Liberelle

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Liberelle (Liberelle 0.25 mg/0.035 mg tablets EFG)

0.25 mg + 0.035 mg, tablets

Norgestrel + Ethinyl Estradiol
Liberelle and Liberelle 0.25 mg/0.035 mg tablets EFG are different trade names for the same medicine.

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more
• Caution should be exercised and a doctor should be consulted if a woman suspects that symptoms of a blood clot have occurred (see section 2 "Blood clots")

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Liberelle and what is it used for
• 2. Important information before taking Liberelle
• 3. How to take Liberelle
• 4. Possible side effects
• 5. How to store Liberelle
• 6. Contents of the packaging and other information

1. What is Liberelle and what is it used for

Liberelle is a combined hormonal oral contraceptive ("birth control pill"). This medicine is used to prevent pregnancy.
This contraceptive contains two types of female sex hormones, estrogen and progestogen. These hormones prevent the release of an egg from the ovaries, making it impossible to become pregnant. Additionally, Liberelle makes the fluid (mucus) in the cervix thicker, making it harder for sperm to enter the uterus.

To prevent pregnancy, Liberelle should be taken as directed.

2. Important information before taking Liberelle

General notes

Before starting to take Liberelle, the information about blood clots in section 2 should be read. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
Before starting to take Liberelle, the doctor will ask the patient a few questions about her previous illnesses and any illnesses that have occurred in her family. The doctor will also measure the patient's blood pressure and, depending on the patient's current condition, may order some other tests.
This leaflet describes several situations in which Liberelle should be stopped or when the effectiveness of Liberelle may be reduced. In such situations, sexual intercourse should not be had or an additional, non-hormonal method of contraception should be used, e.g., a condom or another mechanical method. During this time, the calendar method or temperature measurement method should not be used either. Both of these methods can be unreliable because Liberelle changes the monthly body temperature and the properties of the mucus in the cervix.

Liberelle, like other hormonal contraceptives, does not protect against HIV (AIDS) or other sexually transmitted diseases.

When not to take Liberelle:

Liberelle should not be taken if the patient has any of the following conditions. If the patient has any of the following conditions, they should inform their doctor. The doctor will discuss with the woman which other contraceptive method will be more suitable.

• if the patient has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if the patient knows she has blood clotting disorders - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the patient has had a heart attack or stroke;
• if the patient has (or has had) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms);
• if the patient has any of the following diseases that may increase the risk of a blood clot in an artery: severe diabetes with blood vessel damage; very high blood pressure; very high levels of fats in the blood (cholesterol or triglycerides); a disease called hyperhomocysteinemia;
• if the patient has (or has ever had) a type of migraine called migraine with aura;
• if the patient has a heart valve defect that causes complications;
• if the patient has (or has ever had) liver disease and liver function is still abnormal;
• if the patient has (or has ever had) a liver tumor;
• if the patient has (or has ever had) or is suspected to have breast cancer or cancer of the genital organs;
• if there are vaginal bleeding of unknown cause;
• if the patient had jaundice or liver problems during pregnancy or during previous use of hormonal contraceptives;
• if the patient has a thickened lining of the uterus;
• if the patient is allergic to norgestrel or ethinyl estradiol, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has (or has ever had) pancreatitis (inflammation of the pancreas) associated with high levels of triglycerides in the blood (hypertriglyceridemia);
• if the patient has a liver infection caused by hepatitis C virus and is taking medicines containing ombitasvir, paritaprevir, ritonavir, or dasabuvir, or glecaprevir/pibrentasvir (see also section "Liberelle and other medicines").

Warnings and precautions

When to contact a doctor?

A doctor should be contacted immediately

• if the patient notices any of the possible symptoms of a blood clot, which may indicate that the patient has a blood clot in the leg (deep vein thrombosis), blood clot in the lungs (pulmonary embolism), heart attack, or stroke (see section 2 "Blood clots" below).

