Leaflet: information for the user

Qlaira coated tablets
Valerato de estradiol/ Dienogest

Read this 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. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.

-If you experience any side effects, talk to your doctor or pharmacist. This is because some side effects can be serious.

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 suffering a blood clot in the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a break of 4 weeks or more.
• Be aware and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

1.What is Qlaira and what it is used for2

2.What you need to know before starting to take Qlaira3

You should not take Qlaira3

Warnings and precautions4

Blood clots5

Qlaira and cancer9

Mental health disorders…………………………………………………….10

Spotting between periods10

What to do if you do not have a period on the 26th day or in the following days10

Other medicines and Qlaira10

Use of Qlaira with food and drink10

Laboratory tests11

Pregnancy and breastfeeding11

Driving and operating machinery11

Qlaira contains lactose11

3.How to take Qlaira……………………………………………………...11

Preparing the calendar pack11

When can you start with the first calendar pack?12

What to do if you take more Qlaira than you should13

What to do if you forget to take Qlaira13

Use in children15

What to do in case of severe vomiting or diarrhea15

What to do if you stop taking Qlaira15

4.Possible side effects……………………………………………….15

5.Storage of Qlaira…………………………………………………17

6.Contents of the pack and additional information…………………………18

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

When Not to Take Qlaira

You should not use Qlaira 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) ablood clotin a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• If you know that you have ablood clotting disorder: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.
• If you need surgery or if you spend a lot of time without getting up (see section“Blood Clots”).
• If you have ever had aheart attackor astroke.
• If you have (or have ever had) aangina pectoris(a condition that causes a severe pain in the chest and may be the first sign of a heart attack) or atransient ischemic attack(TIA, symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:

- Severe diabetes with vascular damage.

- Very high blood pressure.

- Very high levels offat in the blood(cholesterol or triglycerides).

- A condition calledhyperhomocysteinemia.

• If you have (or have ever had) a type ofmigrainecalled “migraine with aura”.
• If you have (or have ever had) aliver diseaseand your liver function has not yet normalized.
• If you have (or have ever had) aliver tumor.
• If you have (or have ever had) or are suspected to havebreast cancer or cancer of the reproductive organs.
• If you haveunexplained vaginal bleeding.
• If you areallergic(hypersensitive) to estradiol valerate or to dienogest, or to any of the other components of this medication (including in section 6). This may manifest itself with itching, rash or inflammation.

Warnings and Precautions

When to Consult Your Doctor?

Seek immediate medical attention

• If you notice possible signs of a blood clot that may mean you are suffering from 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”.

Inform your doctor if you suffer from any of the following conditions.

In some 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 the condition develops or worsens while you are using Qlaira, you should also inform your doctor:

• If any close relative has had or has cancer of the breast.
• If you have any liver disease or gallbladder disease.
• If you have jaundice.
• If you have diabetes.
• If you have depression.
• If you have inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
• 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 insufficiency).
• If you have sickle cell anemia (a hereditary disease of 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 surgery or spend a lot of time without getting up (see section2 “Blood Clots”).
• If you have recently given birth, you are at greater risk of developing blood clots. Ask your doctor when you can start taking Qlaira again.
• If you have superficial vein inflammation under the skin (thrombophlebitis).
• If you have varicose veins.
• If you have epilepsy (see “Other Medications and Qlaira”).
• If you have a disease that appeared for the first time during pregnancy or during a previous use of sex hormones, for example, hearing loss, porphyria (a blood disease), gestational herpes (skin rash with blisters during pregnancy), Sydenham’s chorea (a nervous disease with involuntary movements).
• If you have (or have had in the past) brownish-yellow spots, also called “pregnancy spots”, especially on the face (melasma). In that case, avoid direct exposure to the sun or ultraviolet rays.
• If you have hereditary or acquired angioedema. Stop taking Qlaira and consult your doctor immediately if you experience symptoms such as facial swelling, tongue or throat swelling, and difficulty swallowing or urticaria accompanied by difficulty breathing, which suggest angioedema. Estrogen-containing products may induce or worsen angioedema symptoms.
• If you have heart or kidney failure.

Consult your doctor before starting to take Qlaira.

Additional Information on Special Populations

Use in Children

Qlaira is not indicated for use in girls who have not yet started menstruating.

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 veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or TEA).

