Levesialle Diario 0.10 mg/0.02 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levesialle Diario 0.10 mg/0.02 mg film-coated tablets EFG

Levonorgestrel/Ethinylestradiol

Read the entire leaflet carefully before you start using 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, consult your doctor, pharmacist, or nurse.
• 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, because it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects 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 developing blood clots 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”).

Leaflet contents

1. What Levesialle Diario is and what it is used for
2. What you need to know before taking Levesialle Diario
3. How to take Levesialle Diario
4. Possible side effects
5. How to store Levesialle Diario
6. Contents of the pack and other information

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

Levesialle Diario is a contraceptive used to prevent pregnancy.

Each pink tablet contains a small amount of two different female hormones, called levonorgestrel and ethinylestradiol.

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

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

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

General considerations Before starting to use Levesialle Diario, you must 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 Levesialle Diario, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your health status, may carry out other tests. This leaflet describes several situations in which you should stop using Levesialle Diario, or in which the effect of Levesialle may decrease. In such situations, you should not have sexual intercourse or should use additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use the rhythm method or temperature method. These methods may not be reliable since Levesialle Diario alters the monthly changes in body temperature and cervical mucus. Levesialle Diario, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

While being treated with this medicine, you must visit your doctor regularly, at least twice a year.

If you experience unusual symptoms, such as unexplained pain in the chest, abdomen, or legs, you should consult your doctor immediately.

Do not use Levesialle Diario

• If you are pregnant or think you might be pregnant.
• If you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.
• If you have (or have ever had) a heart attack or stroke.
• 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 will be immobile for a prolonged period (see section “Blood clots”). If you have (or have ever had) a condition that may indicate a future risk of heart attack (e.g., angina pectoris, which causes severe chest pain) or stroke (e.g., transient ischaemic attack without residual effects).
• If you have any disease that may increase the risk of arterial clots:
  • Severe diabetes with blood vessel damage.
  • Severely high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.
• If you smoke (see section 2 “Blood clots”).
• If you have (or have ever had) a type of migraine with so-called focal neurological symptoms.
• Do not use Levesialle Diario if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Taking Levesialle Diario with other medicines”).
• If you have (or have ever had) pancreatitis (inflammation of the pancreas) related to a severe disorder of fat metabolism.
• If you have (or have ever had) liver disease and your liver function has not yet returned to normal, or if you have elevated blood levels of the yellow-brown bile pigment (bilirubin) due to an excretion disorder (Dubin-Johnson syndrome or Rotor syndrome).
• If you have (or have ever had) a liver tumor (benign or malignant).
• If you have (or have ever had), or suspect you may have breast cancer or cancer of the genital organs.
• If you have vaginal bleeding of unknown cause.
• If your menstruation has stopped, possibly due to diet or exercise.
• If you are allergic to levonorgestrel or ethinylestradiol, or to any of the other ingredients of Levesialle Diario (listed in section 6).

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 the section «How to recognize a blood clot».

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

• If any close family member has or has ever had breast cancer.
• If you have any liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you require surgery, or will be immobile for a prolonged period (see section 2, “blood clots”).
• If you have recently given birth, you are at increased risk of developing blood clots. You should ask your doctor how long after delivery you may start taking Levesialle.
• If you have inflammation of the veins beneath the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have Crohn's disease or inflammatory bowel disease (ulcerative colitis).
• If you have a blood disorder called HUS (haemolytic uraemic syndrome) which causes kidney damage.
• If you have a blood disorder known as sickle cell anemia.
• If you have epilepsy (see “Use of Levesialle with other medicines”).
• If you have an immune system disorder called SLE (systemic lupus erythematosus).
• If you have any condition that first occurred during pregnancy or during a previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a neurological disorder involving involuntary movements (Sydenham's chorea)).
• If you have or have ever had chloasma (skin discoloration, especially on the face or neck, also known as “melasma” or “pregnancy mask”). In such cases, avoid direct exposure to sunlight or ultraviolet radiation.

