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LILADROS ED 0.02 MG/ 3 MG FILM-COATED TABLETS

Active substance(s): DROSPIRENONE / ETHINYLESTRADIOL / NO ACTIVES PRESENT

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Package leaflet: Information for the user
®
0.02 mg/3 mg film-coated tablets
ethinylestradiol, drospirenone

Liladros ED

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”).
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 includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Liladros ED is and what it is used for
2. What you need to know before you use Liladros ED
3. How to take Liladros ED
4. Possible side effects
5. How to store Liladros ED
6. Contents of the pack and other information
1. What Liladros ED is and what it is used for
–– Liladros ED is a contraceptive pill and is used to prevent pregnancy.
–– Each of the 21 white tablets contains a small amount of two different female
hormones, namely drospirenone and ethinylestradiol.
–– The 7 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 Liladros ED
General notes
Before you start using Liladros ED 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 Liladros ED, 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 Liladros ED,
or where the reliability of Liladros ED 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
Liladros ED alters the monthly changes of body temperature and of the cervical
mucus.
Liladros ED, like other hormonal contraceptives, does not protect against HIV
infection (AIDS) or any other sexually transmitted disease.
Do not use Liladros ED
You should not use Liladros ED 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.
Do not use Liladros ED
–– 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) a 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
–– 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.
–– Liladros ED 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 Liladros ED.
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.
In some situations you need to take special care while using Liladros ED or any other
combination pill, and your doctor may need to examine you regularly. If the condition
develops, or gets worse while you are using Liladros ED, 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 Liladros ED”);
–– 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 blister during pregnancy (gestational herpes), a nerve disease causing sudden
movements of the body (Sydenham’s chorea));
–– if you have or have ever had chloasma (a discoloration of the skin, especially
of the face or neck known as “pregnancy patches”). If so, avoid direct sunlight or
ultraviolet light.
–– if you have hereditary angioedema, products containing oestrogens may cause
or worsen symptoms. You should see your doctor immediately if you experience
symptoms of angioedema such as swollen face, tongue and/or throat and/or
difficulty swallowing or hives together with difficulty breathing.
–– if you 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 Liladros ED.
–– if you have an inflammation in the veins under the skin (superficial thrombophlebitis);
–– if you have varicose veins.
BLOOD CLOTS

It is important to remember that the overall risk of a harmful blood clot due to
Liladros ED 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 Deep vein thrombosis
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.
–– sudden unexplained breathlessness or rapid breathing; Pulmonary embolism
–– 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.
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’).
Symptoms most commonly occur in one eye:
–– immediate loss of vision or
–– painless blurring of vision which can progress to loss
of vision.
–– 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.
–– 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.

Retinal vein thrombosis
(blood clot in the eye)

Heart attack

Stroke

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; Blood clots blocking other
–– severe pain in your stomach (acute abdomen).
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).

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

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 Liladros ED is
very small but can increase:
–– with increasing age (beyond about 35 years);
–– if you smoke. When using a combined hormonal contraceptive like Liladros ED
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 then 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 Liladros ED, 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.
Liladros ED 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.
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.
Bleeding between periods
During the first few months that you are taking Liladros ED, you may have unexpected
bleeding (bleeding outside the week when you are taking the green tablets. 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 to do if no bleeding occurs in 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. Do not start the next strip until you are sure that you
are not pregnant.
Other medicines and Liladros ED
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Always tell your doctor, which medicines or herbal products you are already
using. Also tell any other doctor or dentist who prescribes another medicine (or the
pharmacist) that you use Liladros ED. They can tell you if you need to take additional
contraceptive precautions (for example condoms) and if so, for how long.
Some medicines can have an influence on the blood levels of Liladros ED and can
make it 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 and Hepatitis C Virus infections (so-called protease inhibitors and nonnucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
or other infections (griseofulvin)
–– high blood pressure in the blood vessels in the lungs (bosentan).
–– the herbal remedy St. John’s wort.

