Liladros

Package leaflet: Information for the user

LILADROS 3 mg/0.02 mg film-coated tablets

drospirenone and ethinylestradiol
Generic medicine

Important information 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 blood clots forming in the veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be alert and contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful. If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What LILADROS is and what it is used for
2. What you need to know before taking LILADROS
3. How to take LILADROS
4. Possible side effects
5. How to store LILADROS
6. Contents of the pack and other information

1. What LILADROS is and what it is used for

LILADROS is a contraceptive pill used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones, namely
drospirenone and ethinylestradiol.
Contraceptive pills containing two hormones are known as "combined" pills.

2. What you should know before taking LILADROS

General information
Before starting to take Liladros, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).
Before you start taking LILADROS, your doctor will ask you questions about your medical history and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out additional tests.
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This leaflet describes numerous situations in which you must stop taking LILADROS, or conditions in which the effectiveness of LILADROS may be reduced. In such situations, you must not have sexual intercourse or must use other contraceptive methods, such as condoms or another type of barrier method.
Do not use methods based on the rhythm method or body temperature measurement. These methods may be unreliable because LILADROS alters the monthly fluctuations in body temperature and cervical mucus.
LILADROS, like other hormonal contraceptives, does not provide any protection against HIV (AIDS) infection or against any other sexually transmitted disease.
During the time you are using this medicine, you should have regular medical check-ups, at least twice a year.

Do not take LILADROS
Do not take Liladros if you have any of the conditions listed below. If you have any of the conditions listed below, you should contact your doctor. Your doctor will discuss with you other birth control methods that might be more suitable for your case.

• if you are allergic to ethinylestradiol or drospirenone, or to 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 (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs

• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies

• if you are due to undergo surgery or will be immobile for a long period (see section “Blood clots”)

• if you have (or have ever had) a heart attack or stroke

• if you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms)

• if you have any of the following conditions, which could increase the risk of developing clots in the arteries:

  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats (cholesterol or triglycerides) in the blood
  • a condition known as hyperhomocysteinemia

• if you have (or have ever had) a type of migraine called “migraine with aura”

• if you have (or have ever had) inflammation of the pancreas (pancreatitis)

• if you have (or have ever had) a liver disease and your liver function has not yet returned to normal

• if your kidneys do not work properly (renal failure)

• if you have (or have ever had) a liver tumour

• if you have (or have ever had) or if it is suspected that you may have breast cancer or cancer of the genital organs

• if you experience unexplained vaginal bleeding.

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Liladros contains soya lecithin. If you are allergic to peanuts or soya, do not take this medicine.
Do not use Liladros if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or
sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Liladros”).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking LILADROS.
When should you contact a doctor?
Contact a doctor urgently

• if you notice possible signs of a blood clot, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section “Blood clot”). For a description of the symptoms of these serious side effects, see the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
In some situations, you need to be particularly careful when using LILADROS or any other combined oral contraceptive, and your doctor may need to monitor you regularly. If any of the following conditions apply to you, you must inform your doctor before starting treatment with LILADROS. If any of these conditions develop or worsen while you are taking Liladros, you must inform your doctor:

• if you develop symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with possible breathing difficulties, contact your doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema;
• if a close relative has or has ever had breast cancer
• if you have a liver or gallbladder disease
• if you have diabetes
• if you suffer from depression or mood changes
• if you have epilepsy (see “Other medicines and LILADROS”)
• if you have a condition that first occurred during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, a blistering skin rash during pregnancy (herpes gestationis), a nervous system disorder causing sudden involuntary movements (Sydenham’s chorea))
• if you have or have ever had signs of chloasma (skin pigmentation, especially on the face and neck, also known as “pregnancy mask”). In this case, avoid direct sunlight or ultraviolet radiation
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
• if you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defence system)
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure)
• if you have sickle cell anaemia (an inherited red blood cell disorder)
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas).
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• if you are due to undergo surgery or will be immobile for a long period (see section 2 “Blood clots”)
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after giving birth you can start taking LILADROS
• if you have inflammation of the veins under the skin (superficial thrombophlebitis)
• if you have varicose veins.

BLOOD CLOTS
Using a combined hormonal contraceptive such as LILADROS increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, serious long-term effects may occur, and very rarely, these effects can be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with LILADROS is low.

HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms.
Do you have any of these signs? What might you be suffering from?

• swelling in one leg or along a vein in the leg, or in the foot, especially if accompanied by:

  • pain or tenderness in the leg, which may only be felt when standing or walking
  • increased warmth in the affected leg
  • change in skin colour of the leg, such as paleness, redness, or bluish discoloration
    → Likely condition: Deep vein thrombosis

• sudden and unexplained shortness of breath

• sudden cough without an obvious cause, possibly with coughing up blood

• sharp chest pain that may worsen when breathing deeply

• severe dizziness or fainting

• rapid or irregular heartbeat

• severe stomach pain
  → Likely condition: Pulmonary embolism

If you are unsure, inform your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition such as a respiratory tract infection (e.g. a “common cold”).
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BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of developing blood clots in veins (venous thrombosis). However, these side effects are rare. They occur more frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot breaks away from the leg and travels to the lung, it can cause a pulmonary embolism.

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• Very rarely, a clot may form 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 drug or
a different one) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not
using a combined hormonal contraceptive.
When you stop taking LILADROS, the risk of developing a blood clot
returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE (venous thromboembolism) and the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with
LILADROS is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in a year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as LILADROS, about 9–12 will develop a blood clot in a year.
• The likelihood of developing a blood clot depends on your personal medical history (see below “Factors that increase the risk of developing a blood clot”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with LILADROS is low, but certain conditions can increase it. Your risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you might have an inherited blood clotting disorder. 6/16
• if you are due to undergo surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop taking LILADROS several weeks before surgery or during periods of reduced mobility. If you need to stop taking LILADROS, ask your doctor when you can start taking it again.
• as you get older (especially over 35 years of age);
• if you have given birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, especially if you have some of the other risk factors listed above.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to have you stop taking LILADROS.
If any of the above conditions change while you are using LILADROS—for example, if a close relative develops thrombosis without a known cause or if you gain significant weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems—for example, they can lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of LILADROS is very low but may increase:

• with increasing age (over approximately 35 years);
• if you smoke. When using a combined hormonal contraceptive such as LILADROS, it is advisable to stop smoking. If you cannot stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive.
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• if you or a close relative have high levels of fat in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if one of them is particularly severe, the risk of developing a blood clot may be even higher.
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If any of the above conditions change while you are using LILADROS—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

LILADROS and cancer
Breast cancer has been detected slightly more frequently in women using combined oral contraceptives, but it has not been established whether this increased incidence is due to the treatment. For example, a higher number of tumors may be diagnosed in women taking combined pills because they undergo medical examinations more frequently. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important that you regularly check your breasts and contact your doctor if you notice any lumps.
Rarely, benign liver tumors and even more rarely malignant liver tumors have been reported in women taking the pill. Contact your doctor if you experience unusual and severe abdominal pain.

Psychiatric disorders
Some women using hormonal contraceptives, including LILADROS, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor as soon as possible for further advice.

Bleeding between menstrual periods
During the first few months of using LILADROS, you may experience unexpected bleeding (bleeding not coinciding with the pill-free interval). If this bleeding persists for more than a few months, or if it starts after several months of use, your doctor should investigate the cause.

What to do if no bleeding occurs during the pill-free week
If you have taken all tablets correctly, have not experienced vomiting or severe diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant. If the expected bleeding does not occur twice in a row, you may be pregnant. Consult your doctor immediately. Do not start the next pack until you are certain you are not pregnant.

Other medicines and LILADROS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must also inform the doctor or dentist prescribing another medicine (or the pharmacist dispensing it) that you are using LILADROS.
They will advise you whether additional contraceptive precautions (e.g., condoms) are necessary and, if so, for how long.
Do not use LILADROS if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or
sofosbuvir/velpatasvir/voxilaprevir, as these products may cause increases in blood test results for liver function (elevated liver enzyme ALT).
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Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
LILADROS can be resumed approximately 2 weeks after completing this treatment. See section “Do not take LILADROS”.
Some medicines may affect the levels of LILADROS in the blood and may make it less effective in preventing pregnancy, or may cause unexpected bleeding. These include:

• medicines used to treat:
• epilepsy (e.g., barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate);
• tuberculosis (e.g., rifampicin);
• HIV infection or hepatitis C virus (so-called protease inhibitors or non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz), or other infections (griseofulvin);
• high blood pressure in the blood vessels of the lungs (bosentan);
• ketoconazole (used to treat fungal infections);
• symptomatic treatment of osteoarthritis (etoricoxib);
• the herbal remedy St. John’s wort (Hypericum perforatum). If you wish to use a herbal product containing St. John’s wort while using LILADROS, consult your doctor first.

