Qlaira

Leaflet attached to the packaging: Information for the user

Qlaira, film-coated tablets

Estradiol valerate + Dienogest

You should carefully read the contents of the leaflet before taking the medicine, as it contains

important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of blood clots in the veins and arteries, especially in the first year of use or after restarting use after a break of 4 weeks or more.
• You should be vigilant and consult a doctor if you suspect that you have symptoms of a blood clot (see section 2 "Blood clots").

Table of contents of the leaflet

Important information about combined hormonal contraceptives ....................................................................................... 1

• 1. What is Qlaira and what is it used for ...................................... 2
• 2. Important information before taking Qlaira ................................ 2When not to take Qlaira ....................................................................... 2 Do not take Qlaira:................................................................................ 2 Additional information on special patient groups............................ 4 BLOOD CLOTS ........................................................................................ 4 BLOOD CLOTS IN VEINS ........................................................................... 6Factors that increase the risk of blood clots in veins ................................ 7 BLOOD CLOTS IN ARTERIES .................................................................... 7Qlaira and cancer ............................................................................................... 8 Mental disorders .................................................................................... 8 Intermenstrual bleeding .............................................................................. 9 What to do if bleeding does not occur on the 26th day or within a few subsequent days ............................................................................. 9 Qlaira and other medicines ...................................................................................... 9 Laboratory tests.................................................................................... 10 Pregnancy and breastfeeding ............................................................................... 10 Driving and using machines ..................................................... 10 Qlaira contains lactose ............................................................................ 10
• 3. How to take Qlaira .............................................................................. 10Preparing the carton with blister pack (wallet pack) .................................................................................................... 10 When can you start the first wallet pack?................... 11

Taking more than the recommended dose of Qlaira ....................................... 12
Missing a dose of Qlaira .................................................................. 12
Do not take more than 2 active tablets in one day. ................................................................... 12
Use in children ....................................................................................... 15
What to do if you experience vomiting or severe diarrhea ..................... 15
Stopping Qlaira ............................................................... 15

• 4. Possible side effects ................................................................. 15
• 5. How to store Qlaira .................................................................... 17
• 6. Contents of the pack and other information ......................................... 18

1. What is Qlaira and what is it used for

• Qlaira is a contraceptive pill used to prevent pregnancy.
• Qlaira is used to treat heavy menstrual bleeding (not caused by any disease of the uterus) in women who want to use oral contraception.
• Each colored tablet contains a small amount of female hormones, namely estradiol valerate or estradiol valerate in combination with dienogest.
• The two white tablets do not contain active ingredients and are referred to as "placebo".
• Contraceptive pills that contain two hormones are called "combined pills".

2. Important information before taking Qlaira

General notes

Before starting to take Qlaira, you should read the information about blood clots in section 2. It is especially important to read about the symptoms of a blood clot (see section 2 "Blood clots").
Before you can start taking Qlaira, your doctor will ask you some questions about your health and the health of your close relatives. Your doctor will also measure your blood pressure and, depending on your condition, may also perform other examinations.
This leaflet describes several situations in which you should stop taking Qlaira or in which the reliability of Qlaira may be reduced. In such situations, you should refrain from having sexual intercourse or use additional, non-hormonal contraceptive methods, such as condoms or other mechanical methods. You should not use the calendar method or the temperature measurement method. These methods may be unreliable because Qlaira modifies the monthly changes in body temperature and cervical mucus.

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

When not to take Qlaira

You should not take Qlaira if you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. Your doctor will discuss with you which other contraceptive method will be more suitable for you.