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
Liladros ED may influence the effect of other medicines, e.g
product) after a break of 4 weeks or more.
–– medicines containing ciclosporin,
–– the anti-epileptic lamotrigine (this could lead to an increased frequency of
After the first year, the risk gets smaller but is always slightly higher than if you were
seizures).
not using a combined hormonal contraceptive.
When you stop Liladros ED 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 Liladros ED 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 Liladros ED 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).

Women who are not using a combined
hormonal pill/patch/ring and are not
pregnant
Women using a combined hormonal
contraceptive pill containing levonorgestrel,
norethisterone or norgestimate
Women using Liladros ED

Risk of developing a blood clot in
a year
About 2 out of 10,000 women

About 5‑7 out of 10,000 women

About 9‑12 out of 10,000 women

Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Liladros ED is small but some conditions will increase the
risk. Your risk is higher:
–– if you are very overweight (body mass index or BMI over 30 kg/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
Liladros ED may need to be stopped several weeks before surgery or while you
are less mobile. If you need to stop Liladros ED 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.
The risk of developing a blood clot increases the more conditions you have.

Using a combined hormonal contraceptive such as Liladros ED increases your risk of
developing a blood clot compared with not using one. In rare cases a blood clot can Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if
block blood vessels and cause serious problems.
you have some of the other factors listed.
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).

BLOOD CLOTS IN AN ARTERY
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.

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 Liladros ED needs to be stopped.

Ask your doctor or pharmacist for advice before taking any medicine.
Liladros ED with food and drink
Liladros ED 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 hormone 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 for advice before taking this medicine.
Pregnancy
If you are pregnant, do not take Liladros ED. If you become pregnant while taking
Liladros ED, stop immediately and contact your doctor. If you want to become
pregnant, you can stop taking Liladros ED at any time (see also “If you want to stop
taking Liladros ED”).
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Use of Liladros ED 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 Liladros ED affects driving or use of
machines.
Liladros ED contains lactose, soya lecithin and sunset yellow
In Liladros ED 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 per film-coated tablet. 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 ingredient sunset yellow may cause allergic reactions.
Liladros ED contains 0.07 mg soya lecithin. If you are allergic to peanut or soya, do
not use this medicinal product.
3. How to take Liladros ED
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 21 active white tablets and 7 green placebo tablets. The
two differently coloured tablets of Liladros ED are arranged in order. A strip
contains 28 tablets.

Take one tablet of Liladros ED every day, if necessary with a small amount of water.
If any of the above conditions change while you are using Liladros ED, for example
a close family member experiences a thrombosis for no known reason; or you gain a You may take the tablets with or without food, but you should take the tablets every
day around the same time.
lot of weight, tell your doctor.

Do not confuse the tablets: take a white tablet for the first 21 days and then a green
tablet for the last 7 days. You must then start a new strip straightaway (21 white and
then 7 green tablets). So there is no gap between two strips.

More than 1 white tablet forgotten
in 1 strip

yes

Because of the different composition of the tablets, it is necessary to begin with the
first tablet at position 1 on the strip which is marked with “Start” and that you take
the tablets every day. For the correct order, follow the direction of the arrows and the
numbering on the strips.

Had sex in the previous week
before forgetting?

in week 1

Preparation of the strip
To control the daily intake of the contraceptive, use the arrows and the numbering on
the pack. The arrows and the numbering show the order in which the tablets should
be taken.
You must know on which day of the week you will take the first tablet. You can mark
the first day on the strip. This allows you to determine the day of the week for each
number printed on the strip and to check every day whether you have already taken
the film-coated tablet for that particular day.
During the 7 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 Liladros ED. 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 day of the week.

no
–– Take the forgotten tablet
–– Use a barrier method
(condom) for the following
7 days and
–– Finish the strip.
Only 1 white tablet
forgotten
(taken more than
12 hours late)

–– Take the forgotten tablet and
–– Finish taking the white tablets
–– Throw away the 7 green
tablets
–– Start the next strip.

When can you start with the first strip?
•• If you have not used a contraceptive with hormones in the previous month
Begin with Liladros ED on the first day of the cycle (that is the first day of your period).
If you start Liladros ED on the first day of your period, 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.

in week 3

or
–– Stop the white tablets
immediately
–– Go directly to the 7 green
tablets
–– Then start the next strip.

