Liberelle

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Liberelle (Liberelle 0,25 mg/0,035 mg comprimidos EFG)
0.25 mg + 0.035 mg, tablets
Norgestimatum + Ethinylestradiolum
Liberelle and Liberelle 0,25 mg/0,035 mg comprimidos EFG are different trade names for the
same medicine.
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 developing blood clots in veins and arteries, 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 clot formation (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, so that you can read it again if necessary.
• If you have any doubts, please 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 you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. 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 ("the contraceptive pill"). This medicine is used to prevent pregnancy.
This contraceptive contains two types of female sex hormones, an oestrogen 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 become familiar with the symptoms of blood clots (see section 2 "Blood clots").
Before starting to take 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 recommend certain additional tests.
This leaflet describes several situations in which you should stop taking Liberelle or when its effectiveness 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-based methods. Both of these methods may be unreliable because Liberelle alters the monthly body temperature and cervical mucus characteristics.
Liberelle, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or other sexually transmitted diseases.

When not to take Liberelle:
Do not take Liberelle if you have any of the conditions listed below. If any of these conditions apply to you, inform your doctor. Your doctor will discuss with you which alternative contraceptive method 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 blood clotting disorders – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or presence of antiphospholipid antibodies;
• if you require surgery or will not be able to walk for a prolonged period (see section 2 "Blood clots");
• if you have had (or have ever had) a myocardial infarction or stroke;
• if you suffer from (or have suffered from) 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 suffer from 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 ever had) a type of migraine called migraine with aura;
• if you have a heart valve disorder that causes complications;
• if you have (or have ever had) liver disease and liver function remains abnormal;
• if you have (or have ever had) a liver tumour;
• if you have (or have ever had), or there is suspicion of breast cancer or reproductive organ cancers;
• if you have unexplained vaginal bleeding;
• if you developed cholestasis-induced jaundice during pregnancy or previously experienced jaundice while taking hormonal contraceptives;
• 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 ever had) pancreatitis (inflammation of the pancreas) associated with significantly elevated triglyceride levels (hypertriglyceridaemia);
• if you have hepatitis C and are taking medications containing ombitasvir, paritaprevir, ritonavir, or dasabuvir, or glecaprevir/pibrentasvir (see also section "Liberelle with other medicines").

Warnings and precautions
When should you contact your doctor?
You should contact your doctor immediately:

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

Descriptions of symptoms of these serious adverse effects are provided in the section "How to recognize blood clots".
You should inform your doctor if you have any of the following conditions:
If any of these symptoms 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 defence 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 (hypertriglyceridaemia) or if this condition runs in your family. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will not be able to walk 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. You should 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 suffer from otosclerosis (hearing loss);
• if you have melasma (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) during pregnancy that occurred for the first time during pregnancy;
• if you have (or have ever had) gallstones or cholecystitis;
• if you suffer from a blood disorder called porphyria;
• if you have Sydenham's chorea (a nerve disorder causing sudden involuntary movements);
• 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 mood changes or symptoms of depression occur, 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, or skin rash, and breathing problems, you should contact your doctor immediately. Medicines containing estrogens may cause 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 hormonal contraception. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease");
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").
  Complete 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. It should be remembered that the overall risk of harmful blood clots associated with the use of Liberelle is small.

HOW TO RECOGNIZE BLOOD CLOTS
Contact your doctor immediately if you experience any of the following symptoms.
Does the patient have any of these symptoms? Probable
condition

Swelling of the leg or swelling along a vein in the leg or foot, especially if Deep vein
accompanied by: thrombosis

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

• increased warmth in the affected leg;

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

• sudden unexplained shortness of breath or rapid breathing; Pulmonary

• sudden cough without an obvious cause, possibly accompanied by coughing embolism
  up blood;

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

• severe dizziness or lightheadedness;

• rapid or irregular heartbeat;

• severe abdominal pain.

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

Symptoms most commonly affecting one eye: Retinal vein

• sudden loss of vision or thrombosis (blood

• painless visual disturbances, which may progress to vision loss. clot in the eye)

• chest pain, discomfort, pressure, or heaviness; Myocardial

• sensation of tightness or fullness in the chest, arm, or below the sternum; infarction

• feeling of fullness, indigestion, or choking;

• discomfort in the lower 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.

• sudden weakness or numbness of the face, arms, or legs, especially on one Stroke
  side of the body;

VENOUS BLOOD CLOTS
What can happen if blood clots form in the 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 the development of 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 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 compared to not using combined hormonal contraceptives.
If a patient 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 developing venous thromboembolic disease and on the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs due to taking Liberelle is low.

