Aiqlara film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

aiqlara film-coated tablets EFG

estradiol valerate/dienogest

Read the entire leaflet carefully before you start using 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Important information 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 blood clots 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 be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Leaflet contents

1. What aiqlara is and what it is used for
2. What you need to know before using aiqlara
3. How to use aiqlara
4. Possible side effects
5. How to store aiqlara
6. Contents of the pack and other information

1. What aiqlara is and what it is used for

• Aiqlara is a contraceptive used to prevent pregnancy.
• Each colored active 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 containing two hormones are known as "combined contraceptives".

2. What you need to know before starting to use aiqlara

General considerations Before starting to use aiqlara, 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 aiqlara, 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 situation, may carry out some additional tests. This patient information leaflet describes several situations in which you should stop using aiqlara, or in which the effectiveness of aiqlara may be reduced. In such situations, you should not have sexual intercourse or should use additional non-hormonal contraceptive precautions, for example, use of a condom or another barrier method. Do not use the rhythm method or the temperature method. These methods may not be reliable because aiqlara alters the monthly changes in body temperature and cervical mucus. Aiqlara, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

When not to take aiqlara

Do not use aiqlara 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 other form of contraception would be more suitable.

Do not take aiqlara

• 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 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 diseases 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 hyperhomocysteinaemia.
• If you have (or have ever had) a type of migraine called “migraine with aura”.
• If you have (or have ever had) a liver disease and your liver function has not returned to normal.
• If you have (or have ever had) a liver tumour.
• If you have (or have ever had) or if it is suspected that you have breast cancer or cancer of the reproductive 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 manifest as itching, rash, or swelling.

Warnings and precautions

When should you consult your doctor? Seek urgent medical attention 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 side 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 when taking aiqlara 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 aiqlara, 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 hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anemia (an inherited red blood cell disorder);
• 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 require surgery or will be immobile for long periods (see section 2 “Blood clots”);
• if you have recently given birth, you are at increased risk of blood clots. Ask your doctor when you may start taking aiqlara 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 aiqlara”);
• if you have (or have previously had) brownish-yellow skin patches, also known as “pregnancy mask”, especially on the face (chloasma). In such cases, avoid direct exposure to sunlight or ultraviolet radiation;
• if you have hereditary or acquired angioedema. Stop taking aiqlara and contact 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. Products containing estrogens may trigger or worsen angioedema symptoms;
• if you have heart or kidney failure.

Consult your doctor before starting aiqlara.

Additional information on special populations

Use in children

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

BLOOD CLOTS

Using a combined hormonal contraceptive such as aiqlara 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 may form:

• in veins (known as “venous thrombosis”, “venous thromboembolism” or VTE);
• in arteries (known as “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, they may be fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you notice 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 noticed when standing or walking. Increased warmth in the affected leg. Change in skin color of 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 taking a deep breath. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe stomach pain. If you are unsure, consult a doctor, as some of these symptoms—such as cough or shortness of breath—can 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)
Pain, discomfort, pressure, or heaviness in the chest. Feeling of tightness or fullness in the chest, arm, or below the sternum. Feeling of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Extreme 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 trouble 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 stomach (abdominal) pain.	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 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 of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in 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 higher if you restart 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 somewhat higher than if you were not taking a combined hormonal contraceptive.

When you stop taking aiqlara, 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 aiqlara is small.

• 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 aiqlara is practically the same as with other combined hormonal contraceptives, including contraceptives 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).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal contraceptive pill and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5 - 7 out of 10,000 women
Women who use aiqlara	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 aiqlara 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 approximately 50 years of age). In this case, you might 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 aiqlara several weeks before surgery or while you are less mobile. If you need to stop taking aiqlara, ask your doctor when you can start 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 aiqlara.

If any of the conditions listed above change while you are using aiqlara—for example, a close relative experiences a thrombosis without a known cause, or you gain significant 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 stroke.

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

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

• with age (over about 35 years);
• if you smoke. When using a combined hormonal contraceptive such as aiqlara, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years of age, 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 (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, a heart rhythm disorder 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 further increased.

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

Aiqlara and cancer

Breast cancer has been observed slightly more frequently in women using combined contraceptives, but it is not known whether 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 often. The incidence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important to have regular breast examinations, and you should see your doctor if you notice any lumps.

Rarely, benign liver tumors and, even more rarely, malignant liver tumors have been reported in users of contraceptive pills. 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 unclear to what extent sexual behavior or other factors such as human papillomavirus (HPV) contribute to this risk.

Psychiatric disorders

Some women using hormonal contraceptives such as aiqlara 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 of taking aiqlara, you may experience unexpected bleeding. Usually, bleeding starts on day 26, the day you take the second brown tablet, or in the following days. According to data from women's diaries in a clinical study of aiqlara, it is not unusual to experience unexpected bleeding during 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 day 26 or in the following days

According to data from women's diaries in a clinical study of aiqlara, 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 vomited or had severe diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.

