Zoely ® 2,5 mg/1,5 mg Film-Coated Tablets

ZOELY is a contraceptive pill that is used to prevent pregnancy. When ZOELY is taken correctly (without missing active white tablets), the chance of becoming pregnant is very low.

Do not take ZOELY
You must not take 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 you are allergic to estradiol or nomegestrol acetate, or any other ingredients of ZOELY (listed in section 6).
• If you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs. For possible signs of a blood clot see section ‘Blood clots’.
• If you have a disorder affecting your blood clotting - for instance, protein C deficiency, protein S deficiency, antithrombin – III deficiency, Factor V Leiden or antiphospholipid antibodies.
• If you need an operation or if you are off your feet for a long time (see section ‘Blood clots’).
• If you have ever had a heart attack or a stroke.
• If you have ever had angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack (TIA, temporary stroke symptoms).
• If you have a disease that may increase the risk of a clot in the arteries e.g.:
  • diabetes with damaged blood vessels,
  • very high blood pressure,
  • a very high level of fat in the blood (cholesterol or triglycerides),
  • a condition known as hyperhomocysteinaemia.
• If you have (or have ever had) a type of migraine called ‘migraine with aura’.
• If you have (or have ever had) inflammation of the pancreas (pancreatitis) associated with high levels of fat in your blood.
• If you have (or have ever had) severe liver disease and your liver is not yet working normally.
• If you have (or have ever had) a benign or malignant tumour in the liver.
• If you have ever had, or if you may have, cancer of the breast or the genital organs.
• If you have meningioma or have ever been diagnosed with a meningioma (a generally benign tumour of the tissue layer between the brain and the skull).
• If you have any unexplained bleeding from the vagina.
• If you are pregnant or think you might be pregnant.

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 below.

Warnings and precautions

General notes
Before you start taking 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 ‘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 ZOELY, or where the reliability of ZOELY 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 ZOELY alters the usual changes in temperature and cervical mucus that occur during the menstrual cycle.

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception if used correctly.
• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks.
• Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section ‘Blood clots’).

Talk to your doctor or pharmacist before taking ZOELY.

When should you contact your doctor?
Seek urgent medical attention:

• If you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack or a stroke (see ‘Blood clots' section below). For a description of the symptoms of these serious side effects please go to ‘How to recognise a blood clot’.
• If you notice any changes in your own health, especially involving any of the items mentioned in this leaflet (see also in section 2 ‘Do not take ZOELY’; do not forget about the changes in the health of your immediate family).
• If you feel a lump in your breast.
• If you experience symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or hives together with difficulty breathing.
• If you are going to use other medicines (see also in section 2 ‘Other medicines and ZOELY’).
• If you are to be immobilised or are to have surgery (tell your doctor at least four weeks in advance).
• If you have unusual, heavy vaginal bleeding.
• If you forgot one or more tablets in the first week of the blister pack and had unprotected sex in the seven days before (see also in section 3 ‘If you forget to take ZOELY’).
• If you have severe diarrhoea or experience severe vomiting.
• If you miss periods and suspect you may be pregnant (do not start the next blister pack until your doctor tells you, see also in section 3 ‘If you have missed one or more periods’).

ZOELY does not protect you against HIV infections (AIDS) or any other sexually transmitted disease.

Tell your doctor if any of the following conditions apply to you. If the condition develops, or gets worse while you are taking ZOELY, you must tell your doctor.

• If you have hereditary and acquired angioedema. Consult your doctor immediately if you experience symptoms of angioedema such as swollen face, lips, tongue and/or throat and/or difficulty in swallowing or hives, together with difficulty in breathing. Products containing oestrogens, such as ZOELY, may induce or worsen symptoms.
• If a close relative has or has ever had breast cancer.
• If you have epilepsy (see ‘Other medicines and ZOELY’).
• If you have liver disease (for instance jaundice) or gallbladder disease (for instance gallstones).
• If you have diabetes.
• If you have depression.
• If you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE; a disease affecting your natural defence system).
• If you have haemolytic uraemic syndrome (HUS; a disorder of blood clotting causing failure of the kidneys).
• If you have sickle cell disease (an inherited disease of the red blood cells).
• If you have elevated fatty acid levels in your blood (hypertriglyceridaemia) or a positive family history for this condition (familial hypertriglyceridaemia). If so, you may be at an increased risk of developing pancreatitis (inflammation of the pancreas) when taking ZOELY.
• If you have a condition that occurred for the first time or worsened during pregnancy or previous use of female hormones e.g., hearing loss, porphyria (a disease of the blood), herpes gestationis (skin rash with vesicles during pregnancy), Sydenham’s chorea (a disease of the nerves in which sudden movements of the body occur).
• If you have (or have ever had) chloasma yellowish-brown pigment patches, so called ‘pregnancy patches’, particularly on the face. If so, avoid too much exposure to the sun or ultraviolet light.
• If you have just given birth, you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you can start taking ZOELY (see ‘Blood clots’).
• If you need an operation, or if you are off your feet for a long time (see ‘Blood clots’).
• If you have an inflammation in the veins under the skin (superficial thrombophlebitis).
• If you have varicose veins.

