LEVOBEL DIARIO 0.10 mg/0.02 mg FILM-COATED TABLETS

2. What you need to know before you start taking Levobel Daily

Do not take Levobel Daily

You should not use Levobel Daily 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 you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or other organs.
• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need an operation or if you spend a long time immobile (see section "Blood clots").
• If you have ever had a heart attack or stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary stroke symptoms).
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:
• • Severe diabetes with blood vessel damage.
  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.
• If you have (or have ever had) a type of migraine called "migraine with aura".
• If you have (or have ever had) a severe liver disease and your liver function has not yet returned to normal.
• If you have (or have ever had) a liver tumor.
• If you have (or have ever had), or suspect you have breast cancer or cancer of the genitals.
• If you have vaginal bleeding, whose cause is unknown.
• If you know or suspect you are pregnant.
• If you are allergic to levonorgestrel or ethinylestradiol, soy, or peanut, azo dyes, or any of the other components of this medication (listed in section 6). This may be manifested by itching, rash, or inflammation.
• Do not take Levobel Daily if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir, velpatasvir/voxilaprevir (see also section "Other medications and Levobel Daily").

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

Warnings and precautions

When should you consult your doctor?

Seek urgent medical attention

• If you experience possible signs of a blood clot that may indicate you are suffering from a blood clot in your leg (i.e., deep vein thrombosis), a blood clot in your lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section "Blood clots" (thrombosis) below).

To obtain a description of the symptoms of these serious side effects, see "How to recognize a blood clot".

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

In some situations, you should be extra careful while using Levobel Daily 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 Daily, 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 (SLE, 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 (an inherited 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 an operation or spend a long time immobile (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking Levobel Daily after childbirth.
• If you have inflammation of the veins that are just under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If any of your close relatives have had or have breast cancer.
• If you have any liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have epilepsy (see "Other medications and Levobel Daily").
• If you have any disease that first appeared during pregnancy or during previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, blistering rash during pregnancy (herpes gestationalis), a nervous disease with involuntary movements (Sydenham's chorea)).
• If you have or have ever had chloasma (a skin discoloration, especially on the face or neck, known as "pregnancy patches"). In this case, avoid direct exposure to the sun or ultraviolet rays.
• • If you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

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

Blood clots can form:

• In the veins (this is called "venous thrombosis", "venous thromboembolism", or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism", or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if 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 the veins (venous thrombosis). However, these side 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 can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

The risk of having 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 start taking a combined hormonal contraceptive (the same medication or a different one) after an interruption of 4 weeks or more.

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

When you stop taking Levobel Daily, your risk of having a blood clot returns to normal within a few weeks.

What is the risk of having a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of having a blood clot in the leg or lung (DVT or PE) with Levobel Daily is small.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norethisterone or norgestimate, about 5-7 will have a blood clot in a year.
• The risk of having 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 having a blood clot with Levobel Daily is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI over 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of about 50). In this case, you may have a hereditary blood clotting disorder.
• If you need an operation or spend a long time immobile due to an injury or illness or if you have your leg in a cast. You may need to stop using Levobel Daily several weeks before surgery or while you have reduced mobility. If you need to stop using Levobel Daily, ask your doctor when you can start using it again.
• As you get older (especially above about 35 years).
• If you have given birth in the past few weeks.

The risk of having a blood clot increases with the number of conditions you have.

Long-distance 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 suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using Levobel Daily.

If any of the above conditions change while you are using Levobel Daily, for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain much 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 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 Daily is very small, but it may increase:

• With age (above about 35 years).
• If you smoke. When using a combined hormonal contraceptive like Levobel Daily, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at higher risk of having a 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 have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disturbance called atrial fibrillation).
• If you have diabetes.

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

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

Levobel Daily and cancer

Breast cancer has been observed slightly more frequently in women using combined contraceptives, but it is not known if 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 a doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to have your breasts examined regularly, and you should see your doctor if you notice any lump.

