QLAIRA FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Qlaira film-coated tabletsEstradiol valerate / Dienogest

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception if used correctly.
• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of the package leaflet:

1. What is Qlaira and what is it used for 2
2. What you need to know before you start taking Qlaira 3

When not to take Qlaira 3

Warnings and precautions 4

Blood clots 5

Qlaira and cancer 9

Psychiatric disorders…………………………………………………….10

Irregular bleeding 10

What to do if you do not have your period on day 26 or in the following days 10

Other medicines and Qlaira 10

Using Qlaira with food and drink 10

Laboratory tests 11

Pregnancy and breast-feeding 11

Driving and using machines 11

Qlaira contains lactose 11

1. How to take Qlaira……………………………………………………...11

Preparing the calendar pack 11

When can you start with the first calendar pack? 12

If you take more Qlaira than you should 13

If you forget to take Qlaira 13

Use in children 15

What to do in case of vomiting or severe diarrhea 15

If you stop taking Qlaira 15

1. Possible side effects……………………………………………….15
2. Storage of Qlaira…………………………………………………17
3. Contents of the pack and other information…………………………18

1. What is Qlaira and what is it used for

• Qlaira is a contraceptive used to prevent pregnancy
• Qlaira is used to treat heavy menstrual bleeding (not caused by any disease of the uterus) in women who wish to use oral contraception.
• Each active colored tablet contains a small amount of female hormones: estradiol valerate, or estradiol valerate combined with dienogest.
• The 2 white tablets do not contain active substances and are called inactive tablets. Contraceptives that contain two hormones are called “combined contraceptives”

2. What you need to know before you start taking Qlaira

When not to take Qlaira

Do not use this medicine if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

Do not take Qlaira:

• If you have (or have ever had) a blood clotin a blood vessel in your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or other organs.
• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need an operation or if you are immobile for a long time (see section “Blood clots”).
• If you have ever had a heart attackor a stroke.
• If you have (or have ever had) angina pectoris(a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack(TIA, temporary stroke-like symptoms).
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:

• Severe diabetes with blood vessel damage.
• Very high blood pressure.
• Very high levels of fat in the blood (cholesterol or triglycerides).
• A condition called hyperhomocysteinaemia.
• If you have (or have ever had) a type of migrainecalled “migraine with aura”.
• If you have (or have ever had) a liver diseaseand your liver function has not yet returned to normal.
• If you have (or have ever had) a liver tumor.
• If you have (or have ever had) or are suspected to have breast cancer or cancer of the genital organs.
• If you have vaginal bleeding of unknown cause.
• If you are allergic(hypersensitive) to estradiol valerate or dienogest, or any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash, or inflammation.

Warnings and precautions

When should you contact your doctor?

Seek urgent medical attention

• If you notice any possible signs of a blood clot that may mean you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clots” below).

To get a description of the symptoms of these serious side effects, see “How to recognize a blood clot”.

Tell your doctor if you experience any of the following conditions.

In some situations, you will need to be extra careful while taking Qlaira or any other combined hormonal contraceptive, and your doctor may need to examine you regularly. If the condition develops or worsens while you are using this medicine, you should also tell your doctor:

• If a close relative has had or has breast cancer.
• If you have any liver or gallbladder disease.
• If you have jaundice.
• If you have diabetes.
• If you have depression.
• If you have Crohn’s disease or ulcerative colitis(chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus(SLE, a disease that affects your natural defense system).
• If you have hemolytic uremic syndrome(HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia(a hereditary disease of the red blood cells).
• If you have high levels of fat in the blood(hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you need an operation or are immobile for a long time (see section 2 “Blood clots”).
• If you have just given birth, you are at a higher risk of blood clots. You should ask your doctor how soon after delivery you can start taking Qlaira.
• If you have superficial thrombophlebitis(inflammation of the veins just under the skin).
• If you have varicose veins.
• If you have epilepsy(see “Other medicines and Qlaira”).
• If you have a disease that first appeared during pregnancy or previous use of sex hormones, for example, hearing loss, porphyria(a blood disorder), gestational herpes(a skin rash with blisters during pregnancy), Sydenham's chorea(a nervous disease that causes involuntary movements).
• If you have (or have had in the past) brown patches on the skin, also known as “pregnancy patches”, especially on the face (chloasma). In this case, avoid direct exposure to the sun or ultraviolet rays.
• If you have hereditary or acquired angioedema. Stop taking this medicine and see your doctor immediately if you experience symptoms such as swelling of the face, tongue, or throat, and difficulty swallowing or hives accompanied by difficulty breathing, which suggest angioedema. Medicines containing estrogens may induce or worsen the symptoms of angioedema.
• If you have heart or kidney failure.