Do not take Qlaira:

• if you are allergic (hypersensitive) to estradiol valerate or dienogest, or any of the other ingredients of the medicine (listed in section 6). This may cause itching, rash, or swelling.
• if you currently have (or have ever had) a blood clot in the deep veins of your legs (deep vein thrombosis), in your lungs (pulmonary embolism), or in other organs;
• if you know that you have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time (see section "Blood clots").
• if you have had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a sign of a heart attack) or a transient ischemic attack (a temporary stroke-like condition);
• if you have any of the following diseases that may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage
• very high blood pressure;
• very high levels of fats in the blood (cholesterol or triglycerides).
• hyperhomocysteinemia
• if you have (or have ever had) a type of migraine called "migraine with aura";
• if you have (or have ever had) liver disease, and your liver function is still not normal;
• if you have (or have ever had) a liver tumor;
• if you have (or have ever had) a diagnosed or suspected breast or genital cancer;
• if you have any unexplained vaginal bleeding.

Warnings and precautions

When to contact a doctor
You should immediately contact a doctor

• if you notice any of the following symptoms that may indicate the formation of a blood clot, which may mean that you have a blood clot in your leg (deep vein thrombosis), a blood clot in your lungs (pulmonary embolism), a heart attack, or a stroke (see below "Blood clots"). To find a description of these serious side effects, see "How to recognize a blood clot".

You should tell your doctor if you have any of the following conditions.

In certain situations, you should be particularly careful when taking Qlaira or any other combined contraceptive pill; you may also need to be regularly examined by a doctor. If these symptoms occur or worsen while taking Qlaira, you should also tell your doctor if:

• someone in your close family has (or has ever had) breast cancer;
• you have liver or gallbladder disease;
• you have jaundice;
• you have diabetes;
• you have depression;
• you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• you have sickle cell anemia (a hereditary disease of red blood cells);
• you have elevated levels of fats in the blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of pancreatitis;
• you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots").
• you are immediately after childbirth, in which case you are at increased risk of blood clots. You should consult your doctor to find out how soon you can start taking Qlaira after childbirth.
• you have superficial thrombophlebitis (inflammation of veins under the skin).
• you have varicose veins.
• you have epilepsy (see "Qlaira and other medicines");
• you have a disease that first appeared during pregnancy or while taking sex hormones, such as hearing loss, porphyria (a blood disease), herpes gestationis (a skin rash that occurs during pregnancy), or Sydenham's chorea (a neurological disorder that causes involuntary movements of the body);
• you have (or have ever had) chloasma (brown patches on the skin, especially on the face). In this case, you should avoid direct exposure to sunlight or ultraviolet radiation;
• you have hereditary or acquired angioedema. You should stop taking Qlaira and immediately contact your doctor if you experience symptoms such as: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives with difficulty breathing, which suggest angioedema. Products containing estrogen may cause or worsen the symptoms of angioedema.
• you have heart or kidney failure. You should consult your doctor before taking Qlaira.Additional information on special patient groupsUse in children Qlaira is not intended for use in girls before their first menstrual period.

BLOOD CLOTS

Taking combined hormonal contraceptives, such as Qlaira, is associated with an increased risk of blood clots, compared to not taking them.
In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can form

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

Remember that the overall risk of harmful blood clots caused by taking Qlaira is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should immediately contact a doctor if you notice any of the following symptoms.
Are you experiencing any of these symptoms?
Why is the patient likely to be suffering from

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking,

increased temperature in the affected leg

• change in the color of the skin on the leg, such as paleness, redness, or discoloration
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing; Pulmonary embolism
• severe dizziness or fainting;
• rapid or irregular heartbeat.
• severe abdominal pain; If you are unsure, you should contact a doctor, as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold). Symptoms usually occur in one eye:
• sudden loss of vision or
• painless vision disturbances, which may lead to loss of vision Retinal vein thrombosis (blood clot in the eye)
• chest pain, discomfort, or pressure
• a feeling of tightness or heaviness in the chest, arm, or below the breastbone; Heart attack
• a feeling of fullness, indigestion, or choking;
• a feeling of discomfort in the lower part of the body radiating to the back, jaw, throat, arm, and stomach;
• sweating, nausea, vomiting, or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat.
• sudden weakness or numbness of the face, arms, or legs, especially on one side of the body;
• sudden confusion, speech disturbances, or difficulty understanding;
• sudden vision disturbances in one or both eyes;
• sudden difficulty walking, dizziness, loss of balance, or coordination;
• sudden severe or prolonged headaches without a known cause; Stroke