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

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 immediate medical attentionif 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 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 may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

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

The risk of a blood clot in a vein is higher during the first year of taking a combined hormonal contraceptive for the first time. The risk may be higher if you start taking a combined hormonal contraceptive again (the same medication or a different medication) after a break of 4weeks 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 Qlaira, your risk of developing a blood clot returns to normal in 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 Qlaira is small.

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

• The risk of a blood clot with Qlaira is practically the same as with other combined hormonal contraceptives, including those that contain 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 developing a blood clot is higher:

• If you are overweight (body mass index (BMI) of 30kg/m2or more).
• If any close relative has had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50years). You may have a hereditary blood clotting disorder.
• If you need surgery or spend a lot of time without getting up due to an injury or disease, or if you have a leg cast. You may need to stop taking Qlaira for several weeks before the operation or while you have less mobility. If you need to stop taking Qlaira, ask your doctor when you can start taking it again.
• As you get older (especially over about 35years).
• If you have given birth recently.

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

Long flights (over 4hours) may temporarily increase your 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 conditions listed above, even if you are unsure. Your doctor may decide that you should stop taking Qlaira.

If any of the conditions listed above change while you are using Qlaira, 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 blood 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 Qlaira is very small, but it may increase:

• With age (over about 35years).
• If you smoke.When using a combined hormonal contraceptive like Qlaira, you are advised to quit smoking. If you are unable to quit smoking and are over 35years, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any close relative has had a heart attack or stroke at a young age (less than about 50years). You may also be at higher risk of having a heart attack or stroke.
• If you or any close relative has 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, irregular heartbeat called atrial fibrillation).
• If you have diabetes.

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

If any of the conditions listed above change while you are using Qlaira, 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

There has been an observedbreast cancerslightly more often 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 the doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to undergo regular breast examinations, and you should consult your doctor if you notice any lump.

In rare cases, benign liver tumors and, even more rarely, malignant liver tumors have been reported in users of oral contraceptives. In isolated cases, these tumors have caused internal bleeding that puts the patient’s life at risk. Consult your doctor if you experience severe abdominal pain.

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

Mental Health Disorders

Some women who use combined contraceptives like Qlaira have reported depression or a depressive mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, consult your doctor for additional medical advice as soon as possible.

Spotting

During the first few months of taking Qlaira, you may experience unexpected bleeding. Usually, the bleeding starts on the 26th day, the day you take the second dark red pill, or the following days. According to information provided by women in their diaries during a clinical study of Qlaira, it is not uncommon for women to experience unexpected bleeding in a particular cycle (10-18% of users). If the unexpected bleeding persists 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 information provided by women in their diaries during a clinical study of Qlaira, it is not uncommon for the regular period not to occur on the 26th day (this was observed in about 15% of cycles).

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

If your regular period does not occur for two consecutive times or if you have taken the pills incorrectly, you may be pregnant. Consult your doctor immediately. Do not start the next calendar pack until you are sure you are not pregnant.

Other Medications and Qlairaand 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 another medication (or the pharmacist who dispenses the medication) that you are taking Qlaira. They may advise you to take additional contraceptive precautions (for example, condoms) and, if so, for how long.

Some medications

• may affect the levels of Qlaira in the blood
• may causeloss of contraceptive effect
• may cause unexpected bleeding

These include:

• medications used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate)
• tuberculosis (e.g., rifampicin)
• infections with HIV and hepatitis C (calledprotease inhibitors and non-nucleoside reverse transcriptase inhibitorssuch as ritonavir, nevirapine, efavirenz).
• Medications for hepatitis C (HCV) (e.g., combined regimens for HCV or ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin; glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir) may cause elevated liver enzyme levels (increased ALT) in women using AHC with ethinylestradiol. Qlaira contains estradiol instead of ethinylestradiol. It is unknown whether elevated liver enzyme levels can occur when Qlaira is used with this combined regimen for HCV. Your doctor will inform you about this.
• infections with fungi (e.g., griseofulvin, ketoconazole)

• St. John’s Wort

Qlaira mayaffect the effectof other medications, for example:

• medications containing ciclosporin
• the antiepileptic lamotrigine (may lead to an increase in seizure frequency).

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.

Use of Qlaira with Food and Drinks

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

Laboratory Tests

If you need a blood test or other laboratory tests, inform your doctor or the laboratory staff that you are taking the pill, as combined hormonal contraceptives may affect the results of some tests.

