Liberelle

Package leaflet: Information for the user

Liberelle
0.25 mg + 0.035 mg, tablets
Norgestimet + Ethinylestradiol
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable, reversible methods of contraception
• They slightly increase the risk of venous and arterial blood clots, especially during the first year of use or after restarting following a break of 4 weeks or more
• Be vigilant and consult a doctor if a woman suspects symptoms of blood clots (see section 2 "Blood clots")

Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Liberelle is and what it is 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 Liberelle is and what it is used for

Liberelle is a combined oral hormonal contraceptive ("birth control pill"). This medicine is used to prevent pregnancy.
This contraceptive contains two types of female sex hormones, an estrogen and a progestagen. These hormones prevent the release of an egg from the ovaries, thereby preventing pregnancy. Additionally, Liberelle causes the fluid (mucus) in the cervix to become thicker, making it more difficult for sperm to enter the uterus.
To prevent pregnancy, Liberelle must be taken as directed.

2. Important information before taking Liberelle

General notes
Before starting to take Liberelle, you should read the information about blood clots in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2 "Blood clots").
Before you start taking Liberelle, your doctor will ask you several questions about your medical history and that of your family. Your doctor will also measure your blood pressure and, depending on your current health status, may order additional tests.
This leaflet describes several situations in which you should stop taking Liberelle or when the effectiveness of Liberelle may be reduced. In such cases, you should avoid sexual intercourse or use an additional non-hormonal contraceptive method, such as a condom or another mechanical method. During this time, you should not use the calendar method or temperature monitoring method. Both of these methods may be unreliable because Liberelle alters the monthly body temperature and the characteristics of cervical mucus.
Liberelle, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to take Liberelle:
Do not take Liberelle if any of the following conditions apply to you. If any of the following conditions apply to you, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

• if you have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have disorders affecting blood clotting – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or presence of antiphospholipid antibodies;
• if you are undergoing surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you have had (or have had in the past) a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have (or have had in the past) any of the following conditions that may increase the risk of arterial blood clots:
  o severe diabetes with blood vessel damage;
  o very high blood pressure;
  o very high blood lipid levels (cholesterol or triglycerides);
  o a condition called hyperhomocysteinemia;
• if you have (or have had in the past) a type of migraine called migraine with aura;
• if you have a heart valve disorder that causes complications;
• if you have (or have had in the past) liver disease and liver function remains abnormal;
• if you have (or have had in the past) a liver tumour;
• if you have (or have had in the past), or there is suspicion of breast cancer or reproductive organ cancer;
• if you have vaginal bleeding of unknown cause;
• if you developed jaundice during pregnancy due to bile duct disorders, or if you developed jaundice while taking hormonal contraceptives in the past;
• if the lining of the uterus is abnormally thickened;
• if you are allergic to norgestimate or ethinylestradiol, or any of the other ingredients of this medicine (listed in section 6);
• if you have (or have had in the past) pancreatitis (inflammation of the pancreas) associated with significantly elevated triglyceride levels (hypertriglyceridemia);
• if you have hepatitis C infection and are taking medicines containing ombitasvir, paritaprevir, ritonavir, or dasabuvir, or glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Liberelle and other medicines").

Warnings and precautions
When should you contact your doctor?
Seek immediate medical advice if:

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

For descriptions of symptoms of these serious adverse effects, see the section "How to recognize blood clots".

Tell your doctor if any of the following conditions apply to you:
If any of these conditions develop or worsen during treatment with Liberelle, you should also inform your doctor.

• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease affecting the body's natural immune system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have been diagnosed with high blood lipid levels (hypertriglyceridemia) or if this condition runs in your family. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you are undergoing surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you are in the immediate postpartum period, as you are at increased risk of blood clots. Consult your doctor about how soon after delivery you can start taking Liberelle;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you have otosclerosis (hearing loss);
• if you have, or have ever had, chloasma (skin pigmentation, especially on the face and neck, known as "pregnancy mask"). In such cases, avoid exposure to sunlight and ultraviolet light;
• if you developed a skin rash or blisters (herpes gestationis) for the first time during pregnancy;
• if you have (or have had in the past) gallstones or cholecystitis (inflammation of the gallbladder);
• if you have a blood disorder called porphyria;
• if you have a nerve disorder causing sudden body movements (Sydenham's chorea);
• if a close family member has or has had breast cancer;
• if you suffer from depression. Some women using hormonal contraceptives, including Liberelle, have reported cases of depression or depressive mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor as soon as possible for advice;
• if you have liver disease;
• if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, skin rash, or breathing difficulties, seek immediate medical attention. Medicines containing estrogens may trigger or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives such as Liberelle increases the risk of blood clots compared to not using such medication. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur:

• in veins (referred to below as "venous thrombosis" or "venous thromboembolic disease");
• in arteries (referred to below as "arterial thrombosis" or "arterial thromboembolic events").
  Full recovery after a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal. Remember that the overall risk of harmful blood clots associated with taking Liberelle is small.

HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical advice if you notice any of the following symptoms.
Do you have any of these symptoms? Likely condition
Swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis
especially if accompanied by:

• pain or tenderness in the leg, which may only be felt while standing or walking;

• increased warmth in the affected leg;

• change in skin colour of the leg, such as pallor, redness or blueness.

• sudden unexplained shortness of breath or rapid breathing;

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

• sudden sharp chest pain, which may worsen with deep breathing;

• severe dizziness or vertigo;

• rapid or irregular heartbeat;

• severe abdominal pain.

If you are unsure, consult your doctor,
as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions such as respiratory tract infection (e.g. a cold).

Symptoms usually affect one eye: Retinal vein thrombosis

• sudden loss of vision or (blood clot in the eye)

• painless visual disturbances, which may progress to vision loss.

• chest pain, discomfort, pressure, heaviness;

• squeezing sensation 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, or stomach;

• sweating, nausea, vomiting, or dizziness;

• extreme weakness, anxiety, or shortness of breath;

• rapid or irregular heartbeat.
  Myocardial infarction (heart attack)

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (venous thromboembolism). However, these adverse events are rare. They most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of venous blood clots the highest?
The risk of developing venous blood clots is highest during the first year of using
combined hormonal contraceptives. The risk may also be higher when restarting
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 remains higher than in women who do not use combined hormonal contraceptives.
If a woman stops taking Liberelle, the risk of blood clots returns to baseline within a few weeks.

What factors influence the risk of venous blood clots?
The risk depends on the individual woman’s natural risk of venous thromboembolic disease and on the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with the use of Liberelle is low.

• In the course of one year, about 2 out of 10,000 women who are not using combined hormonal contraceptives and are not pregnant will develop blood clots.
• In the course of one year, about 5–7 out of 10,000 women who are using combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate, such as Liberelle, will develop blood clots.
• The risk of developing venous blood clots depends on the woman’s individual medical history (see “Factors increasing the risk of venous blood clots” below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Liberelle is small, but certain factors may increase this risk. The risk is higher:

• if the patient has significant overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In this case, the patient may have an inherited clotting disorder;
• if the patient requires surgery or will be immobilized for a prolonged period due to injury, illness, or has a leg in a cast. It may be necessary to discontinue use of Liberelle several weeks before surgery or during reduced mobility. If the patient must stop taking Liberelle, ask the doctor when it is safe to resume;
• with increasing age (especially over 35 years);
• if the patient has given birth within the last few weeks.

