Aileva 0.1 mg/0.02 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

aileva 0.1 mg/0.02 mg film-coated tablets EFG

levonorgestrel/ethinylestradiol

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

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

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

• Keep this leaflet, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for 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 any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

Pack contents and additional information.

1. What aileva is and what it is used for

• aileva is a combined oral contraceptive tablet 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 take Aileva if you are allergic to Acidum ascorbicum, Acidum folicum, Pyridoxinum hydrochloridum, or any of the other ingredients of this medicine (listed in section 6).
• Do not take Aileva if you have had an allergic reaction to any of the active substances or other ingredients.
• Consult your doctor or pharmacist before taking Aileva if you have any known allergies or medical conditions.
• Keep out of sight and reach of children.
• Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
• This medicine does not require any special storage conditions.
• Do not dispose of unused medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use—this helps protect the environment.
• Always use this medicine as described in the instructions or as advised by your doctor or pharmacist.
• If symptoms persist or worsen, consult your doctor.
• Do not exceed the recommended dose.
• Keep the medicine in its original packaging to protect it from light and moisture.
• Use only as directed.

General considerations Before starting to use aileva, 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 aileva, your doctor will ask you some questions about your medical history and your personal circumstances. Your doctor will also measure your blood pressure and may carry out other tests. This leaflet describes some situations in which you should stop taking aileva or when the effectiveness of aileva may be reduced, increasing the risk of pregnancy. In these situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive precautions (for example, use condoms or another barrier method). Do not use rhythm or temperature methods. These methods may not be reliable, as aileva alters the monthly changes in body temperature and cervical mucus. aileva, like other oral contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Do not take aileva

• 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 which 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 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 if you are immobile for long periods (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 conditions that may increase your risk of developing a clot in the arteries:
  • Severe diabetes with blood vessel damage.
  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.
• If you have (or have ever had) a type of migraine called “migraine with aura”.
• If you have breast cancer or uterine cancer, or a type of cancer sensitive to female hormones, or if you suspect you may have any of these cancers.
• If you have vaginal bleeding of unknown cause.
• If you have high blood sugar levels (diabetes) associated with blood vessel problems.
• If you are pregnant or suspect you might be pregnant.
• If you have or have had a benign or malignant liver tumour, 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 medications containing ombitasvir / paritaprevir / ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also 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 which may mean 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 clot (thrombosis)” below).

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

Consult your doctor or pharmacist before starting to take aileva.

Special care may be needed when taking aileva or any combined oral contraceptive. Your doctor will routinely monitor you. Smoking increases the risk of serious adverse effects on the heart and blood vessels associated with the use of oral contraceptives. This risk increases with age and the number of cigarettes smoked, and is particularly relevant 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.

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

If any of these conditions develop or worsen while using aileva, you should also inform your doctor.

• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives with possible breathing difficulties, contact a doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.
• 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 cholesterol levels or abnormal blood lipid (fat) levels (dyslipidemia) – these are detected in a blood test.
• 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 are 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 can start taking aileva after delivery.
• If you have inflammation of veins beneath the skin (superficial thrombophlebitis).
• If you have varicose veins or have previously had inflammation in the superficial veins of the legs.
• If you have high blood pressure.
• If you are obese.
• If you are diabetic.
• If you have heart valve problems or an abnormal heart rhythm (atrial fibrillation).
• If you have had, or a close relative (parents, siblings) has had, a condition with a tendency to develop blood clots (in the legs, lungs, or any other part of the body), or a history of heart attacks or strokes.
• If you experience any sudden, unexplained change in vision.
• If you have gallstones, gallbladder disorders, or problems caused by blockage of the bile ducts (cholestasis) – this may cause intense itching.
• If you develop migraine for the first time or if an existing migraine worsens.
• If you have or develop liver disease, jaundice, pancreatitis, or kidney disorder.
• If you have depression.
• If you have hearing loss due to a disorder known as otosclerosis.
• If you previously experienced during pregnancy or while taking another contraceptive pill a skin condition causing itching, red spots, or blisters (herpes gestationis).
• If you previously had temporary brown patches on the skin during pregnancy (chloasma). The pill may cause this to recur, so you should avoid exposure to sunlight or sunbathing while taking aileva.
• If you have a condition known as Sydenham’s chorea. Symptoms include irregular, sudden, and involuntary movements.
• If you have ever had a blood disorder called porphyria.

If you have hereditary angioedema, products containing estrogens may cause or worsen angioedema symptoms. You should seek medical attention immediately if you experience symptoms such as swelling of the face, tongue and/or pharynx and/or difficulty swallowing, or hives accompanied by breathing difficulties.