Consult your doctor before starting to take this medicine.

Additional information on special populations

Use in children

This medicine is not intended for use in girls who have not yet started their periods.

Blood Clots

The use of a combined hormonal contraceptive like Qlaira increases your risk of developing a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In the veins (called "venous thrombosis", "venous thromboembolism" or VTE).
• In the arteries (called "arterial thrombosis", "arterial thromboembolism" or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-lasting effects or, very rarely, they can be life-threatening.

It is essential to remember that the overall risk of a harmful blood clot due to Qlaira is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek medical attention immediately if you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the veins (venous thrombosis). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a clot can form in a vein of another organ, such as the eye (retinal vein thrombosis).

When is the risk of having a blood clot in a vein higher?

The risk of having a blood clot in a vein is higher during the first year you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking this medication, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with this medication is small.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5-7 will develop a blood clot in a year.

• The risk of a blood clot with Qlaira is virtually the same as with other combined hormonal contraceptives, including those containing levonorgestrel.

• The risk of developing a blood clot will depend on your personal history (see "Factors that increase your risk of a blood clot" below).

Factors that increase your risk of a blood clot in a vein

The risk of having a blood clot with this medication is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI over 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of 50). In this case, you may have a hereditary blood clotting disorder.
• If you need to have surgery or if you spend a lot of time in bed due to an injury or illness, or if you have your leg in a cast. You may need to stop taking Qlaira several weeks before surgery or while you are less mobile. If you need to stop taking this medication, ask your doctor when you can start taking it again.
• As you get older (especially above the age of 35).
• If you have recently given birth.

The risk of developing a blood clot increases with the number of conditions you have.

Long-haul flights (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you have any of the above conditions, even if you are not sure. Your doctor may decide that you should stop taking this medication.

If any of the above conditions change while you are taking this medication, for example, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

Blood Clots in an Artery

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

Factors that increase your risk of a blood clot in an artery

It is essential to note that the risk of a heart attack or stroke due to this medication is very small, but it may increase:

• With age (above 35 years).
• If you smoke.When using a combined hormonal contraceptive like Qlaira, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disturbance called atrial fibrillation).
• If you have diabetes.

If you have more than one of these conditions or if any of them are particularly severe, the risk of developing a blood clot may be increased further.

If any of the above conditions change while you are taking this medication, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

Qlaira and Cancer

Breast cancerhas been slightly more frequently observed in women using combined contraceptives, but it is not known if this is due to the treatment. For example, it may be that more tumors are detected in women using combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to have your breasts checked regularly, and you should see your doctor if you notice any lump.

In rare cases, benign liver tumorshave been reported, and even more rarely, malignant liver tumors, in users of oral contraceptives. In isolated cases, these tumors have caused life-threatening internal bleeding. See your doctor if you experience unusually severe abdominal pain.

Some studies suggest that long-term use of the pill increases the risk of developing cervical cancer. However, it is not clear to what extent sexual behavior or other factors, such as the human papillomavirus (HPV), increase this risk.

Psychiatric Disorders

Some women using hormonal contraceptives like Qlaira have reported depression or a depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for further medical advice as soon as possible.

