Label: information for the user

Levobel 0.10 mg/0.02 mg film-coated tablets

Levonorgestrel/Ethinylestradiol

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they 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 label. 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 the 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 is a contraceptive tablet and is used to prevent pregnancy.

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

Contraceptives that contain two hormones are known as "combined contraceptives".

Do not take Levobel

You should not use Levobel 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.

You should not take Levobel if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Other medications and Levobel”).

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 must have special care while using Levobel 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, you should also inform your doctor.

BLOOD CLOTS

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

Blood clots can form:

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

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

It is essential to remember that the overall risk of a blood clot that can cause harm due to Levobel is small.

HOW TO RECOGNIZE A BLOOD CLOT

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

BLOOD CLOTS IN A VEIN

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

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

The risk of a blood clot in a vein is greater during the first year in which you take a combined hormonal contraceptive for the first time. The risk may be greater also if you start taking a combined hormonal contraceptive again (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, your risk of a blood clot returns to normal in a few weeks.

What is the risk of a blood clot?

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

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

• Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norethisterone or norgestimate, about 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 in a vein is small, but some conditions increase the risk. Your risk is greater:

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

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 conditions above, even if you are unsure. Your doctor may decide that you need to stop taking Levobel.

If any of the conditions above change while you are using Levobel, 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 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 conditions above change while you are using Levobel, 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 and cancer

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

There has been an observed increase in breast cancer in women who use 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 who take combined contraceptives because they are examined by the doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to undergo regular breast examinations, and you should consult 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 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 while you are taking Levobel, you may experience unexpected bleeding (bleeding outside of the pill-free week). 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 your period during the pill-free week

If you have taken all the 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 your 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

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

• Medications used to treat:
• • Epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, or felbamate)
  • Tuberculosis (e.g., rifampicin)
  • HIV and hepatitis C infection (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nelfinavir, efavirenz)
  • Fungal infections (e.g., griseofulvin, azole antifungals, e.g., itraconazole, voriconazole, fluconazole)
  • Bacterial infections (macrolide antibiotics, e.g., clarithromycin, erythromycin)
  • Certain heart conditions, high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem)
  • Arthritis, osteoarthritis (etoricoxib)
  • High blood pressure in the blood vessels of the lungs (bosentan)
• Saint John's Wort.
• Orange juice.

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

• Cyclosporin-containing medications (used to suppress the body's immune response)
• Lamotrigine (an antiepileptic medication that may increase the frequency of seizures)
• Melatonin (for insomnia)
• Midazolam (for sedation and insomnia)
• Theophylline (used to treat respiratory problems)
• Tizanidine (used to treat muscle pain and/or muscle cramps).

You should not take Levobel if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver enzyme test results (elevated ALT levels).

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

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

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 may affect the results of some tests.

Pregnancy and breastfeeding

Pregnancy

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

Consult your doctor or pharmacist before using any medication.

Breastfeeding

Levobel is not recommended 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 has any effect on your ability to drive or operate machinery.

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

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

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

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

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

Each blister contains 21 tablets. Each tablet is marked with the day of the week when it should be taken. For example, if you start taking the tablets on a Tuesday, press the tablet through the aluminum foil, in the position marked with "MAR". Take the tablets every day in the order indicated by the arrows.

Take one Levobel tablet every day for 21 days, if necessary with a small amount of water. You can take the tablets with or without food, but you must take the tablets approximately at the same time every day.

The blister contains 21 tablets.

Along with the blisters, adhesive labels with the days of the week are attached. Choose the label that starts with the first day you take the tablet. Place the label on the blister, 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 from the first row where the word "START" appears. Follow the direction of the arrow indicated on the packaging until you have taken the 21 tablets.

Once you have finished the 21 tablets, you will not take any tablets for the next 7 days. Your period (withdrawal bleeding) will begin during these 7 days, usually 2 or 3 days after taking the last Levobel tablet.

Start the next blister on the 8th day, even if your period continues. In this way, you will always start a new package on the same day of the week, and withdrawal bleeding will occur approximately at the same time every month.

When can you start with the first package

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

Start taking Levobel on the first day of the cycle (i.e., the first day of your period). If you start taking Levobel 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) for the first 7 days.

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

Start taking Levobel on the day after taking the last active tablet of your previous contraceptive, or at the latest the day after the break week of your previous contraceptive or after taking the last placebo tablet of your previous contraceptive. In the case of a vaginal ring or patch, start taking Levobel on the day of removal of the last ring or patch of a cycle, or at the latest when it is due for the next application.

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

You can switch from the progestin-only pill to Levobel on any day (if it is an implant or IUS, on the day of 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) for the first 7 days of taking tablets.

• After a first-trimester abortion

Follow your doctor's recommendations.

• After childbirth or a second-trimester abortion

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

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

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

Read the section "Breastfeeding".

Ask your doctor if you are unsure when to start.

Use in children and adolescents

You should not take Levobel before starting your period.

Use in elderly patients

You should not take Levobel after menopause.

