Prospect: information for the patient

aileva 0.1 mg/0.02 mg film-coated tablets

levonorgestrel/etinilestradiol

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

• They are one of the most reliable reversible contraceptive methods if used correctly.

• They slightly increase the risk of suffering a blood clot in the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a 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 this prospect thoroughly before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may have to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospect. See section 4.

Contents of the package and additional information.

• Ailevaisa combined oral contraceptive tablet for the prevention ofpregnancy.It containstwo different female hormones, levonorgestrel and ethinylestradiol.
• Eachof the 21 roundpink tablets contains0.1 milligrams of levonorgestreland0.02milligrams of ethinylestradiol.

Do not takeaileva

• If you are allergic to levonorgestrel or ethinylestradiol, or to any of the other components of this medication (including in section 6).
• You should not useailevaif 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 vein of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
  • If you know that 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 surgery or if you spend a lot of time without standing up (see section “Blood Clots”).
  • If you have ever had a heart attack or 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, symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:
• • Severe diabetes with vascular damage.
  • Very high blood pressure.
  • Very high levels 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 that is sensitive to female hormones, or if you suspect that 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 vascular problems.
• If you are pregnant or suspect that you may be.
• If you have or have had a benign or malignant tumor in the liver, or if you have recently had liver disease. In these cases, your doctor will ask you to stop takingailevauntil the liver has returned to normal.
• If you have hepatitis C and are taking medications that contain ombitasvir / paritaprevir / ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section Taking aileva with other medications).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take aileva.

In some situations, special care may be needed when takingailevaor any combined oral contraceptive. Your doctor will monitor you regularly.Smoking cigarettes increases the risk of serious adverse reactions in the heart and blood vesselsdue to the use of oral contraceptives. This risk increases with age and with the amount of tobacco andis quite 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 suffer from any of the following conditions.

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

• If you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can 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 (LES, a disease that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (a hereditary disease of red blood cells).
• If you have high cholesterol levels or abnormal lipid levels in the blood (hyperlipidemia) - these levels are detected in a blood test.
• If you have high levels of fat in the blood (hypertriglyceridemia) or known family history of this condition. Hypertriglyceridemia has been associated with a higher risk of pancreatitis (inflammation of the pancreas).
• If you need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”).
• If you recently gave birth, you are at higher risk of blood clots. You should ask your doctor when you can start takingailevaafter the birth.
• If you have superficial vein inflammation under the skin (thrombophlebitis).
• If you have varicose veins or have had superficial vein inflammation in the legs.
• If you have high blood pressure.
• If you are obese.
• If you are diabetic.
• If you have heart valve problems or heart rhythm alteration (atrial fibrillation).
• If you have a family history of a disease that tends to develop blood clots in the legs, lungs, or any other part of the body, or if you have had a heart attack or stroke.
• If you experience sudden and inexplicable changes in vision.
• If you have gallstones, bile duct problems, or liver problems caused by bile duct blockage (cholestasis) - may cause intense itching.
• If you develop migraines for the first time or worsen an existing migraine.
• If you have liver disease, jaundice, or pancreatitis or kidney problems.
• If you have depression.
• If you have hearing loss due to a known condition called otosclerosis.
• If you have had during pregnancy or when taking another contraceptive pill a skin problem that caused itching, red patches, or blisters (herpes gestationnis).
• If you have had during pregnancy brownish skin patches (melasma). The pill may cause this to recur, so you should avoid exposure to the sun or lie in the sun while takingaileva.
• If you have a disease known as Sydenham's chorea. Symptoms include involuntary, irregular, and sudden movements.
• If you have ever had a blood disorder called porphyria.

If you have hereditary angioedema, products containing estrogens can cause or worsen the symptoms of angioedema. You should go to your doctor immediately if you experience symptoms such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing, or urticaria with difficulty breathing.

Mental Health Disorders:

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

BLOOD CLOTS

The use of a combined hormonal contraceptive like aileva increases your risk of suffering 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:

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

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical attentionif you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

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

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 start taking a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different medication) 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 aileva, your risk of a blood clot returns to normal in a few weeks.

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

• Of every 10,000 women who do not take a combined hormonal contraceptive and are not pregnant, about 2 may develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel likeaileva, noretisterone, or norgestimato, between 5 and 7 will develop a blood clot in a year.
• The risk of a blood clot will depend 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

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

• If you are overweight (body mass index or BMI greater than 30 kg/m2).
• If one of your close relatives has had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50 years old). In this case, you may have an inherited blood clotting disorder.
• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have a leg cast. You may need to stop takingailevafor several weeks before the operation or while you have less mobility. If you need to stop takingailevaask your doctor when you can start using it again.
• With increasing age (especially over about 35 years).
• If you have given birth recently.

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

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

It is essential to inform your doctor if you suffer from any of the conditions above, even if you are unsure. Your doctor may decide that you need to stop takingaileva.