LILADROS may affect the effectiveness of other medicines, for example:

• cyclosporine (a medicine used to prevent tissue rejection after transplant surgery);
• the antiepileptic lamotrigine (this could lead to an increased frequency of seizures);
• tizanidine (a medicine used to treat muscle spasticity);
• theophylline (a medicine used to treat asthma).

LILADROS with food and drink
LILADROS can be taken with or without food, if necessary with a little water.

Laboratory tests
If you require a blood test, inform your doctor or laboratory staff that you are taking the pill, as hormonal contraceptives may alter the results of certain tests.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnacy
Do not take LILADROS if you are pregnant. If you become pregnant while taking LILADROS, stop immediately and contact your doctor.
If you are planning a pregnancy, you may stop taking LILADROS at any time (see section “If you wish to stop taking LILADROS”).
Consult your doctor or pharmacist before taking any medicine.
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Breastfeeding
The use of LILADROS is generally not recommended while breastfeeding. If you wish to take the pill during breastfeeding, you must first contact your doctor.
Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
No data indicate that taking LILADROS affects the ability to drive or use machines.

LILADROS contains lactose and soy lecithin
LILADROS contains 48.53 mg of monohydrate lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
LILADROS also contains 0.070 mg of soy lecithin. If you are allergic to peanuts or soy, do not use this medicine.

3. How to take Liladros

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Take one Liladros tablet every day, if necessary with a sip of water. You may take the tablets with or
without food, but you should take the tablets every day at approximately the same time.
The blister pack contains 21 tablets. Next to each tablet, the day of the week on which it should be
taken is printed. For example, if you start on Wednesday, take the tablet next to the word “wed”.
Follow the direction of the arrow on the pack until you have taken all 21 tablets.
Then do not take any tablets for 7 days. During these 7 tablet-free days (also called the withdrawal
week or interval), you should experience bleeding. This so-called “withdrawal bleeding” usually
starts on the second or third day of the interval week.
On the eighth day after the last Liladros tablet (i.e. after the seventh day of the interval week), you
must start the next blister pack, regardless of whether the bleeding has stopped or not. This means
you should start each new blister pack on the same day of the week, and the withdrawal bleeding
should occur on the same days every month.
If you use Liladros in this way, you will be protected against pregnancy during the 7 days when
you do not take a tablet.

When can you start the first blister pack?

If you have not used a hormonal contraceptive in the previous month
Begin taking Liladros on the first day of your cycle (i.e. the first day of your menstrual bleeding). If
you start taking Liladros on the first day of your period, you are immediately protected against
pregnancy. You may also start between days 2 and 5 of your cycle; however, in this case, you must
use additional contraceptive methods (for example, a condom) for the first 7 days.

Switching from a combined hormonal contraceptive, vaginal ring, or transdermal contraceptive patch
Start Liladros preferably the day after taking the last active tablet (the last tablet containing active
substances) of your previous pill, but no later than the day after the tablet-free interval of your
previous pill (or after the last inactive tablet of your previous pill). If your previous contraceptive
method was a vaginal ring or transdermal patch, follow your doctor’s advice.

Switching from a progestogen-only contraceptive (progestogen-only pill, injection, implant, or intrauterine system releasing progesterone, IUS)
You may switch to Liladros at any time (from an implant or IUS on the day of removal, from an
injectable contraceptive on the day the next injection would have been given); however, in all these
cases, use additional contraceptive precautions (for example, a condom) for the first 7 days of tablet
intake.

After an abortion
Follow your doctor’s instructions.

After childbirth
You may start Liladros between 21 and 28 days after childbirth. If you start later than 28 days after
childbirth, use a barrier method (for example, a condom) during the first 7 days of using Liladros.
If you have had sexual intercourse after childbirth and before starting Liladros (again), make sure
you are not pregnant, or wait for your next menstrual period.

