DAYLETTE 0.02MG/ 3 MG FILM-COATED TABLETS

Active substance: ETHINYLESTRADIOL

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Package leaflet: Information for the user

DAYLETTE 0.02/3 mg film-coated tablets
ethinylestradiol and drospirenone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or your pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Daylette is and what it is used for
2. What you need to know before you take Daylette
3. How to take Daylette
4. Possible side effects
5. How to store Daylette
6. Contents of the pack and otherurther information

• if you must have surgery, if you have had a serious accident or if
you are immobilized for a long time. It is important to tell your doctor in
advance that you are using Daylette as the treatment may have to be
stopped. Your doctor will tell you when to start Daylette again. This is
usually about two weeks after you are back on your feet.

If you want to become pregnant, you can stop taking {Invented name}
at any time (see also “If you want to stop taking {Invented name}”).

Your chances of having a blood clot are increased by taking the Pill.
– Of 100,000 women who are not on the Pill and not pregnant, about
5‑10 may have a blood clot in a year.
1. What Daylette is and what it is used for
– Of 100,000 women taking a Pill like {Invented name}, 30‑40 may
have a blood clot in a year, the exact number is unknown.
– Daylette is a contraceptive pill and is used to prevent pregnancy.
– Of 100,000 women who are pregnant, around 60 may have a
– Each of the 24 white tablets contains a small amount of two different blood clot in a year.
female hormones, namely drospirenone and ethinylestradiol.
– The 4 green tablets contain no active substances and are also called A blood clot in the veins may travel to the lungs and may block blood
placebo tablets.
vessels (called a lung embolus). Formation of blood clots in the veins

Contraceptive pills that contain two hormones are called may be fatal in 1‑2% of cases.
“combination” pills.
The level of risk may vary according to the type of pill you take. Discuss
with your doctor the available options.
2. What you need to know before you take Daylette
Arterial blood clot
General notes
The use of combination pills has been connected with an increase of
Before you can begin taking Daylette, your doctor will ask you some the risk of an arterial blood clot (arterial thrombosis), for example, in the
questions about your personal health history and that of your close blood vessels of the heart (heart attack) or the brain (stroke).
relatives. The doctor will also measure your blood pressure and,
depending upon your personal situation, may also carry out some other The risk of an arterial blood clot in users of combination pills increases:
tests.
• with increasing age
• if you smoke. You are strongly advised to stop smoking when you
In this leaflet, several situations are described where you should stop use Daylette, especially if you are older than 35 years.
using Daylette, or where the reliability of Daylette may be decreased. • if you have high levels of blood cholesterol or triglycerides
In such situations you should either not have sex or you should take • if you are overweight
extra non-hormonal contraceptive precautions, e.g., use a condom or • if one of your close relatives had a heart attack or a stroke at a young
another barrier method.
age
• if you have high blood pressure
Do not use rhythm or temperature methods. These methods can be • if you suffer from migraine
unreliable because Daylette alters the monthly changes of body • if you have a problem with your heart (valve disorder, a disturbance
temperature and of cervical mucus.
of the cardiac rhythm).

Breast-feeding
Use of Daylette is generally not advisable when a woman is breastfeeding. If you want to take the pill while you are breast-feeding you
should contact your doctor.