Inform your doctor if you develop any of the following conditions

If any of these conditions develop or worsen while using Levesialle Daily, you must 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 difficulty breathing, contact a doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Levesialle Diario 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 may form:

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

Recovery from blood clots is not always complete. In rare cases, 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 Levesialle 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 it be indicating?
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., becoming pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing. Sudden cough without a clear cause, possibly bringing up blood. Sharp chest pain that may worsen when breathing deeply. Rapid or irregular heartbeat. Severe abdominal pain If you are unsure, consult a doctor. 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.	Retinal vein thrombosis (blood clot in the eye)
Pain, discomfort, pressure, or heaviness in the chest. Feeling of tightness or fullness in the chest, arm, or below the sternum. Feeling 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
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 difficulty seeing in one or both eyes. Sudden difficulty walking, dizziness, loss of balance or coordination. Sudden, severe, or prolonged headache without known cause. Loss of consciousness or fainting, with or without seizures. 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 abdominal 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 veins (venous thrombosis). However, these adverse events are rare. They occur more frequently during the first year of using 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 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 you take a combined hormonal contraceptive for the first time. 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 Levesialle Diario, 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 Levesialle Diario is low.

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5 to 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/vaginal ring and who are not pregnant.	About 2 out of 10,000 women
Women using a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate.	About 5-7 out of 10,000 women.
Women using Levesialle Diario	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 Levesialle Daily is small, but certain conditions increase this risk. Your risk is higher:

• If you are overweight (body mass index or BMI above 30 kg/m²)
• If any of your close relatives has had a blood clot in the leg, lung, or another organ at a young age (i.e., before the age of approximately 50). In this case, you might have an inherited blood clotting disorder.
• If you require 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 Levesialle several weeks before surgery or while you are less mobile. If you need to stop taking Levesialle Daily, ask your doctor when you can start taking it 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 Levesialle Daily.

If any of the above conditions change while you are using Levesialle Daily—for example, if a close relative experiences a thrombosis without a known cause or if you gain a significant amount 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 lead to 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 while using Levesialle Diario is very small, but it may increase:

• With age (above approximately 35 years).
• If you smoke. When using a combined hormonal contraceptive such as Levesialle Diario, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend that you 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 an early age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you suffer from migraines, especially migraines with aura.
• If you have heart disease (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, your risk of developing a blood clot may be further increased.

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

Levesialle Daily and cancer

Breast cancer 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 tumors are detected more often in women taking combined oral contraceptives because they undergo medical examinations more frequently. The incidence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important to have regular breast examinations, and you should consult your doctor if you notice any lump.

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

Cervical cancer has been reported in long-term users, but it is unclear whether this is due to sexual behavior or other factors such as human papillomavirus (HPV).

Psychiatric disorders

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

Bleeding between periods

During the first few months of using Levesialle Diario, unexpected bleeding (bleeding outside the rest period) may occur. If you experience such bleeding for longer than a few months, or if it starts after a few months of use, your doctor should investigate the cause.

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

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

If you miss two consecutive menstrual periods, you could be pregnant. In this case, consult your doctor immediately. Do not start the next pack until you have confirmed that you are not pregnant.

Taking Levesialle Diario with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. They can advise you whether you need to take additional contraceptive precautions (for example, condoms) and, if so, for how long.

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

• Medicines used to treat:
  • 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)
  • HIV and hepatitis C virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, indinavir)
  • Fungal infections (e.g., griseofulvin, azole antifungals such as itraconazole, voriconazole, fluconazole)
  • Bacterial infections (macrolide antibiotics, e.g., clarithromycin, erythromycin)
  • Certain heart conditions, high blood pressure (e.g., atorvastatin and calcium channel blockers such as verapamil, diltiazem)
  • Arthritis, osteoarthritis (etoricoxib)
    • Nervous system disorders (narcolepsy, e.g., modafinil)
    • Pain and fever (paracetamol)
    • Ascorbic acid (also known as vitamin C)
• Herbal preparations containing St. John's wort.

Levesialle Diario may influence the effect of other medicines, for example:

• Medicines containing cyclosporine
• The antiepileptic lamotrigine (may lead to an increased frequency of seizures)
• Theophylline (used in the treatment of respiratory problems)
• Melatonin
• Tizanidine (used in the treatment of muscle pain and/or muscle spasms)
• Some benzodiazepines (sedatives, e.g., lorazepam, diazepam)
• Theophylline (a medicine for the treatment of asthma)
• Glucocorticoids (e.g., cortisone)
• Clofibrate (a medicine used to reduce blood fat levels)
• 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 COCs.