The risk of developing blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of venous blood clots, particularly if the patient has another risk factor present.
It is important to inform the doctor if any of these factors apply to the patient, even if uncertain. The doctor may decide to discontinue use of Liberelle.
Inform the doctor if any of the above conditions change during treatment with Liberelle, for example, if a close relative is diagnosed with unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can also cause serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with use of Liberelle is very small, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a combined hormonal contraceptive such as Liberelle, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraine, especially migraine with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Liberelle, for example, if the patient starts smoking, a close relative is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Liberelle and cancer
Breast cancer occurs slightly more frequently in women who take oral contraceptives, but it is not known whether this is caused by the treatment. For example, it is possible that more cancers are detected in women using combined hormonal contraceptives because they are examined more frequently by a doctor. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives.
It is important to regularly examine the breasts and contact the doctor if a lump is detected.
In rare cases, a benign liver tumor may develop, and even more rarely, malignant liver tumors have been reported in women using oral contraceptives. If severe abdominal pain occurs, contact the doctor immediately.

Breakthrough bleeding
During the first few months of taking Liberelle, unexpected bleeding (spotting or intermenstrual bleeding) may occur. If such bleeding persists for longer than a few months, or occurs after several months of treatment, the doctor must determine the cause of the disturbance.

What to do if no bleeding occurs during the tablet-free interval
If all tablets have been taken correctly, the patient has not had vomiting or severe diarrhea, and has not taken other medications, it is very unlikely that she is pregnant.
If expected bleeding does not occur in two consecutive cycles, the patient may be pregnant. In this case, contact the doctor immediately. Until pregnancy is ruled out, do not start taking tablets from the next pack.

Liberelle and other medicines
Inform the doctor about all medicines the patient is taking, including herbal preparations. Also inform any doctor, dentist, or pharmacist prescribing other medicines that the patient is taking Liberelle. The doctor may recommend using an additional method of contraception (e.g., condoms), and will advise how long the additional method should be used or whether another medicine should be used.

Some medicines:

• may affect blood levels of Liberelle;
• may reduce contraceptive effectiveness;
• 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 infection (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
• fungal infections (e.g., griseofulvin);
• arthritis and osteoarthritis (etoricoxib);
• increased blood pressure in the pulmonary arteries (bosentan);
• herbal remedies containing St. John's wort (Hypericum perforatum).

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

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

Do not take Liberelle if the patient has hepatitis C and is taking medicines containing ombitasvir, paritaprevir, ritonavir or dasabuvir, or glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these may cause abnormal liver function test results (increased liver enzyme activity AlAT). Before starting these medicines, the doctor will prescribe another type of contraception.
Liberelle may be restarted approximately 2 weeks after completion of the above treatment. See section "When not to use Liberelle".

Laboratory tests
If blood tests are required, inform the doctor or laboratory staff that the patient is taking a contraceptive, as use of oral contraceptives may affect the results of certain laboratory tests.

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

Pregnancy, breastfeeding and effects on fertility
Pregnancy
Liberelle must not be taken during pregnancy. If pregnancy occurs while taking Liberelle, stop immediately and contact the doctor. If the patient plans to become pregnant, she may stop taking Liberelle at any time.
Consult a doctor or pharmacist before taking any medicine.

Breastfeeding
Use of Liberelle is generally not recommended in women who are breastfeeding. If a woman wishes to use a contraceptive during breastfeeding, she should consult her doctor.
Consult a doctor or pharmacist before taking any medicine.

Driving and using machines
Liberelle has no influence on the ability to drive or operate machinery.

Liberelle contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking Liberelle.

3. How to take Liberelle

How to take the medicine
This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Preparing the sticker
To help keep track of medication intake, 7 self-adhesive stickers with the names of the days of the week are provided. Select the appropriate sticker starting with the day of the week corresponding to the day the woman begins taking the tablets. For example, if starting tablets on Wednesday, choose the sticker beginning with "Wed" ("Śr").

Affix the selected sticker to the upper left corner of the blister marked "Start – Apply day-of-the-week sticker here".

This will place a day symbol above each tablet, indicating the day on which that tablet should be taken. Arrows indicate the order of tablet intake.

Take 1 tablet daily for 21 consecutive days, with or without food, and if necessary, with a small amount of water.

