AILEVA 0.1 mg/0.02 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

aileva 0.1 mg/0.02 mg film-coated tablets EFG

levonorgestrel/ethinylestradiol

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 the use of a combined hormonal contraceptive after a pause of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 "Blood clots").

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the package leaflet:

1. What aileva is and what it is used for.
2. What you need to know before starting to take aileva.
3. How to take aileva.
4. Possible side effects.
5. Storage of aileva

Contents of the pack and additional information.

1. What aileva is and what it is used for

• aileva is a combined oral contraceptive pill for the prevention of pregnancy. It contains two different female hormones, levonorgestrel and ethinylestradiol.
• Each of the 21 round pink tablets contains 0.1 milligrams of levonorgestrel and 0.02 milligrams of ethinylestradiol.

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

Do not takeaileva

• If you are allergic to levonorgestrel or ethinylestradiol, or to any of the other components of this medicine (listed in section 6).
• You should not use aileva 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.
• • 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 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 long time immobile (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 that causes severe chest pain and may be a sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:
• • Severe diabetes with blood vessel damage.
  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinaemia.
• If you have (or have ever had) a type of migraine called “migraine with aura”.
• If you have breast cancer or cancer of the uterus, or a type of cancer that is sensitive to female hormones, or if you suspect you may have one of these cancers.
• If you have vaginal bleeding of unknown cause.
• If you have high blood sugar levels (diabetes) associated with blood vessel damage.
• If you are pregnant or think you may be pregnant.
• If you have or have had a benign or malignant tumour in the liver, or if you have recently had liver disease. In these cases, your doctor will ask you to stop taking aileva until your liver has returned to normal.
• If you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Taking aileva with other medicines”).

Warnings and precautions

When should you consult your doctor?

Seek urgent medical attention

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

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

Consult your doctor or pharmacist before starting to take aileva.

In some situations, special care may be needed when taking aileva or any combined oral contraceptive. Your doctor will regularly check you. Smoking cigarettes increases the risk of serious adverse reactions in the heart and blood vessels due to the use of oral contraceptives. This risk increases with age and the amount of tobacco and is quite significant in women over 35 years of age. Women who use oral contraceptives should not smoke. Women over 35 years of age who smoke should consider using other contraceptive methods.

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

If the condition develops or worsens while you are using aileva, you should also tell your doctor.

• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products that contain oestrogens may cause or worsen the symptoms of hereditary and acquired angioedema.
• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defence system).
• If you have haemolytic uraemic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle-cell anaemia (a hereditary disease of the red blood cells).
• If you have high cholesterol levels or abnormal levels of lipids (fats) in the blood (dyslipidaemia) - these levels are detected in a blood test.
• If you have high levels of fat in the blood (hypertriglyceridaemia) or a known family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas).
• If you need an operation or spend a long time immobile (see section 2 “Blood clots”).
• If you have recently given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking aileva after giving birth.
• If you have inflammation of the veins just under the skin (superficial thrombophlebitis).
• If you have varicose veins or have had inflammation of the superficial veins of the legs.
• If you have high blood pressure.
• If you are obese.
• If you have diabetes.
• If you have problems with your heart valves or an irregular heartbeat (atrial fibrillation).
• If you or a close relative (parents, brothers or sisters) have had a disease that increases the risk of blood clots (in the legs, lungs or any other part of the body) or have had a heart attack or stroke.
• If you experience any sudden or unexplained change in vision.
• If you have gallstones, gallbladder disease or problems caused by blockage of the bile ducts (cholestasis) - this can cause intense itching.
• If you develop migraine for the first time or if a migraine you already have gets worse.
• If you have or develop liver disease, jaundice or inflammation of the pancreas or kidney disorder.
• If you have depression.
• If you have hearing loss due to a condition known as otosclerosis.
• If you have had a skin condition during pregnancy or while taking another oral contraceptive that caused itching, red patches or blistering (herpes gestationis).
• If you have had brown patches on your skin during pregnancy (chloasma). The pill may make this come back, so you should avoid exposure to the sun or sunbeds while taking aileva.
• If you have a disease called Sydenham's chorea. The symptoms include irregular, sudden and involuntary movements.
• If you have ever had a blood disease called porphyria.

