AIQLARA FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

aiqlara film-coated tablets EFG

estradiol valerate/dienogest

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, do not pass it on to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

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

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

Contents of the package leaflet

1. What is aiqlara and what it is used for
2. What you need to know before you start using aiqlara
3. How to use aiqlara
4. Possible side effects
5. Storage of aiqlara
6. Package contents and further information

1. What is aiqlara and what it is used for

• Aiqlara is a contraceptive used to prevent pregnancy
• Each active colored tablet contains a small amount of female hormones: estradiol valerate, or estradiol valerate combined with dienogest.
• The 2 white tablets do not contain active substances and are called inactive tablets.
• Contraceptives that contain two hormones are called “combined contraceptives”.

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

When you should not take aiqlara

You should 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 what other form of contraception would be more suitable.

Do not take aiqlara

• If you have (or have ever had) a blood clotin 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 that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, Factor V Leiden, or antiphospholipid antibodies.
• If you need an operation or if you spend a lot of time without getting up (see section "Blood clots").
• If you have ever had a heart attackor a stroke.
• If you have (or have ever had) angina pectoris(a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack(TIA, temporary 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 diabeteswith 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 migrainecalled "migraine with aura".
• If you have (or have ever had) a liver diseaseand your liver function has not yet returned to normal.
• If you have (or have ever had) a tumor in the liver.
• If you have (or are suspected to have) breast cancer or cancer of the genital organs.
• If you have vaginal bleeding of unknown cause.
• If you are allergic(hypersensitive) to estradiol valerate or dienogest, or to any of the other components of this medicine (listed in section 6). This may be manifested by itching, rash, or inflammation.

Warnings and precautions

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

In some situations, you will need to be especially careful while taking aiqlara or any other combined hormonal contraceptive, and it may be necessary for your doctor to examine you periodically. If the condition develops or worsens while you are using aiqlara, you should also inform your doctor:

Consult your doctor before starting to take aiqlara

Additional information on special populations

Use in children

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

BLOOD CLOTS

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

Blood clots can form:

• in the veins (which is called "venous thrombosis", "venous thromboembolism" or VTE);
• in the arteries (which is called "arterial thrombosis", "arterial thromboembolism" or ATE).

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

It is essential 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.

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 side effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a 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 in which you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medicine or a different one) after an interruption of 4 weeks or more.

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

When you stop taking 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 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.

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

• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will develop a blood clot in a year.

• The risk of a blood clot with aiqlara is virtually 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 a blood clot with aiqlara is small, but some conditions increase the risk. Your risk is higher:

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

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

It is essential to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using aiqlara.

If any of the above conditions change while you are using aiqlara, for example, 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?

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 aiqlara is very small, but it may increase:

smoke. When using a combined hormonal contraceptive like aiqlara, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive;

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

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

Aiqlara and cancer

There has been a slightly increased incidence of breast cancerin women who use 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 who use combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to have your breasts examined regularly, and you should see your doctor if you notice any lump.

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

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

Psychiatric disorders

Some women may experience mood changes or depressive symptoms, including depression, while using aiqlara. If you experience any of these symptoms, you should see your doctor.

3. How to take aiqlara

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

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

Preparing the blister pack

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

Usually, the withdrawal bleeding starts when 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 still experience bleeding after taking the first tablets of the new blister pack.

Start the next blister pack without interruption, i.e., the day after you finish the current blister pack, even if the bleeding has not stopped.

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

When can you start with 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 menstruation).

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

Start aiqlara the day after you take the last active tablet (the last tablet that contains the active substances) of your previous pill. When switching from a combined vaginal ring or patch, start using aiqlara on the same day you remove it or follow your doctor's recommendations.

• Switching from a progestin-only method (progestin-only pill, injection, implant, or intrauterine system (IUS)).

You can switch from a progestin-only pill at any time. If it is an implant or an IUS, on the day of its removal. If it is an injectable, when the next injection is due. In all cases, it is recommended that you use additional contraceptive measures (e.g., a condom) for the first 9 daysof taking aiqlara.

• After an abortion.

Follow your doctor's recommendations.

• After having a child.

You can start taking aiqlara between the 21st and 28th dayafter having a child. If you start later than the 28th day, use a barrier method (e.g., a condom) for the first 9 daysof using aiqlara.

