Package Insert: Information for the User

Levobel Daily 0.10 mg/0.02 mg Film-Coated Tablets

Levonorgestrel/Ethinylestradiol

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. 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 alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood Clots”).

Contents of the package and additional information

Levobel Diario is a contraceptive pill and is used to prevent pregnancy.

Each pink pill contains a small amount of two different female hormones, known as levonorgestrel, a progestogen, and ethinylestradiol, an estrogen.

The white pills do not contain active ingredients and are called placebo pills.

Contraceptives that contain two hormones are called "combined contraceptives". Levobel Diario is called a "low-dose" contraceptive because it only contains a small amount of hormones.

Do not take Levobel Diario

You should not use Levobel Diario if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

If any of the above conditions begin while you are using Levobel, stop taking the pills immediately and consult your doctor.

Warnings and Precautions

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

In some situations, you should have special care while using Levobel Diario or any other combined contraceptive, and your doctor may need to examine you regularly. If any of the following conditions develop or worsen while you are using Levobel Diario, you should also inform your doctor.

• 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 levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”).
• If you recently gave birth, you are at greater risk of blood clots. Ask your doctor when you can start taking Levobel Diario after childbirth.
• If you have superficial vein inflammation under the skin (thrombophlebitis).
• If you have varicose veins.
• If a close relative has or has had breast cancer.
• If you have liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have epilepsy (see “Other medications and Levobel Diario”).
• If you have any disease that appeared for the first time during pregnancy or during a previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, skin rash with blisters during pregnancy (herpes gestationalis), a nervous disorder characterized by involuntary movements (Sydenham's chorea).
• If you have or have had melasma (a skin discoloration, especially on the face or neck, known as “pregnancy mask”). In that case, avoid direct exposure to the sun or ultraviolet rays.
• • 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 Levobel 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 (known as “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (known as “arterial thrombosis”, “arterial thromboembolism” or ATE).

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 Levobel Diario 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?

Like a blood clot in an artery, a blood clot in a vein can cause serious problems. For example, it can cause a deep vein thrombosis (DVT) or a pulmonary embolism (PE).

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 of using 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 one) after a break of 4 weeks or more.

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

When you stop taking Levobel 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 VTE and the type of combined hormonal contraceptive you are taking.

The global risk of a blood clot in the leg or lung (DVT or PE) with Levobel 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 in a vein” below).

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

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

The risk of a blood clot in a vein increases the more conditions you have.

Long flights (≥ 4 hours) may temporarily increase the 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 above conditions, even if you are unsure. Your doctor may decide that you need to stop taking Levobel Diario.

If any of the above conditions change while you are using Levobel 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 Levobel Diario is 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 above conditions change while you are using Levobel 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.

Levobel Diario and cancer

Cancer of the breast has been observed with a slightly higher frequency in women using combined contraceptives, but it is unknown whether this is due to the treatment. For example, it may be that more tumors are detected in women taking combined contraceptives because they are examined by the doctor more often. 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.

Benign liver tumors (non-cancerous) are rare, and in a smaller number of cases, malignant liver tumors (cancerous) have been reported in users of combined contraceptives. Consult your doctor if you experience unusual and severe abdominal pain.

Mental health disorders

Some women who use hormonal contraceptives like Levobel Diario 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.

Spotting between periods

During the first few months of taking Levobel Diario, you may experience unexpected bleeding (bleeding outside the pill pack). If these bleeding episodes occur beyond a few months or start after a few months, your doctor should investigate the cause.

What to do if you do not have a period during the placebo week

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

If this is not the case, or if the period does not appear for the second time in a row, you may be pregnant. Consult your doctor immediately, as pregnancy must be ruled out before continuing to take the pill. Start the next pack only if you are sure you are not pregnant.

Other medications and Levobel Diario

Some medications may affect the levels of Levobel Diario in the blood, and may make it less effective in preventing pregnancy or cause unexpected bleeding. This may occur with:

• medications used to treat:
• • epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, or felbamate)
  • tuberculosis (e.g., rifampicin)
  • HIV and hepatitis C infections (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
  • fungal infections (e.g., griseofulvin, azole antifungals, e.g., itraconazole, voriconazole, fluconazole)
  • bacterial infections (macrolide antibiotics, e.g., clarithromycin, erythromycin)
  • heart disease, high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem)
  • arthritis, osteoarthritis (etoricoxib)
  • high blood pressure in the blood vessels of the lungs (bosentan)
• St. John's Wort herbal preparation.
• grapefruit juice.

Levobel Diario may affect the effect of other medications, for example,

• medications containing ciclosporin (used to suppress the body's immune response)
• the antiepileptic lamotrigine (may lead to an increase in seizure frequency)
• melatonin (for insomnia)
• theophylline (used to treat respiratory problems)
• midazolam (for sedation and epilepsy)
• tizanidine (muscle relaxant).