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms in a vein

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur. Most often, they occur in the first year of taking combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot breaks loose from the leg and lodges in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in veins highest

The risk of blood clots in veins is highest during the first year of taking combined hormonal contraceptives for the first time. 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, but it is always higher than when not taking combined hormonal contraceptives.
If you stop taking Qlaira, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots

The risk of blood clots caused by taking Qlaira is small, but some factors can increase this risk. The risk is higher:

• if you are significantly overweight (body mass index (BMI) over 30 kg/m);
• if someone in your close family has had a blood clot in the legs, lungs, or other organs at a young age (e.g., under 50 years). In this case, you may have a hereditary blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots").
• with age (especially over 35 years);
• if you have recently given birth (the risk of blood clots increases with the number of risk factors present in you). Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor. You should tell your doctor if any of these risk factors apply to you, even if you are not sure. Your doctor may decide to stop Qlaira. You should tell your doctor if any of these conditions change while taking Qlaira, e.g., if someone in your close family is diagnosed with a blood clot without a known cause or if you gain weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery

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

Factors that increase the risk of blood clots in arteries

It should be emphasized that the risk of heart attack or stroke caused by taking Qlaira is very small, but it may increase:

• with age (over approximately 35 years);
• if you smoke.While taking a hormonal contraceptive like Qlaira, it is recommended to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may recommend using a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your close family has had a heart attack or stroke at a young age (under 50 years). In this case, you may also be at increased risk of heart attack or stroke;
• if you or someone in your close family has high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, arrhythmia called atrial fibrillation)
• if you have diabetes. If you have more than one of these conditions or if any of them are severe, the risk of blood clots may be even higher. You should tell your doctor if any of these conditions change while taking Qlaira, e.g., if you start smoking, if someone in your close family is diagnosed with a blood clot without a known cause, or if you gain weight significantly.

Qlaira and cancer

In women taking combined contraceptives, breast cancer is slightly more common ,
but it is not known if this is caused by the pill. For example, the higher detection of tumors in women taking combined pills may be due to the fact that these women are more frequently examined by doctors. The risk of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is important to regularly examine your breasts and contact your doctor if you feel any lump.
In women taking contraceptive pills, rare cases of:
benign liver tumors, and even rarer cases of malignant liver tumorshave been reported. In individual cases, these tumors have led to life-threatening internal bleeding.
If you experience unusual, severe abdominal pain, you should contact your doctor.
Some studies suggest that long-term use of contraceptive pills increases the risk of cervical cancer. However, it is not clear to what extent sexual behavior or other factors, such as human papillomavirus (HPV), increase this risk.

Mental disorders

Some women taking hormonal contraceptives, including Qlaira, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts.
If you experience mood changes and symptoms of depression, you should contact your doctor as soon as possible for further medical advice.

Intermenstrual bleeding

During the first few months of taking Qlaira, unexpected bleeding may occur. Usually, bleeding starts on the 26th day, i.e., on the day of taking the second red tablet, or within a few subsequent days. According to the diaries kept by women participating in the clinical trial of Qlaira, such bleeding occurred frequently (reported by 10-18% of women). If unexpected bleeding occurs for longer than 3 months in a row or starts after several months, your doctor should determine the cause.

What to do if bleeding does not occur on the 26th day or within a few subsequent days

According to the diaries kept by women participating in the clinical trial of Qlaira, bleeding did not occur on the 26th day in many cases (found in 15% of cycles).
If all tablets were taken correctly, there was no vomiting or severe diarrhea, and no other medicines were taken, the likelihood of pregnancy is small.
If the expected bleeding does not occur twice in a row or if the tablets were not taken correctly, it may mean that you are pregnant. You should contact your doctor immediately.
Do not start the next pack until you are sure you are not pregnant.