Begin a new pack after a 7-day break, during which withdrawal bleeding (a period) occurs. Withdrawal bleeding, similar to menstruation, usually starts 2 or 3 days after taking the last tablet and may not finish before starting tablets from the next pack.

If the patient takes Liberelle as described above, she remains protected against pregnancy during the 7-day tablet-free interval.

When to start taking tablets from the first blister

• If no hormonal contraceptive has been used in the previous month. Begin taking Liberelle on the first day of the menstrual cycle (i.e., the first day of menstruation). If the patient starts on the first day of her period, contraceptive protection is immediate. Alternatively, treatment may begin on days 2 to 5 of the cycle, but in this case, additional contraceptive methods (e.g., condoms) must be used for the first 7 days.
• Switching from another combined hormonal contraceptive, combined vaginal contraceptive system, or transdermal contraceptive system. Begin taking Liberelle the day after the last active tablet (i.e., the last tablet containing active ingredients) from the previous pack, but no later than the first day after the tablet-free interval of the previous method (or after the last inactive tablet of the previous pack). If switching from a vaginal ring or transdermal patch, follow the doctor's advice.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progesterone). Switching from progestogen-only pills may occur on any day; from an implant or intrauterine system—on the day of removal; from injections—at the scheduled injection date. However, in all these cases, additional contraceptive methods (e.g., condoms) must be used for the first 7 days.
• After miscarriage or termination of pregnancy Follow the doctor's instructions.
• After childbirth Begin taking Liberelle between days 21 and 28 postpartum. If starting later than day 28, use additional contraceptive methods (e.g., condoms) for the first 7 days. If the woman has had sexual intercourse after childbirth but before (re)starting Liberelle, pregnancy should be ruled out or the next menstrual period awaited before starting the medication.
• If the woman is breastfeeding and wishes to start (or restart) taking Liberelle after childbirth Refer to the section "Pregnancy, breastfeeding and effects on fertility".

If in doubt about when to start taking tablets, consult a doctor.

Taking more than the recommended dose of Liberelle
There are no reports of serious complications following overdose of Liberelle tablets. If a patient takes several tablets at once, nausea or vomiting may occur. In young girls, vaginal bleeding may occur.
If a woman has taken too many tablets or if a child has ingested tablets, seek advice from a doctor or pharmacist immediately.

Missed dose of Liberelle

• If less than 12 hours have passed since the usual time of tablet intake, contraceptive efficacy is not reduced. Take the tablet as soon as remembered, then continue taking subsequent tablets at the usual time.
• If more than 12 hours have passed since the usual time of tablet intake, contraceptive efficacy may be reduced. The more tablets missed, the greater the risk of pregnancy.

The risk of reduced contraceptive efficacy is greatest if a tablet is missed at the beginning or end of a pack.

• Missing more than 1 tablet from the blister Contact a doctor.
• Missing 1 tablet on days 1 to 7 (first row) Take the missed tablet as soon as remembered, even if this means taking two tablets at the same time. Continue taking the remaining tablets at the usual time. Use additional contraceptive methods, such as condoms, for the next 7 days. Consider the possibility of pregnancy if intercourse occurred in the preceding 7 days. In such a case, consult a doctor.
• Missing 1 tablet on days 8 to 14 (second row) Take the missed tablet as soon as remembered, even if this means taking two tablets simultaneously. Continue taking the remaining tablets at the usual time. Contraceptive efficacy is not reduced, and additional contraceptive methods are not required.
• Missing 1 tablet on days 15 to 21 (third row) Two options are available:

  1. Take the missed tablet as soon as remembered, even if this means taking two tablets at the same time. Continue taking the remaining tablets at the usual time. Instead of the tablet-free interval, immediately start taking tablets from a new blister after finishing the current one.
     Withdrawal bleeding will likely occur toward the end of the second blister, but breakthrough bleeding or spotting may occur during the second blister.