Description of symptoms of these serious side effects, see section "How to recognize a blood clot".

The doctor should be told if the patient has any of the following conditions:

If these symptoms occur or worsen while taking Liberelle, the doctor should also be told.

• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell anemia (a hereditary disease of red blood cells);
• if the patient has high levels of fats in the blood (hypertriglyceridemia) or a history of this condition in their family. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the woman has just given birth, she is at a higher risk of blood clots. The doctor should be consulted for information on how soon Liberelle can be started after giving birth;
• if the patient has superficial thrombophlebitis (blood clots in the veins under the skin);
• if the patient has varicose veins;
• if the patient has otosclerosis (hearing loss);
• if the patient has (or has ever had) chloasma (skin discoloration, especially on the face and neck, known as "pregnancy patches"). In this case, sun exposure and ultraviolet light should be avoided;
• if the patient had a skin rash or blisters during pregnancy, which first appeared during pregnancy;
• if the patient has (or has ever had) gallstones or cholecystitis;
• if the patient has a blood disease called porphyria;
• if the patient has a nerve disease characterized by sudden movements of the body (Sydenham's chorea);
• if a close relative has had breast cancer;
• if the patient has depression. Some women taking hormonal contraceptives, including Liberelle, have reported depression or depressive mood. Depression can be severe and sometimes may lead to suicidal thoughts. If mood changes and symptoms of depression occur, a doctor should be consulted as soon as possible;
• if the patient has liver disease;
• if the patient experiences symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing, or skin rash, and breathing problems, they should contact a doctor immediately. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

If any of these conditions occur or worsen while taking Liberelle, a doctor should be consulted.

Blood clots

The use of combined hormonal contraceptives, such as Liberelle, is associated with an increased risk of blood clots, compared to not using hormonal contraceptives. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur:

• in veins (also known as "venous thromboembolism" or "deep vein thrombosis");
• in arteries (also known as "arterial thromboembolism"). Not everyone recovers fully from a blood clot. In rare cases, the effects of a blood clot can be long-lasting or, very rarely, fatal.

It should be remembered that the overall risk of serious blood clots caused by taking Liberelle is small.

How to recognize a blood clot

A doctor should be contacted immediately if any of the following symptoms are noticed.
Does the patient have any of these symptoms?
Probable disease of the patient
Swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by:

• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased temperature in the affected leg;
• change in skin color of the leg, such as pallor, redness, or cyanosis. Deep vein thrombosis
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain.

If the patient is unsure, they should contact a doctor, as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold).
Pulmonary embolism
Symptoms usually occur in one eye:

• sudden loss of vision or
• painless vision disturbances, which may lead to loss of vision. Retinal vein thrombosis (blood clot in the eye)
• chest pain, discomfort, or feeling of pressure;
• feeling of tightness or fullness in the chest, arm, or below the breastbone;
• feeling of fullness, indigestion, or choking;
• discomfort in the upper body radiating to the back, jaw, throat, arm, and stomach;
• sweating, nausea, vomiting, or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat. Heart attack
• sudden weakness or numbness of the face, arms, or legs, especially on one side of the body; Stroke

Blood clots in veins

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). These side effects are rare. They most often occur in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot moves from the leg and settles in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein the highest?

The risk of forming a blood clot in a vein is highest during the first year of using combined hormonal contraceptives. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it is always higher compared to not using combined hormonal contraceptives.
If the patient stops taking Liberelle, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots?

The risk depends on the patient's natural risk of developing venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs caused by taking Liberelle is small.

• In a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate, such as Liberelle, will develop blood clots.
• The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots in veins" below).