Psychiatric disorders:

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

BLOOD CLOTS

Using a combined hormonal contraceptive such as aileva increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

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

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

It is important to remember that the overall risk of a harmful blood clot due to aileva 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 foot, or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticeable when standing or walking. Increased warmth in the affected leg. Change in skin color of the leg, e.g., turning pale, red, or blue. Increased blood pressure	Deep vein thrombosis
Sudden shortness of breath without a known cause or rapid breathing. Sudden cough without a clear cause, possibly bringing up blood. Sharp chest pain that may worsen when breathing deeply. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe stomach pain. If you are unsure, consult a doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition like a respiratory 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. Double vision.	Retinal vein thrombosis (blood clot in the eye).
Pain, discomfort, pressure, heaviness in the chest. Feeling of tightness or fullness in the chest, arm, or below the sternum. Sensation 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.
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.
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech. Sudden vision problems in one or both eyes. Sudden difficulty walking, dizziness, loss of balance or coordination. Sudden, severe, or prolonged headache without a known cause. Loss of consciousness or fainting, with or without seizures. Sudden changes in hearing, sense of smell, or taste. 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 pain (acute abdomen).	Blood clots blocking other blood vessels.

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the veins (venous thrombosis). However, these adverse effects are rare. They occur more frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein 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 remains somewhat higher than if you were not taking a combined hormonal contraceptive.

When you stop taking aileva, 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 on 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 aileva is small.

• Among every 10,000 women who do not take a combined hormonal contraceptive and are not pregnant, about 2 may develop a blood clot in one year.
• Among every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, such as aileva, norethisterone, or norgestimate, between 5 and 7 will develop a blood clot in one year.
• Your risk of developing a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring 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 aileva	About 5-7 out of 10,000 women

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

The risk of having a blood clot with aileva 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 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 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 aileva.

If any of the conditions listed above change while you are taking aileva—for example, if a close relative experiences a thrombosis without a known cause or if 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 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 aileva is very small, but it may increase:

• With age (especially over about 35 years).
• If you smoke. When using a combined hormonal contraceptive such as aileva, 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 are overweight.
• If you have high blood pressure.
• If a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or a close relative 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 disorders, heart rhythm disorder 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 developing a blood clot may be further increased.

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

aileva and cancer

Breast cancer has been diagnosed slightly more frequently in women using the combined pill, but it is unknown whether the pill causes the cancer. It is possible that these women were simply examined more thoroughly and more frequently, making it more likely that breast cancer would be detected earlier. The increased risk gradually disappears after 10 years of stopping combined hormonal contraceptives. It is important to examine your breasts regularly and contact your doctor if you notice any lump.

Studies have reported cases of cervical cancer in women who have taken combined oral contraceptives for a relatively long time. It is currently unknown whether this is caused by the pill or related to sexual behavior (e.g., more frequent partner changes) and other factors.

Rarely, benign liver tumors and even very rare cases of malignant liver tumors have been reported in patients taking the pill. Contact your doctor if you have unusual severe abdominal pain.

Bleeding between periods

During the first few months of taking aileva, you may experience unexpected bleeding (bleeding or spotting outside the pill-free week). If this bleeding lasts longer than a few months, or if it starts after several months, your doctor should investigate the cause.

What to do if there is no bleeding during the pill-free week

Some women do not have bleeding during the pill-free week.

If you have taken all tablets correctly (following the instructions provided), have not vomited or had severe diarrhea, and have not taken any other medication, it is very unlikely that you are pregnant.

If your period does not occur for a second consecutive time, or if you have not taken the tablets as instructed, consult your doctor immediately before the first missed period or if a second period is missed, as you may be pregnant. Do not start the next pack until you are sure you are not pregnant.

Taking aileva with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Some medicines can interact with aileva.

Medicines can sometimes interfere with each other. If you are being treated by another doctor, nurse, or qualified healthcare professional, make sure they are aware that you are taking aileva as a contraceptive.

They may advise you to take additional precautions (e.g., use condoms or other barrier contraceptives) while taking other medicines with aileva.

Some medicines may make aileva less effective in preventing pregnancy or may cause unexpected bleeding.

• These include medicines used to treat:
• HIV infections (ritonavir, nevirapine)
• Epilepsy (e.g., phenobarbital, phenytoin, primidone, felbamate, carbamazepine, oxcarbazepine, or topiramate)
• Infections (e.g., rifabutin, rifampicin, griseofulvin, ampicillin, or other penicillins or tetracyclines)
• Sleep disorders (modafinil)
• Gout (phenylbutazone)
• St. John’s wort (Hypericum perforatum) used to treat certain types of depression.

