Qlaira film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Qlaira film-coated tablets Estradiol, valerate / Dienogest

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Important things you should know about combined hormonal contraceptives (CHCs):

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

Leaflet contents:

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

When not to take Qlaira 3

Warnings and precautions 4

Blood clots 5

Qlaira and cancer 9

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

Bleeding between periods 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

Use of Qlaira with food and drink 10

Laboratory tests 11

Pregnancy and breastfeeding 11

Driving and using machines 11

Qlaira contains lactose 11

3. 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 diarrhoea 15

If you stop treatment with Qlaira 15

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

1. What Qlaira is and what it is used for

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

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

General considerations Before starting this medicine, you should read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”). Before you start taking this medicine, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your personal circumstances, may carry out some additional tests. This leaflet describes several situations in which you should stop using Qlaira, or in which the reliability of the medicine may be reduced. In these situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use rhythm or temperature methods. These methods may not be reliable because Qlaira alters the monthly changes in body temperature and cervical mucus. Qlaira, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

When you should not 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 which alternative method of contraception would be most suitable.

Do not take Qlaira:

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.

• If you know you have a disorder affecting blood clotting : for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.

• If you require surgery or will be immobile for a long period (see section “Blood clots”).

• If you have ever had a heart attack or a stroke.

• If you have (or have ever had) angina pectoris (a condition causing 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 conditions that may increase your risk of developing 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 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 has not yet returned to normal.
  • If you have (or have ever had) a liver tumour.
  • If you have (or have ever had) or there is suspicion of breast cancer or cancer of the genital organs.
  • If you have vaginal bleeding of unknown cause.
  • If you are allergic (hypersensitive) to estradiol valerate or dienogest, or to any of the other ingredients of this medicine (listed in section 6). This may present as itching, rash, or swelling.

Warnings and precautions

When should you consult your doctor?

Seek urgent medical assistance

• If you notice possible signs of a blood clot, which may indicate that 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).

For a description of the symptoms of these serious adverse effects, see “How to recognize a blood clot”.

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

In certain situations, you should take special care while taking Qlaira or any other combined hormonal contraceptive, and your doctor may need to examine you periodically. If any of these conditions develop or worsen while you are using this medicine, you must also inform your doctor:

• If any close family member has or has ever had 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 affecting your body’s natural defense system).
• If you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure).
• If you have sickle cell anaemia (an inherited red blood cell disorder).
• If you have high levels of fat in the blood (hypertriglyceridaemia) or a known family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you require surgery or will be immobile for a long time (see section 2 “Blood clots”).
• If you have recently given birth, you are at increased risk of blood clots. You should ask your doctor when you can start taking Qlaira after childbirth.
• If you have inflammation of veins beneath the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have epilepsy (see “Other medicines and Qlaira”).
• If you have a condition that first occurred during pregnancy or a previous use of sex hormones, for example, hearing loss, porphyria (a blood disorder), herpes gestationis (blistering rash during pregnancy), Sydenham’s chorea (a neurological disorder causing involuntary movements).
• If you have (or have had in the past) brownish-yellow patches, also known as “melasma”, particularly on the face (chloasma). In such cases, avoid direct exposure to sunlight or ultraviolet radiation.
• If you have hereditary or acquired angioedema. Stop taking this medicine and consult your doctor immediately if you experience symptoms such as swelling of the face, tongue, or throat, difficulty swallowing, hives, or difficulty breathing, which may indicate angioedema. Medicinal products containing oestrogens may induce or worsen angioedema symptoms.
• 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 indicated for use in girls who have not yet started menstruating.

Blood clots

Using a combined hormonal contraceptive such as Qlaira increases your risk of developing a blood clot compared to not using one. Rarely, 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. Rarely, there may be long-lasting serious effects, and very rarely, they can be fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you experience any of the following signs or symptoms.