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with taking Liberelle is small, but some factors can increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) over 30 kg/m2);
• if someone in the patient's close family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50). In this case, the patient may have inherited blood clotting disorders;
• if the patient needs to have surgery or will be immobilized for a long time due to injury or illness, or has a leg in a cast. It may be necessary to stop taking Liberelle for a few weeks before surgery or immobilization. If the patient needs to stop taking Liberelle, they should ask their doctor when they can resume taking it;
• with age (especially over 35 years);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Taking a long-haul flight (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of these risk factors are present, even if the patient is unsure. The doctor may decide to stop the use of Liberelle.
If any of the above conditions change while taking Liberelle, e.g., someone in the patient's close family is diagnosed with a blood clot without a known cause or the patient gains significant weight, the doctor should be informed.

Blood clots in arteries

What can happen if a blood clot forms in an artery?

Similar to blood clots in veins, blood clots in arteries can cause serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of a heart attack or stroke associated with taking Liberelle is very small, but it may increase:

• with age (over about 35 years);
• if the patient smokes. While taking a combined hormonal contraceptive like Liberelle, it is recommended to quit smoking. If the patient is unable to quit smoking and is over 35, the doctor may recommend a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's close family has had a heart attack or stroke at a young age (under 50). In this case, the patient may also be at a higher risk of having a heart attack or stroke;
• if the patient or someone in their close family has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has a heart condition (valve damage, arrhythmia called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of these conditions or if any of these conditions are severe, the risk of blood clots may be even higher.
If any of the above conditions change while taking Liberelle, e.g., the patient starts smoking, someone in their close family is diagnosed with a blood clot without a known cause, or the patient gains significant weight, the doctor should be informed.

Liberelle and cancer

In women taking oral contraceptives, breast cancer is slightly more common, but it is not known if this is caused by the treatment. For example, there is a possibility that more tumors are detected in women taking combined contraceptives because they are examined by a doctor more often. The frequency of breast cancer decreases gradually after stopping combined hormonal contraceptives.
It is essential to regularly examine the breasts and contact a doctor if a lump is found.
In rare cases, a benign liver tumor can develop, and even more rarely, malignant liver tumors have been reported in women taking birth control pills. If severe abdominal pain occurs, a doctor should be contacted.
Irregular bleeding
During the first few months of taking Liberelle, unexpected bleeding (spotting or irregular bleeding) may occur. If such bleeding occurs for longer than a few months or occurs after a few months of taking Liberelle, the doctor must determine the cause of the disturbances.
What to do if bleeding does not occur during the break in taking the medicine
If all the tablets were taken correctly, the patient did not vomit or have severe diarrhea, and did not take any other medicines, it is very unlikely that the patient is pregnant. If the expected bleeding does not occur in two consecutive cycles, the patient may be pregnant. In this case, a doctor should be contacted immediately. Until pregnancy is ruled out, the patient should not start taking tablets from the next blister.

Liberelle and other medicines

The patient should tell their doctor about all medicines they are taking, including herbal medicines. The patient should also tell their doctor or pharmacist who prescribes other medicines (and the pharmacist) that they are taking Liberelle. The doctor may recommend using an additional method of contraception (e.g., a condom) and will tell the patient how long to use it or if they should use a different medicine.
Some medicines

• may affect the level of Liberelle in the blood;
• may reduce the effectiveness of contraception;
• may cause unexpected bleeding.

This applies to medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine);
• tuberculosis (e.g., rifampicin);
• HIV or hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz);
• fungal infections (e.g., griseofulvin);
• arthritis or arthrosis (etoricoxib);
• high blood pressure in the blood vessels of the lungs (bosentan);
• herbal medicines containing St. John's Wort (Hypericum perforatum).

Liberelle may affect the action of other medicines, such as:

• medicines containing cyclosporin;
• the antiepileptic medicine lamotrigine (which may increase the frequency of seizures);
• theophylline (used to treat breathing difficulties);
• tizanidine (used to treat muscle pain and/or muscle spasms).