Daylette, like other hormonal contraceptives, does not protect against
HIV infection (AIDS) or any other sexually transmitted disease.
While you are receiving this medication you should see your doctor
regularly, at least twice a year. If you have any unusual symptoms such
as unexplained pains in the chest, abdomen or legs you must consult
your doctor immediately.
Do not take Daylette
• if you are allergic to ethinylestradiol or drospirenone, or any of the
other ingredients of this medicine (listed in section 6) This may cause
itching, rash or swelling
• if you have (or have ever had) a blood clot in a blood vessel of the
leg (thrombosis), of the lung (pulmonary embolism) or other organs
• if you have (or have ever had) a heart attack or stroke
• if you have (or have ever had) a disease that can be an indicator of
a heart attack in the future (for example, angina pectoris, which causes
severe pain in the chest) or of a stroke (for example, a passing slight
stroke with no residual effects)
• if you have a disease that may increase the risk of a clot in the
arteries. This applies to the following diseases:
– diabetes with damaged blood vessels
– very high blood pressure
– a very high level of fat in the blood (cholesterol or triglycerides)
• if you have a disturbance of blood clotting (for example, protein C
deficiency)
• if you have (or have ever had) a certain form of migraine (with socalled focal neurological symptoms)
• if you have (or have ever had) an inflammation of the pancreas
(pancreatitis)
• if you have (or have ever had) liver disease and your liver function is
still not normal
• if your kidneys are not working well (renal failure)
• if you have (or have ever had) a tumour in the liver
• if you have (or have ever had) or if you are suspected of having
breast cancer or cancer of the genital organs
• if you have any unexplained bleeding from the vagina.
Warnings and precautions
Talk to your doctor or pharmacist before taking Daylette.
In some situations you need to take special care while using Daylette
or any other combination pill, and your doctor may need to examine
you regularly. If any of the following conditions applies to you, you must
inform your doctor before starting to use Daylette. Also if any of the
following conditions develops or worsens while you are using Daylette
you must consult your doctor:
• if a close relative has or has ever had breast cancer
• if you have a disease of the liver or the gallbladder
• if you have diabetes
• if you have depression
• if you have Crohn’s disease or inflammatory bowel disease (ulcerative
colitis)
• if you have a blood disease called HUS (haemolytic uraemic
syndrome) that causes kidney damage
• if you have a blood disease called sickle cell anaemia
• if you have epilepsy (see “Other medicines and Daylette”)
• if you have a disease of the immune system, called SLE (systemic
lupus erythematosus)
• if you have a disease that first appeared during pregnancy or earlier
use of sex hormones (for example, hearing loss, a blood disease called
porphyria, skin rash with blisters during pregnancy (gestational herpes),
a nerve disease causing sudden movements of the body (Sydenham’s
chorea)
• if you have or have ever had golden brown pigment patches
(chloasma), so called “pregnancy patches”, especially on the face. If
this is the case, avoid direct exposure to sunlight or ultraviolet light.
• if you have hereditary angioedema, products containing estrogens
may cause or worsen the symptoms. You should see your doctor
immediately if you experience symptoms of angioedema such as
swollen face, tongue and/or pharynx and/or difficulty swallowing or
hives together with difficulty breathing.

Ask your doctor or pharmacist for advice before taking any
medicine.

Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
There is no information suggesting that use of Daylette affects driving
or use of machines.
Daylette contains lactose
In Daylette the white active film-coated tablets contain 48.53 mg of
lactose monohydrate and the green inactive ones contain 37.26 mg of
lactose anhydrous. If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor before taking this
medicinal product.
The hormone-free (placebo) film-coated tablets contain “sunset yellow”,
“indigo carmine” and “quinoline yellow” colouring agents which may
cause allergic reaction.
Daylette also contains 0.070 mg of soya lecithin. If you are allergic to
peanut or soya, do not use this medicinal product.
3. HOW TO TAKE DAYLETTE
Always take Daylette exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.