What to do in the case of vomiting or severe diarrhoea
If you vomit within 3‑4 hours after 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, 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 that is not
possible or 12 hours have passed, you should follow the advice given under “If you
forget to take Liladros ED”.

•• Changing from a progestogen-only method (progestogen-only pill, injection,
implant or a progestogen-releasing intrauterine system (IUS))
You may switch any day from the progestogen-only pill (from an implant or an IUS,
on the day of its removal, from an injectable when the next injection would be due),
but in all of these cases use extra protective measures (for example, a condom) for the
first 7 days of tablet-taking.
Delaying your period: what you need to know
Even though it is not recommended, you can delay your period by not taking the
•• After a miscarriage
green placebo tablets (tablets 22-28) and going straight to a new strip of Liladros ED
Follow the advice of your doctor.
and finishing it. You may experience light or menstrual-like bleeding while using this
second strip. Finish this second strip by taking the 7 green tablets from the end of the
•• After having a baby
row (tablets 22-28). Then start your next strip.
You can start Liladros ED between 21 and 28 days after having a baby. If you start You might ask doctor for advice before deciding to delay your menstrual period.
later than day 28, use a so-called barrier method (for example, a condom) during
the first 7 days of Liladros ED use. If, after having a baby, you have had sex before
Changing the first day of your period: what you need to know
starting Liladros ED (again), be sure that you are not pregnant or you must wait until
If you take the tablets according to the instructions, then your period will begin during
your next period.
the placebo week. If you have to change this day, reduce the number of placebo
days – when you take the green placebo tablets (but never increase them – 7 is the
•• If you are breastfeeding and want to start Liladros ED (again) after having a
maximum!). For example, if you normally start taking the placebo tablets on a Friday,
baby
and you want to change this to a Tuesday (3 days earlier) start a new strip 3 days
Read the section on “Breast-feeding”.
earlier than usual. If you make the placebo period very short (for example, 3 days or
less), you may not have any bleeding during these days. You may then experience
Ask your doctor for advice if you are not sure when to start.
light or menstrual-like bleeding.
If you are not sure what to do, consult your doctor.
If you take more Liladros ED than you should
There are no reports of serious harmful results of taking too many Liladros ED tablets. If you want to stop taking Liladros ED
If you take several tablets at once then you may have symptoms of nausea or
You can stop taking Liladros ED whenever you want. If you do not want to become
vomiting. Young girls may have bleeding from the vagina.
pregnant, ask your doctor for advice about other reliable methods of birth control.
If you want to become pregnant, stop taking Liladros ED and wait for a period before
If you have taken too many Liladros ED tablets, or you discover that a child has taken trying to become pregnant. You will be able to calculate the expected delivery date
some, ask your doctor or pharmacist for advice.
more easily.
If you forget to take Liladros ED
The last seven tablets of the strip are placebo tablets. If you forget one of these
tablets, this has no effect on the reliability of Liladros ED. Throw away the forgotten
placebo tablet.
If you miss a white active tablet from the strip (film-coated tablets 1‑21), do as follows:
•• 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 on the first or on
the third week of taking the white, active tablets. 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 in week 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 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 may be pregnant. In that case contact
your doctor.

blockage of a blood vessel by a clot formed elsewhere in the body,
erythema nodosum (characterised by painful reddish skin nodules),
erythema multiforme (rash with target-shaped reddening or sores),
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).

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 Yellow Card Scheme, Website:www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this
medicine.

–– Take the forgotten tablet
–– Finish the strip

in week 2

If you use Liladros ED in this manner, you are protected against pregnancy also
during the 7 days when you are taking a placebo tablet.

•• Changing from a combination hormonal contraceptive, or combination
contraceptive vaginal ring or patch
You can start Liladros ED preferably on the day after the last active tablet (the last
tablet containing active substances) of your previous pill, but at the latest on the day
after the tablet-free days of your previous pill (or after the last inactive tablet of your
previous pill). When changing from a combination contraceptive vaginal ring or
patch, follow the advice of your doctor.