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

Psychiatric disorders

Some women using hormonal contraceptives like Levobel Daily 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.

Bleeding between periods

During the first few months, you may experience some bleeding between periods. This is usually nothing to worry about and should stop within a few months. If the bleeding is heavy or persistent, you should see your doctor.

While you are taking Levobel Diario, you may have unexpected bleeding (bleeding outside of the placebo pill week). If these bleedings 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 your period during the placebo week

If you have taken all the active pink tablets 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 your period does not appear for the second consecutive time, you may be pregnant. Consult your doctor immediately, as pregnancy must be ruled out before continuing to take the pill. Start the next blister 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 can occur with:

• medications used in the treatment of:
• • epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, or felbamate)
  • tuberculosis (e.g., rifampicin)
  • HIV and hepatitis C virus infection (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)
  • certain heart diseases, high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem)
  • arthritis, osteoarthritis (etoricoxib)
  • high blood pressure in the blood vessels of the lungs (bosentan)
• preparations based on St. John's Wort (Hypericum perforatum)
• grapefruit juice.

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

• medications containing cyclosporin (used to suppress the body's immune response)
• the antiepileptic lamotrigine (may lead to an increased frequency of seizures)
• 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 produce increases in liver test results (increase in liver enzyme ALT).

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

Levobel Diario can be used again approximately 2 weeks after the end of this treatment. See the section "Do not take Levobel Diario".

Tell your doctor or pharmacist if you are taking, have recently taken, 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 tablets immediately and consult your doctor. If you intend to become pregnant, you can 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 indicates it. If you want to take the contraceptive while breastfeeding, you should consult your doctor.

Driving and using machines

There is no information that suggests that the use of Levobel Diario has any effect on the ability to drive or use machines.

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

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

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

Levobel Diario contains soybean oil. Do not use this medication in case of allergy to peanuts or soy.

3. How to Take Levobel Daily

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

If you were taking another contraceptive before starting Levobel Daily, you know that most contraceptives have 21 pills. With these contraceptives, you take a pill for 21 days and then there is a week when you do not take pills (rest week).

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

The two types of pills of different colors of Levobel Daily are placed in order. A package contains 28 pills.

Take a Levobel Daily pill every day, if necessary with a small amount of water. You must take the pills every day at approximately the same time.

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

The blister contains 28 pills. Daily intake for 28 consecutive days is important to maintain the contraceptive effect.

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

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

During the 7 days when you take the placebo pills (called placebo days), you should start bleeding (also called withdrawal bleeding). This normally begins on the 2nd or 3rd day after the last active pink pill of Levobel Daily. Once you have taken the last white pill, you must start with the next blister, even if you have not finished bleeding. This means that you must start a new blister on the same day of the week and that the withdrawal bleeding must occur on the same days every month.

If you use Levobel Daily in this way, you are also protected against pregnancy during the 7 days when you take the placebo pills.

When can you start with the first package

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

Start taking Levobel Daily on the first day of your cycle (i.e., the first day of your period). If you start taking Levobel Daily on the first day of your menstruation, you will be protected immediately against pregnancy. You can also start on days 2-5 of your 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 ring, or patch

Start taking Levobel Daily the day after taking the last active pill (the last pill that contains active ingredients) of your previous contraceptive, but no later than the day after the rest week of your previous hormonal contraceptive (or after taking the last placebo pill of your previous contraceptive). In the case of a vaginal ring or patch, start taking Levobel Daily 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 (minipill, injection, implant, or intrauterine release system (IUS))

You can switch from the progestin-only pill to Levobel Daily on any day (if it's an implant or IUS, on the day of its removal; if it's an injectable, when the next injection is due) but in all cases, use additional contraceptive measures (e.g., a condom) during the first 7 days of pill intake.

• After an abortion in the first trimester

Follow your doctor's recommendations.

• After childbirth or an abortion in the second trimester

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

If, after having a child, you have already had sexual intercourse before starting to take Levobel Daily again, you must be sure that you are not pregnant or wait for your next menstrual period before taking Levobel Daily.

