Package Leaflet: Information for the User

Levesialle Diario 0.10 mg/0.02 mg film-coated tablets

Levonorgestrel/Ethinylestradiol

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

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

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 aware and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”)

1. What is Levesialle Diario and for what it is used

2. What you need to know before starting to take Levesialle Diario.

3. How to take Levesialle Diario.

4. Possible side effects

5. Storage of Levesialle Diario.

6. Contents of the pack and additional information

Levesialle Diario is a contraceptive and is used to prevent pregnancy.

Each pink tablet contains a small amount of two different female hormones, known as levonorgestrel and ethinyl estradiol.

The white tablets do not contain an active ingredient and are called placebo tablets.

Contraceptives that contain two hormones are called "combined" tablets. Levesialle Diario is referred to as "low-dose" because it contains only a small amount of hormones.

While you are on treatment with this medication, you should visit your doctor regularly, at least twice a year.

If you have unusual symptoms, such as unexplained chest, abdominal, or leg pain, you should consult your doctor immediately.

Do not use Levesialle Diario

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Levesialle Diario.

Inform your doctor if you suffer from any of the following conditions

If the condition develops or worsens while you are using Levesialle Diario, 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. Estrogen-containing products can cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

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

Blood clots can form:

• In veins (which is called “deep vein thrombosis”, “thromboembolism”, or TEV).
• In arteries (which is called “arterial thrombosis”, “thromboembolism”, or TEA).

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 blood clot due to Levesialle Diario is small.

HOW TO RECOGNIZE A BLOOD CLOT

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

BLOOD CLOTS IN A VEIN

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

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (deep vein thrombosis). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism.
• In very rare cases, a blood clot may form in a vein in another organ, such as the eye (retinal vein thrombosis).

When is the risk of a blood clot in a vein higher?

The risk of a blood clot in a vein is higher during the first year in which a combined hormonal contraceptive is taken for the first time. The risk may be higher if you start taking a combined hormonal contraceptive again (the same medication or a different medication) 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 Levesialle Diario, 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 TEV 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 Levesialle Diario is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel or norethisterone or norgestimate, 5-7 will develop a blood clot in a year.
• The risk of a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot” below).

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

Your risk of a blood clot is higher:

• If you are overweight (body mass index (BMI) greater than 30 kg/m2).
• If a close relative has had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50 years). In this case, you may have an inherited disorder of blood clotting.
• If you need surgery or spend a lot of time without getting up due to an injury or disease, or if you have a leg cast. You may need to stop taking Levesialle Diario for several weeks before surgery or while you have limited mobility. If you need to stop taking Levesialle Diario, ask your doctor when you can start taking it again.
• As you get older (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 have any of the conditions listed above, even if you are unsure. Your doctor may decide that you should stop taking Levesialle Diario.

If any of the conditions listed above change while you are using Levesialle Diario, 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 Levesialle Diario is very small, but it may increase:

• With age (over about 35 years).
• If you smoke. When using a combined hormonal contraceptive like Levesialle Diario, you are advised to quit smoking. If you are unable to quit 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 (i.e., before about 50 years). In this case, you may also be at higher risk of a heart attack or stroke.
• If you or a close relative has 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, arrhythmia called atrial fibrillation).
• If you have diabetes.

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 listed above change while you are using Levesialle Diario, 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.

Levesialle Diario and Cancer

Cancer of the breast has been observed slightly more frequently in women using combined hormonal contraceptives, but it is not known whether this is due to the treatment. For example, it may be that more tumors are detected in women taking combined hormonal contraceptives because they are examined by their doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to undergo regular breast examinations, and you should visit your doctor if you notice any lump.

In rare cases, benign tumors in the liver have been reported in users of combined hormonal contraceptives, and even more rarely, malignant tumors. You should visit your doctor if you experience severe abdominal pain.

Cancer of the cervix has been reported in long-term users, but it is not clear whether it is due to sexual behavior or other factors such as the human papillomavirus (HPV).

Mental Disorders

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

Spotting

During the first few months of using Levesialle Diario, you may experience unexpected bleeding (bleeding outside of the menstrual period). If you experience these bleedings for more than a few months, or if they start after a few months, your doctor should investigate the cause.