Use in patients with liver problems

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

Use in patients with kidney problems

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

If you take more Levobel than you should

No serious damage has been reported in cases of Levobel overdose. 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 their period but have accidentally taken this medication may experience bleeding.

If you have taken too many Levobel 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 forget to take Levobel

• If you delayless than 12 hoursin taking a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and the subsequent tablets at the usual time.

• If you delaymore than 12 hoursin taking a tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten, the greater the risk of pregnancy.

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

• If you delay more than 12 hours during week 1 (see also the diagram)

Take the last forgotten tablet as soon as you remember, even if this means taking two tablets at once. Then, take the subsequent tablets at the usual time. In addition, you must use a barrier method, such as a condom, for the next 7 days. If you have had sex in the 7 days before forgetting the tablet, you may be pregnant. The more tablets you have forgotten, and the closer to the break week, the greater the risk of pregnancy. Consult your doctor if this has happened to you.

• If you delay more than 12 hours during week 2 (see also the diagram)

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

• If you delay more than 12 hours during week 3 (see also the diagram)

The risk of pregnancy increases the closer you get to the break week. However, pregnancy can still be prevented by adjusting the dose.

If you follow these guidelines, you do not need to take additional contraceptive precautions, as long as all the tablets have been taken correctly in the 7 days before the first forgotten tablet. If this is not the case, you should follow the first of these two options and take additional contraceptive precautions for the next 7 days as well.

• If you have stopped taking several tablets from a package and do not experience withdrawal bleeding during the first break week, you should consider the possibility of pregnancy.

What to do in case of vomiting or intense diarrhea

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

If you vomit within 3-4 hours of taking a tablet or have intense diarrhea, there is a risk that the active principles of the contraceptive will not be fully absorbed by the body. The situation is similar to forgetting to take a tablet. After vomiting or diarrhea, you should take a tablet from a spare package as soon as possible. If possible, take it within 12 hoursafter the usual time you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the guidelines in the section "If you forgot to take Levobel".

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.

Delayed period: what you should know

Although not recommended, you can delay your period if, instead of continuing with the break week, you start taking a new package of Levobel and finish it. You may experience light bleeding or spotting while using the second package. After the usual 7-day break week,startthe next package.

It is advisable to consult your doctor before deciding to delay your menstrual period.

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

If you take the tablets according to the instructions, your period will begin during the break week. If you need to change that day, reduce the number of break days (but never increase it – the maximum is 7!). For example, if your break days usually start on Fridays and you want to change to Tuesdays (3 days earlier), start a new package 3 days earlier than usual. If you make the break week too short (e.g., 3 days or less), you may not experience bleeding during these days. You may experience light bleeding or spotting.

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

Stopping treatment with Levobel

You can stop taking Levobel whenever you want. If you do not want to get pregnant, consult your doctor about other effective birth control methods. If you want to get pregnant, stop taking Levobel and wait until your period before trying to get pregnant. This way, you can calculate your estimated due 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 notice any change in your health that you think may be due to Levobel, 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".

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

• Frequent(may affect up to 1 in 10 people)
• • Mood changes, depression
  • Headaches
  • 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
  • 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
  • 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 symptoms similar to a stroke
  • Blood clots in the liver, stomach/intestine, kidneys, or eyes.

The risk of developing a blood clot may be higher if you have any other condition that increases the risk (see section 2 for more information on conditions 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 "Do not take Levobel" and "Warnings and precautions" sections):

Tumors

• Cancer of the breast has been observed to be slightly more frequent in women using 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 taking combined oral contraceptives because their doctor examines them more frequently. Since breast cancer is rare in women under 40 years of age, 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 disorder called porphyria; systemic lupus erythematosus (a disease that affects your natural defense system); hemolytic-uremic syndrome (a blood clotting disorder); a nervous system disorder called Sydenham's chorea; a skin condition that occurs during pregnancy (herpes gestationalis); hearing loss (related to otosclerosis).
• 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.
• 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 the "Other medications and Levobel" section.

The following diseases may appear or worsen with combined oral contraceptives:Crohn's disease, ulcerative colitis, epilepsy, 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 disorder that occurs after diarrhea caused by E. coli), 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 leaflet. 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.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. This will help protect the environment.

Composition of Levobel

• The active principles are levonorgestrel and ethinylestradiol. Each 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, red allura AC (E129), soy lecithin (E322), iron oxide red (E172), carmine indigo (E132)].

Appearance of the product and content of the container

Coated tablets with a pink film coating and rounded.

Levobel is available in blisters of 21 tablets.

The container sizes are 1, 3 or 6 blisters, and each blister contains 21 tablets.

Only some container sizes may be marketed.

Holder of the marketing authorization

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

or

Hormosan Pharma GmbH

Hanauer Landstraße 139-143

60314 Frankfurt am Main

Germany

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

AustriaMadonella mite

PortugalEffilevo

SpainLevobel

GermanyMaexeni

Date of the last review 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/).