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

Read the "Breastfeeding" section.

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

Use in children and adolescents

You should not take Levobel Daily before you start having your period.

Use in elderly patients

You should not take Levobel Daily after menopause.

Use in patients with liver problems

You should not take Levobel Daily if you have severe liver problems.

Use in patients with kidney problems

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

If you take more Levobel Daily than you should

No cases have been reported in which the ingestion of an overdose of Levobel Daily has caused serious harm. If you take several pills at once, you may have symptoms of nausea or vomiting. Little girls may experience vaginal bleeding. Even girls who have not yet started their period but have accidentally taken this medication may experience such bleeding.

If you have taken too many Levobel Daily pills or 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 ingested.

If you forgot to take Levobel Daily

The pills in the fourthrow of the blister are placebo pills. If you forget to take one of these pills, it will not affect the effectiveness of Levobel Daily. Discard the forgotten pill.

If you forget to take an active pink pill (pills from the 1st, 2nd, and 3rdrow), you must do the following:

• If you delay less than 12 hoursin taking a pill, the protection against pregnancy does not decrease. Take the pill as soon as you remember and the following pills at the usual time.

• If you delay more than 12 hoursin taking a pill, the protection against pregnancy may be reduced. The more pills you have forgotten, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is maximum if you forget to take the pink pill at the beginning (1st row) or at the end of the blister (3rd row).

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

• Never interrupt the intake of pills for more than 7 days.
• The effectiveness of Levobel Daily depends on taking the pills for 7 consecutive days.

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

Take the last forgotten pill as soon as you remember, even if it means taking two pills at the same time. Then, continue taking the pills at the usual time. Additionally, you must use a barrier method such as a condom during the following 7 days. If you have had sexual intercourse in the 7 days prior to forgetting the pill, you should consider the possibility of pregnancy. The more pills you have forgotten, and the closer to the rest period, the higher the risk of pregnancy. Consult your doctor.

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

Take the last forgotten pill as soon as you remember, even if it means taking two pills at the same time. Then, continue taking the pills at the usual time. If you have taken the pills correctly in the 7 days prior to the first forgotten pill, it is not necessary to take additional precautions. If you have not taken the pills correctly or have forgotten to take more than one pill, you must use additional contraceptive measures during the following 7 days.

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

The risk of pregnancy increases as the rest week approaches. However, pregnancy can be avoided by adjusting the dose.

If you follow these tips, it is not necessary to take additional contraceptive precautions, as long as you have taken all the pills correctly in the 7 days prior to the first forgotten pill. If not, you must follow the first of these two options and take additional contraceptive precautions during the following 7 days.

1. Take the forgotten pill as soon as you remember, even if it means taking two pills at the same time. Then, take the rest of the pills at the usual time. Instead of taking the placebo pills, discard them and start taking the next package (the start day will be different).

You will probably not experience withdrawal bleeding until the end of the second package (while taking the white placebo pills), but you may experience light bleeding or bleeding similar to your period while taking the second package.

1. You can also stop taking the active pink pills and take the 7 white placebo pills directly (before starting to take the placebo pills, note the day you forgot to take the pill). Then, start the next package. If you want to start a new package on the same day as always, take the placebo pills for less than 7 days.

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

What to do in case of vomiting or severe diarrhea

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

If you vomit within 3-4 hours after taking an active pink pill or experience severe 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 pill. After vomiting or having diarrhea, you must take a pink pill from a reserve package as soon as possible. If possible, take it within 12 hours after the time you usually take your contraceptive. If it is not possible or more than 12 hours have passed, follow the advice in the "If you forgot to take Levobel Daily" section.

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

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

Delayed period: what you should know

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

It is advisable 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 pills according to the instructions, your period will begin during the placebo days. If you need to change that day, reduce the number of placebo days - when you take the white pills - (but never increase them - the maximum is 7!). For example, if you start taking the placebo pills on Fridays and want to change to Tuesdays (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 your period later.

