Liberelle

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep this leaflet, information on the outer packaging in a foreign language!
Liberelle
0.25 mg + 0.035 mg, tablets
Norgestimatum + Ethinylestradiolum
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 after 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 pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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 oestrogen and a progestogen. 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 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 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-based methods. 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 infection with the HIV virus (AIDS) or other sexually transmitted diseases.

When not to take Liberelle:
Do not take Liberelle if you have any of the following conditions. If any of the conditions listed below 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 deep leg veins (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 are undergoing surgery or will be immobile for a prolonged period (see section 2, "Blood clots");
• if you have had (or have ever had) 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 any of the following conditions that may increase the risk of arterial blood clots: severe diabetes with blood vessel damage; very high blood pressure; very high blood lipid levels (cholesterol or triglycerides); 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 unexplained vaginal bleeding;
• if you developed jaundice during pregnancy due to bile duct disorders, or if you previously developed jaundice while taking hormonal contraceptives;
• if the lining of the uterus is abnormally thickened;
• if you are allergic to norgestimate or ethinylestradiol, or to 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 markedly increased triglyceride levels (hypertriglyceridemia);
• if you have hepatitis C 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?
You should contact your doctor immediately

• if you notice possible symptoms of a blood clot, 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 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 have recently given birth, as you are at increased risk of blood clots. You should consult your doctor for advice on 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) during pregnancy that first appeared 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 involuntary movements (Sydenham's chorea);
• if a close family member has or has had breast cancer;
• if you suffer from depression. Depression or depressive mood has been reported in some women taking hormonal contraceptives, including Liberelle. 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 (swelling of the blood vessels), such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, skin rash, or breathing problems, you should contact your doctor immediately. Medicines containing estrogens may cause or worsen symptoms of congenital or acquired angioedema.

BLOOD CLOTS
The use of combined hormonal contraceptives such as Liberelle is associated with an increased risk of blood clots compared to not using such therapy. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may 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").
  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 THE OCCURRENCE OF BLOOD CLOTS
You should contact your doctor immediately if you experience any of the following symptoms.
Do you have any of these symptoms?
Possible condition
Swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by:
Deep vein thrombosis

• pain or tenderness in the leg, which may occur only when 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;
Pulmonary embolism
Sudden cough without obvious cause, which may be associated with coughing up blood;
Sharp chest pain, which may worsen with deep breathing;

Severe dizziness or vertigo;
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 thrombosis (blood clot in the eye)

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

VENOUS BLOOD CLOTS
What can happen if blood clots form in a vein?

• 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 increased 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 patient's natural risk of 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 the use of Liberelle is low.

• In a year, about 2 out of 10,000 women who are not using combined hormonal contraceptives and are not pregnant will develop blood clots.
• In a 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 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 greater:

• if the patient has significant overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has been diagnosed with 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 needs to undergo surgery or will be immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue use of Liberelle several weeks before surgery or immobilization. If the patient must stop taking Liberelle, ask the doctor when it is safe to resume taking the medicine;
• with increasing age (especially over 35 years);
• if the patient has recently 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 listed above.
It is important to inform the doctor if any of the listed risk factors apply to the patient,
even if there is uncertainty. 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 the arteries?
Similar to venous blood clots, arterial clots can cause serious consequences, such as myocardial infarction (heart attack) or stroke.

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

• with age (over 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 a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has had a myocardial infarction or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of myocardial infarction 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 arterial 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 tumours are detected in women using combined hormonal contraceptives because they are examined more frequently by doctors. 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 tumour may develop, and even more rarely, malignant liver tumours have been reported in women using oral contraceptives. If severe abdominal pain occurs, contact a doctor immediately.

Intermenstrual 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 taking the medicine, 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 vomited or had severe diarrhoea, and has not taken other medicines, 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 pack.

Liberelle and other medicines
Inform the doctor about all medicines the patient is taking, including herbal remedies. Also inform any doctor or dentist prescribing other medicines (and the pharmacist) 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 the 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);
• pulmonary hypertension (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 lamotrigine (which may increase the 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 a different type of contraception.
Liberelle may be restarted approximately 2 weeks after stopping the above-mentioned 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 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 taking it immediately and contact a 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 a doctor.
Before taking any medicine, consult a doctor or pharmacist.

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

Liberelle contains monohydrate lactose.
If the patient has been previously 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 according to the instructions given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Preparing the sticker
To help you keep track of tablet intake, 7 self-adhesive stickers are provided, each showing abbreviated names of the days of the week. Select the appropriate sticker starting with the abbreviation corresponding to the day of the week on which the woman will begin taking tablets. For example, if tablet intake begins on Wednesday, choose the sticker where the abbreviations start with "Wed".