Irregular Bleeding

During the first few months that you are taking this medication, you may have unexpected bleeding. This usually starts on the 26th day, the day you take the second dark red tablet, or the following days. According to the information provided by women in their diaries during a clinical study of Qlaira, it is not uncommon to experience unexpected bleeding in a given cycle (10-18% of users). If unexpected bleeding occurs for more than 3 consecutive months or starts after several months, your doctor should investigate the cause.

What to Do if You Do Not Have Your Period on the 26th Day or the Following Days

According to the information provided by women in their diaries during a clinical study of Qlaira, it is not uncommon for regular bleeding not to occur after the 26th day (this was observed in approximately 15% of cycles).

If you have taken all the tablets correctly, have not had vomiting or severe diarrhea, and have not taken any other medications, it is very unlikely that you are pregnant.

If your expected period does not arrive in two consecutive instances or if you have taken the tablets incorrectly, you may be pregnant. See your doctor immediately. Do not start the next calendar pack until you are sure you are not pregnant.

Other Medications and Qlaira

Inform your doctor at all times about the medications or herbal preparations you are taking. Also, inform any other doctor or dentist who prescribes you another medication (or the pharmacist who dispenses the medication) that you are taking Qlaira. They may advise you to take additional protective measures while you are taking other medications with Qlaira.

Some medications

• may affect Qlaira levels in the blood
• may reduce the contraceptive effect
• may cause irregular bleeding

These include:

• medications used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate)
• tuberculosis (e.g., rifampicin)
• HIV and hepatitis C infections (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
• Medications for hepatitis C (e.g., combination treatments for HCV ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin; glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir) may cause elevations in blood test results of liver function (increase in liver enzyme ALT) in women using CHC with ethinylestradiol. Qlaira contains estradiol instead of ethinylestradiol. It is not known whether an increase in liver enzyme ALT can occur when using this medication with this combination treatment for HCV. Your doctor will inform you about this.
• fungal infections (e.g., griseofulvin, ketoconazole)

• herbal preparations containing St. John's Wort

Qlaira may affect the effectof other medications, for example:

• medications containing cyclosporin
• the antiepileptic lamotrigine (may lead to an increased frequency of seizures)

Consult your doctor or pharmacist before using any medication. Your doctor or pharmacist may advise you to use additional protective measures while you are taking other medications with Qlaira.

Using Qlaira with Food and Drinks

This medication can be taken with or without food, and with some water if necessary.

Lab Tests

If you need a blood test or other lab tests, inform your doctor or the lab staff that you are taking the pill, as oral contraceptives can affect the results of some tests.

Pregnancy and Breastfeeding

If you become pregnant during treatment with this medication, you should stop the treatment immediately and contact your doctor. If you wish to become pregnant, you can stop taking this medication at any time (see also "If you stop taking Qlaira").

In general, it is not recommended to take this medication during breastfeeding. If you want to take the contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before using any medication when you are pregnant or breastfeeding.

Driving and Using Machines

There is no information to suggest that the use of this medication has any effect on the ability to drive or use machines.

Qlaira Contains Lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medication.

3. How to Take Qlaira

Each calendar pack contains 26 active colored tablets and 2 inactive white tablets.

Take one Qlaira tablet every day, with some water if necessary. You can take the tablets with or without food, but try to take them at the same time every day.

Preparing the Calendar Pack

To help you follow the order of intake, 7 self-adhesive strips with the 7 days of the week are provided.

Choose the adhesive strip of the week that starts with the day you take the first tablet. For example, if you take your first tablet on a Wednesday, use the adhesive strip that starts with "WED".

Stick the weekly adhesive strip on the top of the Qlaira calendar pack, where it says "Place the adhesive strip here!", so that the first day is placed above the tablet marked with "1".

Now you will have a day marked above each tablet and you will be able to check visually if you have taken the tablet on a given day. Follow the direction indicated by the arrow on the calendar pack until you have taken the 28 tablets.

Usually, the withdrawal bleeding starts when you are taking the second dark red tablet or the white tablets and may not have finished when you start the next calendar pack. Some women may still experience bleeding after taking the first tablets of the new calendar pack.