If you are breastfeeding after childbirth and wish to start (or restart) Liladros
Read the section “Breastfeeding”.
Ask your doctor for advice if you are unsure about when to start.

If you take more Liladros than you should
There are no reports indicating that taking too many Liladros tablets causes problems. If you have
taken too many tablets at once, you may feel nauseous, vomit, or experience vaginal bleeding.
Even girls who have not yet had their first menstrual period and who have accidentally taken this
medicine may experience vaginal bleeding.
If you have taken too many Liladros tablets, or if you find that a child has taken some, consult your
doctor or pharmacist.

If you forget to take Liladros
If the delay in taking the tablet is less than 12 hours, protection against pregnancy will not be
reduced. Take the missed tablet as soon as you remember, and then continue taking the tablets at
your usual time.

If the delay in taking the tablet is more than 12 hours, protection against pregnancy may be
reduced. The more tablets you miss, the higher the risk of becoming pregnant.
The risk of incomplete protection is greatest if you miss a tablet at the beginning or end of the pack.
Therefore, follow the rules below (see also the diagram below):

More than one tablet missed in this pack
Consult your doctor.

One tablet missed in week 1
Take the missed tablet as soon as you remember, even if this means taking two tablets at the same
time. Continue taking the tablets at your usual time, but use additional precautions for the next 7
days, for example a condom. If you had sexual intercourse during the week before missing the
tablet, you may be pregnant. In this case, consult your doctor.

One tablet missed in week 2
Take the missed tablet as soon as you remember, even if this means taking two tablets at the same
time. Continue taking the tablets at your usual time. Protection against pregnancy is not reduced,
and you do not need to take additional precautions.

One tablet missed in week 3
You have two options:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Instead of observing the 7-day tablet-free interval, start the next blister pack immediately. You will likely have a menstrual period at the end of the second pack, but you may experience light bleeding or spotting during the second pack.
2. You may also stop taking tablets from the current pack and proceed directly to the 7-day tablet-free interval (you must note the day on which you forgot to take the tablet). If you wish to start a new pack on the day you usually start, reduce the tablet-free interval to less than 7 days. By following either of these recommended options, you will remain protected against pregnancy.

If you have missed any tablet from a pack and do not experience any bleeding during the first
tablet-free interval, you may be pregnant. Consult your doctor before starting the next pack.
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Missed several

tablets in a blister
Yes
Week Did you have sexual intercourse during the week
1 before the missed dose?
No

• Take the missed tablet
• Use a barrier method (condom) for the next 7 days
• Finish the blister

Only missed Week - Take the missed tablet and
one tablet (taken 2 - Finish the pack
more than 12 hours
late)

• Take the missed tablet and
• Finish the pack
• Instead of the usual 7-day break, immediately start the next pack

Week or

• Immediately stop taking tablets from the current pack
• Begin the 7-day break (no longer than 7 days, including the day the tablet was missed)
• After the break, continue with the next pack

What to do if you experience vomiting or severe diarrhoea
If you vomit within 3–4 hours after taking a tablet or experience episodes of severe diarrhoea, there is a risk that the active substances in the pill may not be fully absorbed by your body. This situation is almost identical to missing a tablet. After episodes of vomiting or severe diarrhoea, take another tablet from a reserve blister as soon as possible. If possible, take this tablet within 12 hours of when you would normally take your pill. If this is not possible or if more than 12 hours have passed, follow the instructions provided under “If you forget to take LILADROS”.
Delayed menstruation: what you need to know
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Although not a recommended procedure, it is possible to delay menstruation by immediately starting a new blister of LILADROS, skipping the usual break, and continuing to take all tablets in the next blister.
You may experience light bleeding or breakthrough bleeding similar to menstruation while taking the second blister. After completing the usual 7-day tablet-free interval, start the next blister.
You may wish to consult your doctor before deciding to delay your menstrual period.
Changing the first day of menstruation: what you need to know
If you take the tablets as directed, your menstruation will occur during the tablet-free week. If you wish to change this day, shorten the number of tablet-free days ( but never extend them – the maximum is 7 days! ). For example, if your tablet-free days usually start on Friday and you wish them to start on Tuesday (3 days earlier), begin the next blister of tablets 3 days earlier than usual. If you significantly shorten the tablet-free interval (e.g. to 3 days or fewer), you may not have any bleeding during these days. You may then experience light bleeding or breakthrough bleeding similar to menstruation.
If you have any doubts about what to do, consult your doctor.
If you wish to stop treatment with LILADROS
You may stop treatment with LILADROS at any time. If you do not wish to become pregnant, ask your doctor to recommend other reliable methods of contraception.
If you wish to become pregnant, stop taking LILADROS and wait for a menstrual period before trying to conceive. This will allow you to calculate the expected date of delivery more accurately.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think may be due to LILADROS, inform your doctor.

