DAYLETTE 0.02MG/ 3 MG FILM-COATED TABLETS

Active substance: ETHINYLESTRADIOL

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

DAYLETTE®

0.02 mg/3 mg film-coated tablets
Ethinylestradiol and Drospirenone
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 2 “Blood clots”).

What is in this leaflet:
1. What Daylette is and what it is used for
2. What you need to know before you use Daylette
3. How to take Daylette
4. Possible side effects
5. How to store Daylette
6. Contents of the pack and other information

1. What Daylette is and what it is used for
• Daylette is a contraceptive pill and is used to prevent pregnancy.
• Each of the 24 white tablets contains a small amount of two different female
hormones, namely ethinylestradiol and drospirenone.
• The 4 green tablets contain no active substances and are also called placebo
tablets.
• Contraceptive pills that contain two hormones are called “combination” pills.

2. What you need to know before you use Daylette
General notes
Before you start using Daylette you should read the information on blood clots in
section 2. It is particularly important to read the symptoms of a blood clot – see
Section 2 “Blood clots”.
Before you can begin taking Daylette 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 using Daylette,
or where the reliability of Daylette may be decreased. In such situations you should
either 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 Daylette alters the monthly changes of body temperature and of cervical
mucus.
Daylette, like other hormonal contraceptives, does not protect against HIV
infection (AIDS) or any other sexually transmitted disease.
Do not use Daylette
You should not use Daylette 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 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 your legs (deep
vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs.
• if you know 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 (or 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 any of the following diseases that may increase your risk of a clot in
the arteries:
- severe diabetes with blood vessel damage
- 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) 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.
• Daylette contains soya oil. If you are allergic to peanut or soya, do not use this
medicinal product.
Warnings and precautions
Talk to your doctor or pharmacist before taking Daylette.
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”.

Tell your doctor if any of the following conditions apply to you.
If 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.
If the condition develops, or gets worse while you are using Daylette, you should
also tell 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 epilepsy (see “Other medicines and Daylette”);
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 oestrogens 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;
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 anaemia (an inherited disease of the red blood cells);
if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive
family history for this condition. Hypertriglyceridaemia has been associated with
an increased risk of developing pancreatitis (inflammation of the pancreas);
if you need an operation, or you are off your feet for a long time (see in section 2
‘Blood clots’);
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 Daylette;
if you have an inflammation in the veins under the skin (superficial
thrombophlebitis);
if you have varicose veins.

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 pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them.
• If you get any side effects, talk to your doctor or pharmacist. This include any possible side effects not listed in this leaflet.
See section 4.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Daylette increases your risk of
developing a blood clot compared with not using one. In rare cases a blood clot can
block blood vessels and cause serious problems.

Risk of developing a
blood clot in a year
Women who are not using a combined hormonal
pill/patch/ring and are not pregnant

About 2 out of
10,000 women

Blood clots can develop
• in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’ or VTE)
• in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial thromboembolism’
or ATE).

Women using a combined hormonal contraceptive
pill containing levonorgestrel, norethisterone or
norgestimate

About 5-7 out of
10,000 women

Recovery from blood clots is not always complete. Rarely, there may be serious
lasting effects or, very rarely, they may be fatal.

Women using Daylette

About 9-12 out of
10,000 women

It is important to remember that the overall risk of a harmful blood clot due to
Daylette is small.
HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or symptoms:
Are you experiencing any of these signs?

What are you possibly
suffering from?

• swelling of one leg or along a vein
in the leg or foot especially when
accompanied by:
• pain or tenderness in the leg which
may be felt only when standing or
walking;
• increased warmth in the affected leg;
• change in colour of the skin on the leg
e.g. turning pale, red or blue.

Deep vein thrombosis

• sudden unexplained breathlessness or
rapid breathing;
• sudden cough without an obvious cause,
which may bring up blood;
• sharp chest pain which may increase with
deep breathing;
• severe light headedness or dizziness;
• rapid or irregular heartbeat;
• severe pain in your stomach.

Pulmonary embolism

The risk of developing a blood clot increases the more conditions you have.
Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly
if you have some of the other factors listed.
It is important to tell your doctor if any of these conditions apply to you, even if
you are unsure. Your doctor may decide that Daylette needs to be stopped.
If any of the above conditions change while you are using Daylette, for example a
close family member experiences a thrombosis for no known reason; or you gain a
lot of weight, tell your doctor.
BLOOD CLOTS IN AN ARTERY

If you are unsure, talk to a doctor as some
of these symptoms such as coughing or
being short of breath may be mistaken for
a milder condition such as a respiratory
tract infection (e.g. a ‘common cold’).

