LEVOBEL 0.10 MG/0.02 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levobel 0.10 mg/0.02 mg film-coated tablets EFG

Levonorgestrel/Ethinylestradiol

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

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

Important things to 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 having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and see your doctor if you think you might have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of the package leaflet

1. What is Levobel and what it is used for
2. What you need to know before you start taking Levobel
3. How to take Levobel
4. Possible side effects
5. Storage of Levobel

Contents of the pack and further information

1. What is Levobel and what it is used for

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

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

Contraceptives that contain two hormones are called “combined contraceptives”.

2. What you need to know before starting to take Levobel

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.

• 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 are going to be immobile for a long time (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 ischaemic attack (TIA, temporary stroke-like 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 hyperhomocysteinaemia.
• 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 tumour.
• If you have (or suspect you have) breast cancer or cancer of the genital organs.
• If you have vaginal bleeding, the cause of which is unknown.
• If you know or suspect you are pregnant.
• If you are allergic to levonorgestrel, ethinylestradiol, soya, or peanut, azo dyes, or any of the other ingredients of this medicine (listed in section 6). This may be shown as itching, rash, or inflammation.

Do not take Levobel if you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir (see also section "Other medicines and Levobel").

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

Warnings and precautions

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

In some situations, you need to be extra careful 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 get worse while you are using Levobel, you should also tell 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 defence system).
• If you have haemolytic uraemic syndrome (HUS, a blood clotting disorder that causes kidney damage).
• If you have sickle-cell anaemia (an inherited disease of the red blood cells).
• If you have high levels of fat in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas).
• If you need an operation or are going to be immobile for a long time (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 how soon you can start taking Levobel after giving birth.
• If you have inflammation of the veins just under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If any of your close relatives have had breast cancer.
• If you have any liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have epilepsy (see "Other medicines and Levobel").
• If you have any disease that first appeared during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blister-like rash during pregnancy (pregnancy herpes), a nerve disease that causes involuntary movements (Sydenham's chorea)).
• If you 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 oestrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Levobel 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 important to remember that the overall risk of a harmful blood clot due to Levobel 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 medicine 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 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 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 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 are going to be immobile for a long time due to an injury or illness, or if you have a leg in a plaster cast. You may need to stop using Levobel several weeks before the operation or while you are less mobile. If you need to stop using Levobel, ask your doctor when you can start using it again.
• As you get older (especially above about 35 years).
• If you have just given birth.

The risk of having a blood clot increases the more 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 important to tell your doctor if you have any of these conditions, even if you are not sure. Your doctor may decide that you should stop using Levobel.

If any of these conditions change while you are using Levobel, for example, a close relative experiences a clot without known cause or you gain much weight, tell your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or stroke.

Factors that increase your risk of a blood clot in an artery

It is important to note that the risk of a heart attack or stroke due to Levobel is very small, but it may increase:

• With age (above about 35 years).
• If you smoke. When using a combined hormonal contraceptive like Levobel, 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 have a 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 (valvular heart disease, irregular heart rhythm 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 even further.

If any of these conditions change while you are using Levobel, for example, you start smoking, a close relative experiences a clot without known cause, or you gain much weight, tell your doctor.

Levobel and cancer

Cervical cancer has been reported in long-term users, but it is not clear if this is due to sexual behaviour or other factors such as the human papillomavirus (HPV).

Breast cancer has been reported with a slightly higher frequency in women who use combined contraceptives, but it is not known if this is due to the treatment. For example, it may be that more tumours are detected in women who take combined contraceptives because they are examined by a doctor more often. The incidence of breast tumours decreases gradually after stopping combined hormonal contraceptives. It is important to have your breasts checked regularly and you should see your doctor if you notice any lump.

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

Psychiatric disorders

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

Bleeding between periods

During the first few months that you are taking Levobel, you may experience bleeding between periods. This may be ...

3. How to take Levobel

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

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

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

The blister pack contains 21 pills.

Along with the blister packs, adhesive labels with the days of the week are attached. Choose the label that starts with the first day you take the pill. Place the strip on the blister pack, 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 packaging until you have taken all 21 pills.

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

Start the next blister pack on the 8th day, even if your period is still ongoing. This way, you will always start a new pack 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 pack

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

Start taking Levobel on the first day of your 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 your 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 ring, or patch

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

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

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

• 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 between 21 and 28 days after giving birth or having an abortion in the second trimester. If you start later than day 28, use a barrier method (e.g., a condom) for the first 7 days of Levobel use.

If, after having a child, you have already had sexual intercourse before starting to take Levobel again, you should 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 not sure when to start.

Use in children and adolescents

You should not take Levobel before you start having 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 cases have been reported where an overdose of Levobel 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 taken this medication accidentally may experience such bleeding.