  2. Alternatively, stop taking tablets from the current blister and begin a 7-day tablet-free interval ( note the day the tablet was missed ). If the intention is to start the new blister on the day when the first tablet from a new blister is usually taken, the tablet-free interval may be shortened.

If the patient follows these instructions, contraceptive protection will be maintained.

• If any tablet from the blister was missed and no bleeding occurs during the first 7-day tablet-free interval, pregnancy is possible. Consult a doctor before starting tablets from the next blister.

Missed
Contact doctor
more than 1
Yes
tablet from blister
Days 1-7 Did the patient have intercourse within 7 days
before missing the tablet?
No
Take the missed tablet.
Use a barrier method (condom) for the next 7 days
and finish the blister.
Missing only
1 tablet (taken more than 12 hours
after scheduled time)
Days 8-14 Take the missed tablet.
Finish the blister.
Take the missed tablet and finish
the blister.
Instead of a break, start the
next blister.
Days
15-21 or
Immediately stop taking tablets.
Begin a break (no longer than 7 days,
including the day the tablet was missed).
Then start the next blister.

Managing vomiting or severe diarrhoea
If vomiting occurs within 3–4 hours of taking a tablet, there is a risk that the active ingredients are not fully absorbed. This situation is similar to missing a tablet. After vomiting or diarrhoea, take another tablet from a spare blister as soon as possible. If possible, take the replacement tablet within 12 hours of the usual intake time. If this is not possible, or if more than 12 hours have passed, follow the instructions under "Missed dose of Liberelle".

How to delay withdrawal bleeding
Although not recommended, withdrawal bleeding can be delayed by starting a new Liberelle blister immediately without a tablet-free interval, continuing until the pack is finished. Breakthrough bleeding or spotting may occur during the second blister. After a normal 7-day tablet-free interval, begin the next blister.
Before deciding to delay withdrawal bleeding, consult a doctor.

Changing the day of withdrawal bleeding: what to know
If the patient takes tablets as directed, bleeding will occur during the 7-day tablet-free interval. If a change in the bleeding day is needed, shorten the tablet-free interval ( but never extend it—7 days is the maximum allowed break ). For example, if the tablet-free week usually starts on Friday, to change the bleeding day to Tuesday (3 days earlier), start the new blister 3 days earlier than usual. If the tablet-free interval is very short (e.g., 3 days shorter), bleeding may not occur during this time. However, light bleeding or menstrual-like bleeding may occur.
If the patient is unsure how to proceed, she should consult a doctor.

Stopping treatment with Liberelle
Liberelle may be discontinued at any time. If the patient does not wish to become pregnant, she should discuss other effective contraceptive methods with her doctor. If she wishes to become pregnant, stop taking Liberelle and wait until the next menstrual period before trying to conceive. This will make it easier to calculate the expected date of delivery.
For any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse reactions occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Liberelle, the patient should consult a doctor.

All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2, "Important information before using Liberelle".

Immediate medical attention should be sought if the patient develops symptoms of angioedema, such as swelling of the face, tongue and (or) throat and (or) difficulty swallowing, skin rash, or breathing difficulties (see section "Warnings and precautions").

Adverse reactions that may be associated with the use of Liberelle:

Very common (may affect more than 1 in 10 people):

• Headache (if severe, unusual, or persistent, contact a doctor immediately);
• Gastrointestinal disturbances such as nausea, vomiting, diarrhoea;
• Intermenstrual bleeding and spotting, occurring during the first few months (these symptoms usually resolve as the body adjusts to Liberelle); intermenstrual bleeding should not persist for long periods;
• Painful menstrual cycles and irregular withdrawal bleeding.

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

• Urinary tract infection (painful urination);
• Vaginal infection, e.g. candidiasis;
• Depression, mood changes, nervousness;
• Migraine (contact a doctor if this is the first migraine attack or if attacks are more severe than usual);
• Acne, rash;
• Breast pain;
• Chest pain;
• Muscle cramps, limb, arm, and back pain;
• Absence of menstruation;
• Weight gain;
• Feeling of weakness;
• Stomach pain and bloating, constipation, flatulence;
• Swelling of hands, ankles, or feet;
• Sleep disturbances (insomnia);
• Hypersensitivity (anaphylactic reaction).