Each blister contains 24 active white tablets and 4 green placebo
tablets.
Stop taking Daylette and contact your doctor immediately if you The two differently coloured tablets of Daylette are arranged in order.
notice possible signs of a blood clot, such as:
A strip contains 28 tablets.
• severe pain and/or swelling in one of your legs
• sudden severe pain in the chest which may reach the left arm
Take one tablet of Daylette every day, if necessary with a small amount
• sudden breathlessness
of water. You may take the tablets with or without food, but you should
• sudden cough without an obvious cause
take the tablets every day around the same time.
• any unusual, severe or long-lasting headache or worsening of
migraine
Do not confuse the tablets: take a white tablet for the first 24 days and
• partial or complete blindness or double vision
then a green tablet for the last 4 days. You must then start a new strip
• difficulty in speaking or inability to speak
straightaway (24 white and then 4 green tablets). There is therefore no
• giddiness or fainting
gap between two strips.
• weakness, strange feeling, or numbness in any part of the body.
Because of the different composition of the tablets it is necessary to
Daylette and cancer
begin with the first tablet on the upper left and that you take the tablets
Breast cancer has been observed slightly more often in women using every day. For the correct order, follow the direction of the arrows on
combination pills, but it is not known whether this is caused by the the strip.
treatment. For example it may be that more tumours are detected in
women on combination pills because they are examined by their doctor Preparation of the strip
more often.
To control the daily intake of the contraceptive, use the arrows on the strip.
The arrows show the order you are to take the pills.
The occurrence of breast tumours becomes gradually less after stopping During the 4 days when you are taking the green placebo tablets (the
the combination hormonal contraceptives. It is important to regularly placebo days), bleeding should begin (so-called withdrawal bleeding).
check your breasts and you should contact your doctor if you feel any This usually starts on the 2nd or 3rd day after the last white active tablet
lump.
of {Invented name}. Once you have taken the last green tablet, you
should start with the following strip, whether your bleeding has stopped
In rare cases, benign liver tumours, and in even fewer cases malignant or not. This means that you should start every strip on the same day of
liver tumours have been reported in pill users. Contact your doctor if you the week, and that the withdrawal bleed should occur on the same
have unusual severe abdominal pain.
days each month.
Bleeding between periods
During the first few months that you are taking Daylette, you may
have unexpected bleeding (bleeding outside the placebo days). If this
bleeding occurs for more than a few months, or if it begins after some
months, your doctor must find out what is wrong.

If you use Daylette in this manner you are protected against pregnancy
also during the 4 days when you are taking a placebo tablet.

When can you start with the first strip?
• If you have not used a contraceptive with hormones in the previous
month
What you must do if no bleeding occurs during the placebo days
Begin with Daylette on the first day of the cycle (that is, the first day of
If you have taken all the white active tablets correctly, have not had your period). If you start Daylette on the first day of your menstruation
vomiting or severe diarrhoea and you have not taken any other you are immediately protected against pregnancy. You may also begin
medicines, it is highly unlikely that you are pregnant.
on day 2-5 of the cycle, but then you must use extra protective measures
(for example, a condom) for the first 7 days.
If the expected bleeding does not happen twice in succession, you may
be pregnant. Contact your doctor immediately. Only start the next strip • Changing from a combined hormonal contraceptive (combined
if you are sure that you are not pregnant.
oral contraceptive(COC), vaginal ring or transdermal patch)
You can start Daylette preferably on the day after the last active tablet
Other medicines and Daylette
(the last tablet containing the active substances) of your previous pill,
Tell your doctor or pharmacist if you are taking, have recently taken or but at the latest on the day after the tablet-free days of your previous pill
might take any other medicines.
finish (or after the last inactive tablet of your previous pill).
When changing from a vaginal ring or transdermal patch, follow the
They can tell you if you need to take additional contraceptive precautions advice of your doctor.
(for example condoms) and if so, for how long.
• Changing from a progestogen-only method (progestogen-only
• Some medicines can make Daylette less effective in preventing pill, injection, implant or a progestogen-releasing IUD)
pregnancy, or can cause unexpected bleeding. These include You may switch any day from the progestogen-only pill (from an implant
medicines used for the treatment of
or an IUD on the day of its removal, from an injectable when the next
epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, injection would be due) but in all of these cases you must use extra
oxcarbazepine)
protective measures (for example, a condom) for the first 7 days of
tuberculosis (e.g. rifampicin)
tablet-taking.
HIV infections (ritonavir, nevirapine) or other infections (antibiotics
such as griseofulvin, penicillin, tetracycline)
• After a miscarriage
high blood pressure in the blood vessels in the lungs (bosentan)
Follow the advice of your doctor.
the herbal remedy St. John’s wort.
• Daylette may influence the effect of other medicines, e.g.
• After having a babyYou can start taking Daylette between 21 and
medicines containing ciclosporin,
28 days later after having a baby. If you start later than day 28, you