If you have hereditary angioedema, products that contain oestrogens may cause or worsen the symptoms of angioedema. You should contact your doctor immediately if you experience symptoms such as swelling of the face, tongue and/or pharynx and/or difficulty swallowing, or urticaria with difficulty breathing.

Psychiatric disorders:

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

BLOOD CLOTS

The use of a combined hormonal contraceptive like aileva increases your risk of having 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 (this is called “venous thrombosis”, “venous thromboembolism” or VTE).
• In the arteries (this 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 important to remember that the overall risk of a harmful blood clot due to ailevais small.

HOW TO RECOGNISE 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 linked to 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 your leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from your leg to your lungs, it can cause a pulmonary embolism.
• In very rare cases, a 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 having a blood clot in a vein is higher during the first year you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medicine or a different one) after a break of 4 weeks or more.

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

When you stop taking aileva, your risk of having a blood clot returns to normal within a few weeks.

What is the risk of having 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 having a blood clot in the leg or lung (DVT or PE) with aileva is small.

• Out of 10,000 women who do not take a combined hormonal contraceptive and are not pregnant, about 2 may have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, such as aileva, norethisterone or norgestimate, 5-7 may have a blood clot in a year.
• The risk of having a blood clot depends on your personal medical history (see “Factors that increase your risk of a blood clot” below)

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

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

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

The risk of having a blood clot increases with the number of risk factors you have.

Long-distance 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 important to tell your doctor if you have any of the conditions listed above, even if you are not sure. Your doctor may decide that you should stop taking aileva.

If any of the conditions listed above change while you are taking aileva, for example if you start smoking, a close relative experiences a clot without known cause, or you gain a lot of weight, tell 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 due to the use of aileva is very small, but it can increase:

• With age (above about 35 years of age).
• If you smoke.When you use a combined hormonal contraceptive like aileva, 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 (i.e. under about 50 years of age). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, irregular heartbeat called atrial fibrillation).
• If you have diabetes.

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

If any of the conditions listed above change while you are taking aileva, for example if you start smoking, a close relative experiences a clot without known cause, or you gain a lot of weight, tell your doctor.

ailevaand cancer

Breast cancer has been diagnosed slightly more frequently in women who use the combined pill, but it is not known whether the cancer is caused by the pill. It is possible that these women are examined more thoroughly and more frequently, so that breast cancer is more likely to be detected earlier. The increased risk disappears gradually after 10 years of stopping the use of combined hormonal contraceptives. It is important to check your breasts regularly and you should contact your doctor if you notice any lump.

There have been studies in which it has been reported that...

3. How to take aileva

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Each aileva blister pack contains 21 pills. Take the first pill from the blister pack on the correct day of the week. You should take one pill each day, with water if necessary, and at the same time every day until the pack is finished.

Then, you will have a pill-free week before starting the next pack of pills. You should always start the next pack on the same day of the week.

During the pill-free week, you will have a bleeding similar to your period. This bleeding usually starts 2 or 3 days after finishing the pack and may not have stopped before starting the next pack of pills.

If this is the first time you are starting the pill or have not used any hormonal contraceptive in the previous month

Take the first pill on the first day of your period.

If you start after the first day of your period (on days 2-7 of the cycle), you will need to use an additional barrier contraceptive method (e.g., condoms) for the first 7 days.

If you are switching from a combined contraceptive pill

If you are taking pills that contain 21 pills in the pack

Finish the current pill pack and start taking aileva the next day without a break.

If you are taking “daily” pills that contain 28 pills in the pack

If your current pill pack contains inactive pills (placebo), do not take these pills and start aileva immediately the next day without leaving any break.

If you are switching from a progestin-only pill, injection, orimplant

• If you switch from a progestin-only pill, you can start aileva at any time during your menstrual cycle, the day after stopping the progestin-only pill.
• If you switch from an implant, start using aileva the day after the implant is removed.
• If you switch from an injectable contraceptive, start aileva the day after you would have had your next injection.

In all cases, you must use a barrier contraceptive method during the first 7 days of taking the pill.

If you start ailevaafter an abortion during the first trimester (3 months) of pregnancy

You can start taking aileva immediately, but you should follow your doctor's advice before doing so. No additional barrier contraceptive method is needed.