If you are advised to take additional contraceptive precautions while taking any of the medicines listed above, follow your doctor's instructions carefully, as you may need a non-hormonal backup method of birth control. If you need to continue taking the medicine after finishing your current pack, do not take the pill-free week and start a new pack immediately.

In some cases, you may need to continue using an additional barrier contraceptive for several weeks after stopping the medicine.

aileva may interfere with the following medicines:

• Cyclosporine (used to reduce immune response)
• Lamotrigine (used to treat epilepsy)

Taking an antibiotic called troleandomycin may increase the risk of intrahepatic cholestasis (bile retention in the liver) during treatment with the combined pill.

Taking a medicine called flunarizine used to prevent migraines may increase the risk of galactorrhea. This is a condition in which the breasts secrete milk spontaneously without breastfeeding or having recently given birth.

Do not take aileva if you have Hepatitis C and are taking medicines containing ombitasvir / paritaprevir / ritonavir, dasabuvir; glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in liver function test results (elevated liver enzyme ALT).

Your doctor will prescribe another type of contraceptive before starting treatment with these medicines. aileva can be used again approximately 2 weeks after completing this treatment. See section “Do not take aileva.”

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Consult your doctor or pharmacist before using any medicine.

The combined pill is not recommended while breastfeeding, as hormones may affect milk production. If you wish to breastfeed, your doctor will advise you on suitable alternative contraceptive methods. Consult your doctor, nurse, or healthcare professional before using any medicine.

Driving and using machines

The effect of aileva on the ability to drive or use machines has not been studied. Dizziness has been reported as an adverse effect. If you experience dizziness, do not drive or use machines until symptoms resolve.

aileva contains lactose.

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

3. How to take aileva

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Each aileva blister pack contains 21 tablets. Take the first tablet from the blister pack on the day of the week indicated. You must take one tablet every day, with water if necessary, at the same time each day, until the pack is finished.

Afterwards, you will have a tablet-free week before starting the next pack of tablets. You must always start the next pack on the same day of the week.

During the tablet-free week, you will experience a withdrawal bleed similar to a period. This bleeding usually begins two or three days after stopping the tablets and may not have finished before you start the next pack.

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

Take the first tablet 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 must use an additional barrier contraceptive method (e.g., condoms) for the first 7 days.

If switching from a combined oral contraceptive pill

If you are currently taking 21-tablet packs

Finish the current pack of your current pill and start taking aileva the next day, without any break.

If you are currently taking "daily" pills containing 28 tablets in the pack

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

If switching from a progestogen-only pill, an injection, or an implant

• If switching from a progestogen-only pill, you may start aileva at any time during the menstrual cycle, the day after stopping the progestogen-only pill.
• If switching from an implant, start using aileva the day after removal of the implant.
• If switching from an injectable contraceptive, start aileva the day after the next injection would have been due.

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

If starting aileva after a first-trimester abortion (within 3 months of pregnancy)

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

If starting aileva after childbirth or after a second-trimester abortion

Like any other oral contraceptive, aileva should not be started earlier than 28 days after childbirth or after a second-trimester abortion, as the risk of blood clots is increased. If you start later, you are advised to use a barrier contraceptive method for 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.

If in doubt, always consult your doctor.

If you take more aileva than 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 gradually subside as your body processes the excess hormones.

If you are concerned, consult your doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take aileva

If you forget to take a tablet, there is a risk that you may become pregnant

• If less than 12 hours have passed since you missed the tablet, protection against pregnancy remains intact. You can still take the missed tablet as soon as you remember, and then continue taking the following tablets at your usual time.

• If more than 12 hours have passed since you missed the tablet, protection against pregnancy may be reduced. The more tablets you miss, the greater the risk that protection against pregnancy will decrease.

The risk of incomplete protection against pregnancy is greater if you missed a tablet at the beginning or end of a blister pack. Therefore, follow the rules below (see also the diagram further below):

• More than 1 tablet missed in this blister pack

Consult your doctor.

• One tablet missed in week 1

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the remaining tablets at your usual time and use additional contraceptive precautions for the next 7 days (e.g., a condom). If you had sexual intercourse during the week before the missed tablet, or if you failed to start a new blister pack after the tablet-free interval, be aware that there is a risk of pregnancy. In such cases, consult your doctor.