Start the next calendar pack without interruption, i.e. on the day after you have finished the current calendar pack, even if the bleeding has not stopped. This means that you should start the next calendar pack on the same day of the week as the current calendar pack and that the withdrawal bleeding should take place during the same days of the week every month.

If you use Qlaira in this way, you are protected against pregnancy even during the 2 days when you take the inactive tablets.

When can you start with the first calendar pack?

• If you have not used any hormonal contraceptive in the previous month.Start taking Qlaira on the first day of your cycle (i.e. the first day of your menstruation).
• Switching from another combined hormonal contraceptive pill, vaginal ring, or patch.Start Qlaira the day after taking the last active tablet (the last tablet that contains the active substances) of your previous pill. When switching from a combined vaginal ring or patch, start using Qlaira on the same day as its removal or follow your doctor's recommendations.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system (IUS) of progestogen).You can switch from the progestogen-only pill at any time. If it is an implant or IUS, on the same day of its removal. If it is an injectable, when the next injection is due. In all cases, it is recommended that you use additional contraceptive measures (e.g. a condom) during the first 9 daysof taking Qlaira.
• After an abortion.Follow your doctor's recommendations.
• After having a child.You can start taking Qlaira between 21 and 28 daysafter having a child. If you start later than the 28th day, use a barrier method (e.g. a condom) during the first 9 daysof using Qlaira.

If, after having a child, you have already had sexual intercourse before taking Qlaira again, you must be sure that you are not pregnant or wait for your next menstrual period.

If you want to start taking this medication after having a child and are breastfeeding, read the section "Pregnancy and breastfeeding".

Consult your doctor if you have any doubts about when to start.

If you take more Qlaira than you should

No cases have been reported in which the ingestion of an overdose of the medication has caused serious harm.

If you take many active tablets at the same time, you may experience nausea or vomiting. Young girls may suffer from vaginal bleeding.

If you have taken too many tablets of the medication, or discover that a child has taken them, consult your doctor or pharmacist. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Qlaira

Inactive tablets:If you forget to take a white tablet (2 tablets at the end of the calendar pack), you do not need to take it later since it does not contain any active ingredient. However, it is important that you discard the white tablets you have forgotten to take, to ensure that the number of days you take the inactive tablets does not increase, as this would increase the risk of pregnancy. Continue with the next tablet at the usual time.

Active tablets:Depending on the day of the cycle as indicated in the current calendar pack on which you have forgotten to take oneactive tablet, you may need to take additional contraceptive precautions, for example, a barrier method such as a condom. Take the tablets according to the principles described below.See more details in the "Missed tablet scheme".

• If you are less than 12 hourslate in taking a tablet, the protection against pregnancy does not decrease. Take the tablet as soon as you remember and the following tablets at the usual time.
• If you are more than 12 hourslate in taking a tablet, the protection against pregnancy may be reduced. Depending on the day of the cycle as indicated in the current calendar pack on which you have forgotten to take the tablet, take additional contraceptive precautions, for example, a barrier method such as a condom. See more details in the "Missed tablet scheme".
• If you have forgotten more than one tablet from the calendar pack.Consult your doctor.

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

If you forget to start a new calendar pack or if you forget to take one or more tablets between the 3rd and 9th dayof your calendar pack, there is a risk that you may be pregnant (if you have had sexual intercourse in the 7 days before forgetting the tablet). In this case, consult your doctor. The more tablets you have forgotten (especially between the 3rd and 24th day) and the closer they are to the phase of inactive tablets, the greater the risk of reduced protection against pregnancy. See more details in the"Missed tablet scheme".

If you have forgotten to take an active tablet from a calendar pack and you do not have your period at the end of the calendar pack, you may be pregnant. Consult your doctor before continuing with the next calendar pack.

Use in children

No data are available in adolescents under 18 years of age.

What to do in case of vomiting or severe diarrhea

If you vomit within 3-4 hours after taking an active tablet or if you have severe diarrhea, there is a risk that the active substances of the tablet may not be fully absorbed by your body.