• In the course of one year, about 2 out of 10,000 women who do not use 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 use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate, such as Liberelle, will develop blood clots.
• The risk of developing blood clots depends on the individual's 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, however
some factors may increase this risk. The risk is higher:

• if the patient has a high body weight (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 of age). In this case, the patient may have an inherited clotting disorder;
• if the patient needs to undergo surgery or is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to discontinue use of Liberelle several weeks before surgery or immobilization. If the patient needs to stop taking Liberelle, ask the doctor when it is safe to restart;
• 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 blood clots,
particularly if the patient has another risk factor present.
It is important to inform the doctor if any of these risk 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 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 the use of Liberelle is very small, but may increase:

• with age (above approximately 35 years);
• if the patient smokes. When 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 of age). 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 is 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 taking 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 oral 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 a 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 a doctor.

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

What to do if withdrawal bleeding does not occur during the tablet-free interval
If all tablets were taken correctly, the patient did not experience vomiting or severe diarrhea, and did not take other medications, it is very unlikely that she is pregnant.
If the expected withdrawal 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 blister pack.

Liberelle and other medicines
Inform the doctor about all medicines the patient is taking, including herbal preparations. Also inform any doctor or dentist (and pharmacist) who prescribes other medicines that the patient is taking Liberelle. The doctor may recommend using an additional method of contraception (e.g. condom), 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 cause reduced 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);
• high blood pressure in the pulmonary blood vessels (bosentan);
• herbal medicines 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/pibrentasvir, as this may lead to increased liver function test results (increased activity of the liver enzyme AlAT).
Before starting these medicines, the doctor will recommend another method of contraception.
Liberelle may be restarted 2 weeks after stopping treatment with these medicines. 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 the 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 fertility
Pregnancy
Liberelle must not be taken during pregnancy. If a woman becomes pregnant while taking Liberelle, stop immediately and contact the doctor. If the patient plans to become pregnant, she may stop taking Liberelle at any time.
Before taking any medicine, consult a doctor or pharmacist.

Breastfeeding
The use of Liberelle is generally not recommended for breastfeeding women. If a woman wishes to use a contraceptive during breastfeeding, she should consult her doctor.
Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines
Liberelle has no influence on the ability to drive and use machines.

Liberelle contains monohydrate 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 your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Preparing the sticker
To help keep track of tablet intake, 7 self-adhesive stickers are provided, each marked with days of the week. Select the appropriate sticker starting with the symbol corresponding to the day of the week on which the woman begins taking the tablets. For example, if starting on a Wednesday, choose the sticker beginning with "Wed".

Place the selected sticker on the blister section marked “Coloque la etiqueta aquí (Place the label here)”.
Each tablet will then be labeled with the day of the week it should be taken. Arrows indicate the order of tablet intake.

Take 1 tablet daily for 21 consecutive days, with a meal or independently of food, if necessary, with a small amount of water.

Begin a new pack after a 7-day break, during which withdrawal bleeding (a period-like bleed) occurs. Withdrawal bleeding, similar to menstruation, usually starts 2 or 3 days after taking the last tablet and may not have finished 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 pack

• 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). Starting on the first day of the period provides immediate protection against pregnancy. Alternatively, tablets may be started 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 or a combined vaginal contraceptive system or transdermal patch. Begin taking Liberelle the day after taking the last active tablet (i.e., the last tablet containing active ingredients) of the previous product, but no later than the first day after the tablet-free interval of the previous product (or after taking the last inactive tablet). If switching from a vaginal ring or transdermal patch, follow your doctor’s advice.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progesterone). Switching from progestogen-only pills can be done on any day; from an implant or intrauterine system, on the day of removal; from injections, at the time of the next scheduled injection. 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 your doctor’s advice.

• 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 before (or after) restarting Liberelle postpartum, ensure she is not pregnant or wait until the next menstrual period.

• If the woman is breastfeeding and wishes to start (or restart) taking Liberelle after childbirth Refer to section “Pregnancy, breastfeeding and fertility”.

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

Taking more Liberelle than you should
There are no reports of serious complications following overdose with Liberelle tablets. If a woman 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 swallowed any tablets, seek advice from a doctor or pharmacist immediately.

Missing a dose of Liberelle

• If less than 12 hours have passed since the usual time of taking the tablet, contraceptive effectiveness is not reduced. Take the missed tablet as soon as remembered, then continue taking the next tablets at the usual time.

• If more than 12 hours have passed since the usual time of taking the tablet, contraceptive effectiveness may be reduced. The more tablets missed, the higher the risk of pregnancy.

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

• Missing more than 1 tablet from the blister pack Consult your doctor.

• Missing 1 tablet between days 1 and 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 an additional contraceptive method, such as condoms, for the next 7 days. Consider the possibility of pregnancy if intercourse occurred within the previous 7 days. In such a case, consult your doctor.