What to do if you do not have your period during the week of rest

If you have taken all the pills correctly, have not vomited, and have not had severe diarrhea, and have not taken any other medication, it is very unlikely that you are pregnant.

If you do not have two consecutive menstrual periods, you may be pregnant. In this case, visit your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Taking Levesialle Diario with other medications

Some medications may affect the levels of Levesialle Diario in the blood, reducing its contraceptive effect, or may cause unexpected bleeding. This may occur with:

• medications used in the treatment of:
• • gastrointestinal motility disorders (e.g., metoclopramide)
  • epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, or felbamate)
  • tuberculosis (e.g., rifampicin, rifabutin)
  • arthritis, osteoarthritis (etoricoxib)
  • infections with HIV and hepatitis C (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, indinavir)
  • infections with fungi (e.g., griseofulvin, azole antimycotics such as itraconazole, voriconazole, fluconazole)
  • bacterial infections (macrolide antibiotics, e.g., clarithromycin, erythromycin)
  • cardiac disorders, high blood pressure (e.g., atorvastatin and calcium channel blockers such as verapamil, diltiazem)
  • arthritis, osteoarthritis (etoricoxib)
  • • neurological disorders (narcolepsy, e.g., modafinil)
    • fever and pain (paracetamol)
    • ascorbic acid (also known as vitamin C)
• herbal preparations containing St. John's Wort.

Levesialle Diario may affect the effect of other medications, for example:

• medications containing ciclosporin
• the antiepileptic lamotrigine (may lead to an increase in seizure frequency)
• theophylline (used in the treatment of respiratory problems)
• melatonin
• tizanidine (used in the treatment of muscle pain and/or muscle cramps)
• some benzodiazepines (sedatives, e.g., lorazepam, diazepam)
• theophylline (a medication for the treatment of asthma)
• glucocorticoids (e.g., cortisone)
• clofibrate (a medication used to reduce fat levels in the blood)
• paracetamol (an analgesic and antipyretic)
• morphine (a strong analgesic)

In women with diabetes, the need for hypoglycemic agents (e.g., insulin) may vary.

Troleandomycin may increase the risk of intrahepatic cholestasis during co-administration with AOCs.

• Do not take Levesialle Diario if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver enzyme tests (elevated ALT levels).

Your doctor will prescribe another type of contraceptive before starting treatment with these medications.

Levesialle Diario can be taken again approximately 2 weeks after the end of this treatment. See the section “Do not use Levesialle Diario”.

Ask your doctor or pharmacist for advice before taking any medication. Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication.

Taking Levesialle Diario with food and drinks

This medication can be taken with or without food, if necessary, with a little water. This medication should not be taken with grapefruit juice.

Laboratory Tests

If you need a blood test, inform your doctor or the laboratory staff that you are taking a contraceptive, as hormonal contraceptives can affect the results of some tests.

Fertility, Pregnancy, and Breastfeeding

If you are pregnant or breastfeeding, or if you plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

If you are pregnant, do not take Levesialle Diario. If you become pregnant while taking Levesialle Diario, stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Levesialle Diario at any time (see “If you interrupt treatment with Levesialle Diario”)

Breastfeeding

Generally, it is not recommended to take Levesialle Diario during breastfeeding. If you want to take the contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before taking any medication.

Driving and Operating Machinery

There is no information to suggest that the use of Levesialle Diario has any effect on the ability to drive or operate machinery.

Levesialle Diario contains lactose

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

The coated tablet of Levesialle Diario containsaluminum lake allura (E129)andsoy lecithin, which may cause allergic reactions. Do not use this medication in case of an allergy to peanuts or soy.

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

If you were taking another contraceptive before starting Levesialle Diario 28 tablets, you know that most contraceptives contain 21 tablets. With these contraceptives, you take a tablet for 21 days and then there is a week without taking tablets (tablet-free interval).

The system to follow when using Levesialle Diario 28 tablets is different. After taking the 21 pink tablets, you must continue with the 7 placebo tablets and, consequently, there is no tablet-free interval, but a week of "placebo" (the week of taking the placebo tablets from row 4). Since you have to take a tablet every day and there is no tablet-free interval between the two packs, taking tablets becomes a routine and there is less risk, therefore, of forgetting to take a tablet.