Liberelle should not be taken if the patient has a liver infection caused by hepatitis C virus and is taking medicines containing ombitasvir, paritaprevir, ritonavir, or dasabuvir, or glecaprevir/pibrentasvir, as this may increase liver function test results (increase in liver enzyme ALT activity). Before starting these medicines, the doctor will recommend a different contraceptive method.
Taking Liberelle can be resumed 2 weeks after finishing treatment with these medicines. See section "When not to take Liberelle".
Lab tests
If lab tests are necessary, the doctor or lab staff should be told that the patient is taking a contraceptive. Taking oral contraceptives can affect the results of some lab tests.

Liberelle with food and drink

Liberelle can be taken with or without food, and if necessary, the tablet can be taken with a small amount of water.

Pregnancy, breastfeeding, and fertility

Pregnancy
Liberelle should not be taken during pregnancy. If a woman becomes pregnant while taking Liberelle, she should stop taking it immediately and contact her doctor. If the patient plans to become pregnant, she can stop taking Liberelle at any time. Before taking any medicine, a doctor or pharmacist should be consulted.
Breastfeeding
Taking Liberelle is not generally recommended for women who are breastfeeding. If a woman wants to use a contraceptive while breastfeeding, she should consult her doctor.
Before taking any medicine, a doctor or pharmacist should be consulted.

Driving and using machines

Liberelle does not affect the ability to drive or use machines.

Liberelle contains lactose monohydrate.

If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking Liberelle.

3. How to take Liberelle

How to take the medicine

This medicine should always be taken as directed by the doctor or pharmacist. If in doubt, the doctor or pharmacist should be consulted.

Preparing the sticker

To help control the intake of the medicine, 7 self-adhesive stickers with symbols of the days of the week are available. The appropriate sticker should be chosen, starting with the symbol of the day of the week corresponding to the day the woman starts taking the tablets. For example, if the tablets are started on a Wednesday, the sticker should be chosen with the symbols of the days of the week starting with "Wed".
The chosen sticker should be placed in the part of the blister marked "Coloque la etiqueta aquí (Place the sticker here)".
Then each tablet will be marked with the symbol of the day of the week it should be taken.
The arrows show the order of taking the tablets.
One tablet should be taken for 21 consecutive days, during a meal or independently of food, if necessary with a small amount of water.
A new pack should be started after a 7-day break, during which withdrawal bleeding (menstruation) occurs. Withdrawal bleeding, which is similar to menstruation, will occur 2-3 days after taking the last tablet and may not end before starting the tablets from the next pack.

When to start taking the tablets from the first pack

• •If no hormonal contraceptive has been used in the previous month.Taking Liberelle should be started on the first day of the menstrual cycle (i.e., the first day of menstruation). If the patient starts taking Liberelle on the first day of menstruation, she is immediately protected against pregnancy. Alternatively, Liberelle can be started on days 2-5 of the menstrual cycle, but in this case, additional contraceptive methods (e.g., condoms) should be used for the first 7 days.
• Switching from another combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or patch.Taking Liberelle can be started the day after taking the last active tablet (the last tablet containing the active substance) from the previous contraceptive pack, but no later than the first day after the break in taking the previous contraceptive (or after taking the last inactive tablet from the previous contraceptive pack). In the case of a vaginal ring or transdermal patch, the doctor's instructions should be followed.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen)The switch can be made on any day, in the case of an implant or intrauterine system - on the day of its removal, in the case of injections - on the scheduled injection date. However, in all these cases, additional contraceptive methods (e.g., condoms) should be used for the first 7 days.
• After a miscarriage or abortionThe doctor's instructions should be followed.
• After childbirthTaking Liberelle can be started between 21 and 28 days after childbirth. If taking Liberelle starts later than 28 days, additional contraceptive methods (e.g., condoms) should be used for the first 7 days.

If the woman has had sexual intercourse since giving birth and before restarting Liberelle, she should ensure she is not pregnant or wait for her next menstrual period.

• If the woman is breastfeeding and wants to start taking Liberelle after childbirthShe should read the section "Pregnancy, breastfeeding, and fertility".