Qlaira and other medicines

Your doctor prescribing Qlaira should always be told what other medicines or herbal products you are already taking. Similarly, any other doctor or dentist prescribing another medicine or pharmacist dispensing another medicine should be told that you are taking Qlaira. They will inform you whether you need to use additional contraceptive methods (e.g., condoms) and for how long.
Some medicines may:

• affect the level of Qlaira in your blood
• make Qlaira less effective in preventing pregnancy
• cause unexpected bleeding. This applies to medicines:
• used to treat:
• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g., rifampicin);
• HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz);
• medicines used to treat hepatitis C (such as a treatment regimen using ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, or using glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir) (see section 4) may cause elevated liver enzymes in blood tests in women taking combined hormonal contraceptives containing ethinyl estradiol. Qlaira contains estradiol instead of ethinyl estradiol. It is not known whether elevated liver enzymes may occur when taking Qlaira with this type of treatment regimen;
• fungal infections (griseofulvin, ketoconazole); herbal products containing St. John's wort ( Hypericum perforatum).

Qlaira may affect the action of other medicines, e.g., those containing:

cyclosporin;
antiepileptic drugs - lamotrigine (this may lead to an increased frequency of seizures).
Before taking any medicine, you should consult your doctor or pharmacist. Your doctor or pharmacist may recommend using additional protective measures during the administration of another medicine with Qlaira.

Qlaira with food and drink

Qlaira can be taken with or without food, if necessary, with a small amount of water.

Lab tests

If you need to have a blood test or other lab tests, you should tell your doctor or lab staff that you are taking Qlaira, as oral contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

If you become pregnant while taking Qlaira, you should stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Qlaira at any time (see also "Stopping Qlaira").
It is generally not recommended to take Qlaira while breastfeeding. If you want to take Qlaira while breastfeeding, you should contact your doctor.
Before taking any medicine, you should consult your doctor or pharmacist if you are pregnant or breastfeeding.

Driving and using machines

There is no information to suggest that taking Qlaira affects your ability to drive or use machines.

Qlaira contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking Qlaira.

3. How to take Qlaira

Each carton with a blister pack (wallet pack) contains 26 colored tablets with active ingredients and 2 white placebo tablets.
You should take one Qlaira tablet every day, if necessary, with a small amount of water. The tablets can be taken with or without food, but you should take them at approximately the same time every day.

Preparing the carton with blister pack (wallet pack)

To make it easier to check if you have taken a tablet every day, the pack contains 7 self-adhesive strips with abbreviated day names.
You should choose a strip where the first day of the week is the same as the day you start the pack. For example, if the first day of taking the pack is Wednesday, you should choose the strip where the first day of the week is "WED".
The self-adhesive strip should be stuck to the top of the Qlaira blister pack, in the place marked "Place the day sticker here". This way, the first day is above the tablet marked "1".
Each tablet now has a day of the week assigned to it, and you can check if you have taken the correct tablet every day. The tablets should be taken in the direction of the arrow on the pack until all 28 tablets have been taken.
The so-called withdrawal bleeding usually starts after taking the second red tablet or during the intake of white tablets and may not have stopped by the time the next pack is started. In some women, bleeding may continue after taking the first tablets from a new pack.
The next pack should be started without interruption; in other words, on the day after finishing the current pack, even if bleeding has not stopped yet. This means that the next pack is started on the same day of the week as the pack that has just been finished, and withdrawal bleeding will occur at approximately the same days of the week every month.
If you take Qlaira in this way, you will also be protected from pregnancy during the 2 days when you take the placebo tablets.

When can you start the first wallet pack?