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

• Breast disorders, such as breast enlargement, breast discharge;
• Cervical dysplasia (identified by cytology);
• Anxiety or fainting, tingling sensation or numbness;
• Skin pigmentation changes;
• Skin disorders, such as redness and itching or discoloration;
• Hair thinning (alopecia), excessive body hair growth;
• Changes in appetite, weight fluctuations, weight loss;
• Sexual dysfunction;
• Dry eyes;
• Vision disturbances;
• Palpitations (strong sensation of heartbeat);
• Hot flushes;
• Muscle pain;
• Vaginal dryness;
• Ovarian cyst (may cause abdominal pain, swelling, and menstrual disturbances);
• Elevated blood pressure;
• Shortness of breath or dyspnoea (subjective feeling of breathing difficulty).

Rare (may affect 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;
• Hypersensitivity to light;
• Hepatitis (liver inflammation causing severe abdominal and back pain);
• Vaginal discharge (changes in vaginal secretion).

Frequency not known (frequency cannot be estimated from available data):

• Reduced milk production (in breastfeeding women);
• Intolerance to contact lenses;
• Painful red nodules on legs;
• Disorders of blood lipid concentrations (fats in blood) (detected by blood tests);
• Excessive night sweating;
• Hepatic adenomas (benign liver tumours, usually hormone-induced);
• Breast cancer;
• Benign breast tumour;
• Focal nodular hyperplasia (benign tumour);
• Fibroadenoma of the breast;
• Cerebrovascular events;
• Involuntary, sudden, and severe muscle contractions or repeated muscle spasms (convulsions);
• Myocardial infarction;
• Angioedema (swelling in deep layers of skin).

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

• Increased blood pressure;
• Liver tumours or breast cancer;
• Liver function disorders;
• Dangerous blood clots in veins or arteries, e.g.:
  • in legs or feet (venous thromboembolic disease),
  • in lungs (pulmonary embolism),
  • myocardial infarction,
  • stroke,
  • transient ischaemic attack or transient stroke-like symptoms, known as transient ischaemic attacks,
  • or blood clots in the liver, stomach/intestines, kidneys, or eye.

The risk of thrombosis may be higher if other conditions that increase this risk are also present (for more information on conditions increasing thrombosis risk and symptoms of a clot, see section 2).

The following conditions may occur or worsen during use of combined oral contraceptives: Crohn's disease, ulcerative colitis, epilepsy, uterine fibroids, porphyria (a metabolic disorder causing abdominal pain and psychiatric disturbances), systemic lupus erythematosus (the body attacks and damages its own organs and tissues), herpes gestationis, Sydenham's chorea (sudden, involuntary jerking or twitching movements), haemolytic-uraemic syndrome (occurring after diarrhoea caused by E. coli bacteria), liver disorders manifesting as jaundice, gallbladder disorders or gallstone formation.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Liberelle

Keep this medicine 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 "EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated after "Lot" on the carton and on the blister.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Liberelle contains:
The active substances are 250 micrograms of norgestrel and 35 micrograms of ethinylestradiol.
Liberelle also contains the following excipients: corn starch, monohydrate lactose, magnesium stearate and indigotine (E 132).

What Liberelle looks like and contents of the pack

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warsaw
Manufacturer
Cyndea Pharma S.L.
Poligono Industrial Emiliano Revilla Sanz
Avenida de Ágreda 31
42110 Ólvega (Soria)
Spain

This medicinal product is authorised 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 tablets EFG
Netherlands Norgestimaat/Ethinylestradiol Xiromed 0.25mg/0.035mg tabletten
Poland Liberelle
Italy Briladona