Liberelle

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Liberelle

0.25 mg + 0.035 mg, tablets

Norgestimate+ Ethinyl estradiol

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception
• To a small extent, they 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
• One should be vigilant and consult a doctor if a woman suspects that symptoms of blood clots have occurred (see section 2 "Blood clots")

One should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• One should keep this leaflet, so that it can be re-read if necessary.
• In case of any doubts, one should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. It should not be passed on 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 not listed in this leaflet, they should tell their doctor or pharmacist. 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 pack 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 according to the instructions.

2. Important information before taking Liberelle

General notes
Before starting to take Liberelle, one should read the information about blood clots in section 2. 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, as well as illnesses that occur 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 one should stop taking Liberelle, or when the effectiveness of Liberelle may be reduced. In such situations, one should not have sexual intercourse or use an additional, non-hormonal method of contraception, e.g. a condom or another mechanical method. During this time, one should not use the calendar method or the temperature measurement method. Both of these methods can be unreliable, as 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:

One should not use Liberelle 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 they have blood coagulation disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient is going 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 impaired;
• if the patient has (or has ever had) a liver tumor;
• if the patient has (or has ever had) or suspects they have breast cancer or cancer of the genital organs;
• if the patient has bleeding from the genital tract of unknown cause;
• if the patient had jaundice during pregnancy or while taking contraceptives in the past;
• if the patient has an abnormal thickening of the lining of the uterus;
• if the patient is allergic to norgestimate 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 the hepatitis C virus and is taking medicines containing ombitasvir, paritaprevir, ritonavir, or dasabuvir, or glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also "Liberelle and other medicines").

Warnings and precautions

When to contact a doctor?

One should contact a doctor immediately

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

Descriptions of the symptoms of these serious side effects can be found in the section "How to recognize the occurrence of blood clots".

One should tell the doctor if the patient has any of the following conditions:

If these symptoms occur or worsen while taking Liberelle, one should also tell the doctor.
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 been found to have high levels of fats in the blood (hypertriglyceridemia) or has a history of this condition in their family. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient is going to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the woman is immediately after childbirth, she is at increased risk of blood clots. One should consult a doctor for information on how soon it is possible to start taking Liberelle after childbirth;
• 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 spots"). In this case, one should avoid exposure to the sun and ultraviolet light;
• if the patient had a skin rash or blisters (pregnancy pemphigoid) that 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 someone in the patient's close family has or 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 cause suicidal thoughts. If mood changes and symptoms of depression occur, one should contact a doctor 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, and/or skin rash, and/or breathing problems, one should contact a doctor immediately. Medicines containing estrogens may cause or worsen the symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Taking 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 (this is also called "venous thromboembolism");
• in arteries (this is also called "arterial thromboembolism"). Not everyone recovers fully from a blood clot. In rare cases, the effects of a blood clot can be long-term, or very rarely fatal.

One should remember that the total risk of harmful blood clots caused by taking Liberelle is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS

One should contact a doctor 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 it is 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 the color of the leg skin, e.g. 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; Pulmonary embolism

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).
Symptoms usually occur in one eye:

• immediate loss of vision or
• painless vision disturbances, which may lead to loss of vision. Retinal vein thrombosis (blood clot in the eye)

BLOOD CLOTS IN VEINS

What can happen if blood clots form in veins?

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thromboembolism). These side effects are rare. They most often occur in the first year of taking 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 veins the highest?

The risk of forming blood clots in veins is highest during the first year of taking combined hormonal contraceptives. The risk may also be higher when resuming 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 taking 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 in veins?

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

• During a year, about 2 in 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5-7 in 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/m);
• 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 years old). 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 old);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul flights (>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 one is unsure. The doctor may decide to stop the patient from taking Liberelle.
One should tell the doctor if any of the above conditions change while taking Liberelle, e.g. if someone in the patient's close family is found to have a blood clot without a known cause or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in arteries?

Similarly 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 heart attack or stroke associated with taking Liberelle is very small, but it may increase:

• with age (over about 35 years old);
• 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 years old, the doctor may recommend using 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 years old). In this case, the patient may also be at increased risk of having a heart attack or stroke;
• if the patient or someone in their close family has been found to have high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, arrhythmia called atrial fibrillation);
• if the patient has diabetes.

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

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 hormonal 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 may develop, and even more rarely, malignant liver tumors have been reported in women taking birth control pills. If severe abdominal pain occurs, one should contact a doctor.
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 a break in taking Liberelle
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, one should contact a doctor immediately. Until pregnancy is ruled out, one should not start taking tablets from the next blister.

Liberelle and other medicines

One should tell the doctor about all medicines the patient is taking, including herbal remedies. One should also tell the doctor or dentist 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 make the contraceptive less effective;
• may cause unexpected bleeding.

This applies to medicines used to treat:

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine);
• tuberculosis (e.g. rifampicin);
• HIV and hepatitis C virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz);
• fungal infections (e.g. griseofulvin);
• arthritis and arthrosis (etoricoxib);
• high blood pressure in the blood vessels of the lungs (bosentan);
• herbal remedies 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).