• If you have not taken a hormonal contraceptive in the previous month.You should start taking Qlaira on the first day of your cycle (i.e., on the first day of menstrual bleeding).
• Switching from another combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or patch.You should start taking Qlaira on the day after taking the last active tablet of your previous contraceptive. In the case of switching from a combined hormonal contraceptive vaginal ring or patch, you should start taking Qlaira on the day of removal or as advised by your doctor.
• Switching from a progestogen-only method (mini-pill, injection, implant, or intrauterine system releasing progestogen IUS).You can switch from a mini-pill at any time (from an implant or intrauterine system on the day of its removal, or from injections when the next injection is scheduled), but in all cases, you should use additional contraceptive methods (e.g., condoms) for the first 9 daysof taking Qlaira.
• After a miscarriage.Follow your doctor's advice.
• After childbirth.You can start taking Qlaira 21-28 daysafter childbirth. If you start later than 28 days, you should use a mechanical method (e.g., condoms) for the first 9 daysof taking Qlaira. If you have had sexual intercourse after childbirth before starting Qlaira, you should make sure you are not pregnant or wait for your next menstrual period.

If you want to start taking Qlaira after childbirth and are breastfeeding, you should read the section "Pregnancy and breastfeeding".
If you are unsure when to start taking Qlaira, you should consult your doctor.

Taking more than the recommended dose of Qlaira

There are no reports of serious harmful effects from taking too many Qlaira tablets at once.
If you have taken several active tablets at the same time, you may experience nausea or vomiting. Young girls may experience vaginal bleeding.
If you have taken too many Qlaira tablets or if you discover that a child has taken them, you should contact your doctor or pharmacist.

Missing a dose of Qlaira

Placebo tablets:If you forget to take a white tablet (the 2 tablets at the end of the pack), you do not need to take it later, as these tablets do not contain any active ingredients. However, it is important to discard the missed white tablet to avoid increasing the number of days of taking placebo tablets, which could increase the risk of pregnancy. Take the next tablet at the usual time.
Active tablets:Depending on the day of your cycle indicated on the current pack, if you miss oneactive tablet, you may need to use additional contraceptive methods (e.g., condoms). You should take the tablets as follows.

More detailed information is also presented in the "Missed pill guidance".

• If less than 12 hourshave passed since the scheduled time of taking the tablet, the protection against pregnancy will not be reduced. Take the tablet as soon as possible, and then take the next tablets at the usual time.
• If more than 12 hourshave passed since the scheduled time of taking the tablet, the protection against pregnancy may be reduced. Depending on the day of your cycle indicated on the current pack, if you miss one tablet, you should use additional contraceptive methods (e.g., condoms). More detailed information is also presented in the "Missed pill guidance".

If you miss more than one active tablet

You should contact your doctor.

Do not take more than 2 active tablets in one day.

If you forget to start a new pack, or if you miss one or more tablets between days 3 and 9, there is a risk that you may be pregnant (if you had sexual intercourse during the 7 days before missing the tablet). In this case, you should contact your doctor. The more tablets you miss (especially between days 3 and 24) and the closer you are to the placebo tablet phase, the higher the risk that the contraceptive protection will be reduced. More detailed information is also presented in the "Missed pill guidance".
If you miss an active tablet and do not experience bleeding during the placebo tablet phase, it may mean that you are pregnant. In this case, you should contact your doctor before starting the next pack.

YES

NO

Use in children

There are no data on the use of Qlaira in persons under 18 years of age.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any side effects occur, especially severe and persistent ones or changes in health status that the patient considers related to the use of Qlaira, a doctor should be consulted. All women taking combined hormonal contraceptives have an increased risk of blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disease). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, the section "2. Important information before taking Qlaira" should be consulted.

Severe side effects

Severe reactions related to the use of the medicine, as well as related symptoms, are described in the following chapters: "Blood clots"and "Qlaira and cancer". These chapters should be read carefully and, if necessary, a doctor should be consulted.