If you startailevaafter having a baby or after an abortion during the secondtrimester

Like any other contraceptive pill, aileva should not be started before 28 days after giving birth or after an abortion in the second trimester of pregnancy, as this increases the risk of blood clots. If you start later, you are advised to use a barrier contraceptive method during the first 7 days of taking the pill. If you have had sexual intercourse before starting aileva, make sure you are not pregnant or wait until your next period.

In case of doubt, always consult your doctor.

If you take moreailevathan you should

If you accidentally take more aileva than you should, you may experience symptoms including gastrointestinal problems (e.g., nausea, vomiting, abdominal pain), breast tenderness, dizziness, numbness/fatigue, and vaginal bleeding. These symptoms will naturally decrease as your body handles the excess hormones.

If you are concerned, consult your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeaileva

• If it has been less than 12 hourssince you forgot to take the pill, your protection against pregnancy will not be affected. You can still take the pill as soon as you remember and take the following pills at the usual time.
• If it has been more than 12 hourssince you forgot to take the pill, your protection against pregnancy may be reduced. The more pills you forget to take, the greater the risk that your protection against pregnancy will be reduced.

The risk of incomplete protection against pregnancy is greater if you forget to take a pill at the beginning or end of a blister pack. Therefore, you must follow these rules (see also the diagram below):

• More than 1 forgotten pill in this blister pack

Consult your doctor.

• 1 forgotten pill in week 1

Take the forgotten pill as soon as you remember, even if it means taking two pills at the same time. Take the following pills at the usual time and take extra precautions for the next 7 days, for example, using a condom. If you have had sexual intercourse in the week before the missed pill or if you forgot to start a new blister pack after the pill-free week, you should be aware that there is a risk of pregnancy. In this case, consult your doctor.

• 1 forgotten pill in week 2

Take the forgotten pill as soon as you remember, even if it means taking two pills at the same time. Take the following pills at the usual time. Your protection against pregnancy will not be reduced, and you will not need to take extra precautions.

• 1 forgotten pill in week 3

You can choose between 2 options:

1. Take the forgotten pill as soon as you remember, even if it means taking two pills at the same time.

Take the following pills at the usual time. Instead of the pill-free week, start the next blister pack immediately.

It is likely that you will have a withdrawal bleed (menstruation) after finishing the second blister pack, but you may also have spotting or intermenstrual bleeding when taking the second blister pack.

1. You can also stop taking the current blister pack and go directly to the 7-day pill-free period (note the day you forgot to take your pill). If you want to start a new blister pack on a specific day, you can shorten the pill-free period to less than 7 days.

If you follow one of these two recommendations, you will still be protected against pregnancy.

If you forget to take any of the pills in a blister pack and do not have bleeding during the first pill-free week, it could mean that you are pregnant. You should contact your doctor before continuing with the next blister pack.

If you experience vomiting or diarrhea

If you vomit or have severe diarrhea within 4 hours of taking the pill, it is as if you had forgotten to take the pill. After vomiting or having diarrhea, you should take another pill from the reserve pack as soon as possible. If possible, take it within 12hoursor when you would normally take the pill. If it is not possible or more than 12 hours have passed, you should follow the recommendations given in “If you realize you have forgotten to take apill more than 12 hours after the usual time of intake”.

If episodes of vomiting or severe diarrhea recur over several days, you should use a barrier contraceptive method (e.g., condoms) until the start of the next pack. Consult your doctor in case of doubt.

How to delay your period

You can delay your period by starting another pack of aileva immediately without leaving a break. You may have some spotting or bleeding while taking the second pack, but you do not need to worry about this. You should have a normal bleed after finishing the second pack.

4. Possible Adverse Effects

Like all medicines, this medicine 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 if you have any change in health that you think may be due to aileva, consult your doctor.

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

If you experience any of the following serious adverse effects, consult your doctor immediately:

• A severe allergic reaction: the frequency is unknown.

The symptoms consist of sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat, skin rash, hives.

• A blood clot in the eye: the frequency is unknown.

The symptoms consist of vision loss, pain and swelling of the eye, especially if they are sudden.

• Hemolytic uremic syndrome (a condition that affects the blood and kidneys): the frequency is unknown.