If you have taken too many Levobel pills, 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 ingested.

If you forget to take Levobel

• If you are less than 12 hourslate in taking a pill, the protection against pregnancy is not reduced. Take the pill as soon as you remember and the following pills at the usual time.

• If you are more than 12 hourslate in taking a pill, the protection against pregnancy may be reduced. The more pills you have missed, the higher the risk of becoming pregnant.

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

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

Take the last missed pill as soon as you remember, even if it means taking two pills at once. Then, continue taking the pills at the usual time. Additionally, you should use a barrier method, such as a condom, for the next 7 days. If you have had sexual intercourse in the 7 days before missing a pill, you may be pregnant. The more pills you have missed, and the closer you are to the rest week, the higher the risk of pregnancy. Consult your doctor if this happens.

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

Take the last missed pill as soon as you remember, even if it means taking two pills at once. Then, continue taking the pills at the usual time. If you have taken the pills correctly in the 7 days before missing the first pill, you do not need to take additional contraceptive precautions. If you have not taken the pills correctly or have missed more than one pill, you should take additional contraceptive precautions for the next 7 days.

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

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

If you follow these tips, you do not need to take additional contraceptive precautions, provided that all pills have been taken correctly in the 7 days before missing the first pill. If this is not the case, you should follow the first of these two options and take additional contraceptive precautions also during the next 7 days.

1. Take the missed pill as soon as you remember, even if it means taking two pills at once. Then, take the rest of the pills at the usual time. Instead of the rest week, continue immediately with the next pack of 21 pills. You will probably not have withdrawal bleeding until the end of the second pack, but you may experience spotting or intermenstrual bleeding during pill-taking days.
2. You can stop taking the pills from the current pack and have a 7-day break without taking pills, including the days you did not take them, and then continue with the next pack.

• If you have missed several pills from a blister pack and do not have withdrawal bleeding during the first rest week, you should consider the possibility of pregnancy.

What to do in case of vomiting or severe diarrhea

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

If you vomit within 3-4 hours after taking a pill or have 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 miss a pill. After vomiting or having diarrhea, you should take a pill from a reserve pack as soon as possible. If possible, take it within 12 hours of the time you usually take your contraceptive. If it is not possible or more than 12 hours have passed, follow the advice in the section "If you forget to take Levobel".

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

If 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 continuing with the rest week you start taking a new pack of Levobel and finish it. You may experience light bleeding or spotting while using the second pack. After the usual 7-day rest week, startthe next pack.

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 start during the rest week. If you need to change that day, reduce the number of rest days (but never increase them – the maximum is 7!). For example, if your rest days usually start on Fridays and you want to change to Tuesdays (3 days earlier), start a new pack 3 days earlier than usual. If you make the rest week very short (e.g., 3 days or less), you may not have bleeding during these days. You may experience light bleeding or spotting.

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

If you interrupt treatment with Levobel

You can stop taking Levobel 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 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 if you have any change in your health that you think may be due to Levobel, 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 the 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".

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

• 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 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 are listed with a very low frequency or delayed onset of symptoms that are considered related to the group of combined oral contraceptives (see also the sections "Do not take Levobel" 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. As breast cancer is rare in women under 40 years of age, the excess cases are small in relation to the general risk of breast cancer.
• Liver tumors (benign and malignant).

Other Conditions

• Women with increased fats in the blood (hypertriglyceridemia) that cause a higher 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); formation of bile stones; a blood disease called porphyria; systemic lupus erythematosus (a disease that affects your natural defense system); hemolytic uremic syndrome (a blood clotting disease); a nervous disease called Sydenham's chorea; a type of skin condition that occurs during pregnancy (gestational herpes); hearing loss (related to otosclerosis).
• Alteration of liver function.
• If you are diabetic, your blood glucose control may be affected. Generally, it is not necessary to change your diabetes treatment while using Levobel.
• Crohn's disease or ulcerative colitis (chronic inflammatory disease of the intestine).
• Cloasma (a skin discoloration, especially on the face/neck, known as "pregnancy spots").

Interactions

Unexpected bleeding and/or contraceptive failure 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 section "Other medications and Levobel".

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 (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 bile stone formation, hearing loss.

Reporting of 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

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Expiry Date

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE Point of the pharmacy. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Levobel

• The active ingredients are levonorgestrel and ethinylestradiol. Each 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), red iron oxide (E172), carmine indigo (E132)].

Appearance of the Product and Package Contents

Round, film-coated pink tablets.

Levobel is available in blisters of 21 tablets.

Package sizes are 1, 3, or 6 blisters, and each blister contains 21 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

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 under the following names:

Austria Madonella mite

Portugal Effilevo

Spain Levobel

Germany Maexeni

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/).