What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a clot in an artery can cause serious problems. For
example, it can cause a heart attack or a stroke.

Symptoms most commonly occur in
one eye:
• immediate loss of vision or
• painless blurring of vision which can
progress to loss of vision.

Retinal vein thrombosis
(blood clot in the eye)

• chest pain, discomfort, pressure,
heaviness;
• sensation of squeezing or fullness in the
chest, arm or below the breastbone;
• fullness, indigestion or choking feeling;
• upper body discomfort radiating to the
back, jaw, throat, arm and stomach;
• sweating, nausea, vomiting or dizziness;
• extreme weakness, anxiety, or shortness
of breath;
• rapid or irregular heartbeats.

Heart attack

• sudden weakness or numbness of the
face, arm or leg, especially on one
side of the body;
• sudden confusion, trouble speaking or
understanding;
• sudden trouble seeing in one or both
eyes;
• sudden trouble walking, dizziness, loss of
balance or coordination;
• sudden, severe or prolonged headache
with no known cause;
• loss of consciousness or fainting with or
without seizure.

Stroke

Factors that increase your risk of a blood clot in an artery
It is important to note that the risk of a heart attack or stroke from using Daylette is
very small but can increase:
• with increasing age (beyond about 35 years);

­ if you smoke. When using a combined hormonal contraceptive like Daylette you
are advised to stop smoking. If you are unable to stop smoking and are older than
35 your doctor may advise you to use a different type of contraceptive;

­ if you are overweight;

­ if you have high blood pressure;

­ if a member of your immediate family has had a heart attack or stroke at a young
age (less than about 50). In this case you could also have a higher risk of having a
heart attack or stroke;

­ if you, or someone in your immediate family, have a high level of fat in the blood
(cholesterol or triglycerides);

­ if you get migraines, especially migraines with aura;

­ if you have a problem with your heart (valve disorder, disturbance of the rhythm
called atrial fibrillation);

­ if you have diabetes.
If you have more than one of these conditions or if any of them are particularly
severe the risk of developing a blood clot may be increased even more.
If any of the above conditions change while you are using Daylette, for example you
start smoking, a close family member experiences a thrombosis for no known
reason or you gain a lot of weight, tell your doctor.
Daylette and cancer
Breast cancer has been observed slightly more often in women using combination
pills, but it is not known whether this is caused by the treatment. For example it
may be that more tumours are detected in women on combination pills because
they are examined by their doctor more often.
The occurrence of breast tumours becomes gradually less after stopping the
combination hormonal contraceptives. It is important to regularly check your
breasts and you should contact your doctor if you feel any lump.

Sometimes the symptoms of stroke can be
brief with an almost immediate and full
recovery, but you should still seek urgent
medical attention as you may be at risk
of another stroke.
• swelling and slight blue discolouration of
an extremity;
• severe pain in your stomach (acute
abdomen).

Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Daylette is small but some conditions will increase the
risk. Your risk is higher:
• if you are very overweight (body mass index or BMI over 30kg/m2);
• if one of your immediate family has had a blood clot in the leg, lung or other
organ at a young age (e.g. below the age of about 50). In this case you could have
a hereditary blood clotting disorder;
• if you need to have an operation, or if you are off your feet for a long time
because of an injury or illness, or you have your leg in a cast. The use of Daylette
may need to be stopped several weeks before surgery or while you are less
mobile. If you need to stop Daylette ask your doctor when you can start using
it again;
• as you get older (particularly above about 35 years);
• if you gave birth less than a few weeks ago.

In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours
have been reported in pill users. Contact your doctor if you have unusually severe
abdominal pain.
Blood clots blocking
other blood vessels

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
• The use of combined hormonal contraceptives has been connected with an
increase in the risk of blood clots in the vein (venous thrombosis). However, these
side effects are rare. Most frequently, they occur in the first year of use of a
combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot it can cause a deep vein
thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung it can cause a
pulmonary embolism.
• Very rarely a clot may form in a vein in another organ such as the eye (retinal vein
thrombosis).
When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking
a combined hormonal contraceptive for the first time. The risk may also be higher if
you restart taking a combined hormonal contraceptive (the same product or a
different product) after a break of 4 weeks or more.
After the first year, the risk gets smaller but is always slightly higher than if you were
not using a combined hormonal contraceptive.
When you stop Daylette your risk of a blood clot returns to normal within a few
weeks.
What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined hormonal
contraceptive you are taking.
The overall risk of a blood clot in the leg or lung (DVT or PE) with Daylette is small.
• Out of 10,000 women who are not using any combined hormonal contraceptive
and are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who are using a combined hormonal contraceptive that
contains levonorgestrel, norethisterone, or norgestimate about 5-7 will develop a
blood clot in a year.
• Out of 10,000 women who are using a combined hormonal contraceptive that
contains drospirenone such as Daylette between about 9 and 12 women will
develop a blood clot in a year.
• The risk of having a blood clot will vary according to your personal medical
history (see “Factors that increase your risk of a blood clot”below).