Do not share medicines prescribed for you with any other person. Always take ZOELY exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

When and how to take the tablets
The ZOELY blister contains 28 tablets: 24 white tablets with the active substances (number 1 to 24) and 4 yellow tablets without active substances (number 25 to 28).

Each time you start a new blister of ZOELY, take the number 1 active white 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 active white tablets where it reads ‘Place day label here’. This allows you to check whether you took your daily tablet.

Each day take 1 tablet at about the same time, with some water. Follow the direction of the arrows on the blister, so use the active white 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 to 3 days after the last active white 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 has not 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 approximately 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 ‘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.

You may also start on days 2 to 5 of your cycle, but if you do, 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 pill (COC), 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 tablet 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 have used the pill, patch or ring consistently and correctly and if you are sure that you are not pregnant, you can also 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 pill (minipill)

You can stop taking the minipill any day and start taking ZOELY the next day, at the same time. But if you are having intercourse, make sure you also use an additional contraceptive method (barrier method) for the first 7 days that you are taking ZOELY.

When changing from a progestogen-only injectable, implant or hormone-medicated intra-uterine system (IUS)

Start taking ZOELY when your next injection is due or on the day your implant or IUS is removed. But if you are having intercourse, make sure you also use an additional contraceptive method (barrier method) 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, use an additional contraceptive method (barrier method) during the first 7 days of ZOELY use. If, after having a baby, you have had sex 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 breastfeeding, see ‘Pregnancy and breastfeeding’.

Ask your doctor what to do if you are not sure when to start.

After a miscarriage or an abortion

Your doctor will advise you.

If you take more ZOELY than you should (overdose)

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. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take ZOELY

The following advice only refers to missed active white tablets

• If you are less than 24 hours late in taking a tablet, the reliability of the pill is maintained. Take the tablet as soon as you remember and take the next tablets at the usual time.
• If you are 24 or more hours late in taking any tablet, the reliability of the pill may be reduced. The more consecutive tablets you have missed, the higher the risk that the contraceptive efficacy is decreased. There is a particularly high risk of becoming pregnant if you miss active white tablets at the beginning or at the end of the blister. Therefore, you should follow the rules given below.

Day 1 to 7 active white tablet intake (see picture and schedule)
Take the last active white missed 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. 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 to 17 active white tablet intake (see picture and schedule)
Take the last missed 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. If you have taken you 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 to 24 active white tablet intake (see picture and schedule)
There is a particularly high risk of becoming pregnant if you miss active white 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 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 blister as soon as the active white 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.

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 tablets is not more than 4. For example, if you missed one active white tablet, you should take 3 days of the placebo yellow tablets; if you missed 3 active white tablets, you should take only 1 day of the placebo yellow tablets. At the end of the placebo tablet interval, start the next blister.

If you cannot remember how many active white 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 active white 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.

ZOELY can have side effects. 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 take ZOELY’.

If any of the following happens, stop taking ZOELY and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the face, tongue and/or throat and/or difficulty swallowing or hives, together with difficulty breathing
• rash or itching
• pins and needles

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

The following side effects have been linked with the use of ZOELY:

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

• acne
• changes to menstrual periods (e.g., absence of menstruation or breakthrough bleeding or spotting)

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

• decreased interest in sex; depression/depressed mood; mood changes
• headache or migraine
• feeling sick (nausea)
• heavy menstrual periods, breast pain, pelvic pain
• weight gain

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

• increased appetite, fluid retention (oedema)
• hot flush
• swollen abdomen (belly)
• increased sweating, hair loss, itching, dry skin, oily skin
• heaviness in limbs
• regular but scanty periods, larger breasts, breast lump, milk production while not pregnant, premenstrual syndrome (symptoms may include breast swelling or tenderness, bloating, cramps, low back pain, depression, irritability), pain during sex, dryness in the vagina or vulva, spasm of the uterus
• irritability
• increased liver enzymes

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

• harmful blood clots in a vein or artery, for example:
  • in a leg or foot (i.e., DVT)
  • in a lung (i.e., PE)
  • heart attack
  • stroke
  • mini-stroke or temporary stroke-like symptoms known as a transient ischaemic attack (TIA)
  • blood clots in the liver, stomach/intestine, kidneys or eye.
• 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.)
• decreased appetite
• increased interest in sex
• disturbance in attention
• dry eye, contact lens intolerance
• dry mouth
• golden brown pigment patches, mostly in the face, excessive hair growth
• vaginal smell, discomfort in the vagina or vulva
• hunger
• disease of the gallbladder

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’. Not all side effects reported for ZOELY are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ZOELY, please consult your doctor, pharmacist or other healthcare provider for advice. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects
If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of ZOELY.

Store all medicines out of reach of children. Do not use ZOELY after the expiry date which is stated on the carton. The expiry date refers to the last day of the indicated month. Store at or below 30 °C. Do not remove tablets from blister until required for use. Medicines should not be disposed of via waste water or household water. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.