This is similar to what happens when you forget a tablet. After vomiting or diarrhea, you should take the next tablet as soon as possible. If possible, take it within 12 hours after the usual time you take your contraceptive. If it is not possible or more than 12 hours have passed, follow the advice in the section "If you forget to take Qlaira". If you do not want to change your normal tablet-taking schedule, take the corresponding tablet from another calendar pack.

If you interrupt treatment with Qlaira

You can stop taking the medication whenever you want. If you do not want to become pregnant, consult your doctor about other effective methods of birth control. If you want to become pregnant, stop taking the medication and wait until your menstrual period before trying to become pregnant. This way, you will be able to calculate the estimated date of delivery more easily.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any side effect, especially if it is severe and persistent, or if you have any change in your health that you think may be due to Qlaira, consult your doctor.

All women who take combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 "What you need to know before taking Qlaira".

Serious side effects

Severe reactions related to the use of the pill, as well as related symptoms, are described in the following sections "Blood clots" and "Qlaira and cancer". Read these sections carefully and consult your doctor when necessary.

Other possible side effects

The following side effects have been associated with the use of Qlaira:

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

• headache
• abdominal pain, nausea
• acne
• absence of periods, breast tenderness, painful periods, irregular bleeding (irregular and heavy bleeding)
• weight gain

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

• fungal infections, vaginal fungal infection, vaginal infection
• increased appetite
• depression, depressive mood, emotional disorders, sleep disorders, loss of interest in sex, mental disorder, mood changes
• dizziness, migraine
• hot flashes, high blood pressure
• diarrhea, vomiting
• increased liver enzymes
• hair loss, excessive sweating (hyperhidrosis), itching and skin rash
• muscle cramps
• breast enlargement, breast lumps, abnormal cell growth in the cervix (cervical dysplasia), dysfunctional genital bleeding, painful intercourse, fibrocystic breast disease, heavy menstruation, menstrual disorders, ovarian cyst, pelvic pain, premenstrual syndrome, uterine growth, uterine contractions, uterine/vaginal bleeding including spotting, vaginal discharge, vulvovaginal dryness
• fatigue, irritability, swelling of body parts, e.g. ankles (edema)
• weight loss, changes in blood pressure

Rare side effects(may affect up to 1 in 1,000 people):

• candida infection, oral herpes, pelvic inflammatory disease, eye vascular disease resembling a fungal infection (presumed ocular histoplasmosis syndrome), skin fungal infection (pityriasis versicolor), urinary tract infection, bacterial vaginitis
• fluid retention, increase in some blood fats (triglycerides)
• aggression, anxiety, feeling of unhappiness, increased interest in sex, nervousness, nightmares, restlessness, sleep disorders, stress
• decreased attention, tingling sensation, dizziness
• intolerance to contact lenses, dry eyes, eye swelling
• heart attack (myocardial infarction), palpitations
• varicose vein bleeding, low blood pressure, superficial vein inflammation, painful veins
• harmful blood clots in a vein or artery, for example:
• • In a leg or foot (i.e. DVT).
  • In a lung (i.e. PE).
  • Heart attack.
  • Stroke.
  • Mild stroke or similar temporary symptoms, called transient ischemic attack (TIA).
  • Blood clots in the liver, stomach/intestine, kidneys, or eye.

The risk of having a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

• constipation, dry mouth, indigestion, heartburn
• liver nodules (focal nodular hyperplasia), chronic inflammation of the gallbladder
• allergic skin reactions, brownish discoloration (chloasma) and other pigmentation disorders, male-pattern hair growth, excessive hair growth, skin diseases such as dermatitis and neurodermatitis, dandruff and oily skin (seborrhea) and other skin disorders
• back pain, jaw pain, feeling of heaviness
• urinary tract pain
• abnormal withdrawal bleeding, benign breast lumps, early-stage breast cancer, breast cysts, breast secretion, cervical polyp, cervical reddening, bleeding during intercourse, spontaneous milk secretion, genital discharge, less heavy menstruation, delayed menstruation, rupture of an ovarian cyst, vaginal odor, feeling of itching in the vulva and vagina, vulvovaginal discomfort
• lymph node inflammation
• asthma, difficulty breathing, nosebleed
• chest pain, fatigue, and general feeling of discomfort, fever
• abnormal cervical smear

Additional information (according to diaries kept by women in a clinical trial of Qlaira) about the possible side effects of "irregular bleeding (irregular and heavy bleeding)" and "absence of periods" is provided in the sections "Bleeding between periods" and "What to do if you do not have your period on the 26th day or in the following days".