The two types of tablets of different colors of Levesialle Diario 28 tablets are placed in order. One pack contains 28 tablets.

Take one Levesialle tablet every day. You can take it with or without food, if necessary with a small amount of water. You must take the tablets every day at the same time.

Do not confuse the tablets:take one pink tablet once a day for the first 21 days, and then one white tablet a day for the last 7 days. Then, you must start a new blister, immediately (21 pink tablets and 7 white tablets). Without leaving, therefore, a period of rest between the two blisters.

To help you remember to take the tablets, each pack of Levesialle Diario comes, for each blister, with a sticker that consists of 7 adhesive stickers with the days of the week printed on them. Take the sticker of the week that starts with the day you started taking the tablets. For example, if you started on a Wednesday, use the sticker that starts with "WED".

Place the sticker of the week along the blister where you can read "Place the sticker here".

Thus, for each tablet, there is a day indicated at the top and you can see, therefore, that you are taking the correct tablet. The arrows show the order in which you take the tablets.

Over the 7 days in which you take the white placebo tablets (called placebo days), menstruation (also known as withdrawal bleeding) should occur. This usually starts on the 2nd or 3rd day after the last pink Levesialle Diario tablet. Once you have taken the last white tablet, you should start with the next blister, even if you have not finished bleeding. This means that you must start each strip on the same day of the week and that withdrawal bleeding should occur on the same days of each month.

If you use Levesialle Diario in this way, you will also be protected against pregnancy during the 7 days when you take the white placebo tablets.

When can you start with the first pack:

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

Start taking Levesialle Diario on the first day of the cycle (i.e. the first day of your period). If you start Levesialle Diario on the first day of your menstruation, you will be protected immediately against pregnancy. You can also start on days 2-5 of the cycle, but you must use additional contraceptive methods (e.g. a condom) during the first 7 days.

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

You can start taking Levesialle Diario preferably on the day after taking the last active tablet (the last tablet containing active ingredients) of your previous contraceptive, or the day after removing the vaginal ring or patch, but no later than the day after the ring-free or patch-free week of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive).

• Change from a progestin-only method (progestin-only pill, injection, implant or progestin-releasing intrauterine system SLI).

You can change from the progestin-only pill, any day (if it is an implant or an SLI, on the day of its removal; if it is an injectable, on the day of the next injection), but in all cases use additional contraceptive methods (e.g. a condom) during the first 7 days of taking tablets.

• After a spontaneous abortion or a miscarriage after the first three months of pregnancy:

Follow your doctor's recommendations.

• After having a child or after a spontaneous abortion after the third month of pregnancy:

Do not start taking Levesialle Diario between 21 and 28 days after having a child or a spontaneous abortion. You must use one of the so-called barrier methods (e.g. a condom) during the first 7 days of using Levesialle Diario.

If, after having a child, you have already had sex before starting to take Levesialle Diario (again), you must be sure you are not pregnant or wait for your next menstrual period.

• If you are breastfeeding and want to start taking Levesialle Diario (again) after having a child.

Read the section "Breastfeeding".

Ask your doctor if you are not sure when to start.

Duration of use:

You can take this medication as long as you want to use a hormonal contraceptive and the benefits of a hormonal contraceptive are greater than the risks for your health (see section 2 'Do not take Levesialle Diario' and 'Warnings and precautions').

If you take more Levesialle Diario than you should:

No cases of severe damage have been reported due to the ingestion of an overdose of Levesialle Diario. If you take several tablets at once, you may have symptoms of nausea or vomiting. Girls may have vaginal bleeding.

If you have taken too many Levesialle Diario tablets, or if you discover that a child has taken them, consult your doctor or pharmacist immediately or call the Toxicology Information Service 91 562 04 20 indicating the medication and the amount used.

If you forgot to take Levesialle Diario:

The tablets of the 4th row of the blister are placebo tablets. If you forget to take one of these tablets, it will not affect the efficacy of Levesialle Diario. Dispose of the forgotten tablet.