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.
What you must do if no bleeding occurs during the placebo days
If you have taken all the white active tablets correctly, have not had vomiting or
severe diarrhoea and you have not taken any other medicines, it is highly unlikely
that you are pregnant.
If the expected bleeding does not happen twice in succession, you may be pregnant.
Contact your doctor immediately. Only start the next strip if you are sure that you
are not pregnant.
Other medicines and Daylette
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
They can tell you if you need to take additional contraceptive precautions (for
example condoms) and if so, for how long.
Some medicines can make Daylette less effective in preventing pregnancy, or can
cause unexpected bleeding. These include:
• medicines used for the treatment of
- epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine,
oxcarbazepine);
- tuberculosis (e.g. rifampicin);
- HIV infections (ritonavir, nevirapine) or other infections (antibiotics such as
griseofulvin, penicillines, tetracycline);
- high blood pressure in the blood vessels in the lungs (bosentan);
- the herbal remedy St. John’s wort.
• Daylette may influence the effect of other medicines, e.g.
- medicines containing ciclosporin.
- the anti-epileptic lamotrigine (this could lead to an increased frequency of
seizures).
Taking Daylette with food and drink
Daylette may be taken with or without food, if necessary with a small amount of
water.
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are taking
the pill, because hormonal contraceptives can affect the results of some tests.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are pregnant, you must not take Daylette. If you become pregnant while
taking Daylette you must stop immediately and contact your doctor.
If you want to become pregnant, you can stop taking Daylette at any time (see also
“If you want to stop taking Daylette”).
Ask your doctor or pharmacist for advice before taking any medicine
Breast-feeding
Use of Daylette is generally not advisable when a woman is breast-feeding. If you
want to take the pill while you are breast-feeding you should contact your doctor.
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, sunset yellow and soya lecithin
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 intolerance to some sugars,
contact your doctor before taking this medicinal product.
The hormone-free (placebo) film-coated tablets contain “sunset yellow”, a colouring
agent which may cause an 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.

• One tablet forgotten between days 8-14 (second 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.
The protection against pregnancy is not reduced, and you do not need to take extra
precautions.
• One tablet forgotten between days 15-24 (third or fourth row)
You can choose between two possibilities:
1. 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. Instead of taking the green placebo tablets on this strip, throw them
away, and start the next strip (the starting day will be different).
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 menstruation-like bleeding
during the second strip.
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 day on which you forgot
your tablet). If you want to start a new strip on the day you always start, take the
placebo tablets for less than 4 days.
If you follow one of these two recommendations, you will remain protected against
pregnancy.
• If you have forgotten any of the tablets in a strip, and you do not 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.
More than 1 white
tablet forgotten
in 1 strip

Ask your doctor for advice

3. How to take Daylette
Yes

Always take this medicine 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.
The two differently coloured tablets of Daylette are arranged in order. A strip
contains 28 tablets.

Had sex in the previous
week before forgetting?

Day 1-7

Take one tablet of Daylette every day, if necessary with a small amount of water. You
may take the tablets with or without food, but you should take the tablets every
day around the same time.

No

Do not confuse the tablets:
Take a white tablet for the first 24 days and then a green tablet for the last 4 days.
You must then start a new strip straightaway (24 white and then 4 green tablets).
There is therefore no gap between two strips.
Because of the different composition of the tablets it is necessary to begin with the
first tablet on the upper left and that you take the tablets every day. For the correct
order, follow the direction of the arrows on the strip.
Preparation of the strip:
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. During the 4 days when you are
taking the green placebo tablets (the placebo days), bleeding should begin
(so-called withdrawal bleeding). This usually starts on the 2nd or 3rd day after the
last white active tablet of Daylette. Once you have taken the last green tablet, you
should start with the following strip, whether your bleeding has stopped or not.
This means that you should start every strip on the same day of the week, and that
the withdrawal bleed should occur on the same days each month.