Other possible side effects

The following side effects have been reported in connection with the use of Qlaira: Common side effects(occurring in 1 to 10 out of 100 people):

• headache;
• abdominal pain, vomiting;
• acne;
• absence of menstruation, breast tenderness, painful menstruation, irregular bleeding (heavy irregular bleeding);
• weight gain. Uncommon side effects(occurring in 1 to 10 out of 1,000 people):
• fungal infections, fungal infection of the vulva and vagina, vaginal infection;
• increased appetite;
• depression, low mood, emotional disturbances, difficulty sleeping, decreased interest in sex, mental disorders, mood swings;
• dizziness, migraine;
• hot flashes, high blood pressure;
• diarrhea, vomiting;
• increased liver enzyme activity;
• excessive hair loss, excessive sweating, itching, rash;
• muscle spasms;
• breast enlargement, breast lumps, abnormal cell growth on the cervix (cervical dysplasia), menstrual disorders, painful intercourse, fibrocystic breast disease, heavy menstruation, irregular menstruation, ovarian cyst, pelvic pain, premenstrual syndrome, endometrial hyperplasia, uterine contractions, genital bleeding, including spotting, discharge, and dryness of the vulva and vagina;
• fatigue, irritability, swelling of certain areas of the body, e.g., ankles;
• weight loss, changes in blood pressure. Rare side effects(occurring in 1 to 10 out of 10,000 people):
• candidiasis, oral thrush, pelvic inflammatory disease, eye disease resembling fungal infection (presumed histoplasmosis syndrome), fungal skin infections (pityriasis versicolor), urinary tract infection, bacterial vaginosis;
• fluid retention, increased triglyceride levels in the blood;
• aggression, anxiety, feeling unhappy, increased interest in sex, nightmares, nervousness, psychomotor agitation, sleep disturbances, tension;
• concentration disorders, tingling sensation, dizziness;
• intolerance to contact lenses, dry eye syndrome, eye swelling;
• myocardial infarction, palpitations;
• variceal bleeding, decreased blood pressure, superficial thrombophlebitis, vein pain;
• harmful blood clots in a vein or artery, for example:
• in the leg or foot (e.g., deep vein thrombosis)
• in the lungs (e.g., pulmonary embolism)
• myocardial infarction
• stroke
• mini-stroke or transient stroke symptoms, known as a transient ischemic attack
• blood clots in the liver, stomach, and/or intestine, kidneys, or eye. The risk of blood clots may be higher if the patient has any other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots).
• constipation, dry mouth, dyspepsia, heartburn;
• liver tumors (benign and malignant), chronic gallbladder inflammation;
• allergic skin reactions, chloasma (melasma) and other pigmentation disorders, hirsutism, excessive hair growth, skin inflammation and pruritus (neurodermatitis), dandruff, and seborrheic dermatitis (seborrhea) and other skin changes;
• back pain (lower back), jaw pain, feeling of heaviness;
• urinary tract pain;
• unusual withdrawal bleeding, benign breast tumors, early-stage breast cancer, breast cysts, breast discharge, cervical polyp, cervical erosion, bleeding during intercourse, unexpected milk secretion, genital discharge, less heavy menstruation, delayed menstruation, ovarian cyst rupture, burning sensation in the vagina, unpleasant odor from the vagina, discomfort of the vulva and vagina;

enlargement of lymph nodes; asthma, breathing difficulties, nosebleeds; chest pain, feeling of fatigue and general malaise, fever; abnormal Pap smear. Other information (from diaries kept by women participating in the clinical trial with Qlaira) regarding possible side effects, such as irregular bleeding (heavy irregular bleeding) and absence of menstruation, is presented in the sections: "Irregular bleeding" "What to do if no bleeding occurs on the 26th day or within several subsequent days"Description of selected side effects Side effects that occur very rarely or whose symptoms occur with a delay and may be related to the use of combined oral contraceptives and may occur during the use of Qlaira are listed below (see also the sections "Contraindications", "Special warnings and precautions for use"):