Do not take Levobel 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 test results (elevated ALT enzyme levels).

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

Levobel Diario can be restarted approximately 2 weeks after the completion of this treatment. See the section “Do not take Levobel Diario”.

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

Laboratory tests

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

Pregnancy and breastfeeding

Pregnancy

Do not take Levobel Diario if you are pregnant. If you become pregnant while taking Levobel Diario, stop taking the pills immediately and consult your doctor. If you intend to become pregnant, you may stop taking Levobel Diario at any time (see “If you interrupt treatment with Levobel Diario”).

Consult your doctor or pharmacist before using any medication.

Breastfeeding

It is not recommended to take Levobel Diario during the breastfeeding period unless your doctor advises you to do so. If you want to take the contraceptive while breastfeeding, you should consult your doctor.

Driving and operating machinery

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

Levobel Diario contains lactose, soy, red allura AC, and carmine

Levobel Diario contains lactose. If your doctor has told you that you have a intolerance to certain sugars, consult with them before taking this medication.

Levobel Diario contains the azo dyes red allura AC (E129) and carmine (E132). It may cause allergic reactions.

Levobel Diario contains soy oil. Do not use this medication if you are allergic to peanuts or soy.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

If you were taking another contraceptive before starting Levobel Diario, you know that most contraceptives have 21 tablets. With these contraceptives, you take a tablet for 21 days and then there is a week in which no tablets are taken (week of rest).

The system to follow when using Levobel Diario is different. After taking the 21 pink tablets, you must continue taking the 7 placebo tablets, and therefore, there is no week of rest, but rather a week of "placebo" (the week in which the placebo tablets of row 4 are taken). Since you have to take a tablet every day and there is no interval without tablets between the two packages, taking tablets becomes a routine and therefore, there is less risk of forgetting to take a tablet.

The two different colored tablets of Levobel Diario are placed in order. A package contains 28 tablets.

Take a Levobel Diario tablet every day, if necessary with a small amount of water. You must take the tablets every day at approximately the same time.

Do not confuse the tablets: take a pink tablet once a day for the first 21 days, and then a white tablet a day for the last 7 days. Then, you must start a new package immediately (21 pink tablets and 7 white tablets). Therefore, there is no period of rest between the two packages.

The package contains 28 tablets. Taking a tablet every day for 28 consecutive days is important to maintain the contraceptive effect.

Along with the packages, adhesive labels with the days of the week are included. Choose the label that starts with the first day you take the tablet. Place the label on the package over the words "START. Place the adhesive label here". Each day will align with a row of tablets. It is essential that you take your tablet every day. Take the first tablet of the first row, where the word "START" appears.

Follow the direction of the arrow indicated on the package, first take the pink tablets for 21 days, and then the white tablets for 7 days, until you have taken the 28 tablets. Then, you must start a new package. This means that there is no period of rest between packages.

During the 7 days in which the placebo tablets are taken (called placebo days), you must start bleeding (also called withdrawal bleeding). This usually starts on the 2nd or 3rd day after the last active pink tablet of Levobel Diario. Once you have taken the last white tablet, you must start with the next package, even if bleeding has not finished. This means that you must start a new packageon the same day of the weekand that withdrawal bleeding must occur on the same days each month.

If you use Levobel Diario in this way, you are also protected against pregnancy during the 7 days in which you take the placebo tablets.

When can you start with the first package

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

Start taking Levobel Diario on the first day of the cycle (i.e., the first day of your period). If you start taking Levobel 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 then you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

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

Start taking Levobel Diario on the day after taking the last active tablet (the last tablet containing active ingredients) of your previous contraceptive, but no later than the day after the week of rest of your previous hormonal contraceptive (or after taking the last placebo tablet of your previous contraceptive).In the case of a vaginal ring or patch, start taking Levobel Diario on the day of removal of the last ring or patch of a cycle, or no later than when the next application is due.

• Switching from a progestin-only method (mini-pill, injection, implant, or intrauterine system (IUS))

You can switch from the progestin-only pill to Levobel Diario on any day (if it is an implant or IUS, 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 first-trimester abortion

Follow your doctor's recommendations.

• After a second-trimester abortion or delivery

You can start taking Levobel Diario between 21 and 28 days after giving birth or after a second-trimester abortion. If you start later than day 28, use one of the barrier methods (e.g., a condom) during the first 7 days of using Levobel Diario.

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

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

Read the "Breastfeeding" section.

Ask your doctor if you are unsure when to start.

Use in children and adolescents

You must not take Levobel Diario before starting menstruation.

Use in elderly patients

You must not take Levobel Diario after menopause.

Use in patients with liver problems

You must not take Levobel Diario if you have severe liver problems.

Use in patients with kidney problems

Consult your doctor before starting to take Levobel Diario if you have kidney problems.