The symptoms consist of vomiting, diarrhea (which may be bloody), fever, feeling of weakness, urinating less than usual.

• Pancreatitis: the frequency is unknown.

The symptoms consist of severe pain in the upper abdomen, which can spread to the back.

• Harmful blood clots in a vein or artery, for example:

• In a leg or foot (i.e., DVT).
• In a lung (i.e., PE).
• Heart attack.
• Stroke.
• Mild or temporary stroke-like symptoms, called transient ischemic attack (TIA).
• Blood clots in the liver, stomach/intestine or kidneys.

The chances 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).

• Erythema multiforme: the frequency is unknown.

The symptoms consist of a skin rash with pink-red spots, especially on the palms or soles of the feet, which may have blisters. You may also have ulcers in the mouth, eyes or genitals, and may have a fever.

Other adverse effects include:

• Contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing (see also section "Warnings and precautions").

Very common(may affect more than 1 in 10 people)

• headache, including migraines
• bleeding and spotting outside of the period
• nausea
• abdominal pain
• painful periods

Common(may affect up to 1 in 10 people)

• vaginal irritation and infection, including candidiasis
• mood changes, including depression
• decreased sexual desire
• feeling nervous
• feeling dizzy
• vomiting
• diarrhea
• feeling bloated in the abdomen
• acne (pimples)
• skin rash
• absence of period (amenorrhea)
• changes in the amount of blood loss and duration of periods
• pain/tenderness in the breasts, enlargement or secretion in the breasts
• changes in the cervix that can be seen in a Pap smear
• fluid retention (e.g., swollen ankles)
• weight gain or loss
• changes in blood lipid levels (observed through blood tests)

Uncommon(may affect up to 1 in 100 people)

• increased appetite
• decreased appetite
• hives (urticaria)
• abnormal hair growth (hirsutism)
• hair loss
• dark spots on the skin (which may be from a previous pregnancy)
• increased blood pressure
• gallstones
• intolerance to a sugar called glucose
• worsening of varicose veins

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

• yellowing of the skin and eyes (jaundice caused by abnormal bile flow in the liver)
• painful and reddened lumps under the skin (erythema nodosum)

Frequency not known:cannot be estimated from the available data

• benign or malignant liver tumor
• worsening of an autoimmune disease called systemic lupus erythematosus
• worsening of a hereditary blood disease called porphyria
• worsening of uncontrolled or spasmodic body movements (chorea)
• inflammation of the optic nerve: symptoms include blurred vision and can lead to total or partial loss of vision
• intolerance to contact lenses
• gallbladder disease or worsening of this condition
• inflammatory or ischemic intestinal disease: symptoms include abdominal pain and cramps, diarrhea (which may be bloody), weight loss.
• stomach cramps
• vaginal discharge
• decreased blood folate levels

If you are concerned about new symptoms or other aspects related to your health while taking aileva, consult your doctor.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 aileva

Keep this medicine out of the sight and reach of children. Do not store above 30°C.

Do not use aileva after the expiration date that appears on the outer packaging and on the blister after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of aileva

The active ingredients are levonorgestrel and ethinylestradiol.

Each tablet contains 0.1 mg of levonorgestrel and 0.02 mg of ethinylestradiol. The other components (excipients) are lactose monohydrate, potassium polacrylate, microcrystalline cellulose, magnesium stearate, and opadry II pink: poly(vinyl alcohol), talc (E553b), titanium dioxide (E171), Macrogol 3350, red iron oxide (E172), and yellow iron oxide (E172).

Appearance ofailevaand package contents

• Each film-coated tablet is cylindrical, biconvex, and pink in color.
• aileva 0.1 mg/0.02 mg is marketed in strips (PVC/PVDC/Aluminum blisters) of 21 tablets.
• The package sizes are 1 or 3 strips, and each strip contains 21 tablets. Not all package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Manufacturer

Cyndea Pharma, S.L.

Pol. Ind. Emiliano Revilla Sanz

Av. De Ágreda 31, 42110 Ólvega;

Soria

Spain

Or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Date of the last revision of this prospectus:September 2023

"Detailed and updated information on 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 mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82082/P_82082.html

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