Are you experiencing any of these signs?	What might you be suffering from?
Swelling in one leg or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticeable when standing or walking.Increased warmth in the affected leg.Skin discoloration in the leg, e.g., turning pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without a known cause or rapid breathing. Sudden cough without a clear cause, possibly bringing up blood. Sharp chest pain that may worsen when breathing deeply. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe stomach (abdominal) pain. If you are unsure, consult a doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition like a respiratory tract infection (e.g., a “common cold”).	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision, or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye)
Chest pain, discomfort, pressure, or heaviness. Feeling of tightness or fullness in the chest, arm, or below the breastbone. Feeling of fullness, indigestion, or suffocation. Upper body discomfort spreading to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Severe weakness, anxiety, or shortness of breath. Rapid or irregular heartbeat.	Heart attack
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech. Sudden vision problems in one or both eyes. Sudden difficulty walking, dizziness, loss of balance or coordination. Sudden, severe, or prolonged headache without a known cause. Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of a limb. Severe abdominal pain (acute abdomen).	Blood clots blocking other blood vessels

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 during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and travels to the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

The risk of developing a blood clot in a vein is higher during the first year of first-time use of a combined hormonal contraceptive. The risk may also be increased if you restart 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 remains somewhat higher than if you were not taking a combined hormonal contraceptive.

When you stop taking this medicine, 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 venous thromboembolism (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 medicine is low.

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.

• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.

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

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

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill and who are not pregnant	About 2 in 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5–7 in 10,000 women
Women who use Qlaira	Almost the same as with other combined hormonal contraceptives, including contraceptives containing levonorgestrel

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

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

• If you are overweight (body mass index or BMI above 30 kg/m²).
• If any of your close relatives have had a blood clot in the leg, lung, or another organ at a young age (i.e., before the age of approximately 50). In this case, you may have an inherited blood clotting disorder.
• If you need surgery or will be immobile for a long time due to injury or illness, or if your leg is 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 medicine, ask your doctor when you can start taking it again.
• As you get older (especially over about 35 years of age).
• If you have given birth within the last few weeks.

The risk of developing a blood clot increases the more of these conditions you have.

Air travel (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed above.

It is important to inform your doctor if you have any of the conditions listed above, even if you are unsure. Your doctor may decide that you need to stop taking this medicine.

If any of the conditions listed above change while you are using this medicine—for example, if a close relative experiences a thrombosis 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?

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

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

It is important to note that the risk of heart attack or stroke from using this medicine is very small, but it may increase:

• With age (especially over about 35 years).
• If you smoke. You are advised to stop smoking when using a combined hormonal contraceptive such as Qlaira. 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 a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of 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 suffer from migraines, especially migraines with aura.
• If you have a heart condition (valve disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

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

If any of the conditions listed above change while you are using this medicine—for example, if you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a lot of weight—inform your doctor.

Qlaira and cancer

Breast cancer has been observed slightly more often in women using combined hormonal contraceptives, but it is not known whether this is due to the treatment. For example, more tumors may be detected in women using combined contraceptives because they are examined by a physician more frequently. The incidence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important to have regular breast examinations, and you should consult your doctor if you notice any lump.

In rare cases, benign liver tumors have been reported in users of contraceptive pills, and even more rarely, malignant liver tumors. In isolated cases, these tumors have caused life-threatening internal bleeding. Seek medical attention if you experience unusually severe abdominal pain.

Some studies suggest that long-term use of oral contraceptives may increase the risk of developing cervical cancer. However, it is unclear to what extent sexual behavior or other factors, such as human papillomavirus (HPV), contribute to this increased risk.

Psychiatric disorders

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

Bleeding between periods

During the first few months you are taking this medication, you may experience unexpected bleeding. Usually, the bleeding starts on day 26, the day you take the second dark red tablet, or on the following days. According to data recorded by women in their diaries during a clinical study of Qlaira, it is not unusual to experience unexpected bleeding in any given cycle (10-18% of users). If unexpected bleeding occurs for more than three consecutive months, or if it starts after several months of use, your doctor should investigate the cause.