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

Other medicines and aiqlara

Inform your doctor at all times about any medicines or herbal preparations you are taking. Also inform any other doctor or dentist who prescribes you a medicine (or the pharmacist who dispenses it) that you are taking aiqlara. They may advise you whether you need to take additional contraceptive precautions (for example, condoms) and, if so, for how long.

Some medicines

• can affect the levels of aiqlara in the blood
• may cause loss of 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 ribavirin; glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir) may cause elevations in blood liver function test results (increase in liver enzyme ALT) in women using COCs containing ethinylestradiol. Aiqlara contains estradiol instead of ethinylestradiol. It is unknown whether an increase in liver enzyme ALT may occur when using aiqlara with this HCV combination regimen. Your doctor will inform you about this;

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

  • herbal St. John's wort preparations.

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

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

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

Use of aiqlara with food

Aiqlara can be taken with or without food.

Laboratory tests

If you need 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 some tests.

Pregnancy and breastfeeding

Do not take aiqlara if you are pregnant. If you become pregnant while taking aiqlara, stop treatment immediately and contact your doctor. If you wish to become pregnant, you may stop taking aiqlara at any time (see also “If you stop taking aiqlara”).

In general, taking aiqlara during breastfeeding is not recommended. If you wish to take a contraceptive during 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 aiqlara has any effect on the ability to drive or operate machinery.

Aiqlara contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take aiqlara

Each blister contains 26 colored active tablets and 2 white inactive tablets.

Take one aiqlara tablet every day. You may take the tablets with or without food, but at approximately the same time each day.

Blister preparation

To help you follow the correct order of administration, the aluminum side of the blister is marked with a number and an arrow indicating the sequence in which the tablets should be taken. Start with the tablet marked number 1 and follow the direction of the arrows until you have taken all 28 tablets.

Withdrawal bleeding usually begins while you are taking the second brown tablet or the white tablets, and may not have finished when you start the next blister pack. Some women may continue to bleed after taking the first tablets of the new blister pack.

Start the next blister pack the day after finishing the current one, without interruption, even if the bleeding has not yet stopped.

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

When to start the first blister pack

• If you have not used any hormonal contraceptive in the previous month

Start taking aiqlara on the first day of your cycle (i.e., the first day of your menstrual period).

• Switching from another combined hormonal contraceptive pill, combined vaginal ring, or contraceptive patch

Start aiqlara the day after taking the last active tablet (the last tablet containing active substances) of your previous pill. When switching from a combined vaginal ring or contraceptive patch, start using aiqlara on the same day of removal, or follow your doctor's recommendations.

• Switching from a progestogen-only method (progestogen-only contraceptive pill, injection, implant, or intrauterine system (IUS) containing progestogens)

You may switch from a progestogen-only pill on any day. If you are using an implant or IUS, switch on the same day of removal. If switching from an injectable contraceptive, switch 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 aiqlara.

• After an abortion

Follow your doctor's advice.

• After giving birth

You may start taking aiqlara between day 21 and day 28 after giving birth. If you start later than day 28, use a barrier method (e.g., a condom) during the first 9 days of using aiqlara.

If, after giving birth, you have already had sexual intercourse before restarting aiqlara, you must ensure that you are not pregnant or wait until your next menstrual period.

If you wish to start taking aiqlara after giving birth and are breastfeeding, please read the section “Pregnancy and breastfeeding”.

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

If you take more aiqlara than you should

No serious harm has been reported from overdosing on aiqlara.

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 aiqlara tablets, or if you discover that a child has taken them, consult your doctor or pharmacist. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

If you forget to take aiqlara

Inactive tablets: If you forget to take a white tablet (the 2 tablets at the end of the blister pack), you do not need to take it later, as they do not contain any 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 would increase the risk of pregnancy. Continue taking the next tablet at your usual time.

Active tablets: Depending on the day of the cycle 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.

Take the tablets according to the principles described below. See further details in the “missed tablet schedule”.

• If you are less than 12 hours late in taking a tablet, contraceptive protection is not reduced. Take the tablet as soon as you remember and continue taking the following tablets at your usual time.
• If you are more than 12 hours late in taking a tablet, contraceptive protection may be reduced. Depending on the day of the cycle 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 in this blister pack

Consult your doctor.

Do not take more than 2 active tablets in a single day.

If you forgot to start a new blister pack or missed one or more tablets between day 3 and day 9 of your blister pack, there is a risk you may be pregnant (if you had sexual intercourse within 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 in a blister pack and do not have your period at the end of the pack, you may be pregnant. Consult your doctor before starting the next blister pack.