If you take more Levobel Diario than you should

No serious cases of overdose of Levobel Diario have been reported. If you take several tablets at once, you may experience nausea or vomiting. Young girls may experience vaginal bleeding. Even girls who have not yet started menstruating but have accidentally taken this medication may experience bleeding.

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

If you forgot to take Levobel Diario

The tablets in thefourthrow of the package are placebo tablets. If you forget to take one of these tablets, it will not affect the effectiveness of Levobel Diario. Dispose of the forgotten tablet.

If you forget to take an active pink tablet (tablets of the1st, 2nd, and 3rdrow), you must do the following:

• If you are delayedless than 12 hoursin taking a tablet, 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 delayedmore than 12 hoursin taking a tablet, the protection against pregnancy may be reduced. 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 package (3rd row).

Therefore, you must follow the following recommendations (see also the diagram below):

• You must never interrupt taking tablets for more than 7 days.
• The effectiveness of Levobel Diario depends on taking tablets for 7 consecutive days.

• If you are delayed more than 12 hours in taking a tablet during week 1 (1st row) (see also the diagram)

Take the last forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then, take the remaining tablets at the usual time. In addition, you must use a barrier method such as a condom, during the next 7 days. If you have had sex in the 7 days before forgetting the tablet, you must consider the possibility of pregnancy. The more tablets you have forgotten, and the closer to the rest period, the greater the risk of pregnancy. Consult your doctor.

• If you are delayed more than 12 hours in taking a tablet during week 2 (2nd row) (see also the diagram)

Take the last forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then, take the remaining tablets at the usual time. If you have taken the tablets correctly in the 7 days before the first forgotten tablet, you do not need to take additional precautions. If you have not taken the tablets correctly, or have forgotten to take more than one tablet, you must use additional contraceptive methods during the next 7 days.

• If you are delayed more than 12 hours in taking a tablet during week 3 (3rd row) (see also the diagram)

The risk of pregnancy increases as you approach the rest period. However, you can prevent pregnancy by adjusting the dose.

If you follow the following instructions, you do not need to take additional contraceptive precautions, as long as you have taken all the tablets correctly in the 7 days before the first forgotten tablet. If not, you must follow the first of these two options and take additional contraceptive precautions during the next 7 days.

Probable bleeding withdrawal will not occur until the end of the second package (while taking the white placebo tablets), but you may experience light bleeding or bleeding similar to menstruation while taking the second package. Finish the second package, taking the 7 white placebo tablets of the 4th row. Then, start the next package.

• If you have forgotten several tablets from a package and do not have withdrawal bleeding during the placebo week, you may be pregnant.

What to do in case of vomiting or intense diarrhea

Vomiting or intense diarrhea can make Levobel Diario less effective in preventing pregnancy.

If you vomit within 3-4 hours of taking an active pink 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 the same as when you forget to take a tablet. After vomiting or diarrhea, you must take a pink tablet from a spare package as soon as possible. If possible, take it within 12 hoursafter the usual time you take your contraceptive. If not possible or more than 12 hours have passed, follow the instructions in the "If you forgot to take Levobel Diario" section.

If you do not want to change your usual tablet-taking routine, you can take the extra tablet from another package.

If vomiting or diarrhea continues, consult your doctor. You will need to use additional contraceptive methods.

Delaying your period: what you should know

Although not recommended, you can delay your period if, instead of taking the white placebo tablets, you start taking a new package of Levobel Diario and finish it. You may experience light bleeding or bleeding similar to menstruation while using the second package. Finish the second package, taking the 7 white placebo tablets of the 4th row. Then, start the next package.

It is recommended to 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 according to the instructions, your period will start during the placebo days. If you need to change that day, reduce the number of placebo days (but never increase it- the maximum is 7!). For example, if you start taking the placebo tablets on Friday and want to change to Tuesday (3 days earlier), you must start a new package 3 days earlier than usual. You may not experience bleeding during these days. You may experience light bleeding or bleeding similar to menstruation later.

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

If you interrupt treatment with Levobel Diario

You can stop taking Levobel 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 Levobel Diario and wait until your period before trying to become pregnant. This way, you can calculate your estimated delivery date more easily.

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

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 change in your health that you think may be due to Levobel Diario, consult your doctor.

Severe side effects

Contact your doctor immediately 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 the "Warnings and precautions" section).

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 Levobel Diario".

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

• Frequent(may affect up to 1 in 10 people)
• • Mood changes, depression.
  • Headache.
  • Nausea, abdominal pain.
  • Breast tenderness or sensitivity.
  • Weight gain.

• Infrequent(may affect up to 1 in 100 people)
• • Decreased interest in sex.
  • Skin rash.
  • Migraine.
  • Vomiting, diarrhea.
  • Itching or hives on the skin.
  • Breast swelling.
  • Fluid retention.