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

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

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

If you miss your expected period for two consecutive cycles, or if you have not taken the tablets correctly, you may be pregnant. Consult your doctor immediately. Do not start the next calendar pack until you are certain that you are not pregnant.

Other medicines and Qlaira

Always inform your doctor about any medicines or herbal preparations you are taking. Also inform any other doctor or dentist who prescribes you a new medicine (or the pharmacist dispensing the medicine) that you are taking Qlaira. They will advise you whether you need to take additional contraceptive precautions (for example, condoms), and if so, for how long.

Some medicines:

• may affect the levels of Qlaira in the blood
• may cause Qlaira to lose its contraceptive effect
• may cause unexpected bleeding

These include:

• medicines used to treat:

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate)

• tuberculosis (e.g. rifampicin)

• HIV and hepatitis C virus infections (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)

• Medicines for hepatitis C virus (HCV) (e.g., HCV combination regimens ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirine; glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir) may cause increases in blood test results for liver function (elevation of liver enzyme ALT) in women using combined hormonal contraceptives containing ethinylestradiol. Qlaira contains estradiol instead of ethinylestradiol. It is unknown whether an increase in liver enzyme ALT may occur when this medicine is used with these HCV combination regimens. Your doctor will advise you accordingly.

• fungal infections (e.g. griseofulvin, ketoconazole)

• herbal preparations containing St. John’s wort

Qlaira may affect the action of other medicines, for example:

• medicines containing cyclosporine
• the antiepileptic lamotrigine (which may lead to an increased frequency of seizures)

Consult your doctor or pharmacist before using any medicine. Your doctor or pharmacist may advise you to use additional protective measures while taking other medicines together with Qlaira.

Use of Qlaira with food and beverages

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

Laboratory tests

If you require a blood test or other laboratory tests, inform your doctor or laboratory staff that you are taking the pill, as oral contraceptives may influence the results of certain tests.

Pregnancy and breastfeeding

If you become pregnant while being treated with this medicine, you should stop treatment immediately and contact your doctor. If you wish to become pregnant, you may stop taking this medicine at any time (see also “If you stop taking Qlaira”).

In general, it is not recommended to take this medicine during breastfeeding. If you wish to take a contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before using any medicine if you are pregnant or breastfeeding.

Driving and use of machines

There is no information suggesting that the use of this medicinal product has any effect on the ability to drive or operate machinery.

Qlaira contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Qlaira

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

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

Preparation of the calendar pack

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

Choose the adhesive strip for the week starting with the day on which you take the first tablet. For example, if you take your first tablet on a Wednesday, use the strip starting with "WED".

Attach the weekly adhesive strip to the top of the Qlaira calendar pack, where indicated "Place the adhesive strip here!", so that the first day is positioned above the tablet marked with "1".

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

Typically, the so-called withdrawal bleeding starts while 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 continue to experience bleeding after taking the first tablets of the new calendar pack.

Begin the next calendar pack without interruption, that is, the day after finishing the current calendar pack, even if bleeding has not stopped. This means you should start the next calendar pack on the same day of the week as the current one, and withdrawal bleeding should occur on 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 are taking 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 menstrual period).
• Switching from another combined hormonal contraceptive pill, vaginal combined contraceptive ring, or contraceptive patch. Start Qlaira the day after taking the last active tablet (the last tablet containing active substances) of your previous pill. When switching from a vaginal combined contraceptive ring or patch, start using Qlaira on the same day of removal or follow your doctor's recommendations.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or progestogen-releasing intrauterine system (IUS)). You may switch from the progestogen-only pill on any day. If switching from an implant or IUS, on the same day of its removal. If switching from an injectable, at the time the next injection would have been due. In all cases, it is recommended that you use additional contraceptive measures (e.g., a condom) during the first 9 days of taking Qlaira.
• After an abortion. Follow your doctor's advice.
• After childbirth. You may start taking Qlaira between 21 and 28 days after giving birth. If you start later than the 28th day, use a barrier method (e.g., a condom) during the first 9 days of using Qlaira.

