Nomegestrol Acetate and Estradiol
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about ZOELY. It does not contain all the
available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
ZOELY against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Read this information carefully before you start taking ZOELY tablets.
Keep this leaflet.
You may need to read it again.
What ZOELY is used for
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:
It inhibits the egg release by stopping it maturing.
Changing the cervical mucus consistency making it difficult for the sperm to reach
Changing the lining of the uterus making it less suitable for implantation.
ZOELY consists of 24 white tablets, each containing 2 active ingredients: 2.5 milligrams
of nomegestrol acetate (a progestogen) and 1.5 milligrams of estradiol (the natural
estrogen) and 4 yellow inactive tablets. ZOELY contains estradiol, the natural estrogen,
compared with most Pills which contain the synthetic estrogen ethinylestradiol.
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
Your periods may be lighter and shorter. As a result, the risk of anaemia may be lower.
Your period pains may become less severe or may completely disappear.
ZOELY is available only with a doctor's prescription.
When you must not use ZOELY
Do not take ZOELY if you have an allergy to:
any medicine containing nomegestrol acetate or estradiol
any ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or troubled breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not use the Combined Pill if you have or have had any of the conditions listed
below. If any of these conditions apply to you, tell your doctor before starting to
use ZOELY. Your doctor may advise you to use a different type of Pill or an entirely
different (non-hormonal) method of birth control.
a blood clot (venous thrombosis) in a blood vessel of your legs, lungs (embolus) or
other organs (see also the section later in this leaflet called "The Pill and Thrombosis")
a heart attack or stroke
a condition that may be a first sign of a heart attack (such as angina pectoris which
causes severe chest pain) or stroke (such as a transient ischaemic attack)
a serious risk factor or several risk factors for developing a blood clot
very high blood pressure
a very high level of fat in the blood (cholesterol or triglycerides)
a disorder affecting your blood clotting - for instance Protein C deficiency
if you have major surgery (e.g., an operation) and your ability to move around is
limited for a long period of time (see also the section later in this leaflet called
"The Pill and Thrombosis")
diabetes mellitus with blood vessel damage
a history of migraine accompanied by e.g. visual symptoms, speech disability, or weakness
or numbness in any part of the body
pancreatitis (an inflammation of the pancreas) associated with high levels of fatty
substances in your blood
jaundice (yellowing of the skin) or severe liver disease and your liver is not yet
a benign or malignant liver tumour
a cancer that may grow under the influence of sex hormones (e.g. of the breast or
of the genital organs)
any unexplained vaginal bleeding
you are pregnant or think you might be pregnant.
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.
See also "General Notes" in the next section.
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.
What you need to know before using ZOELY
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
Before you start to use ZOELY
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:
anyone in your immediate family has had breast cancer
you suffer from epilepsy (see "Taking other medicines")
you are overweight
you have diabetes
you have high blood pressure
you have a heart valve disorder or a certain heart rhythm disorder
anyone in your immediate family has had a thrombosis, a heart attack or a stroke
you have sickle cell disease you have liver disease (jaundice) or gall bladder disease
you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease)
you have systemic lupus erythematosus (SLE, a disease affecting the skin all over
you have haemolytic uraemic syndrome (HUS; a disorder of blood coagulation causing
failure of the kidneys)
if you have elevated fatty acid levels in the blood (hypertriglyderidaemia) 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 using combined pills
you have a condition that occurred for the first time or worsened during pregnancy
or previous use of sex hormones (e.g. hearing loss, a metabolic disease called porphyria,
a skin disease called herpes gestationis, a neurological disease called Sydenham's
you have or have had chloasma (yellow brownish pigmentation patches on the skin, particularly
of the face); if so, avoid too much exposure to the sun or ultraviolet radiation
you have recently given birth you are at an increased risk of blood clots. You should
ask your doctor how soon after delivery you can start using ZOELY (see also the section
later in this leaflet called "The Pill and Thrombosis")
You need an operation or if your ability to move around is limited for a long period
of time. This includes travelling by plane for greater than 4 hours.
Tell your doctor if any of the above conditions appear for the first time, recur or
worsen while using the Pill.
The Pill and Thrombosis
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. It is not yet known how ZOELY
influences the risk of getting a thrombosis compared with other contraceptive pills.
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
If you develop high blood pressure while using the Pill, you may be told to stop using
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 (See also "When should you contact your doctor?").
The Pill and Cancer
Regularly examine your breasts.
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. 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
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.
The Pill and Pregnancy
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.
The Pill and Breastfeeding
ZOELY is not recommended for use during breastfeeding. If you wish to take the Pill
while breastfeeding, please seek the advice of your doctor.
The Pill and Ability to Drive
There are no observed effects.
Taking Other Medicines
Tell your doctor if you are taking or have recently taken any other medicines or herbal
products you buy without a prescription from a pharmacy, supermarket or health food
Some medicines may stop the Pill from working properly. These include:
medicines for epilepsy such as
medicines for tuberculosis
(e.g. rifampicin and rifabutin)
medicines for HIV infections (ritonavir, nevirapine, nelfinavir, efavirenz)
medicines for Hepatitis C virus infection (e.g. boceprevir, telaprevir)
(e.g. penicillin, ampicillin, tetracyclines)
medicines for high blood pressure in the blood vessels of the lungs (bosentan)
herbal medicines containing St John's Wort primarily for the treatment of depressive
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
When should you contact your doctor?
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.