• Rare(may affect up to 1 in 1,000 people)
• • Intolerance to contact lenses.
  • Allergic reactions.
  • Increased interest in sex.
  • Milk or vaginal discharge.
  • Lesions or red nodules on the skin.
  • Redness or patches on the skin.
  • Weight loss.
  • Detrimental blood clots in a vein or artery, for example

• in a leg or foot (e.g., DVT)
• in a lung (e.g., PE)
• Myocardial infarction.
• Stroke.
• Transient ischemic attack (TIA) or temporary symptoms similar to a stroke.
• Blood clots in the liver, stomach/intestine, kidneys, or eyes.

The likelihood of developing a blood clot may be higher if you have any other disease that increases the risk (see section 2 for more information on diseases that increase the risk of blood clots and symptoms of a blood clot).

Description of selected adverse reactions

The following adverse reactions with a very low frequency or delayed onset of symptoms are considered related to the group of combined oral contraceptives (see also the sections "Do not take Levobel Diario", "Warnings and precautions"):

Tumors

• It has been observed that breast cancer is slightly more frequent in women using combined hormonal contraceptives, but it is not known if this is due to treatment. For example, it is possible that more tumors are detected in women taking combined oral contraceptives because their doctor examines them more frequently. Since breast cancer is rare in women under 40, the excess cases are small compared to the general risk of breast cancer.
• Benign and malignant liver tumors.

Other conditions

• Women with increased triglycerides in the blood (hypertriglyceridemia) that increases the risk of pancreatitis when using combined oral contraceptives.
• High blood pressure.
• Appearance or worsening of diseases whose relationship with combined oral contraceptives is not definitive: jaundice and/or itching related to bile duct obstruction (cholestasis); formation of gallstones; a blood disease called porphyria; systemic lupus erythematosus (a disease that affects your natural defense system); hemolytic-uremic syndrome (a blood clotting disorder); a nervous system disease called Sydenham's chorea; a skin condition that occurs during pregnancy (herpes gestationalis); hearing loss (related to otosclerosis).
• In women with hereditary angioedema (symptoms include sudden swelling of, for example, the eyes, mouth, throat, etc.) the medications containing estrogen can induce or worsen the symptoms of angioedema.
• Liver function alteration.
• If you are diabetic, your blood glucose control may be affected. In general, you do not need to change your diabetes treatment while using Levobel Diario.
• Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• Chloasma (a skin discoloration, especially on the face/neck, known as "pregnancy spots").

Interactions

Unforeseen bleeding and/or contraceptive failures may occur due to the interaction of other medications with oral contraceptives (e.g., St. John's Wort, or medications for epilepsy, tuberculosis, HIV infections, and other infections). See section "Other medications and Levobel Diario").

The following diseases may appear or worsen with combined oral contraceptives:

Crohn's disease, ulcerative colitis, migraine, cervical cancer, porphyria (a metabolic disorder that causes abdominal pain and mental disorders), systemic lupus erythematosus (your body attacks and damages its own organs and tissues), herpes at the end of pregnancy, Sydenham's chorea (rapid, involuntary movements), hemolytic-uremic syndrome (a blood clotting disorder), liver problems with jaundice, bile duct obstruction or gallstone formation, hearing loss.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse reactions, 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.

Expiration Date

Do not use this medication after the expiration date that appears 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 packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Levobel Daily

• The active principles are levonorgestrel and ethinylestradiol. Levobel Daily has tablets of two colors:

• Each pink tablet contains0.10mg of levonorgestrel and0.02mg of ethinylestradiol. The other components (excipients) are: lactose, povidone K30 (E1201), magnesium stearate (E572) and opadry II pink [polyvinyl alcohol, talc (E553b), titanium dioxide (E171), polyethylene glycol 3350, allura red AC (E129), soy lecithin (E322), iron oxide red (E172), indigo carmine (E132)].
• Each white tablet (inactive tablets or placebo tablets) contains only the following excipients (no active principles): lactose, povidone K30 (E1201), magnesium stearate (E572) and opadry II white [polyvinyl alcohol, talc (E553b), titanium dioxide (E171), polyethylene glycol 3350].

Appearance of the product and contents of the package

The active tablets are film-coated, pink, rounded tablets.

The placebo tablets are film-coated, white, rounded tablets.

Levobel Daily is available in blisters of 28 tablets: 21 active pink tablets and 7 placebo white tablets.

The package sizes are 1, 3 or 6 blisters, and each blister contains 28 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Effik Laboratories, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

León Farma Laboratories, S.A.

Navatejera Industrial Estate

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:

AustriaMelleva

SlovakiaLevonille

SpainLevobel Daily

HungaryMissee 0.10 mg/0.02 mg filmtabletta

PolandOrlifique

PortugalGesffiset

Czech RepublicAsumate

Last review date of this leaflet: April 2023

The 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/).