If any of the conditions above change while you are usingaileva, for example, a close relative experiences a blood clot without a known cause or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a blood clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

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

It is essential to note that the risk of a heart attack or stroke due to ailevais very small, but it may increase:

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

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

aileva and Cancer

There has been a slightly higher incidence of breast cancer diagnosed in women whouse the combined pill, but it is unknown whether the cancer is caused by the pill.It is possible that these women are simply examined more rigorously and frequently, so there would be a greater chance of detecting breast cancer before it becomes a problem.The increased risk disappears gradually after 10 years of stopping the use of combined hormonal contraceptives. It is essential to have regular breast checks and to contact your doctor if you notice any lumps.

There have been studies in which cases of cervical cancer have been reported in women who take combined pills for a relatively long period. Currently, it is unknown whether this is caused by the pill or is related to sexual behavior (e.g., more frequent changes of partner) and other factors.

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

Menstrual Bleeding

During the first few monthsof takingaileva, you may experience unexpected bleeding (hemorrhages or spotting outside of the pill-free week).If these bleeding episodes last more than a few months or start after a few months, your doctor will 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 the pills correctly(following the instructions provided), have not had severe vomiting or diarrhea, and have not taken any other medication, it is unlikely that you are pregnant.

If you have missed a period or have not taken the pills correctly, or if you have taken the pills but have not had bleeding during the pill-free week, you should consult your doctor immediatelyas you may be pregnant.Do not start a new pack until you are sure you are not pregnant.

Taking aileva with other medications

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

There are medications that can interact withaileva.

Medications can sometimes interfere with each other. If you are receiving treatment from another doctor, nurse, or qualified healthcare professional, make sure they are aware that you are takingailevaas a contraceptive.

They may advise you to take additional precautions (e.g., use condoms or other barrier methods) while taking other medications withaileva.

Some medicationsmay makeailevaless effective in preventing pregnancy, or may cause unexpected bleeding.

• These include medications used to treat:
• infections caused by HIV (ritonavir, nevirapina)
• 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 (modafinilo)
• gout (phenylbutazone)
• St. John's Wort (Hypericum perforatum) used to treat certain types of depression.

If you have been advised to take additional contraceptive precautions while taking one of the medications mentioned above, follow your doctor's instructions carefullyas you may need to use a non-hormonal backup method of contraception.If you need to continue taking the medication after finishing your current pack, do not skip the pill-free week and start a new pack immediately.

In some cases, you may need to continue using a barrier contraceptive method for several weeks after stopping the medication.

ailevamay interact with the following medications:

• Ciclosporin (used to reduce the immune response)
• Lamotrigine (used to treat epilepsy)

Taking a medication called troleandomycin can increase the risk of intrahepatic cholestasis (retention of bile in the liver) during treatment with the combined pill.

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

Do not takeailevaif you have hepatitis C and are taking medications that contain ombitasvir / paritaprevir / ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications can cause increases in liver enzyme levels (ALT).

Your doctor will prescribe another type of contraceptive before starting treatment with these medications.ailevacan be used again approximately 2 weeks after completing this treatment. See the section “Do not takeaileva”.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant, consult your doctor or pharmacist before using this medication.

Consult your doctor or pharmacist before using any medication.

It is not recommended to take the combined pill while breastfeedingas the hormones may affect the milk. If you want to breastfeed, your doctor will advise you on suitable alternative contraceptive methods.Consult your doctor, nurse, or healthcare professional before using any medication.

Driving and Operating Machines

No studies have been conducted on the effect ofailevaon the ability to drive or operate machines. Dizziness has been reported as an adverse effect. If you experience dizziness, do not drive or operate machines until the symptoms have resolved.

aileva contains lactose.

This medication contains lactose. If your doctor has told you that you have a lactose intolerance, consult them before taking this medication.

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

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

You will have a week off from taking tablets before starting the next pack of tablets. Always start the next pack on the same day of the week.

During the week off from taking tablets, you will have a bleeding similar to your period. This bleeding usually starts after two or three days, and may not have finished before starting the next pack of tablets.

If this is the first time you start taking the pill or you have not used any hormonal contraceptive in the past month

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

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

If you are changing from a combined oral contraceptive pill

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

Finish the pack of the current pill, and start takingailevathe next day, without a break.

If you are taking "daily" pills that contain 28 tablets in the pack

If your current pack of pills contains inactive tablets (placebo), do not take these tablets, and start withailevathe next day without leaving a break.

If you are changing from a pill that only contains a progestogen, an injection, or an implant

• If you change from a pill that only contains progestogen, you can start withailevaat any time of the menstrual cycle, the day after stopping the pill that only contains progestogen.
• If you change from an implant, start usingailevathe day after the implant is removed.
• If you change from an injectable contraceptive, start withailevathe day after the next scheduled injection.

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

If you start taking aileva after a first-trimester abortion (3 months) of pregnancy

You can start takingailevaimmediately, but you should follow your doctor's advice before doing so. No additional barrier method of contraception is needed.

If you start taking aileva after having a baby or after a second-trimester abortion

Like any other oral contraceptive, aileva should not be initiated before 28 days after giving birth, or after a second-trimester abortion, as the risk of blood clots increases. If you start later, you are recommended to use a barrier method of contraception during the first 7 days you take the pill. If you have had sex before starting with aileva, make sure you are not pregnant or wait until your next period.

Consult your doctor in case of doubt.