• One tablet missed in week 2

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the remaining tablets at your usual time. Protection against pregnancy is not reduced, and no additional precautions are necessary.

• One tablet missed in week 3

You have two options:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time.
   Then continue taking the remaining tablets at your usual time. Instead of the tablet-free interval, start the next blister pack immediately.
   You will most likely experience menstruation (withdrawal bleeding) after finishing the second blister pack, but you may also experience spotting or breakthrough bleeding during the second pack.

2. Alternatively, you may stop taking tablets from the current blister pack and proceed directly to the 7-day tablet-free interval (note the day on which you missed the tablet). If you wish to start a new blister pack on a specific day, you may shorten the tablet-free interval to less than 7 days.

If you follow either of these two recommendations, you will remain protected against pregnancy.

If you missed any tablets in a blister pack and do not experience bleeding during the first tablet-free interval, this could indicate pregnancy. You must contact your doctor before starting the next blister pack.

If you experience vomiting or diarrhea

If you vomit or have severe diarrhea within 4 hours after taking the tablet, it is as if you had missed the tablet. After vomiting or having severe diarrhea, take another tablet from your reserve pack as soon as possible. If possible, take it within the next 12 hours or at your usual tablet-taking time. If this is not possible or more than 12 hours have passed, follow the instructions given under "If you realize you missed a tablet more than 12 hours after your usual time".

If episodes of vomiting or severe diarrhea persist over several days, a barrier contraceptive method (e.g., condoms) should be used until you start the next pack. Consult your doctor if you have any doubts.

How to delay your period

You can delay your period by starting a new pack of aileva immediately, without a break. You may experience some spotting or breakthrough bleeding while taking the second pack, but this is not a cause for concern. 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 everyone experiences them.

If you experience any adverse effect, especially if it is severe and persistent, or if you notice any change in your health that you think may be due to aileva, consult your doctor.

All women who take combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting to take aileva”.

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

• A severe allergic reaction: frequency unknown.

Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat, skin rash, hives.

• A blood clot in the eye: frequency unknown.

Symptoms include sudden loss of vision, eye pain and swelling.

• Haemolytic uraemic syndrome (a condition affecting the blood and kidneys): frequency unknown.

Symptoms include vomiting, diarrhoea (which may be bloody), fever, feeling weak, passing less urine than usual.

• Pancreatitis: frequency unknown.

Symptoms include severe upper abdominal pain, which may 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.

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

• Blood clots in the liver, stomach/intestines or kidneys.

Your chances of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information about conditions that increase the risk of blood clots and symptoms of a blood clot).

• Erythema multiforme: frequency unknown.

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

Other adverse effects include:

• Contact a 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 hives 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 between periods
• 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
• dizziness
• vomiting
• diarrhoea
• feeling of abdominal bloating
• acne (spots)
• skin rash
• absence of periods (amenorrhoea)
• changes in the amount of blood loss and duration of periods
• breast pain/tenderness, breast enlargement or breast discharge
• changes in the cervix that may be seen on a smear test
• fluid retention (e.g., swollen ankles)
• weight gain or weight loss
• changes in blood fat levels (seen 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 patches on the skin (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 due to abnormal bile flow in the liver)
• painful red lumps under the skin (erythema nodosum)

Frequency not known: cannot be estimated from available data

• benign or malignant liver tumour
• worsening of an autoimmune disease called systemic lupus erythematosus
• worsening of a hereditary blood disorder called porphyria
• worsening of uncontrolled or spasmodic body movements (chorea)
• optic neuritis: symptoms include blurred vision and may lead to partial or complete vision loss
• intolerance to contact lenses
• gallbladder disease or worsening of this condition
• inflammatory or ischaemic bowel disease: symptoms include abdominal pain and cramps, diarrhoea (which may be bloody), weight loss
• stomach cramps
• vaginal discharge
• decreased blood folate levels

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

Reporting of adverse effects

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

5. Storage of aileva

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

Do not use aileva after the expiry date stated on the outer packaging and 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 unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of aileva

The active substances 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 polacrilin, 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 of aileva and contents of the pack

• Each film-coated tablet is cylindrical, biconvex and pink in colour.
• aileva 0.1 mg/0.02 mg is available in strips (PVC/PVDC/Aluminum blisters) of 21 tablets.
• Pack sizes are 1 or 3 strips, each strip containing 21 tablets. Only certain pack 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 most recent revision of this leaflet: September 2023

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

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82082/P_82082.html

QR code to: https://cima.aemps.es/cima/dochtml/p/82082/P_82082.html