––
––
––
––

Ask your doctor for advice

If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

5. How to store Liladros ED
Keep this medicine out of the sight and reach of children.
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 store above 25 °C. Store in the original package in order to protect from
light.
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 Liladros ED contains
–– The active substances are 0.02 mg ethinylestradiol and 3 mg drospirenone in
each white tablet.
–– The other ingredients are:
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).
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 aluminium lake (E132), quinoline yellow aluminium lake (E104), iron
oxide black (E172), sunset yellow FCF aluminium lake (E110).
What Liladros ED 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.
Liladros ED 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 enclosed in each box.
Pack sizes:
1×(21+7) film-coated tablets
3×(21+7) film-coated tablets
6×(21+7) film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

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

Gedeon Richter Plc.
1103 Budapest,
Gyömrői út 19-21.
Hungary
This medicinal product is authorised in the Member States of the EEA under the
following names:
United Kingdom

Liladros ED

This leaflet was last revised in April 2016.

The following is a list of the side effects that have been linked with the use of Liladros ED.
Common side effects (may affect up to 1 in 10 people):
–– mood swings,
–– headache,
–– abdominal pain (stomach ache),
–– acne,
–– breast pain, breast enlargement, breast tenderness, painful or irregular periods,
–– weight gain.

•• One tablet forgotten in week 2
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.

Uncommon side effects (may affect up to 1 in 100 people):
–– Candida (fungal infection),
–– cold sores (herpes simplex),
–– allergic reactions,
–– increased appetite,
–– depression, nervousness, sleep disorder,
•• One tablet forgotten in week 3
–– feeling of ‘pins and needles’, giddiness (vertigo),
You can choose between two possibilites:
–– problems with vision,
–– irregular heart beat or unusually fast heart rate,
1. Take the forgotten tablet as soon as you remember, even if that means that you
–– a blood clot (thrombosis) in a vessel of the leg or the lungs (pulmonary embolism),
have to take two tablets at the same time. Continue taking the tablets at the usual
high blood pressure, low blood pressure, migraine, varicose veins,
time. Instead of taking the green placebo tablets on this strip, throw them away, and –– sore throat,
start the next strip.
–– nausea, vomiting, inflammation of stomach and/or intestine, diarrhoea,
constipation,
Most likely you will have a period at the end of the second strip, while taking the
–– sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat),
green placebo tablets, but you may have light or menstruation-like bleeding during
and/or difficulty swallowing or hives together with difficulty breathing (angioedema),
the second strip.
hair loss (alopecia), eczema, itching, rashes, dry skin, oily skin disorders (seborrheic
dermatitis),
2. You can also stop the active, white tablets and go directly to the 7 green placebo –– neck pain, limb pain, muscle cramps,
tablets (before taking the placebo tablets, record the day on which you forgot
–– bladder infection,
your tablet, so that the number of placebo days does not exceed the maximum
–– breast lump (benign and cancer), milk production while not pregnant
of 7). If you want to start a new strip on the day you always start, take the placebo
(galactorrhea), ovarian cysts, hot flushes, absence of periods, very heavy periods,
tablets for less than 7 days.
vaginal discharge, vaginal dryness, lower abdominal (pelvic) pain, abnormal cervical
smear (Papanicolaou or Pap smear), decreased interest in sex,
If you follow one of these two recommendations, you will remain protected against
–– fluid retention, lack of energy, excessive thirst, increased sweating,
pregnancy.
–– weight loss.
Rare side effects (may affect up to 1 in 1,000 people):
–– asthma,
–– hearing impairment,

00000000

Liladros ® ED 0.02 mg/3 mg film-coated tablets

00000000

ethinylestradiol, drospirenone

ethinylestradiol, drospirenone

K-24113-1.2

Liladros ® ED 0.02 mg/3 mg film-coated tablets

If you have forgotten any of the tablets in a strip, and you do not have a bleeding
during the normal placebo days, you may be pregnant. Contact your doctor before
you start the next strip.

UK

LILADROS ED ftbl.

pil

K-24113-1.2
635x345 mm
PBlack
9 pt
2016.05.03.

35850

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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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