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 naturally decrease as your body handles the excess hormones.

Consult your doctor if you are concerned.

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 take aileva

• If you forget to take a tablet less than 12 hours before the usual time, the protection against pregnancy is not affected. You can still take the tablet as soon as you remember and then take the next tablets at the usual time.
• If you forget to take a tablet more than 12 hours before the usual time, the protection against pregnancy may be reduced. The more tablets you forget to take, the greater the risk of reduced protection against pregnancy.

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

• More than 1 tablet forgotten in this pack

Consult your doctor.

• One tablet forgotten in week 1

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Take the tablets afterwards at the usual time and take extra precautions for the next 7 days, for example, a condom. If you have had sex in the week before the mistake, or if you forgot to start a new pack after your period, you should be aware that there is a risk of pregnancy. In that case, consult your doctor.

• One tablet forgotten in week 2

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Take the tablets afterwards at the usual time. The protection against pregnancy is not reduced and you do not need to take extra precautions.

• One tablet forgotten in week 3

You can choose between two options:

Take the tablets afterwards at the usual time. Instead of the week off from taking tablets, start the next pack immediately.

It is likely that you will have a menstrual period (withdrawal bleeding) at the end of the second pack, but you may also have spotting or bleeding while taking the second pack.

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

If you forgot to take one of the tablets from a pack and do not have bleeding in the first break, it may mean you are pregnant. You should contact your doctor before continuing with the next pack.

If you experience vomiting or diarrhea

If you vomit or have severe diarrhea within 4 hours of taking the tablet, it is as if you forgot to take the tablet. After vomiting or diarrhea, you should take another tablet from the spare pack as soon as possible. If possible, take it within the next 12 hours or when you normally take the pill. If not possible or more than 12 hours have passed, you should follow the recommendations given in "If you realize you have forgotten to take a tablet more than 12 hours after the usual time of taking."

If the episodes of vomiting or diarrhea are repeated over several days, a barrier method of contraception (e.g., condoms) should be used 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 ofailevaimmediately 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 menstrual period after finishing the second pack.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be related to aileva, 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 starting to take aileva”.

If you experience any of the following severe side 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 loss of vision, eye pain and swelling, especially if they are sudden.

• Sickle cell disease (a condition that affects the blood and kidneys): the frequency is unknown.

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

• Pancreatitis: the frequency is unknown.

The symptoms consist of severe upper abdominal pain that may radiate to the back.

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

• In a leg or foot (i.e., deep vein thrombosis (DVT)).
• In a lung (i.e., pulmonary embolism (PE)).
• Heart attack.
• Stroke.
• Mild or transient symptoms similar to those of a stroke, known as a transient ischemic attack (TIA).
• Blood clots in the liver, stomach/intestine, or kidneys.

The risk 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 the symptoms of a blood clot).

• Erythema multiforme: the frequency is unknown.

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

Other side 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 menstruation.
• Nausea.
• Abdominal pain.
• Menstrual cramps.

Common (may affect up to 1 in 10 people)

• Vaginal irritation and infection, including candidiasis.
• Mood changes, including depression.
• Decreased libido.
• Feeling nervous.
• Dizziness.
• Vomiting.
• Diarrhea.
• Abdominal bloating.
• Acne (pimples).
• Skin rash.
• Amenorrhea (absence of menstruation).
• Changes in the amount of bleeding and duration of menstruation.
• Breast tenderness, enlargement, or discharge.
• Changes in the cervix that can be seen on 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 skin patches (which may be from a previous pregnancy).
• High blood pressure.
• Gallstones.
• Glucose intolerance.
• Worsening of varicose veins.

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

• Yellowing of the skin and eyes (jaundice caused by an abnormal flow of bile in the liver).
• Boils under the skin that are painful and red (erythema nodosum).

Frequency unknown:cannot be estimated from available data

• Benign or malignant liver tumor.
• 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).
• Inflammation of the optic nerve: the symptoms consist of blurred vision and may lead to total or partial loss of vision.
• Lens intolerance.
• Biliary tract disease or worsening of this condition.
• Inflammatory or ischemic intestinal disease: the symptoms consist of abdominal pain and cramps, diarrhea (which may be bloody), weight loss.
• Stomach cramps.
• Vaginal discharge.
• Decreased folate levels in the blood.

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

Reporting of side effects

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

Keep this medication out of the sight and reach of children. Do not store at a temperature above 86°F (30°C).

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

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy . If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of aileva

The active principles are levonorgestrel and etinilestradiol.

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

Appearance of aileva and contents of the packaging

• Each coated tablet is cylindrical, biconvex of pink color.
• aileva 0.1 mg/0.02 mg is marketed in strips (PVC/PVDC/Aluminum blisters) of 21 tablets.
• The packaging sizes are 1 or 3 strips, and each strip contains 21 tablets. It may only be marketed in some packaging sizes.

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Responsible for Manufacturing

Cyndea Pharma, S.L.

Pol. Ind. Emiliano Revilla Sanz

Av. De Ágreda 31, 42110 Ólvega;

Soria

Spain

O

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: September 2023

"Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)" http://www.aemps.gob.es/ "

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your 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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