If in doubt about when to start taking the tablets, the doctor should be consulted.

What to do if too much Liberelle is taken

There are no reports of serious complications after taking too many Liberelle tablets. If the patient takes many tablets at once, they may experience nausea or vomiting. In young girls, vaginal bleeding may occur.
If the patient has taken too many tablets or it is noticed that a child has swallowed tablets, a doctor or pharmacist should be consulted.

Missing a dose of Liberelle

• If it has been less than 12 hours since the time the woman would have normally taken the tablet, the contraceptive effectiveness of Liberelle is not reduced. The tablet should be taken as soon as possible, and subsequent tablets should be taken at the usual time.
• If it has been more than 12 hours since the time the woman would have normally taken the tablet, the effectiveness of contraception may be reduced. The more tablets that are missed, the higher the risk of becoming pregnant.

The risk of reduced contraceptive effectiveness is highest if the patient misses a tablet at the beginning or end of the pack.

• •Missing more than 1 tablet from the packThe doctor should be contacted.
• •Missing one tablet in days 1-7 (first row)The missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. The remaining tablets should be taken at the usual time. An additional method of contraception, such as a condom, should be used for the next 7 days. The possibility of pregnancy should be considered if sexual intercourse was had in the previous 7 days. In this case, the doctor should be contacted.
• •Missing one tablet in days 8-14 (second row)The missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. The remaining tablets should be taken at the usual time. The effectiveness of contraception is not reduced, and there is no need to use additional contraceptive methods.
• •Missing one tablet in days 15-21 (third row)There are two options to choose from:
• 1. The missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. The remaining tablets should be taken at the usual time. Instead of the break, the tablets from the next pack should be started immediately. Withdrawal bleeding will probably occur at the end of the second pack, but spotting or irregular bleeding may occur during the second pack.

• 2. The tablets from the current pack can be stopped, and a 7-day break in taking the tablets can be started (the day the tablet was missed should be noted). If the woman wants to start the new pack on the day she would normally start the new pack, the break in taking the tablets can be shortened.

If the patient follows these instructions, the contraceptive effectiveness of Liberelle will be maintained.

• If the patient misses a tablet and withdrawal bleeding does not occur during the first 7-day break, pregnancy is possible. Before starting the tablets from the next pack, the doctor should be contacted.

Missing more than 1 tablet from the pack
The doctor should be contacted
Yes
Has the patient had sexual intercourse in the 7 days before missing the tablet?
Days 1-7
No
The missed tablet should be taken.
An additional method of contraception (e.g., a condom) should be used for the next 7 days, and the tablets from the pack should be finished.
Missing only 1 tablet (taken more than 12 hours after the scheduled time)
The missed tablet should be taken.
The tablets from the pack should be finished.
Days 8-14
The missed tablet should be taken, and the tablets from the pack should be finished.
Instead of the break, the tablets from the next pack should be started immediately.
Days 15-21
or
The tablets should be stopped immediately.
A break (not longer than 7 days, including the day the tablet was missed) should be started. Then the tablets from the next pack should be started.

What to do in case of vomiting or severe diarrhea

If vomiting occurs within 3-4 hours of taking a tablet, there is a risk that the active substances of the tablet may not be fully absorbed. This is almost the same situation as missing a tablet. After vomiting or diarrhea, a new tablet should be taken from the reserve pack as soon as possible. If possible, the new tablet should be taken within 12 hours of the usual time of taking the tablet. If this is not possible or more than 12 hours have passed, the instructions in the section "Missing a dose of Liberelle" should be followed.

How to delay the day of withdrawal bleeding

Although this is not recommended, the day of withdrawal bleeding can be delayed by starting a new pack of Liberelle immediately without taking a break. During the second pack, there may be some spotting or irregular bleeding. After the usual 7-day tablet-free period, the tablets from the next pack should be started.
Before deciding to delay the withdrawal bleeding, the doctor should be consulted.

