this pack for as long as you wish, until this pack is empty. When you wish your period to begin, just stop tablet-taking. While using the second pack you may have some breakthrough bleeding or spotting on active tablet-taking days. Start your next pack after the usual 4-day inactive tablet interval.

You want to change the starting day of your period

If you take your tablets as directed, you will have your period on about the same day every 4 weeks. If you want to change this, just shorten (never lengthen) the next placebo tablet interval. For example, if your period usually starts on a Friday and in future you want it to start on Tuesday (3 days earlier) you should now start your next pack 3 days sooner than you usually do. If you make your placebo tablet interval very short (e.g. 3 days or less), you may not have a bleeding during the interval. You may have some breakthrough bleeding or spotting during the use of the white tablets in the next pack.

If you vomit or have diarrhoea

If you vomit within 3-4 hours of taking an active white 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 an active white tablet. After vomiting or diarrhoea, you must take another active white 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 "What to do if… you forget to take your tablets". If you have severe diarrhoea, please contact 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 have unexpected bleeding

With all Pills, for the first few months, you can have breakthrough bleeding or spotting between your periods. You may need to use sanitary protection but continue to take your tablets as normal. Breakthrough bleeding or spotting usually stops once your body clock has adjusted to the Pill (usually after about 3 tablet-taking cycles). Tell your doctor if it continues, becomes heavy or starts again.

If you have missed a period

If you have taken all of your tablets at the right time, and you have not vomited, or had severe diarrhoea or used other medicines then you are very unlikely to be pregnant. Continue to take ZOELY as usual.

If you miss your period twice in a row, you may be pregnant. Do not start the next pack of ZOELY until your doctor has checked you are not pregnant.

There have been no reports of serious harmful effects from taking too many ZOELY tablets at one time. If you take too much ZOELY you may feel sick, vomit, or have vaginal bleeding.

If you discover a child has taken ZOELY, ask your doctor for advice.

If you are not sure of what to do:

You should do this even if there are no signs of discomfort or poisoning.

When you are using the Pill, your doctor will tell you to return for regular check-ups. You should have a check-up at least once a year.

Remind any doctor, dentist, or pharmacist you visit that you are using ZOELY.

Stop taking tablets and see your doctor immediately if you notice possible signs of thrombosis, myocardial infarction, or a stroke such as:

Be careful before you drive or use any machines or tools until you know how ZOELY affects you.

ZOELY is not expected to affect your ability to drive or operate machinery. If you experience any side effects which impact your ability to drive or operate machinery when taking this medicine, act appropriately and contact your doctor.

Tell your doctor if you drink alcohol.

Alcohol is not expected to interact with ZOELY. If you drink alcohol, talk to your doctor about the possible effects of taking alcohol with this medicine.

Follow the instructions in the carton on how to take care of your medicine properly.

Keep your tablets in the original pack until it is time to take them. If you take your tablets out of the pack, they may not keep well.

Store ZOELY in a cool dry place below 30°C, away from moisture, heat, or sunlight; for example, do not store it:

Keep it where young children cannot reach it.

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

A thrombosis is the formation of a blood clot which may block a blood vessel.

A thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this blood clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called "pulmonary embolism". Deep venous thrombosis is a rare occurrence. It can develop whether or not you are taking the Pill. The risk is higher in Pill-users than in non-users. The chance of getting a thrombosis is highest during the first year a woman uses the Pill. The risk is also higher if you restart using a combined pill (the same product or a different product) after a break of 4 weeks or more. Thrombosis can also happen if you become pregnant. The risk of thrombosis also increases if you gave birth less than a few weeks ago. ZOELY contains estradiol instead of ethinylestradiol. ZOELY may have a risk of VTE in the same range as observed with a combined hormonal contraceptive that contains levonorgestrel/ethinyl estradiol.

Blood clots can also occur very rarely in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). Extremely rarely blood clots can occur in the liver, gut, kidney or eye.

Very occasionally thrombosis may cause serious permanent disabilities or may even be fatal.

If you develop high blood pressure while using the Pill, you may be told to stop using it.

The risk of having deep venous thrombosis is temporarily increased as a result of an operation or immobilisation (for example when you have your leg or legs in plaster or splints). In women who use the Pill, the risk may be yet higher. Tell your doctor you are using the Pill well in advance of any expected hospitalisation or surgery. Your doctor may tell you to stop taking the Pill several weeks before surgery or at the time of immobilisation. Your doctor will also tell you when you can start taking the Pill again after you are back on your feet.

If you notice possible signs of a thrombosis, stop taking the Pill and consult your doctor immediately.

Regularly examine your breasts.

The information given below was obtained from studies of women who used combined oral hormonal contraceptives, as the combined pill containing ethinylestradiol, and from an additional study that included both oral and non-oral hormonal contraceptive-users.

In studies with the combined Pill, breast cancer has been diagnosed slightly more often in women who use the Pill than in women of the same age who do not use the Pill. This slight increase in the numbers of breast cancer diagnoses gradually disappears during the course of the 10 years after stopping use of the Pill.

In the additional study that included both oral and non-oral hormonal contraceptive-users, the occurrence of breast cancer was reported to increase the longer the women used the contraceptive. The difference in the reported risk of breast cancer between women who have never used the contraceptive and those who had used the contraceptive was small: 13 additional cases of breast cancer per 100,000 women-years.

It is not known whether this is caused by the Pill. It may be that the women were examined more often, so that the breast cancer was noticed earlier.

Tell your doctor immediately if you have severe pain in your stomach.

In rare cases benign liver tumours and even more rarely, malignant liver tumours have been reported in users of the Pill. These tumours may lead to internal bleeding.

Chronic infection with Human Papilloma Virus (HPV) is the single most important risk factor for cervical cancer. HPV is a sexually transmitted infection. In women who use combined oral contraceptives for a long time the chance of getting cervical cancer may be slightly higher. This finding may not be caused by the Pill itself but may be related to sexual behaviour and other factors.

Use of nomegestrol acetate (an ingredient in ZOELY), has been linked to the development of a generally benign tumour of the tissue layer between the brain and the skull (meningioma). The risk increases especially when you use it at high doses and for longer duration (several years). If you are diagnosed with meningioma, your doctor will stop your treatment with ZOELY. If you notice any symptoms such as changes in vision (e.g. seeing double or blurriness), hearing loss or ringing in the ears, loss of smell, headaches that worsen with time, memory loss, seizures, weakness in your arms or legs, you must tell your doctor straight away.

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

This medicine is only available with a doctor's prescription.

Do not take this medicine if you are allergic to any of these ingredients.

ZOELY is presented in 1 or 3 PVC/Aluminium backed blister strips containing 28 film-coated tablets (24 white active tablets and 4 yellow inactive tablets).

The blister is packed in a carton together with the package leaflet. Each carton also contains a single paper sleeve, designed to carry one strip of tablets when removed from the outer carton.

The white, round active tablets are coded with 'ne' on both sides. The yellow, round inactive tablets are coded with 'p' on both sides.

Australia Registration Number:

ZOELY oral-contraceptive AUST R 168332

Theramex Australia Pty Ltd

Level 22, 60 Margaret Street,

Sydney NSW 2000

1800 THERAMEX or 1800 843 726

This leaflet was updated in December 2022.