Serious side effects
Contact your doctor immediately if you experience any of the following symptoms of angioedema:
swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives accompanied by potential breathing difficulties (see also section “Warnings and precautions”).

An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before using LILADROS”.

The following is a list of side effects that have been reported with the use of Liladros:

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

• mood changes
• headache
• abdominal pain (stomach ache)
• acne
• breast pain, breast enlargement, breast tenderness, painful or irregular menstrual cycles
• weight gain

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

• candidiasis (fungal infection)
• cold sores (herpes simplex)
• allergic reactions
• increased appetite
• depression, nervousness, sleep disturbances
• tingling sensation, dizziness
• vision problems
• irregular or unusually rapid heartbeat
• presence of a blood clot (thrombosis) in a blood vessel of the leg or lungs (pulmonary embolism), high blood pressure, low blood pressure, migraine, varicose veins
• sore throat
• nausea, vomiting, inflammation of the stomach and/or intestine, diarrhoea, constipation
• sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat), and/or difficulty swallowing, or hives accompanied by breathing difficulties (angioedema), hair loss (alopecia), eczema, itching, skin rashes, dry skin, skin disorders with oily skin (seborrhoeic dermatitis)
• neck pain, limb pain, muscle cramps
• bladder infections
• breast lumps (benign and malignant), milk production in the absence of pregnancy (galactorrhoea), ovarian cysts, hot flushes, absence of menstrual periods, heavy menstrual bleeding, vaginal discharge, vaginal dryness, lower abdominal (pelvic) pain, abnormal cervical smear (Papanicolaou or Pap test)
• decreased interest in sex
• fluid retention, lack of energy, excessive thirst, increased sweating
• weight loss

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

• asthma
• hearing impairment
• blockage of a blood vessel due to a clot formed elsewhere in the body
• erythema nodosum (characterized by red, painful nodules on the skin)
• erythema multiforme (skin rash with redness or sores resembling a target)
• harmful blood clots in a vein or artery, for example:
  • in a leg or foot (DVT),
  • in a lung (PE),
  • heart attack,
  • stroke,
  • mini-stroke or temporary symptoms similar to stroke, known as transient ischaemic attack (TIA),
  • blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 “For more information on conditions that increase the risk of blood clots and symptoms of a blood clot”).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LILADROS

Keep this medicine out of sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the blister and on the carton. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LILADROS contains

• The active substances are 3 mg drospirenone and 0.02 mg ethinylestradiol.
• The other components are: Tablet core: monohydrate lactose, corn starch, pregelatinized corn starch, graft copolymer of poly(vinyl alcohol) and polyethylene glycol, magnesium stearate. Tablet coating: poly(vinyl alcohol), titanium dioxide (E 171), talc, macrogol 3350, lecithin (soy).

Description of the appearance of LILADROS and package contents
White or almost white, round, biconvex, film-coated tablet with a diameter of approximately 6 mm. On one side there is an indentation: “G73”, the other side is plain.
LILADROS 3 mg/0.02 mg film-coated tablets are packed in PVC/PE/PVDC-Al blister packs.
The blisters are packed in folding cartons containing the patient leaflet; a storage box for the product is included in each carton.
Pack sizes:
1x21 film-coated tablets
16/16
3x21 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary

Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

This medicinal product is authorized in the European Economic Area countries under the following names:
Portugal LILADROS 3 mg/0.02 mg comprimidos revestidos por película
Italy LILADROS, 3 mg/0.02 mg compressa rivestita con film
17/16