If you forget to take an active pink tablet (tablets of the 1st, 2nd and 3rd row), you must do the following:

• If you are lateless than 12 hoursin taking some tablets, the protection against pregnancy does not decrease. Take the tablet as soon as you remember and the subsequent tablets at the usual time.
• If you are latemore than 12 hoursin taking some tablets, the protection against pregnancy may decrease. The more tablets you have forgotten, the greater the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is maximum if you forget to take the pink tablet, at the beginning (1st row) or at the end of the pack (3rd row). Therefore, you must follow the following recommendations (see also the diagram below):

?Forgetting more than one tablet from the pack:

?If you have forgotten more than 1 Levesialle Diario tablet from the current blister, the contraceptive protection is no longer guaranteed.

?Forgetting a tablet between days 1-7:

Take the forgotten tablet as soon as you remember, although this means you will have to take two tablets at once. Continue taking the tablets at the usual time and useadditional precautions, for example, a condom, during the next 7 days. If you have had sex in the week before forgetting the tablet, you may be pregnant. In that case, consult your doctor.

?Forgetting a tablet between days 8-14:

Take the forgotten tablet as soon as you remember, although this means you will have to take two tablets at once. Continue taking the tablets at the usual time. The contraceptive protection does not decrease and you do not need to take additional precautions if the tablets have been taken correctly in the 7 days before the forgotten tablet. However, if you have not taken the tablets correctly or if you have forgotten more than one tablet, additional non-hormonal contraceptive methods (e.g. condoms) will be needed during the next 7 days.

?Forgetting a tablet between days 15-21:

You can choose between two options:

• Take the forgotten tablet as soon as you remember, although this means you will have to take two tablets at once. Continue taking the tablets at the usual time. Instead of starting the placebo week, discard them and start taking the next pack (the day you usually start the packs, it will change).

You may experience light bleeding or menstrual-like bleeding during the use of the second pack.

• You can also interrupt the active pink tablets and start directly with the 7 white placebo tablets (noting the day you forgot to take the tablet). Then, continue with a new pack. If you want to start a new pack on the day you always start, your placebo week should lastless than 7 days.

If you follow one of these two recommendations, you will remain protected against pregnancy as long as you have taken the tablets correctly during the 7 days before the forgotten tablet.

• If you have forgotten to take a tablet and you do not have bleeding during the first rest period, you may be pregnant. Contact your doctor before continuing with the next pack.

What to do in case of vomiting or intense diarrhea:

If you experience vomiting or intense diarrhea in the 3-4 hours after taking a tablet or have intense diarrhea, there is a risk that the active ingredients of the contraceptive will not be fully absorbed by the body. The situation is almost equivalent to forgetting a tablet. After the vomiting or diarrhea, take a pink tablet from a reserve pack as soon as possible. If possible, take it within 12 hours after the usual time you take your contraceptive. If not possible or more than 12 hours have passed, follow the advice in the section "If you forget to take Levesialle Diario".

Delayed period: what you should know:

Although not recommended, you can delay your period if you start taking a new pack of Levesialle Diario instead of continuing to take the placebo tablets, and finish it. You may experience light bleeding or menstrual-like bleeding during the use of the second pack.

You should ask your doctor for advice before deciding to delay your menstrual period.

Change of the first day of your period: what you should know:

If you take the tablets according to the instructions, your period will start during the placebo days. If you have to change that day, reduce the number of placebo days (but never increase them - 7 at most!). For example, if you start taking the placebo tablets on Fridays and want to change to Tuesdays (3 days earlier), start a new pack 3 days earlier than usual. You may not have bleeding during these days. You may experience light bleeding or menstrual-like bleeding.

If you are not sure how to proceed, consult your doctor.

If you interrupt the treatment with Levesialle Diario:

You can stop taking Levesialle Diario when you want. If you do not want to become pregnant, consult your doctor about other effective birth control methods. If you want to become pregnant, stop taking Levesialle Diario and wait until your period before trying to become pregnant. This way, you can calculate your estimated due date more easily.

If you stop taking this medication, it is possible that your periods will take some time to become regular again, especially if you have had irregular periods before taking the "pill".

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

Like all medicines, Levesialle Diario may 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 notice any changes in your health that you think may be related to this medicine, consult your doctor.

Severe side effects

Seek immediate medical attention if you experience any of the following angioedema symptoms: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing (see also "Warnings and precautions").

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 use Levesialle Diario".