If, after childbirth, you have already had sexual intercourse before restarting Qlaira, you must be sure that you are not pregnant or wait until your next menstrual period.

If you wish to start taking this medicine after childbirth 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 ingestion of an overdose of the medicine has caused serious harm.

If you take many active tablets at once, you may experience nausea or vomiting. Young girls may experience vaginal bleeding.

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

If you forget to take Qlaira

Inactive tablets: If you forget to take a white tablet (the last 2 tablets in the calendar pack), you do not need to take it later, as these contain no active ingredient. However, it is important that you discard any missed white tablets to ensure that the number of days you take inactive tablets does not increase, as this could increase the risk of pregnancy. Continue taking the next tablet at your usual time.

Active tablets: Depending on the day of the cycle shown in your current calendar pack when you forget to take one active tablet, you may need to take additional contraceptive precautions, such as using a barrier method like a condom. Follow the instructions outlined below. See further details in the “Missed tablet schedule”.

• If you are less than 12 hours late taking a tablet, contraceptive protection will not be reduced. Take the tablet as soon as you remember, and take subsequent tablets at your usual time.
• If you are more than 12 hours late taking a tablet, contraceptive protection may be reduced. Depending on the day of the cycle shown in your current calendar pack when you missed the tablet, take additional contraceptive precautions, such as using a barrier method like a condom. See further details in the “Missed tablet schedule”.
• If you have missed 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 miss one or more tablets between day 3 and day 9 of your calendar pack, 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, consult your doctor. The greater the number of tablets missed (especially between day 3 and day 24) and the closer they are to the inactive tablet phase, the higher the risk of reduced protection against pregnancy. See further details in the “Missed tablet schedule”.

If you have missed one or more active tablets from a calendar pack and do not have your period at the end of the pack, you may be pregnant. Consult your doctor before starting the next calendar pack.

Forgot more than 1 coloured tablet Forgot to start a new calendar pack			Contact your doctor immediately
					YES
Forgot 1 tablet only (more than 12 hours have passed)			Days 1-9		Have you had sexual intercourse in the 7 days prior to the missed tablet(s)?
		NO
		Take the missed tablet immediately Take the next tablet at the same time as usual (this may mean taking 2 tablets on the same day) Continue taking one tablet daily at the same time as usual Use a barrier method (e.g., condom) for the next 9 days
		Days 10-17
	Do not take the missed tablet; discard the current calendar pack Take the first tablet from a new calendar pack Continue taking one tablet daily from the new calendar pack at the same time as usual Use a barrier method (e.g., condom) for the next 9 days
		Days 18-24
	Take the missed tablet immediately Take the next tablet at the same time as usual (this may mean taking 2 tablets on the same day) Continue taking one tablet daily at the same time as usual No additional contraceptive method is necessary
		Days 25-26
	Discard the missed tablet Take the next tablet at the same time as usual When missing the last tablet in the current calendar pack, continue by taking the first tablet from the new calendar pack at the same time as usual No additional contraceptive method is necessary
		Days 27-28

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 experience severe diarrhea, there is a risk that the active substances in the tablet may not be completely absorbed by your body.

This situation is similar to forgetting to take a tablet. After vomiting or severe diarrhea, you should take the next tablet as soon as possible. If possible, take it within 12 hours of your usual time for taking the contraceptive. If this is not possible, or if more than 12 hours have passed, follow the advice in the section “If you forget to take Qlaira”. If you do not wish to alter your normal tablet-taking schedule, take the corresponding tablet from another calendar pack.

If you stop treatment with Qlaira

You may stop taking the medication at any time. If you do not wish to become pregnant, consult your doctor about other effective methods of contraception. If you wish to become pregnant, stop taking the medication and wait until your next menstrual period before trying to conceive. This will make it easier to estimate the due date.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone gets them. If you experience any adverse 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 have an increased 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 associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting Qlaira”.