Pregnancy and Breastfeeding

Do not take Qlaira if you are pregnant. If you become pregnant during treatment with Qlaira, stop treatment immediately and consult your doctor. If you want to become pregnant, you can stop taking Qlaira at any time (see also “Stopping Qlaira”).

Generally, it is not recommended to take Qlaira during breastfeeding. If you want to take the contraceptive while breastfeeding, consult your doctor.

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

Driving and Operating Machines

There is no information to suggest that the use of Qlaira has any effect on your ability to drive or operate machines.

Qlaira Contains Lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

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

Preparing the calendar pack

To help you keep track of the tablets, 7 adhesive strips with the 7 days of the week are provided.

Choose the strip for 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 strip that starts with “WED”.

Stick the strip on the top of the Qlaira calendar pack, where it says “Stick the strip here!”, so that the first day is above the tablet marked with “1”.

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

Usually, 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 have bleeding after taking the first tablets of the new calendar pack.

Start the next calendar pack without interruption, that is, the day after you have finished the current calendar pack, even if the bleeding has not finished. This means that you must start the next calendar pack on the same day of the week as the current calendar pack and the withdrawal bleeding must 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 take the inactive tablets.

When to 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 (that is, the first day of your menstruation).
• Switching from another combined hormonal contraceptive pill, vaginal combined contraceptive ring, or patch.
  Start Qlaira the day after taking the last active tablet (the last tablet that contains the active ingredients) of your previous pill.When switching from a vaginal combined contraceptive ring or patch, start using Qlaira on the same day of its removal or follow your doctor's recommendations.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system (IUS) releasing progestogen).
  You can switch from the progestogen-only pill on any day. If it is an implant or an IUS, on the same day of its removal. If it is an injection, when the next injection is due. In all cases, it is recommended that you use additional contraceptive methods (for example, a condom) during the first 9 days of taking Qlaira.
• After an abortion.
  Follow your doctor's recommendations.
• After giving birth.
  You can start taking Qlaira between 21 and 28 days after giving birth. If you start later than the 28th day, use a barrier method (for example, a condom) during the first 9 days of taking Qlaira.

If, after giving birth, you have already had sex before taking Qlaira again, you must be sure you are not pregnant or wait for your next menstrual period.

If you want to start taking Qlaira after giving birth and you 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 serious harm has been reported in cases of Qlaira overdose.

If you take many 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 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 as it does not contain any active ingredient. However, it is essential to 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 when you forgot to takeoneactive tablet, you may need to takeadditional contraceptive precautions, for example, a barrier method like a condom.Take the tablets according to the principles described below.See more details in the “table for forgetting a tablet”.

• If you are lateless than 12 hoursin taking a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and the subsequent tablets at the usual time.
• If you are latemore than 12 hoursin taking a tablet, the protection against pregnancy may be reduced. Depending on the day of the cycle when you forgot to take the tablet, take additional contraceptive precautions, for example, a barrier method like a condom.See more details in the “table for forgetting a tablet”.
• If you have forgotten more than one tablet from the calendar pack.
  Consult your doctor.

Do not take more than 2 active tablets on the same day.

If you forgot to start a new calendar pack or if you forgot to take one or more tablets between the3rd and 9th dayof your calendar pack, there is a risk that you are pregnant (if you have had sex in the 7 days before forgetting the tablet). In that case, see your doctor.The more tablets you have forgotten (especially between the3rd and 24th day) and the closer they are to the inactive tablets phase, the greater the risk of reduced protection against pregnancy.See more details in the “table for forgetting a tablet”.

If you forgot 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. See your doctor before continuing with the next calendar pack.

Use in children

No data is available for adolescents under 18 years old.

What to do in case of vomiting or intense diarrhea

If you have vomiting within 3-4 hours after taking an active tablet or if you have intense diarrhea, there is a risk that the active ingredients of the tablet will 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 for taking your contraceptive. If not possible or more than 12 hours have passed, follow the instructions in the section “If you forgot to take Qlaira”. If you do not want to change your usual tablet-taking schedule, take the corresponding tablet from another calendar pack.

If you interrupt treatment with Qlaira

You can stop taking Qlaira whenever you want. If you do not want to get pregnant, consult your doctor about other effective methods of birth control.If you want to get pregnant, stop taking Qlaira and wait until your menstrual period before trying to get pregnant. This way, you can calculate your estimated due date more easily.