The following list of side effects has been associated with the use of Levesialle Diario:

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

• Headaches (including migraines)

Common(may affect up to 1 in 10 people):

- Mood changes, depression

• Changes in sexual desire
• Nausea, vomiting, abdominal pain (stomach pain)
• Acne
• Fluid retention
• Breast pain or tenderness, breast discharge, menstrual cramps, change in menstrual flow, increased vaginal discharge, absence of menstrual bleeding
• Weight changes (weight gain or loss)
• Vaginal inflammation including fungal infection (candidiasis)

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

• Changes in appetite (increased or decreased), reduced ability to break down glucose (glucose intolerance)
• Abdominal cramps, bloating, diarrhea
• Skin rash, possible persistent brown-yellowish skin patches (chloasma), increased body and facial hair, hair loss
• Urticaria
• Breast swelling
• Increased blood pressure, changes in blood lipid levels

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

• Lens intolerance.
• Allergic reactions including severe ones with respiratory and circulatory symptoms, painful skin and mucous membrane swelling (angioedema)
• Deleterious 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, known as transient ischemic attack (TIA) or blood clots in the liver, stomach/intestine, kidneys, or eye
• Jaundice due to bile flow obstruction
• Painful red skin nodules (erythema nodosum)
• Skin rash with target-shaped redness or ulcers (erythema multiforme)
• Decreased blood folate levels (blood folate levels may decrease with "the pill"; in the case of a pregnancy, decreased blood folate levels may be important)

Very rare(may affect up to 1 in 10,000 people):

• Hepatocellular cancer

The following conditions may be caused or worsened by combined oral contraceptives: Inflammation of the optic nerve (may lead to partial or total loss of vision), increased formation of varicose veins, inflammation of the pancreas with severe disturbance of fat metabolism, inflammation of the large intestine, Crohn's disease, ulcerative colitis, migraine, porphyria (metabolic disorder causing abdominal pain and mental disturbances), systemic lupus erythematosus (where the body attacks and damages its own organs and tissues), herpes in late pregnancy, Sydenham's chorea (rapid involuntary jerks or nervous movement), hemolytic-uremic syndrome (a disorder that occurs after diarrhea caused by E. coli), liver problems with jaundice, bile duct or gallstone formation, a form of hearing loss (otosclerosis).

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in the leaflet.

You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: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.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. By doing so, you will help protect the environment.

The active principles are 0.10 mg of levonorgestrel and 0.02 mg of ethinylestradiol.

Levesialle Diario has tablets of 2 colors:

Appearance of the product and contents of the package

The active tablets are pink and rounded, with an approximate diameter of 5.7 mm.

The placebo tablets are white and rounded, with an approximate diameter of 5.7 mm.

Each blister contains 21 active tablets coated with a pink film distributed between the 1st, 2nd, and 3rd row and 7 placebo tablets coated with a white film located in the 4th row.

Levesialle Diario is available in packages of 1, 3, 6, or 13 blisters of 28 tablets.

Not all packages may be marketed.

Holder of the marketing authorization and responsible manufacturer.

Holder

Exeltis Healthcare S.L

Avda. de Miralcampo, 7.

Polígono Industrial Miralcampo.

19200 Azuqueca de Henares,

Guadalajara (Spain)

Manufacturer

Laboratorios León Farma, S.A.

Polígono Industrial Navatejera, La Vallina S/N

24008 Villaquilambre (León) - Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Belgium: Levesialle Continu 20 0.10 mg/0.02 mg coated tablets

Denmark: Mirabella 28, film-coated tablets

Finland: Levesia 100 micrograms / 20 micrograms film-coated tablets

France: ASTERLUNA CONTINU 100 micrograms / 20 micrograms, coated tablet

Italy: Lasca 100 micrograms / 20 micrograms coated tablets

Luxembourg: Levesialle Continu 20 0.10 mg / 0.02 mg coated tablets

Norway: Mirabella 100 micrograms / 20 micrograms film-coated tablets

Spain: Levesialle Diario 0.10 mg / 0.02 mg coated tablets EFG

Sweden: Levesia, 100 micrograms / 20 micrograms film-coated tablet

Last review date of this leaflet: June 2023

The 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.es.gob