Place the selected sticker at the top of the blister pack marked “coloque la etiqueta aqui”, which means “Apply the sticker here”. This will ensure that each tablet is marked with the symbol of the day on which it should be taken. Arrows indicate the order in which tablets should be taken.

Take 1 tablet daily for 21 consecutive days, during 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 to 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 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). If the patient starts taking the medicine on the first day of her period, immediate contraceptive protection is provided. Alternatively, Liberelle 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 ring or transdermal patch system.
  Liberelle may be started the day after taking the last active tablet (i.e., the last tablet containing active ingredients) of the previous contraceptive, but no later than the first day after the tablet-free interval of the previous contraceptive (or after taking the last inactive tablet). If the patient has been using a vaginal ring or transdermal patch, follow your doctor’s instructions.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progesterone)
  Switching from a progestogen-only pill can be done on any day; from an implant or intrauterine system – on the day of removal; from an injection – 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
  Liberelle may be started between day 21 and day 28 after childbirth. If tablet intake begins later than day 28, additional contraceptive methods (e.g., condoms) must be used for the first 7 days. If the woman has had sexual intercourse after childbirth and before (re)starting Liberelle, pregnancy should be ruled out or the next menstrual period awaited.

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

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

Taking more Liberelle than prescribed

There have been no reports of serious complications following overdose with 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 swallowed any 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 missed tablet as soon as remembered, then continue taking the remaining 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 higher the risk of pregnancy.

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

• Missing more than 1 tablet from the blister pack
  Contact your 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 within the previous 7 days. In such a case, consult your 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 at the same time. 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)
  There are two options:

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, start the next blister pack immediately after finishing the current one. 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 pack and begin a 7-day tablet-free interval (note the day the tablet was missed). If you wish to start the new pack on the day you usually start, you may shorten the tablet-free interval accordingly.

If these instructions are followed, contraceptive protection will be maintained.

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

What to do in case of vomiting or severe diarrhoea
If vomiting occurs within 3–4 hours after taking a tablet, there is a risk that the active ingredients may not be 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 “Missed dose of Liberelle”.

How to delay withdrawal bleeding
Although not recommended, withdrawal bleeding can be delayed by starting a new blister pack of Liberelle immediately, without a tablet-free interval, and continuing until the pack is finished. During the second pack, light bleeding or spotting may occur. After the usual 7-day tablet-free interval, start taking tablets from the next blister pack.

Before deciding to delay withdrawal bleeding, consult your doctor.

Changing the first day of bleeding: what you need to know
If the patient takes tablets as directed, bleeding will occur during the weekly 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 the bleeding day 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 during this time. However, light bleeding or breakthrough bleeding resembling a period may occur.

If the patient is unsure what to do, she should consult her doctor.

Stopping treatment with 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 the patient 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.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe or persistent ones, or changes in health which the patient considers to be 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, refer to 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, and 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 prolonged, contact a doctor immediately);
• Gastrointestinal disturbances such as nausea, vomiting, diarrhoea;
• Intermenstrual bleeding and spotting, occurring during the first few months (these symptoms usually subside as the woman's 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 (consult 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, 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 or numbness;
• Skin pigmentation changes;
• Skin disorders, such as redness, itching or discoloration;
• Hair thinning (alopecia), excessive body hair growth;
• Change in appetite, weight fluctuations, weight loss;
• Sexual dysfunction;
• Dry eyes;
• Visual 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 difficulty breathing).

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;
• Light sensitivity;
• 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 (fat) concentrations (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 violent muscle contractions or repeated muscle spasms (convulsions);
• Myocardial infarction;
• Angioedema (swelling in deep layers of the skin).

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 thromboembolic disease),
  • in lungs (pulmonary embolism),
  • myocardial infarction,
  • stroke,
  • transient ischaemic attack or transient symptoms resembling stroke, known as transient ischaemic attacks,
  • 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 thrombosis and symptoms of thrombosis, 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 movements such as jerking or twitching), 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 any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can also 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 this medicine out of the 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/CAD". The expiry date refers to the last day of the stated month. The batch number is indicated after "Lot/Lote" on the carton and blister.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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: maize starch, monohydrate lactose, magnesium stearate, 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 a thickness of 2.5 mm (from 1.5 mm to 3.5 mm).
• Liberelle is available in PVC/PVDC/Aluminium foil blisters containing 21 tablets.
• The pack contains 1 or 3 blisters, each blister containing 21 tablets.

For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation 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 in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing Authorisation Number in Spain, the country of export: 725350.1
725351.8
Parallel Import Licence Number: 138/22
This medicinal product is authorised for marketing 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