the anti-epileptic lamotrigine (this could lead to an increased must use a so-called barrier method (for example, a condom) during the
frequency of seizures).
first seven days of Daylette use.
If, after having a baby, you have had sex before starting Daylette
Taking Daylette with food and drink
(again), you must first be sure that you are not pregnant or you must
Daylette may be taken with or without food, if necessary with a small wait until your next period.
amount of water.
• If you are breast-feeding and want to start taking Daylette (again)
Laboratory tests
after having a baby
If you need a blood test, tell your doctor or the laboratory staff that you Read the section on “Breast-feeding”.
are taking the pill, because oral contraceptives can affect the results of
some tests.
Ask your doctor what to do if you are not sure when to start.

Daylette and venous and arterial blood clots
Venous blood clot
The use of any combination pill, including Daylette, increases a Pregnancy and breast-feeding
woman’s risk of developing a venous blood clot (venous thrombosis) If you are pregnant or breast-feeding, think you may be pregnant or
compared with women who do not take any contraceptive pill.
are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
The risk of venous thrombosis in users of combined pills increases:
• with increasing age,
Pregnancy
• if you are overweight,
If you are pregnant, you must not take Daylette. If you become pregnant
• if one of your close relatives had a blood clot in the leg, lung while taking Daylette you must stop immediately and contact your
(pulmonary embolism), or other organ at a young age,
doctor.

If you take more Daylette than you should
There are no reports of serious harmful results of taking too many
Daylette tablets.
If you take several tablets at once then you may have symptoms
of nausea or vomiting. Young girls may have bleeding from the
vagina.
If you have taken too many Daylette tablets, or you discover that a child
has taken some, ask your doctor or pharmacist for advice.

If you forget to take Daylette
The last 4 tablets in the 4th row of the strip are the placebo tablets. If
you forget to take one of these tablets, this has no effect on the reliability
of Daylette.
Throw away the forgotten placebo tablet.
If you miss a white, active tablet (tablets 1-24 of your blister-strip), you
must do the following:
• If you are less than 12 hours late taking a tablet, the protection
against pregnancy is not reduced.
Take the tablet as soon as you remember and then take the following
tablets again at the usual time.
• If you are more than 12 hours late taking a tablet, the protection
against pregnancy may be reduced. The greater the number of tablets
that you have forgotten, the greater is the risk of becoming pregnant.
The risk of incomplete protection against pregnancy is greatest if you
forget a white tablet at the beginning or at the end of strip. Therefore,
you should keep to the following rules (see also the diagram):
• More than one tablet forgotten in this strip
Contact your doctor.
• One tablet forgotten between days 1-7 (first row)
Take the forgotten tablet as soon as you remember, even if that means
that you have to take two tablets at the same time. Continue taking
the tablets at the usual time and use extra precautions, for the next
7 days, for example, a condom. If you have had sex in the week before
forgetting the tablet, you must realize that there is a risk of pregnancy.
In that case, contact your doctor.

The situation is almost the same as forgetting a tablet. After vomiting
or diarrhoea, you must take another white tablet from a reserve strip
as soon as possible. If possible take it within 12 hours of when
you normally take your pill. If this is not possible or 12 hours have
passed, you should follow the advice given under “If you forget to
take Daylette”.
Delaying your period: what you need to know
Even if it is not recommended, you can delay your period by not taking
the green placebo tablets from the 4th row and going straight to a
new strip of {Invented name} and finishing it. You may experience light
or menstruation-like bleeding while using the second trip. Finish this
second strip by taking the 4 green tablets from the 4th row. Then start
your next strip.
You might
ask your doctor for advice before deciding to delay your menstrual
period.
Changing the first day of your period: what you need to know
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 green placebo tablets (but never increase them- 4 is the maximum!). For example, if you start
taking the placebo tablets on a Friday and you want to change this to a
Tuesday (3 days earlier), you must start a new strip 3 days earlier than
usual. You may not have any bleeding during this time. You may then
experience light or menstruation-like bleeding.
If you are not sure what to do, consult your doctor.