Changing the first day of bleeding: what to know

If the patient is taking the tablets as directed, bleeding will start during the tablet-free week. If the day of the tablet-free week needs to be changed, the break in taking the tablets should be shortened (but never extended - 7 days is the maximum length of the break!). For example, if the tablet-free week usually starts on a Friday, to change this day to Tuesday (3 days earlier), the tablets from the new pack should be started 3 days earlier than usual. If the break in taking the tablets is very short (e.g., shorter by 3 days), bleeding may not occur during this time. However, some spotting or irregular bleeding may occur during the tablets from the next pack.
If the patient is unsure what to do, they should contact their doctor.

Stopping Liberelle

Taking Liberelle can be stopped at any time. If the patient does not want to become pregnant, they should talk to their doctor about other effective contraceptive methods. If the patient wants to become pregnant, they should stop taking Liberelle and wait until their next menstrual period before trying to conceive. This way, it will be easier to calculate the expected date of delivery.
In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible Undesirable Effects

Like all medicines, this medicine can cause undesirable effects, although not everybody gets them.
If any undesirable effects occur, especially severe and persistent ones or changes in
health status that the patient considers related to the use of Liberelle, you should talk to
your doctor.
In all women using combined hormonal contraceptives, there is an increased risk of blood clots in veins (venous thromboembolic disease) or blood clots in arteries (arterial thromboembolic disease). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2: "Important information before taking Liberelle".
You should contact your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or skin rash, and breathing problems (see "Warnings and precautions").
Undesirable effects that may be associated with the use of Liberelle:
Very Common(may occur in more than 1 in 10 people):

• headache(if severe, unusual, or prolonged, you should contact your doctor as soon as possible);
• gastrointestinal disorderssuch as nausea, vomiting, diarrhea;
• bleeding and spottingthat occurs for a few months (these symptoms subside when the woman's body adapts to Liberelle), intermenstrual bleeding should not last for a long time;
• painful menstrual cycles and abnormal bleedingfrom withdrawal.

Common(may occur in up to 1 in 10 people):

• urinary tract infection(painful urination);
• vaginal infection, such as thrush;
• depression, mood changes, nervousness;
• migraine(you should contact your doctor if this is your first migraine or if it is worse than usual);
• acne, rash;
• breast pain;
• chest pain;
• muscle cramps, pain in limbs, arms, and back;
• absence of menstruation;
• weight gain;
• feeling of weakness;
• stomach pain and bloating, constipation, gas;
• swelling of hands, ankles, or feet;
• sleep disorders(insomnia);
• hypersensitivity (anaphylactic reaction).

Uncommon(may occur in up to 1 in 100 people):

• breast disorders, such as breast enlargement, breast discharge;
• abnormal growth of cervical cells(identified by cytology);
• anxietyor fainting, feeling of tinglingor numbness;
• skin color changes;
• skin disorders, such as redness, itching, or discoloration;
• hair loss(alopecia), excessive body hair;
• changes in appetite, weight fluctuations, weight loss;
• libido disorders;
• dry eye;
• vision disorders;
• heart palpitations(strong feeling of heartbeat);
• hot flashes;
• muscle pain;
• vaginal dryness;
• ovarian cyst(may cause abdominal pain and swelling, as well as menstrual disorders);
• high blood pressure;
• shortness of breath or dyspnea(subjective feeling of difficulty breathing).

Rare(may occur in up to 1 in 1000 people):

• breast cyst;
• dizziness;
• rapid heart rate;
• pancreatitis(inflammation of the pancreas causing severe abdominal and back pain);
• excessive sweating;
• photosensitivity;
• hepatitis(inflammation of the liver causing severe abdominal and back pain);
• vaginal discharge(changes in vaginal discharge).