Serious adverse effects

Serious reactions related to the use of the pill, as well as associated symptoms, are described in the following sections “Blood clots” and “Qlaira and cancer”. Please read these sections carefully and consult your doctor when appropriate.

Other possible adverse effects

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

Frequent adverse effects (may affect up to 1 in 10 people):

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

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

• fungal infections, fungal infection of the vulva and vagina, vaginal infection
• increased appetite
• depression, depressed mood, emotional disorders, sleep disturbance, loss of interest in sex, mental disorder, mood changes
• dizziness, migraine
• hot flushes, high blood pressure
• diarrhoea, 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 sexual intercourse, fibrocystic breast disease, heavy menstruation, menstrual disorders, ovarian cyst, pelvic pain, premenstrual syndrome, growth in the uterus, uterine contractions, uterine/vaginal bleeding including spotting, vaginal discharge, vulvovaginal dryness
• fatigue, irritability, swelling of parts of the body, e.g. ankles (oedema)
• weight loss, changes in blood pressure

Rare adverse 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), fungal skin infection (pityriasis versicolor), urinary tract infection, bacterial vaginosis
• fluid retention, increase in certain blood fats (triglycerides)
• aggression, anxiety, feeling of unhappiness, increased interest in sex, nervousness, nightmares, restlessness, sleep disorders, stress
• reduced attention, tingling sensation, dizziness
• intolerance to contact lenses, dry eyes, eye swelling
• heart attack (myocardial infarction), palpitations
• bleeding from varicose veins, low blood pressure, inflammation of superficial veins, 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.
  • Mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA).
  • Blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information about 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
• skin allergic reactions, golden-brown skin patches (chloasma) and other pigment disorders, growth of hair in a male pattern, excessive hair growth, skin disorders such as dermatitis and neurodermatitis, dandruff and oily skin (seborrhoea) and other skin disorders
• back pain, jaw pain, feeling of heaviness
• pain in the urinary tract
• abnormal withdrawal bleeding, benign breast lumps, early-stage breast cancer, breast cysts, breast discharge, cervical polyp, redness of the cervix, bleeding during sexual intercourse, spontaneous milk discharge, genital discharge, less heavy menstruation, delayed menstruation, rupture of an ovarian cyst, vaginal odour, burning sensation in the vulva and vagina, vulvovaginal discomfort
• inflammation of lymph nodes
• asthma, difficulty breathing, nosebleeds
• chest pain, tiredness and general malaise, fever
• abnormal cervical smear test

Additional information (based on diaries kept by women in a clinical trial of Qlaira) about the possible adverse 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 day 26 or the following days”.

Description of selected adverse reactions

Listed below are very rare or delayed-onset adverse reactions considered related to the group of combined oral contraceptives, which may also occur during the use of Qlaira (see also sections “When not to take Qlaira” and “Warnings and precautions”).

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

In case of impaired liver function, temporary discontinuation of combined oral contraceptives may be necessary.

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Qlaira

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the calendar pack after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other 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 colours in the first, second, third and fourth rows, and two white inactive tablets in the fourth row.

Composition of the coloured 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 any active substances.

Other components of the coloured active tablets:

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

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

Other components of the white inactive tablets:

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

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

Appearance of Qlaira and contents of the pack

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 dark yellow active tablet is round, biconvex-faced, and marked on one side with the letters “DD” within a regular hexagon.

The medium red active tablet is round, biconvex-faced, and marked on one side with the letters “DJ” within a regular hexagon.

The light yellow active tablet is round, biconvex-faced, and marked on one side with the letters “DH” within a regular hexagon.

The dark red active tablet is round, biconvex-faced, and marked on one side with the letters “DN” within a regular hexagon.

The white inactive tablet is round, biconvex-faced, and marked on one side with the letters “DT” within a regular hexagon.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Bayer Hispania, S.L.
Av. Baix Llobregat, 3 – 508970 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 authorised 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 the most recent revision of this leaflet: May/2025

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