If you want to stop taking Daylette
• One tablet forgotten between days 8–14 (second row)
You can stop taking Daylette whenever you want. If you do not want
Take the forgotten tablet as soon as you remember, even if that means to become pregnant, ask your doctor for advice about other reliable
that you have to take two tablets at the same time. Continue taking methods of birth control.
the tablets at the usual time. The protection against pregnancy is not
reduced and you do not need to take extra precautions.
If you want to become pregnant, stop taking {Invented name}and wait
for a menstrual period before trying to become pregnant. You will be
• One tablet forgotten between days 15–24 (third or fourth row)
able to calculate the expected delivery date more easily.
You can choose between two possibilities:
1.
Take the forgotten tablet as soon as you remember, even if that If you have any further questions on the use of this product, ask your
means that you have to take two tablets at the same time. Continue doctor or pharmacist.
taking the tablets at the usual time. Instead of taking the green placebo
tablets on this strip, throw them away, and start the next strip (the starting
day will be different).
4. POSSIBLE SIDE EFFECTS
Most likely, you will have a period at the end of the second strip,
while taking the green placebo tablets, but you may have light or Like all medicines, this medicine can cause side effects although not
menstruation-like bleeding during the second strip.
everybody gets them.
2.
You can also stop the active white tablets and go directly to the
4 green placebo tablets (before taking the placebo tablets, record The following is a list of the side effects that have been linked with the
the day on which you forgot your tablet). If you want to start a new use of drospirenone/ethynilestradiol:
strip on the day you always start, take the placebo tablets for less than
4 days.
Common side effects (may affect up to 1 in 10 people):
– mood swings
If you follow one of these two recommendations, you will remain – headache
protected against pregnancy.
– nausea
– breast pain, problems with your periods, such as irregular periods,
• If you have forgotten any of the tablets in a strip, and you do not absence of periods.
have a bleeding during the placebo days, this may mean that you are
pregnant. You must contact your doctor before you start the next strip. Uncommon side effects (may affect up to 1 in 100 people):
– depression, decreased interest in sex, nervousness, sleepiness
– dizziness, ‘pins and needles’
Several white tablets forgotten
Ask your doctor for advice. – migraine, varicose veins, increased blood pressure
in 1 strip
– stomach ache, vomiting, indigestion, intestinal gas, inflammation of
the stomach, diarrhoea
Yes
– acne, itching, rash
– aches and pains, e.g. back pain, limb pain, muscle cramps
Had sex in the previous
– vaginal fungal infection, pelvic pain, breast enlargement, benign
Day 1-7
week before forgetting?
breast lumps, uterine/vaginal bleeding (which usually subsides during
continued treatment), genital discharge, hot flushes, inflammation of the
vagina (vaginitis), problems with your periods, painful periods, reduced
No
periods, very heavy periods, vaginal dryness, abnormal cervical smear
– Take the forgotten table – lack of energy, increased sweating, fluid retention
– weight increase.
– use a barrier method
(condom) for the following
7 days
– finish the strip.

Only 1 white
tablet forgotten
(taken more than
12 hours late)

day 8-14

– Take the forgotten
tablet and
– finish the pack.
– Take the forgotten
tablet and
– finish the white tablets
of the strip
– discard the placebo
tablets
– start the next pack
immediately.

Day 15-24

or
– Stop taking the tablets
in the pack immediately
– start a placebo tablet
period (of no more than
4 days, including the day
of the forgotten tablet)
– afterwards, continue
on to the next pack.