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

If you interrupt treatment with Levobel Daily

You can stop taking Levobel Daily whenever 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 Daily and wait until your period before trying to become pregnant. This way, you will be able to calculate the estimated date of delivery more easily.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. If you experience any adverse effect, especially if it is severe and persistent, or have any change in your health that you think may be due to Levobel Diario, consult your doctor.

Severe 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 urticaria with possible difficulty breathing (see also section "Warnings and Precautions").

All women who take 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 taking Levobel Diario".

The following list of adverse 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
  • Pain in the breasts or sensitivity
  • Weight gain.

• Uncommon(may affect up to 1 in 100 people)
• • Decreased interest in sex
  • Rash
  • Migraine
  • Vomiting, diarrhea
  • Itching or hives on the skin
  • Swelling of the breasts
  • Fluid retention.

• Rare(may affect up to 1 in 1,000 people)
• • Intolerance to contact lenses.
  • Allergic reactions
  • Increased interest in sex
  • Breast or vaginal discharge
  • Lesions or red nodules on the skin
  • Redness or spots on the skin
  • Weight loss
  • Harmful 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
• mini-stroke or temporary symptoms similar to those of a stroke, known as a transient ischemic attack (TIA)
• blood clots in the liver, stomach/intestine, kidneys, or eyes.

The likelihood of suffering 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 sections "Do not take Levobel Diario" and "Warnings and Precautions"):

Tumors

• It has been observed that breast cancer is slightly more frequent in women who use combined hormonal contraceptives, but it is not known if this is due to the treatment. For example, it is possible that more tumors are detected in women who take combined oral contraceptives because the doctor examines them more frequently. Since breast cancer is rare in women under 40 years of age, the excess cases are small in relation to the overall risk of breast cancer.
• Liver tumors (benign and malignant).

Other Conditions

• Women with increased fats 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 flow obstruction (cholestasis); gallstone formation; 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 disease called Sydenham's chorea; a type of skin condition that occurs during pregnancy (gestational herpes); hearing loss (related to otosclerosis).
• In women with hereditary angioedema (symptoms include sudden swelling of, for example, the eyes, mouth, throat, etc.) estrogen-containing medications may induce or worsen angioedema symptoms.
• Liver function disorder.
• If you are diabetic, your blood sugar control may be affected. Generally, it is not necessary to change your diabetes treatment while using Levobel Diario.
• Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• Cloasma (a skin discoloration, especially on the face/neck, known as "pregnancy spots").

Interactions

Unexpected 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 (the body attacks and damages its own organs and tissues), herpes at the end of pregnancy, Sydenham's chorea (rapid, involuntary muscle movements), hemolytic uremic syndrome (a disorder that occurs after diarrhea caused by E. coli), liver problems with jaundice, gallbladder disorders or gallstone formation, hearing loss.

Reporting Adverse Effects

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

5. Storage of Levobel Diario

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

This medicine does not require special storage conditions.

Expiration Date

Do not use this medicine after the expiration date that appears on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Levobel Diario

• The active ingredients are levonorgestrel and ethinylestradiol. Levobel Diario has tablets of two colors:

• Each pink tablet contains 0.10 mg of levonorgestrel and 0.02 mg 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), carmine indigo (E132)].
• Each white tablet (inactive or placebo tablets) only contains the following excipients (no active ingredients): 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 Package Contents

The active tablets are film-coated, pink, and round.

The placebo tablets are film-coated, white, and round.

Levobel Diario 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

Laboratorios Effik, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera

La Vallina s/n

24193 Villaquilambre, León

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria Melleva

Slovakia Levonille

Spain Levobel Diario

Hungary Missee 0.10 mg/0.02 mg filmtabletta

Poland Orlifique

Portugal Gesffiset

Czech Republic Asumate

Date of the last revision of this prospectus: April 2023

Updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).