Take the forgotten tablet
Use a barrier method (condom)
for the following 7 days and
Finish the strip
Only 1 white
tablet forgotten

Day 8-14





Day 15-24

When can you start with the first strip?

• Changing from a combined hormonal contraceptive (combined oral
contraceptive(COC), vaginal ring or transdermal patch)
You can start Daylette preferably on the day after the last active tablet (the last
tablet containing the active substances) of your previous pill, but at the latest on
the day after the tablet-free days of your previous pill finish (or after the last
inactive tablet of your previous pill).When changing from a vaginal ring or
transdermal patch, follow the advice of your doctor.
• Changing from a progestogen-only method (progestogen-only pill, injection,
implant or a progestogen-releasing IUD)
You may switch any day from the progestogen-only pill (from an implant or an
IUD on the day of its removal, from an injectable when the next injection would
be due) but in all of these cases you must use extra protective measures (for
example, a condom) for the first 7 days of tablet-taking.
• After a miscarriage
Follow the advice of your doctor.
• After having a baby
You can start taking Daylette between 21 and 28 days after having a baby. If you
start later than day 28, you must use a so-called barrier method (for example, a
condom) during the first seven days of Daylette use.
If, after having a baby, you have had sex before starting Daylette (again), you must
first be sure that you are not pregnant or you must wait until your next period.
• If you are breast-feeding and want to start taking Daylette (again) after having
a baby
Read the section on “Breast-feeding”.
Ask your doctor what to do if you are not sure when to start.
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.
Discard 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 the 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.

Take the forgotten tablet and
Finish taking the white tablets
Throw away the 4 green tablets
Start the next strip
Or

• Stop the white tablets
immediately
• Go directly to the 4 green
tablets
• Then start the next strip

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

• If you have not used a contraceptive with hormones in the previous month
Begin with Daylette on the first day of the cycle (that is, the first day of your
period). If you start Daylette on the first day of your menstruation you are
immediately protected against pregnancy. You may also begin on day 2-5 of the
cycle, but then you must use extra protective measures (for example, a condom)
for the first 7 days.

Finish the strip

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. 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 Daylette 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
You can stop taking Daylette whenever you want. If you do not want to become
pregnant, ask your doctor for advice about other reliable methods of birth control.
If you want to become pregnant, stop taking Daylette and wait for a menstrual
period before trying to become pregnant. You will be able to calculate the expected
delivery date more easily.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects although not everybody
gets them. If you get any side effect, particularly if severe and persistent, or have
any change to your health that you think may be due to Daylette, please talk to
your doctor.


­ aches and pains, e.g. back pain, limb pain, muscle cramps

­ vaginal fungal infection, pelvic pain, breast enlargement, benign 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 periods, very heavy periods, vaginal
dryness, abnormal cervical smear

­ lack of energy, increased sweating, fluid retention

­ weight increase.
Rare side effects (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))

­ 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.
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).
Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety of this medicine.

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 and 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.

An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or
blood clots in your arteries (arterial thromboembolism (ATE)) is present for all
women taking combined hormonal contraceptives. For more detailed information
on the different risks from taking combined hormonal contraceptives please see
section 2 “What you need to know before you use Daylette”.

The placebo film-coated tablet is green, round, biconvex film-coated tablet,
diameter about 6 mm, without engraving.

The following is a list of the side effects that have been linked with the use of
ethinylestradiol/drospirenone:

Pack sizes:
1×28 film-coated tablets
3×28 film-coated tablets
6×28 film-coated tablets
13×28 film-coated tablets

Common side effects (may affect up to 1 in 10 people):
• mood swings

­ headache

­ nausea
­ breast pain, problems with your periods, such as irregular periods, absence of

periods.
Uncommon side effects (may affect up to 1 in 100 people):

­ depression, decreased interest in sex, nervousness, sleepiness

­ dizziness, ‘pins and needles’

­ migraine, varicose veins, increased blood pressure

­ stomach ache, vomiting, indigestion, intestinal gas, inflammation of the stomach,
diarrhoea

­ acne, itching, rash

Daylette 0.02 mg/3 mg 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.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Gedeon Richter Plc.
1103 Budapest, Gyömrői út 19-21, Hungary
Distributed by:
Consilient Health (UK) Ltd.,
No.1 Church Road, Richmond upon Thames, Surrey. TW9 2QE.
This leaflet was last revised in August 2014.

P0289

Expand view ⇕

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.

Hide
(web2)