Contact your doctor as soon as possible if:
you notice any changes in your own health, especially involving any of the items mentioned
in this leaflet (see also "When you must not use ZOELY?" and "Before you start to
use ZOELY"); do not forget about the items related to your immediate family
you feel a lump in your breast
you are going to use other medicines (see also "Taking Other Medicines")
your ability to move around is limited for a long period of time or you are to have
surgery (consult your doctor at least 4 weeks in advance)
you have unusual, heavy vaginal bleeding
you forgot tablets at the beginning or end of the pack and had intercourse in the
seven days before
you have severe diarrhoea
you miss your period twice in a row or suspect you are pregnant. Do not start the
next pack until told to by your doctor.
Stop taking tablets and see your doctor immediately if you notice possible signs of
thrombosis, myocardial infarction or a stroke such as:
an unusual cough
severe pain in the chest which may reach the left arm - this discomfort may include
the back, jaw, throat, arm, stomach
feeling of being full, having indigestion or choking
sweating, nausea, vomiting, anxiety
breathlessness or rapid breathing
any unusual, sudden, severe or prolonged headache or migraine attack
partial or complete loss of vision, or double vision
confusion, slurring or speech disability
sudden changes to your hearing, sense of smell or taste
dizziness or fainting
fast or irregular heartbeat
weakness or numbness in any part of your body
severe pain in your stomach
severe pain or swelling in either of your legs
pain or tenderness in the leg which may be felt only when standing or walking
warmth, red or discoloured skin on the leg
sudden pain, swelling and slight blue discoloration of an extremity
sudden trouble walking, loss of balance or coordination
The situations and symptoms mentioned above are described and explained in more detail
in the following section "What you need to know before using ZOELY".
How to use ZOELY
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
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,
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
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
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
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
What to do if...
You forget to take your tablets
The following advice only refers to missed white active 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 further 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 white active tablets at
the beginning or at the end of the strip. Therefore you should follow the rules given
Day 1-7 (the first 7 days of white active tablet intake)
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
Days 8 to 17 from the first white active tablet intake.
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)
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 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.
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
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.
If you take too much (overdose)
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 what to do, telephone your doctor or the Poisons Information Centre
on 13 11 26 for advice.
Tell your doctor or pharmacist as soon as possible if you do not feel well while taking
Like all medicines, ZOELY can have side effects. Sometimes they are serious, most
of the time they are not.
Serious side effects
Serious reactions associated with the use of the Pill, as well as the related symptoms,
are described in the following sections "The Pill and Thrombosis/The Pill and Cancer".
Please read these sections for additional information and consult your doctor at once
Other possible side effects
The following side effects have been linked with the use of ZOELY.
Very common side effects (occurring in more than one per 10 users):
changes in the menstrual cycle (e.g. absence of menstruation or breakthrough bleeding/spotting)
Common side effects (occurring in more than one per 100 users, but less than one in
decreased interest in sex;
headache or migraine;
feeling sick (nausea);
Uncommon side effects (occurring in more than one per 1000 users, but less than one
in 100 users):
fluid retention (oedema);
sensation of heaviness;
regular but scanty periods;
milk production while not pregnant;
pain during intercourse;
dryness in the vagina or vulva;
spasm of the uterus;
increase in the level of liver enzymes.
Rare side effects (occurring in more than one per 10,000 users but less than one per
increased interest in sex;
disturbance in attention;
dry eye; contact lens intolerance;
golden brown pigment patches, mostly in the face;
excessive hair growth;
discomfort in the vagina or vulva;
The following side effect has been reported during market use of Zoely: allergic (hypersensitivity)
You should stop taking ZOELY if you experience any signs of thrombosis (headache or
pain elsewhere in your body, dizziness, fainting, disturbances in vision, swollen
ankles), or jaundice (yellowing of the eyes or skin).
Tell your doctor or pharmacist if you notice any side effects not mentioned in this
After taking ZOELY
If you want to stop taking ZOELY
You can stop taking ZOELY any time you want to.
If you do not want to get pregnant, use another reliable birth control method after
stopping ZOELY. Ask your doctor for advice.
If you stop because you want to get pregnant, it is generally recommended that you
wait until you have had a natural period before trying to conceive. This helps you
to work out when the baby will be due.
Ask your doctor or pharmacist for advice about taking folate if you plan to become
Store your tablets below 30°C in a dry place.
Do not store ZOELY or any other medicine in the bathroom or near a sink. Do not leave
it in the car or on a window sill.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least 1.5 metres above the ground is a good place to store medicines.
Do not use after the expiry date stated on the blister and outer box.
Do not use the product if you notice, for example, colour change in the tablet, crumbling
of the tablet or any other visible signs of deterioration.
If your doctor tells you to stop using ZOELY or the tablets have passed their expiry
date, ask your pharmacist what to do with any left over.
What it looks like
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.
In the white tablets:
nomegestrol acetate 2.5 milligrams
estradiol 1.5 milligrams
In the yellow tablets:
no active ingredients
In the white tablets:
lactose, microcrystalline cellulose, crospovidone, talc, magnesium stearate, silica
colloidal anhydrous, polyvinyl alcohol, titanium dioxide, macrogol 3350.
In the yellow tablets:
lactose, microcrystalline cellulose, crospovidone, talc, magnesium stearate, silica
colloidal anhydrous, poly vinyl alcohol, titanium dioxide, iron oxide yellow, iron
oxide black, macrogol 3350.
Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A,
26 Talavera Road,
Macquarie Park NSW 2113
This leaflet was prepared in
AUST R 168332