• Do not take Levesialle Diario 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 (elevation of liver enzyme ALT).

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

Levesialle Diario may be restarted approximately 2 weeks after completion of this treatment. See the section "Do not use Levesialle Diario".

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

Taking Levesialle Daily with food and drink

This medicine can be taken with or without food, if necessary, with a small amount of water. This medicine must 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 an oral contraceptive, as oral contraceptives may influence the results of certain tests.

Fertility, pregnancy and breastfeeding

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

Pregnancy

If you are pregnant, do not take Levesialle Daily. If you become pregnant during treatment with Levesialle, stop treatment immediately and contact your doctor. If you wish to become pregnant, you may stop taking Levesialle Daily at any time (see "If you stop taking Levesialle Daily").

Breastfeeding

In general, taking Levesialle Daily is not recommended during breastfeeding. If you wish to take the contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before taking any medicine.

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 informed you of an intolerance to certain sugars, consult him before taking this medicine.

The coated tablet of Levesialle Diario contains allura red aluminium lake (E129) and soybean lecithin, which may cause allergic reactions. Do not use this medicine if you are allergic to peanuts or soybeans.

3. How to take Levesialle Diario

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

If you were using another contraceptive before starting Levesialle Diario 28 tablets, you may be familiar with the fact that most contraceptives contain 21 tablets. With these contraceptives, you take one tablet daily for 21 days, followed by a week without tablets (tablet-free interval).

The regimen for using Levesialle Diario 28 tablets is different. After taking the 21 pink tablets, you must continue with the 7 placebo tablets, meaning there is no tablet-free interval, but rather a "placebo" week (the week during which you take the placebo tablets in row 4). Since you must take a tablet every day and there is no break between packs, tablet-taking becomes a routine, thereby reducing the risk of forgetting a dose.

The two differently colored tablets in Levesialle Diario 28 tablets are arranged in a specific order. Each pack contains 28 tablets.

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

Do not confuse the tablets: take one pink tablet once daily for the first 21 days, followed by one white tablet daily for the last 7 days. Then, immediately start a new blister pack (21 pink tablets and 7 white tablets), without leaving any gap between packs.

To help you remember to take your tablets, each Levesialle Diario pack includes, for each blister, a sticker composed of 7 adhesive labels with the days of the week printed on them. Select the weekly sticker starting with the day you began taking the tablets. For example, if you started on a Wednesday, use the sticker beginning with “WED”.

Place the weekly sticker along the blister where it says “Place sticker here”.

Thus, each tablet will have a corresponding day marked above it, allowing you to confirm that you are taking the correct tablet. The arrows indicate the order in which you should take the tablets.

During the 7 days when you take the white placebo tablets (referred to as placebo days), you should experience menstruation (also known as withdrawal bleeding). This usually begins on the 2nd or 3rd day after the last pink tablet of Levesialle Diario. After taking the last white tablet, you must start the next blister pack immediately, even if bleeding has not stopped. This means you should begin each new pack on the same day of the week, and withdrawal bleeding should occur during the same days 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 to start the first pack

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

Start taking Levesialle Diario on the first day of your 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 against pregnancy immediately. You may also start on days 2–5 of your cycle, but you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

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

You may start taking Levesialle Diario preferably 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 tablet-free, ring-free, or patch-free interval of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive).

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or progestogen-releasing intrauterine device, IUD).

You may switch from the progestogen-only pill on any day (if using an implant or IUD, on the same day of removal; if using an injectable, at the time of the next scheduled injection), but in all cases, you must use additional contraceptive measures (e.g., a condom) during the first 7 days of taking Levesialle Diario tablets.

• After a spontaneous abortion or induced abortion in the first three months of pregnancy:

Follow your doctor’s recommendations.

• After childbirth or abortion occurring after the third month of pregnancy:

Do not start taking Levesialle Diario earlier than 21 to 28 days after childbirth or 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 childbirth, you have already had sexual intercourse before starting Levesialle Diario (again), you must ensure you are not pregnant or wait until your next menstrual period.