What to do in the case of vomiting or severe diarrhoea
If you vomit within 3-4 hours of taking an active white tablet or you have
severe diarrhoea, there is a risk that the active substances in the pill will
not be fully taken up by your body.

Rare side effects (may affect up to 1 in 1,000 people):
– candida (fungal infection)
– decrease in the number of red blood cells in the blood (anemia),
increase in the number of platelets in the blood (thrombocythaemia)
– allergic reaction
– hormonal (endocrine) disorder
– increased appetite, loss of appetite, abnormally high concentration
of potassium in the blood, abnormally low concentration of sodium in
the blood
– failure to experience an orgasm, insomnia
– giddiness, tremor
– eye disorders, e.g. inflammation of the eyelid, dry eyes
– abnormally rapid heartbeat
– inflammation of a vein, nosebleed, fainting
– enlarged abdomen, bowel disorder, feeling bloated, stomach
hernia, fungal infection of the mouth, constipation, dry mouth
– pain of bile ducts or the gallbladder, inflammation of the gallbladder
– yellow brown patches on the skin, eczema, hair loss, acne like
inflammation of the skin, dry skin, lumpy inflammation of the skin,
excessive hair growth, skin disorder, stretch marks on the skin, skin
inflammation, light-sensitive skin inflammation, skin nodules
– difficult or painful sex, inflammation of the vagina (vulvovaginitis),
bleeding following intercourse, withdrawal bleeding, breast cyst,
increased number of breast cells (hyperplasia), malignant lumps in the
breast, abnormal growth on the mucosal surface of the neck of the
womb, shrinkage or wasting of the lining of the womb, ovarian cysts,
enlargement of the womb
– feeling generally unwell
– weight loss.

Dietary soya-products are known to cause allergic reactions including
severe anaphylaxis in persons with soya allergy. Patients with known
allergy to peanut protein carry an enhanced risk for severe reactions to
soya preparations.
If you get any side effects talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
5. How to store Daylette
Keep this medicine out of the sight and reach of children.
Do not store above 25 °C. Store in the original package in order to
protect from light.
Do not use this medicine after the expiry date which is stated on the
blister and carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
6. Contents of the pack and other information
What Daylette contains
– The active substances are 0.02 mg ethinylestradiol and 3 mg
drospirenone in each white tablet.
– The other ingredients are:
White active film-coated tablets:
Tablet core:
lactose monohydrate,
maize starch,
pregelatinised maize starch,
macrogol poly(vinyl alcohol) grafted copolymer,
magnesium stearate.
Film-coating:
poly(vinyl alcohol),
titanium dioxide (E171),
talc,
macrogol 3350,
lecithin (soya).
Green placebo film-coated tablets:
Tablet core:
microcrystalline cellulose,
lactose anhydrous,
pregelatinised maize starch,
magnesium stearate,
colloidal anhydrous silica.
Film-coating:
poly(vinyl alcohol),
titanium dioxide (E171),
macrogol 3350,
talc,
indigo carmine (E132),
quinoline yellow (E104),
iron oxide black (E172),
sunset yellow FCF (E110).
What Daylette looks like and contents of the pack
The active film-coated tablet is white or almost white, round, biconvex
film-coated tablet, diameter about 6 mm. Engraving on one side:
“G73”, other side is without engraving.
The placebo film-coated tablet is green, round, biconvex film-coated
tablet, diameter about 6 mm, without engraving.
Daylette film-coated tablets are packed in PVC/PE/PVDC-Al blister
packs. The blisters are packed into folding box with patient leaflet and
etui storage bag is enclosed in each box.
Pack sizes:
1×28 film-coated tablets
3×28 film-coated tablets
6×28 film-coated tablets
13×28 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
1103 Budapest,
Gyömrői út 19-21.
Hungary
This leaflet was last revised in 09/2012.

The following side effects have also been reported, but their frequency
cannot be estimated from the available data:
– hypersensitivity
– rash with target-shaped reddening or sores (Erythema multiforme).

K-17726-1.1, 00000000

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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