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

Like all medicines, Qlaira may cause side effects, although not everyone will experience them.If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be related to Qlaira, consult your doctor.

All women taking 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 section2 “What you need to know before starting to take Qlaira”.

Severe 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 related to the use of Qlaira:

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

• Headache
• Abdominal pain, nausea
• Acne
• Amenorrhea, breast tenderness, painful periods, irregular bleeding (irregular and heavy bleeding)
• Weight gain

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

• Fungal infections, vulvovaginal candidiasis, vaginal infection
• Increased appetite
• Depression, depressive mood, emotional disorders, sleep disorders, loss of interest in sex, mental disorders, mood changes
• Dizziness, migraine
• Seizures, hypertension
• Diarrhea, vomiting
• Increased liver enzymes
• Loss of hair, excessive sweating (hyperhidrosis), itching, skin rash
• Muscle cramps
• Breast enlargement, breast lumps, abnormal cell growth in the cervix (cervical dysplasia), dysfunctional genital bleeding, painful sex, fibrocystic breast disease, heavy menstrual bleeding, menstrual disorders, ovarian cysts, pelvic pain, premenstrual syndrome, uterine growth, uterine contractions, vaginal bleeding/spotting, vaginal discharge, vaginal 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):

• Fungal infection, oral herpes, pelvic inflammatory disease, eye disease that resembles a fungal infection (presumed histoplasmosis ocular), skin fungal infection (pityriasis versicolor), urinary tract infection, bacterial vaginosis
• Fluid retention, increased triglycerides
• Aggression, anxiety, feeling of unhappiness, increased interest in sex, nervousness, nightmares, restlessness, sleep disorders, stress
• Decreased attention, tingling sensation, dizziness
• Eye lens intolerance, dry eyes, eye swelling
• Heart attack (myocardial infarction), palpitations
• Varicose vein bleeding, low blood pressure, superficial vein inflammation, painful veins
• Detrimental blood clots in a vein or artery, e.g.
• In a leg or foot (i.e. DVT).
• In a lung (i.e. PE).
• Heart attack.
• Stroke.
• Transient ischemic attack (TIA), which is a temporary stroke-like symptom.
• 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 section2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

• Constipation, dry mouth, indigestion, heartburn
• Hepatic nodules (focal nodular hyperplasia), chronic inflammation of the gallbladder
• Skin allergic reactions, brownish-yellow patches (melasma) and other skin disorders, male pattern hair growth, excessive hair growth, skin diseases such as dermatitis and neurodermatitis, dandruff, and other skin disorders
• Back pain, jaw pain, feeling of heaviness
• Urinary tract pain
• Abnormal menstrual bleeding, breast nodules, early breast cancer, breast cysts, nipple discharge, cervical polyp, cervical inflammation, painful sex, fibrocystic breast disease, heavy menstrual bleeding, menstrual disorders, ovarian cysts, pelvic pain, premenstrual syndrome, uterine growth, uterine contractions, vaginal bleeding/spotting, vaginal discharge, vaginal dryness
• Lymph node inflammation
• Asthma, difficulty breathing, nasal bleeding
• Chest pain, fatigue, general feeling of illness, fever
• Abnormal cervical smear

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

Description of selected adverse reactions

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

• Hepatic tumors (benign and malignant)
• Erythema nodosum (red, sensitive nodules under the skin), erythema multiforme (skin eruptions with red patches 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.), 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 discontinue the use of combined oral contraceptives.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the package calendar after CAD. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Qlaira Composition

The active principles are valerianate of estradiol, or valerianate of estradiol combined with dienogest.

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

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

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

Composition of the inactive white tablets:

These tablets do not contain active principles.

The other components of the colored active tablets are:

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

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

The other components of the inactive white tablets are:

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

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

Appearance of the product and contents of the pack:

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

Each calendar pack (28 film-coated tablets) contains 2 dark yellow tablets in the first row; 5 intermediate 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; 2 white tablets in the fourth row.

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

The active intermediate 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.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder:

Bayer Hispania, S.L.
Av. Baix Llobregat, 3 – 5
08970 Sant Joan Despí - Barcelona

Spain

Responsible for manufacturing:

Bayer Weimar GmbH und Co. KG
Doebereiner Str. 20

99427 Weimar

Germany

Or

Bayer AG
13342, Berlin

Germany

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) 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, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland):QLAIRA/Qlaira
• Italy:KLAIRA

Last revision date of this leaflet: May 2025

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es