• If you are breastfeeding and wish to start (or restart) taking Levesialle Diario after childbirth.

Read the section “Breast-feeding”.

Ask your doctor if you are unsure about when to start.

Duration of use

You may take this medicine for as long as you wish to use a hormonal contraceptive method and the benefits of hormonal contraception outweigh the health risks (see section 2 'Do not take Levesialle Diario' and 'Warnings and precautions').

If you take more Levesialle Diario than you should

No serious harmful effects have been reported from overdosing on Levesialle Diario. If you take several tablets at once, you may experience symptoms such as nausea or vomiting. Girls may experience vaginal bleeding.

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

If you forget to take Levesialle Diario

The tablets in the fourth row of the blister are placebo tablets. If you forget to take one of these tablets, it will not affect the effectiveness of Levesialle Diario. Discard the missed tablet.

If you forget to take an active pink tablet (tablets in rows 1, 2, and 3), follow these instructions:

• If you are less than 12 hours late in taking a tablet, protection against pregnancy is not reduced. Take the tablet as soon as you remember, and continue taking subsequent tablets at your usual time.
• If you are more than 12 hours late in taking a tablet, protection against pregnancy may be reduced. The more tablets you miss, the higher the risk of becoming pregnant.

The risk of inadequate protection against pregnancy is greatest if you miss a pink tablet at the beginning (row 1) or end (row 3) of the pack. Therefore, follow the recommendations below (see also the diagram below):

?Forgot more than one tablet from the pack

If you have missed more than 1 tablet of Levesialle Daily from the current blister pack, contraceptive protection is no longer guaranteed. Missed tablet between days 1-7

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time and use additional precautions, such as a condom, for the next 7 days. If you have had sexual intercourse in the week before missing the tablet, you may be pregnant. In this case, consult your doctor.

?Forgot a tablet between days 8-14

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking your tablets at the usual time. Contraceptive protection is not reduced, and you do not need to take additional precautions if the tablets have been taken correctly in the 7 days prior to the missed tablet. However, if you have not taken the tablets correctly or if you have missed more than one tablet, additional non-hormonal contraceptive methods (for example, condoms) will be required for the next 7 days.

?Forgot a tablet between days 15-21

You have two options:

• Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking your tablets at the usual time. Instead of starting the placebo week, discard it and immediately start the next pack (your usual starting day for packs will therefore change).

You will likely get your period at the end of the second pack, during the placebo period, although you may also experience light bleeding or spotting similar to a period during the second pack.

• Alternatively, you may stop taking the active pink tablets and start directly with the 7 placebo tablets (noting the day on which you missed the tablet). After this, continue with a new pack. If you wish to start the new pack on your usual starting day, your placebo period must last less than 7 days.

If you follow either of these two recommendations, you will remain protected against pregnancy, provided you have taken your tablets correctly during the 7 days prior to the missed tablet.

• If you have missed taking any tablets and do not have bleeding during the first placebo period, you may be pregnant. Contact your doctor before continuing with the next pack.

What to do in case of vomiting or severe diarrhoea

If you experience vomiting or severe diarrhoea within 3-4 hours after taking a tablet, or have persistent severe diarrhoea, there is a risk that the active ingredients of the contraceptive may not be fully absorbed by your body. This situation is almost equivalent to missing a tablet. After vomiting or diarrhoea, take a pink tablet from a备用 pack as soon as possible. If possible, take it within 12 hours of your usual time for taking the contraceptive. If this is not possible, or more than 12 hours have passed, follow the advice in the section “If you forget to take Levesialle Diario”.

Delaying your period: what you should know

Although not recommended, you may delay your period by starting a new pack of Levesialle Diario instead of taking the placebo tablets, and finishing the pack. During the second pack, you may experience light bleeding or spotting similar to a period. Complete the second pack by taking the 7 white tablets in the 4th row. Then, start the next pack.

You should consult your doctor before deciding to delay your menstrual period.

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

If you take the tablets as instructed, your period will start during the placebo days. If you wish to change this day, reduce the number of placebo days (but never extend them—maximum 7 days!). For example, if you usually start your placebo tablets on Fridays and want to change to Tuesdays (3 days earlier), start the new pack 3 days earlier than usual. Bleeding may not occur during these days. You may experience light bleeding or spotting.