• Missing 1 tablet between days 8 and 14 (second 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. Contraceptive effectiveness is not reduced, and additional contraceptive methods are not required.

• Missing 1 tablet between days 15 and 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 usual 7-day break, immediately start the next blister pack. Withdrawal bleeding will likely occur towards the end of the second pack, but breakthrough bleeding or spotting may occur during the second pack.

  2. Alternatively, stop taking tablets from the current blister pack and begin a 7-day tablet-free interval (note the day on which the tablet was missed). If you wish to start the next pack on the day you usually start a new pack, you may shorten the tablet-free interval accordingly.

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

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

| Missed more than 1 tablet from the blister pack | Yes |
|---|---|
| Did the patient have intercourse within the 7 days before missing the tablet? | |
| No | |
| Take the missed tablet. Use a barrier method (condom) for the next 7 days and complete the current blister pack. | |
| Missed only 1 tablet (taken more than 12 hours after the usual time) | |
| Days 1–7 | |
| Days 8–14 | Take the missed tablet. Complete the current blister pack. |
| Days 15–21 | Take the missed tablet and complete the current blister pack.
| | Instead of taking a break, immediately start the next blister pack.
| | OR
| | Stop taking tablets immediately. Begin the 7-day break (no longer than 7 days, including the day the tablet was missed). Then start the next blister pack.

What to do if you vomit or have severe diarrhoea
If vomiting occurs within 3–4 hours of taking a tablet, there is a risk that the active ingredients have not been fully absorbed. This situation is similar to missing a tablet. After vomiting or diarrhoea, take another tablet from a spare blister pack as soon as possible. If possible, take the replacement tablet within 12 hours of the usual time. If this is not possible, or if more than 12 hours have passed, follow the advice under “Missing a dose of Liberelle”.

How to delay withdrawal bleeding
Although not recommended, withdrawal bleeding can be delayed by immediately starting a new blister pack of Liberelle without taking a break, continuing until the pack is finished. During the second pack, slight breakthrough bleeding or spotting may occur. After the usual 7-day tablet-free interval, start the next blister pack.
Before deciding to delay withdrawal bleeding, consult your doctor.

Changing the day of withdrawal bleeding: what you need to know
If the patient takes the tablets as directed, bleeding will occur during the 7-day tablet-free interval. If a change in the bleeding day is required, 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 it to Tuesday (3 days earlier), start the new blister pack 3 days earlier than usual. If the tablet-free interval is very short (e.g., 3 days shorter), bleeding may not occur. However, slight bleeding or breakthrough bleeding resembling a period may occur.
If the patient is unsure what to do, she should consult her doctor.

Stopping Liberelle
Liberelle may be stopped 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 makes it easier to calculate the expected date of delivery.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
If any adverse effects occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Liberelle, 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, see section 2, "Important information before taking Liberelle".
Seek immediate medical advice if the patient experiences symptoms of angioedema, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or skin rash, as well as breathing difficulties (see section "Warnings and precautions").

Adverse effects 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 subside as the woman's body adjusts to Liberelle); intermenstrual bleeding should not last 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 pain, arm and back pain;
• Absence of menstruation;
• Weight gain;
• Feeling of weakness;
• Stomach pain, 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, nipple discharge;
• Cervical dysplasia (identified by cytology);
• Anxiety or fainting, tingling sensation or numbness;
• Skin pigmentation changes;
• Skin disorders, such as redness and itching or pigmentation changes;
• Hair thinning (alopecia), excessive body hair growth;
• Change in appetite, weight fluctuations, weight loss;
• Disturbances in sexual desire;
• 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);
• Increased 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 heartbeat;
• 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 lipid concentration 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 seizures;
• Myocardial infarction;
• Angioedema (swelling in deep skin layers).

In women using hormonal contraceptives, the following serious adverse effects have been reported slightly more frequently (see section 2: "Important information before taking 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 thromboembolism), in lungs (pulmonary embolism), myocardial infarction, stroke, transient ischaemic attack or transient symptoms resembling stroke, 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 the risk of clot formation 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 effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Liberelle

Keep the 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 packaging. The expiry date refers to the last day of the stated month.
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 package and other information

What Liberelle contains:
The active substances are 250 micrograms of norgestimate and 35 micrograms of ethinylestradiol.
Liberelle also contains the following excipients: corn starch, lactose monohydrate, magnesium stearate and indigo carmine (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 thickness of 2.5 mm (from 1.5 mm to 3.5 mm).
• Liberelle is available in blister packs containing 21 tablets.
• The pack contains 1 or 3 blisters, each blister containing 21 tablets.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Spain, 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
Marketing Authorisation number in Spain, country of export: 725351.8
725350.1
Parallel Import Authorisation number: 98/22
This medicinal product is authorised for sale in 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