• liver tumor (benign and malignant),
• erythema nodosum (painful red nodules under the skin), erythema multiforme (skin rash with red spots or sores),
• hypersensitivity reactions (including symptoms such as rash, urticaria),
• in women with hereditary angioedema (characterized by sudden swelling, e.g., of the eyes, face, throat, etc.), estrogens in combined oral contraceptives may trigger or worsen the symptoms of this disease. In case of liver function disorders, it may be necessary to discontinue the use of combined oral contraceptives.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, a doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicinal product.

5. How to store Qlaira

The medicinal product should be stored out of sight and reach of children. There are no special precautions for storage. This medicinal product should not be used after the expiry date stated on the carton after "Expiry date (EXP):" The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Qlaira contains

The active substances of Qlaira are estradiol valerate or estradiol valerate in combination with dienogest. Each "wallet" pack contains 26 active film-coated tablets (in 4 different colors) arranged in rows 1, 2, 3, and 4, and 2 white inactive tablets in row 4. The composition of the colored tablets containing one or two active substances: 2 dark yellow tablets, each containing 3 mg of estradiol valerate; 5 light red tablets, each containing 2 mg of estradiol valerate and 2 mg of dienogest; 17 light yellow tablets, each containing 2 mg of estradiol valerate and 3 mg of dienogest; 2 dark red tablets, each containing 1 mg of estradiol valerate; Composition of the white tablets (placebo): White tablets (placebo) do not contain active substances. Other ingredients of the colored tablets with active substances: Tablet core: lactose monohydrate, cornstarch, pregelatinized cornstarch, povidone K25 (E1201), magnesium stearate (E572); Coating: hypromellose 2910 (E464), macrogol 6000, talc (E553b), titanium dioxide (E171), iron oxide red (E172), and/or iron oxide yellow (E172); Other ingredients of the white tablets without active substances: Tablet core: lactose monohydrate, cornstarch, povidone K25 (E1201), magnesium stearate (E572); Coating: hypromellose 2910 (E464), talc (E553b), titanium dioxide (E171)

What Qlaira looks like and contents of the pack

Qlaira tablets are film-coated; the tablet core is coated with a coating. Each carton box with a blister pack (wallet-type packaging) contains 28 film-coated tablets, including: 2 dark yellow tablets and 5 light red tablets in the first row, 17 light yellow tablets in the second, third, and fourth rows, 2 dark red tablets in the fourth row, and 2 white tablets (placebo) in the fourth row. The dark yellow active tablets are round, biconvex; one side is marked with the letters "DD" in a hexagonal shape. The light red active tablets are round, biconvex; one side is marked with the letters "DJ" in a hexagonal shape. The light yellow active tablets are round, biconvex; one side is marked with the letters "DH" in a hexagonal shape. The dark red active tablets are round, biconvex; one side is marked with the letters "DN" in a hexagonal shape. The white inactive tablets are round, biconvex; one side is marked with the letters "DT" in a hexagonal shape. Qlaira is available in packs containing 1, 3, or 6 carton boxes with a blister pack (wallet-type packaging), each containing 28 tablets. Not all packs may be available on the market.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bayer AG Kaiser-Wilhelm-Allee 1 51373 Leverkusen Germany

Manufacturers:

Bayer Weimar GmbH und Co. KG 99427 Weimar Germany Bayer Pharma AG 13353 Berlin Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

• Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden: QLAIRA / Qlaira
• Italy: KLAIRA

For more detailed information on this medicinal product, a doctor or a representative of the marketing authorization holder should be consulted.

Bayer Sp. z o.o.

Al. Jerozolimskie 158

02-326 Warsaw, Poland tel. (0 22) 572 35 00

Date of last revision of the leaflet: April 2025