If you are unsure how to proceed, consult your doctor.

If you stop treatment with Levesialle Diario

You may stop taking Levesialle Diario at any time. If you do not wish to become pregnant, consult your doctor about other effective methods of contraception. If you wish to become pregnant, stop taking Levesialle Diario and wait until your next period before trying to conceive. This will allow you to estimate your due date more easily.

If you stop taking this medicine, it may take some time for your periods to return to regularity, especially if you previously had irregular menstrual cycles before taking the “pill”.

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

4. Possible adverse effects

Like all medicines, Levesialle Diario may 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 this medicine, consult your doctor.

Serious adverse effects

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”).

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 Levesialle Diario”.

The following list of adverse 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 ache)
  • Acne
  • Fluid retention
  • Breast pain or tenderness, breast discharge, menstrual pain, change in the intensity of menstrual bleeding, increased vaginal discharge, absence of menstrual bleeding
  • Weight changes (weight gain or weight 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)
• Stomach cramps, abdominal distension, diarrhea
• Skin rash, possible persistent brownish-yellow patches on the skin (chloasma), increased body and facial hair, hair loss
• Urticaria
• Breast swelling
• Increased blood pressure, changes in blood fat levels

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

• Intolerance to contact lenses
• Allergic reactions including severe reactions with respiratory and circulatory symptoms, painful swelling of the skin and mucous membranes (angioedema)
• 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), or blood clots in the liver, stomach/intestines, kidneys or eye
• Jaundice due to blockage of bile flow
• Painful red nodules on the skin (erythema nodosum)
• Skin rash with target-shaped redness or ulcers (erythema multiforme)
• Decreased levels of folic acid in the blood (folic acid levels may decrease with the “pill”; if pregnancy occurs shortly after stopping the “pill”, reduced folic acid levels may be significant)

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

• Hepatocellular carcinoma

The following conditions may occur or worsen with combined oral contraceptives: Optic neuritis (which may lead to partial or complete vision loss), increased development of varicose veins, inflammation of the pancreas with severe fat metabolism disorder, inflammation of the colon, Crohn’s disease, ulcerative colitis, migraine, porphyria (a metabolic disorder causing abdominal pain and mental disturbances), systemic lupus erythematosus (a condition in which the body attacks and damages its own organs and tissues), herpes in late pregnancy, Sydenham’s chorea (rapid involuntary jerking or nervous movements), haemolytic-uraemic syndrome (a disorder occurring after diarrhoea caused by E. coli), liver disorders with jaundice, gallbladder disorders or gallstone formation, a form of hearing loss (otosclerosis).

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, even if it involves possible adverse reactions not listed in this leaflet.

You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Levesialle Diario

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. This helps protect the environment.

6. Contents of the pack and other information

The active substances are 0.10 mg levonorgestrel and 0.02 mg ethinylestradiol.

Levesialle Diario contains tablets of 2 colours:

• Each pink tablet contains 0.10 mg levonorgestrel and 0.02 mg ethinylestradiol. The other ingredients (excipients) are: anhydrous lactose, povidone K-30 (E1201), magnesium stearate (E470b), and a pink coating system (partially hydrolysed polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), macrogol 3350, aluminium lake of Allura red (E129), soybean lecithin (E322), iron oxide red (E172), aluminium lake of indigo carmine (E132).
• Each white tablet (inactive tablets or placebo tablets) contains only other ingredients (excipients, no active substance), which are: anhydrous lactose, povidone K-30 (E1201), magnesium stearate (E470b), and a white coating system (partially hydrolysed polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), macrogol 3350).

Appearance of the product and contents of the pack

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

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

Each blister contains 21 pink film-coated active tablets distributed in rows 1, 2 and 3, and 7 white film-coated placebo tablets located in row 4.

Levensialle Daily is available in packs containing 1, 3, 6 or 13 blisters of 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and 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
24193 Villaquilambre (León) - Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

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

Denmark: Mirabella 28, film-coated tablets

Finland: Levesia 100 mikrog / 20 mikrog kalvopäällysteiset tabletit

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

Italy: Lasca 100 micrograms/20 micrograms film-coated tablets

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

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

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

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

Date of the most recent review of this leaflet: June 2023

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