One should not take Liberelle if the patient has a liver infection caused by the hepatitis C virus and is taking medicines containing ombitasvir, paritaprevir, ritonavir, or dasabuvir, or glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may cause abnormal liver function test results (increased liver enzyme activity). Before starting these medicines, the doctor will prescribe a different type of contraception.
One can start taking Liberelle again about 2 weeks after finishing the above treatment. See the section "When not to take Liberelle".
Lab tests
If blood tests are necessary, one should tell the doctor or laboratory staff that they are taking a contraceptive, as taking oral contraceptives may affect the results of some laboratory 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 a doctor. If the patient plans to become pregnant, she can stop taking Liberelle at any time. Before taking any medicine, one should consult a doctor or pharmacist.
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 a doctor.
Before taking any medicine, one should consult a doctor or pharmacist.

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 exactly as prescribed by the doctor or pharmacist. In case of doubt, one should consult a doctor or pharmacist.

Preparing the sticker

To help control the intake of the medicine, 7 self-adhesive stickers are available, with abbreviations of the days of the week. One should choose the appropriate sticker, starting with the abbreviation 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, one should choose the sticker with the abbreviations of the days of the week starting with "Wed".
The chosen sticker should be placed in the upper part of the blister marked "coloque la etiqueta aqui", which means "Put the sticker here". Then, above each tablet, there will be a symbol of the day, indicating the day on which the tablet should be taken. The arrows show the order in which the tablets should be taken.
One should take 1 tablet daily for 21 consecutive days, during a meal or independently of food intake, 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 tablets from the first pack

• If the patient did not use a hormonal contraceptive in the previous month.One should start taking Liberelle on the first day of the menstrual cycle (i.e. on the first day of menstruation). If the patient starts taking Liberelle on the first day of menstruation, they are immediately protected against pregnancy. One can also start taking Liberelle 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 transdermal system.

One can start taking Liberelle the next day after taking the last active tablet (the last tablet containing the active substance) from the previous medicine pack, but no later than the first day after the break in taking the previous medicine (or after taking the last inactive tablet from the previous medicine pack). In the case of a transdermal system, one should follow the doctor's instructions.

• 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 day of the planned injection. However, in all these cases, additional contraceptive methods (e.g. condoms) should be used for the first 7 days.
• After a miscarriage or abortionOne should follow the doctor's instructions.
• After childbirthOne can start taking Liberelle between 21 and 28 days after childbirth. If one starts taking Liberelle 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 after giving birth before (re)starting to take Liberelle, she should make sure she is not pregnant or wait for her next menstrual period.
• If the woman is breastfeeding and wants to start (again) taking Liberelle after childbirthOne should read the section "Pregnancy, breastfeeding, and fertility".

In case of doubt about when to start taking the tablets, one should consult a doctor.

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 discovered that a child has swallowed some tablets, one should consult a doctor or pharmacist.

Missing a dose of Liberelle

• If less than 12 hours have passed since the time the woman usually takes the tablet, the contraceptive effect of the medicine is not reduced. The tablet should be taken as soon as possible, and the next tablets should be taken at the usual time.
• If more than 12 hours have passed since the time the woman usually takes the tablet, the contraceptive effect 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 packOne should contact a doctor.
• Missing one tablet in days 1-7 (first row)

One should take the last missed tablet 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. One should use an additional contraceptive method, e.g. condoms, for 7 consecutive days. One should consider the possibility of pregnancy if they had sexual intercourse in the previous 7 days. In this case, one should contact a doctor.

• Missing one tablet in days 8-14 (second row)One should take the last missed tablet 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 contraceptive effect 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. One should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time. Instead of a break in taking the tablets, after finishing the tablets from the current pack, one should start taking the tablets from a new pack immediately. Withdrawal bleeding will probably occur at the end of the second pack, but spotting or irregular bleeding may occur while taking the tablets from the second pack.
• 2. One can also stop taking the tablets from the current pack and start a 7-day break in taking the tablets ( one should note the day on which the woman missed a tablet). If one wants to start a new pack on the day they usually start a new pack, one can shorten the break in taking the tablets.

If the patient follows these instructions, the contraceptive effect of the medicine will be maintained.

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

What to do in case of vomiting or severe diarrhea

In case of vomiting 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 and diarrhea, one should take another tablet 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, one should follow the instructions described in the section "Missing a dose of Liberelle".

How to delay the day of withdrawal bleeding

Although this is not recommended, one can delay the day of withdrawal bleeding by starting a new pack of Liberelle immediately without taking a break in taking the tablets until the pack is finished. While taking the tablets from the second pack, spotting or irregular bleeding may occur. After the usual 7-day break in taking the tablets, one should start taking the tablets from the next pack.
Before deciding to delay the day of withdrawal bleeding, one should consult a doctor.