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

If you want to start taking aiqlara after having a child and are breastfeeding, read the section “Pregnancy and lactation”.

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

If you take more aiqlara than you should

No cases have been reported where an overdose of aiqlara has caused serious harm.

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

If you forget to take 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 since it does not contain any active ingredients. However, it is essential that you discard the white tablets you forgot 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 your cycle when you forgot to take oneactive tablet, you may need to take additional contraceptive precautions, for example, a barrier method like a condom.

Take the tablets according to the principles described below. See more details in the “forgotten tablet scheme”.

• If you delay less than 12 hoursin taking a tablet, the protection against pregnancy does not decrease. Take the tablet as soon as you remember and the following tablets at the usual time.
• If you delay more than 12 hoursin taking a tablet, the protection against pregnancy may be reduced. Depending on the day of your 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 “forgotten tablet scheme”.
• If you have forgotten more than one tablet in this blister pack.

Consult your doctor.

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

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

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

Use in children

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

What to do in case of vomiting or severe diarrhea

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

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

If you interrupt treatment with aiqlara

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

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

4. Possible Adverse Effects

Like all medicines, aiqlara can cause adverse effects, although not all people suffer from them. If you experience any adverse effect, especially if it is severe and persistent, or have any change in health that you think may be due to aiqlara, 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 section 2 "What you need to know before taking aiqlara".

Severe Adverse Effects

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

Other Possible Adverse Effects

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

Frequent Adverse Effects(may affect up to 1 in 10 people):

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

Uncommon Adverse Effects(may affect up to 1 in 100 people):

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

Rare 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), skin fungal infection (pityriasis versicolor), urinary tract infection, bacterial vaginitis.
• fluid retention, increased triglycerides in the blood
• aggression, anxiety, feeling of unhappiness, increased interest in sex, nervousness, nightmares, restlessness, sleep disorders, stress
• decreased attention, tingling sensation, dizziness
• intolerance to contact lenses, dry eyes, eye swelling
• heart attack (myocardial infarction), palpitations
• varicose vein bleeding, low blood pressure, superficial vein inflammation, painful veins
• harmful blood clots in a vein or artery, for example:

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

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

o Heart attack.

o Stroke.

o Mild stroke or temporary symptoms similar to those of a stroke, called a transient ischemic 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 on conditions that increase the risk of blood clots and symptoms of a blood clot).

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

Additional information (according to diaries kept by women in a clinical trial of 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 in the following days".

Description of Selected Adverse Reactions

The following are very rare or delayed adverse reactions that are considered related to the group of combined oral contraceptives and may also occur during the use of aiqlara (see also sections "When not to take aiqlara" and "Warnings and Precautions").

• Liver tumors (benign and malignant).
• Erythema nodosum (red sensitive 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 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 Adverse Effects

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

5. Storage of Aiqlara

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the blister pack after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away via wastewater or household waste. Deposit the packaging and medicines that you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Aiqlara Composition

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

Each blister pack (28 film-coated tablets) of aiqlara 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 ingredients:

2 tablets of dark yellow color. Each tablet contains 3 mg of estradiol valerate.

5 tablets of pink color. Each tablet contains 2 mg of estradiol valerate and 2 mg of dienogest.

17 tablets of light yellow color. Each tablet contains 2 mg of estradiol valerate and 3 mg of dienogest.

2 tablets of brown color. Each tablet contains 1 mg of estradiol valerate.

Composition of the inactive white tablets:

These tablets do not contain active ingredients.

The other components of the active colored tablets are:

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

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

The other components of the inactive white tablets are:

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

Tablet film coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b).

Product Appearance and Package Contents

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

Each blister pack (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 active dark yellow tablets are round, biconvex, and engraved with the letter "L" on one side.

The active pink tablets are round, biconvex, and engraved with the letter "L" on one side.

The active light yellow tablets are round, biconvex, and engraved with the letter "L" on one side.

The active brown tablets are round, biconvex, and engraved with the letter "L" on one side.

The inactive white tablets are round, biconvex, and engraved with the letters "PL" on one side.

Aiqlara is available in packages of 1, 3, or 6 blister packs, each containing 28 tablets.

A cardboard box is included to store the blister pack.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

SE: Aiqlara film-coated tablets

Date of the last revision of this prospectus:April 2025

Detailed information about this medicine 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 updated information about this medicine by scanning the QR code included in the prospectus and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90155/P_90155.html

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