Frequency Not Known(frequency cannot be estimated from the available data):

• reduced milk production (in breastfeeding women);
• intolerance to contact lenses;
• painful red lumpson the legs;
• lipid metabolism disorders(fats) in the blood (detected by blood tests);
• excessive night sweating;
• liver tumors (benign liver tumors, usually hormone-induced);
• breast cancer;
• benign breast tumor;
• focal nodular hyperplasia (a benign tumor);
• breast fibroadenoma;
• vascular and cerebral incidents;
• abnormal, sudden, and involuntary muscle contractions or serial muscle contractions (seizures);
• myocardial infarction;
• angioedema (swelling that occurs in the deep layers of the skin).

In women taking contraceptives, the following serious undesirable effects have been reported slightly more frequently (see section 2: "Important information before taking Liberelle"):

• high blood pressure;
• liver tumors or breast cancer;
• liver function disorders;
• dangerous blood clots in veins or arteries, such as in the legs or feet (venous thromboembolic disease), in the lungs (pulmonary embolism), myocardial infarction, stroke, mini-stroke, or transient symptoms similar to stroke, called transient ischemic attacks, or blood clots in the liver, stomach/intestine, kidneys, or eye.

The risk of thrombosis may be higher if other conditions that increase this risk also occur (more information on conditions that increase the risk of thrombosis and symptoms of thrombosis, see section 2).
The following conditions may occur or worsen during the use of combined oral contraceptives: Crohn's disease, ulcerative colitis, epilepsy, uterine fibroids, porphyria (a metabolic disorder that causes abdominal pain and mental disorders), systemic lupus erythematosus (the body attacks and damages its own organs and tissues), pregnancy herpes, Sydenham's chorea (sudden involuntary movements of the type of jerking or twitching), hemolytic-uremic syndrome (which occurs after diarrhea caused by the bacteria E. coli), liver disorders with jaundice, gallbladder disorders, or the formation of gallstones.

Reporting Undesirable Effects

If you experience any undesirable effects, including any undesirable effects not listed in the leaflet, you should inform your doctor, pharmacist, or nurse. Undesirable effects can be reported directly to the Department of Monitoring of Undesirable Effects of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
By reporting undesirable effects, you can help gather more information on the safety of the medicine.

5. How to Store Liberelle

The medicine should be stored out of sight and reach of children.
Do not store above 30°C.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Packaging and Other Information

What Liberelle Contains:

The active substances of the medicine are 250 micrograms of norgestimate and 35 micrograms of ethinylestradiol.
Liberelle also contains other ingredients: cornstarch, lactose monohydrate, magnesium stearate, and indigo carmine (E 132).

What Liberelle Looks Like and What the Packaging Contains

• Each tablet is blue, cylindrical, biconvex, 6 mm in diameter (from 5.9 mm to 6.1 mm) and 2.5 mm thick (from 1.5 mm to 3.5 mm).
• Liberelle is available in blisters containing 21 tablets.
• The packaging contains 1 or 3 blisters, each blister containing 21 tablets.

For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Spain, the Country of Export:

Exeltis Healthcare, S.L., Avenida de Miralcampo, 7, Polígono Industrial Miralcampo, 19200 Azuqueca de Henares, Guadalajara, Spain

Manufacturer:

CYNDEA PHARMA, S.L, Polígono Industrial Emiliano Revilla Sanz, Avenida de Ágreda, 31, 42110 Olvega, Soria, Spain

Parallel Importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Spanish export authorization number: 725351.8

• 725350.1

Parallel Import Authorization Number: 98/22

This medicinal product is authorized for sale in the Member States of the European

Economic Area under the following names:
Denmark
Liberelle
France
Liberelle 0.035mg/0.25 mg, comprimé
Spain
Liberelle 0,25mg/0,035 mg comprimidos EFG
Netherlands
Norgestimaat/Ethinylestradiol Xiromed 0,25mg/0,035mg tabletten
Poland
Liberelle
Italy
Briladona
Date of approval of the leaflet: 22.02.2022
[Information about the trademark]