Changing the first day of withdrawal bleeding: what to know

If the patient takes the tablets according to the instructions, withdrawal bleeding will start during
the weekly break in taking the tablets. If it is necessary to change this day, one should shorten the break in taking the tablets ( but never extend it - 7 days is the maximum length of the break!). For example, if the week without taking tablets usually starts on a Friday, to change this day to Tuesday (3 days earlier), one should start taking the tablets from a new pack 3 days earlier than usual. If the break in taking the tablets is very short (e.g. shorter by 3 days), withdrawal bleeding may not occur during this time. However, spotting or bleeding similar to menstruation may occur.
If the patient is unsure how to proceed, they should contact a doctor.

Stopping Liberelle

One can stop taking Liberelle at any time. If the patient does not want to become pregnant, they should talk to a doctor about other effective contraceptive methods. If the patient wants to become pregnant, they should stop taking Liberelle and wait for a menstrual period before trying to conceive. This will make it easier to calculate the expected date of delivery.
In case of any further doubts about using this medicine, one should contact a doctor or pharmacist.

4. Possible Adverse Reactions

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effects, especially severe or persistent ones, or changes in your health that you think are related to the use of Liberelle, you should talk to your doctor.
In all women taking combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disease). For more 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, as well as breathing problems (see section "Warnings and precautions").
Adverse reactions 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 persistent, you should contact your doctor as soon as possible);
• Gastrointestinal disorderssuch as nausea, vomiting, diarrhea;
• Breakthrough bleeding and spotting, which occurs for a few months (these symptoms subside when the woman's body adapts to Liberelle), breakthrough bleeding should not last for a long time;
• Painful menstrual cycles and irregular 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 attack or if it is worse than usual);
• Acne, rash;
• Breast pain;
• Chest pain;
• Muscle spasms, pain in limbs, arms, back;
• Amenorrhea;
• Weight gain;
• Feeling of weakness;
• Stomach pain and bloating, constipation, gas;
• Swelling of hands, ankles, or feet;
• Sleep disturbances(insomnia);
• Hypersensitivity (anaphylactic reaction). Uncommon(may occur in up to 1 in 100 people):
• Breast disorders, such as breast enlargement, breast discharge;
• Abnormal cervical cell growth(identified based on cytology);
• Anxietyor syncope, feeling of tinglingor numbness;
• Change in skin color;
• Skin disorders, such as redness, itching, or discoloration;
• Hair loss(alopecia), excessive body hair;
• Change in appetite, weight fluctuations, weight loss;
• Libido disorders;
• Dry eye;
• Vision disturbances;
• Palpitations(strong feeling of heartbeat);
• Hot flashes;
• Muscle pain;
• Vaginal dryness;
• Ovarian cyst(may cause abdominal pain and swelling, as well as menstrual disturbances);
• Increased blood pressure;
• Dyspnea or shortness of breath(subjective feeling of difficulty breathing).

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

• Breast cyst;
• Dizziness;
• Accelerated heart rate;
• Pancreatitis(pancreatitis causing severe abdominal and back pain);
• Excessive sweating;
• Photosensitivity;
• Hepatitis(hepatitis causing severe abdominal and back pain);
• Vaginal discharge (changes in vaginal discharge).

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

• Decreased milk production (in breastfeeding women);
• Intolerance to contact lenses;
• Painful red lumps on the legs;
• Lipid metabolism disorders (fats) in the blood (detected by blood tests);
• Excessive night sweating;
• Hepatic adenomas (benign liver tumors, usually hormone-induced);
• Breast cancer;
• Benign breast tumor;
• Focal nodular hyperplasia (benign tumor);
• Breast fibroadenoma;
• Cerebrovascular incidents;
• Abnormal, sudden, and involuntary muscle contractions or serial muscle contractions (seizures);
• Myocardial infarction;
• Angioedema (swelling occurring in the deep layers of the skin).

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

• Increased blood pressure;
• Liver tumors or breast cancer;
• Liver function disorders;
• Life-threatening blood clots in veins or arteries, such as:deep vein thrombosis (blood clot in the leg or foot), pulmonary embolism (blood clot in the lungs), myocardial infarction, stroke, transient ischemic attack, or other conditions.

The risk of thrombosis may be higher if other conditions that increase this risk are also present (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), herpes gestationis, Sydenham's chorea (sudden, involuntary movements of the type of twitching or jerking), hemolytic-uremic syndrome (occurs after diarrhea caused by the bacterium E. coli), liver disorders manifested by jaundice, gallbladder disorders, or the formation of gallstones.

Reporting Adverse Reactions

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to 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 side effects, you can help provide more information on the safety of this 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 carton and blister after the words "EXP/CAD". The expiry date stated is the last day of the month.
After the abbreviation "Lot/Lote" on the carton and blister, the batch number is stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Liberelle Contains:

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

What Liberelle Looks Like and What the Package 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 PVC/PVDC/Aluminum foil blisters containing 21 tablets.
• The package 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
Poligono Industrial Miralcampo 7
19200 Azuqueca de Henares
Guadalajara
Spain

Manufacturer:

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

Parallel Importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Spain, the country of export: 725350.1

• 725351.8

Parallel import authorization number: 138/22

This medicinal product is authorized 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: 29.12.2023

[Information about the trademark]