Description of selected adverse reactions

The following adverse reactions are listed, which are very rare or have a delayed onset of symptoms, and are considered to be related to the group of combined oral contraceptives, and may also occur during the use of Qlaira (see also sections "When not to take Qlaira" and "Warnings and precautions").

• Liver tumors (benign and malignant)
• Erythema nodosum (red sensitive nodules under the skin), erythema multiforme (skin rash with red spots or lesions)
• Hypersensitivity (including symptoms such as skin rash, hives)
• In women with hereditary angioedema (characterized by sudden swelling, e.g. of the eyes, mouth, throat, etc.), the estrogens in combined oral contraceptives may induce or worsen the symptoms of angioedema

In case of altered liver function, it may be necessary to temporarily interrupt the use of combined oral contraceptives.

Reporting of side effects:

If you experience any side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for human use medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Qlaira

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Qlaira

The active substances are estradiol valerate, or estradiol valerate combined with dienogest.

Each calendar pack (28 film-coated tablets) contains 26 active tablets of four different colors in the first, second, third, and fourth rows, and two white inactive tablets in the fourth row.

Composition of the colored tablets containing one or two active substances:

2 dark yellow tablets. Each tablet contains 3 mg of estradiol valerate. 5 medium red tablets. Each tablet contains 2 mg of estradiol valerate and 2 mg of dienogest. 17 light yellow tablets. Each tablet contains 2 mg of estradiol valerate and 3 mg of dienogest. 2 dark red tablets. Each tablet contains 1 mg of estradiol valerate.

Composition of the white inactive tablets:

These tablets do not contain active substances.

The other components of the colored active tablets are:

Tablet core: lactose monohydrate, corn starch, pregelatinized corn starch, povidone K25 (E1201), magnesium stearate (E572).

Tablet film coating: hypromellose type 2910 (E464), macrogol 6000, talc (E553b), titanium dioxide (E171), yellow iron oxide (E172) and/or red iron oxide (E172).

The other components of the white inactive tablets are:

Tablet core: lactose monohydrate, corn starch, povidone K25 (E1201), magnesium stearate (E572).

Tablet film coating: hypromellose type 2910 (E464), talc (E553b), titanium dioxide (E171).

Appearance of Qlaira and pack contents

Film-coated tablets; the tablet core is coated with a film.

Each calendar pack (28 film-coated tablets) contains 2 dark yellow tablets in row 1; 5 medium red tablets in row 1; 17 light yellow tablets in rows 2, 3, and 4; 2 dark red tablets in row 4; 2 white tablets in row 4.

The active dark yellow tablet is round, biconvex, and engraved on one side with the letters “DD” included in a regular hexagon.

The active medium red tablet is round, biconvex, and engraved on one side with the letters “DJ” included in a regular hexagon.

The active light yellow tablet is round, biconvex, and engraved on one side with the letters “DH” in a regular hexagon.

The active dark red tablet is round, biconvex, and engraved on one side with the letters “DN” in a regular hexagon.

The inactive white tablet is round, biconvex, and engraved on one side with the letters “DT” in a regular hexagon.

This medicine is available in packs of 1, 3, or 6 calendar packs, each with 28 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder

Bayer Hispania, S.L. Av. Baix Llobregat, 3 – 08970 Sant Joan Despí - Barcelona

Spain

Manufacturer

Bayer Weimar GmbH und Co. KG Doebereiner Str. 20

99427 Weimar

Germany

Or

Bayer AG 13342, Berlin

Germany

This medicine 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

Date of last revision of this leaflet:May/2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es