Forgot more than 1 coloured tabletForgot to start a new blister pack
Contact your doctor immediately
YES
			Days 1-9		Have you had sexual intercourse in the 7 days prior to these missed tablets?
					NO
					Take the missed tablet and continue taking your tablets as usual (this may mean taking 2 tablets on the same day) Use a barrier method (condom) for the next 9 days
Days 10-17
Forgot only 1 tablet (more than 12 hours have passed)
					Do not take the missed tablet Start the next blister pack immediately Use a barrier method (condom) for the next 9 days
Days 18-24
					Take the missed tablet and continue taking your tablets as usual (this may mean taking 2 tablets on the same day) No additional contraceptive method is necessary
Days 25-26
					Discard the missed tablet and continue taking your tablets 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 you should do in case of vomiting or severe diarrhoea

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

This is similar to what happens if you forget to take a tablet. After vomiting or diarrhoea, you should take the next tablet as soon as possible. If possible, take it within 12 hours of your usual pill-taking time. If this is not possible or more than 12 hours have passed, follow the advice in the section “If you forget to take aiqlara”. If you do not wish to change your usual tablet-taking schedule, take the corresponding tablet from another blister pack.

If you stop taking aiqlara

You may stop taking aiqlara 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 aiqlara and wait until your next menstrual period before trying to conceive. This will make it easier to calculate the estimated date of delivery.

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

4. Possible adverse effects

Like all medicines, aiqlara can cause adverse effects, although not everyone will experience 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 aiqlara, 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 about the different risks of taking combined hormonal contraceptives, see section 2 “What you need to know before starting aiqlara”.

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 “Aiqlara 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 aiqlara:

Common 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, depressive mood, emotional disorders, sleep disorders, 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, vaginal/uterine bleeding including spotting, vaginal discharge, vulvovaginal dryness
• fatigue, irritability, swelling of body parts, 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, restlessness, nightmares, agitation, 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:

  o In a leg or foot (i.e., DVT).

  o In a lung (i.e., PE).

  o Heart attack.

  o Stroke.

  o Mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA).

  o Blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of having 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, brownish-yellow 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 greasy skin (seborrhoea) and other skin disorders
  • back pain, jaw pain, feeling of heaviness
  • urinary tract pain
  • abnormal withdrawal bleeding, benign breast nodules, early-stage breast cancer, breast cysts, breast discharge, cervical polyp, redness of the cervix, bleeding during sexual intercourse, spontaneous milk discharge, genital discharge, less abundant menstruation, delayed menstruation, rupture of an ovarian cyst, vaginal odour, burning sensation in the vulva and vagina, vulvovaginal discomfort
  • lymph node inflammation
  • asthma, difficulty breathing, nosebleeds
  • chest pain, tiredness and general malaise, fever
  • abnormal cervical smear.

Additional information (based on diaries kept by women in a clinical trial of aiqlara) about 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 adverse reactions or those with delayed onset considered related to the group of combined oral contraceptives, which may also occur during the use of aiqlara (see also sections “When not to take aiqlara” 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.), the oestrogens in combined oral contraceptives may induce or worsen angioedema symptoms.

If liver function is impaired, 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 it is a possible adverse effect 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. Conservation of aiqlara

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 stated on the blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly 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 aiqlara

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

Each blister (28 film-coated tablets) of aiqlara 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 pink 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 brown 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, maize starch, pregelatinised maize starch, povidone (E1201), colloidal anhydrous silica, magnesium stearate (E572).

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

Other components of the white inactive tablets:

Tablet core: monohydrate lactose, microcrystalline cellulose, magnesium stearate (E572).

Film coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b).

Appearance of the product and contents of the pack

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

Each blister (28 film-coated tablets) contains 2 dark yellow tablets in row 1; 5 pink tablets in row 1; 17 light yellow tablets in rows 2, 3 and 4; 2 brown tablets in row 4; and 2 white tablets in row 4.

The dark yellow active tablets are round, biconvex-faced tablets, marked on one side with the letter “L”.

The pink active tablets are round, biconvex-faced tablets, marked on one side with the letter “L”.

The light yellow active tablets are round, biconvex-faced tablets, marked on one side with the letter “L”.

The brown active tablets are round, biconvex-faced tablets, marked on one side with the letter “L”.

The white inactive tablets are round, biconvex-faced tablets, marked on one side with the letters “PL”.

aiqlara is available in packs of 1, 3 or 6 blisters, each containing 28 tablets.

A cardboard sleeve is provided to store the blister.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Cyndea Pharma, S.L.

Polígono Industrial Emiliano Revilla

Avenida de Ágreda 31

42110 Ólvega (Soria) - Spain

This medicinal product is authorised in the European Economic Area countries under the following names:

SE: Aiqlara filmdragerade tabletter

Date of the most recent revision of this leaflet: April 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90155/P_90155.html

QR code to: https://cima.aemps.es/cima/dochtml/p/90155/P_90155.html