Levofloxacin Genoptim

Patient Information Leaflet: User Information

Levofloxacin Genoptim, 250 mg, film-coated tablets

Levofloxacin Genoptim, 500 mg, film-coated tablets

Levofloxacin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Levofloxacin Genoptim and what is it used for
• 2. Important information before using Levofloxacin Genoptim
• 3. How to use Levofloxacin Genoptim
• 4. Possible side effects
• 5. How to store Levofloxacin Genoptim
• 6. Contents of the pack and other information

1. What is Levofloxacin Genoptim and what is it used for

The name of the medicine is Levofloxacin Genoptim. Levofloxacin Genoptim contains the active substance levofloxacin, which belongs to a group of medicines called antibiotics. Levofloxacin is a "quinolone" antibiotic. Its action involves killing bacteria that cause infections in the body.

Levofloxacin Genoptim is used to treat infections:

• of the sinuses
• of the lungs, in people with chronic breathing difficulties or pneumonia
• of the urinary system, including the kidneys and bladder
• of the prostate, when the infection is long-term
• of the skin and subcutaneous tissue, including muscles, sometimes referred to as "soft tissues"

In some cases, Levofloxacin Genoptim may be used to prevent a lung disease called anthrax, which can occur after contact with anthrax-causing bacteria or may be used to treat this disease.

2. Important information before using Levofloxacin Genoptim

When not to use this medicine and consult a doctor:

• If the patient has been diagnosed with an allergy to levofloxacin, any other quinolone antibiotic, such as moxifloxacin, ciprofloxacin, or ofloxacin, or any of the other ingredients of Levofloxacin Genoptim (listed in section 6). Symptoms of an allergic reaction are: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

of an allergic reaction are: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

• If the patient has ever had seizures.
• If the patient has ever had tendon problems, such as tendonitis related to quinolone antibiotic treatment. A tendon is a cord that connects muscles to the skeleton.
• In children and adolescents during growth.
• In pregnant women, women who may become pregnant, or when pregnancy is suspected.
• During breastfeeding.

Do not use this medicine if any of the above statements apply to the patient. In case of doubts, before using Levofloxacin Genoptim, consult a doctor or pharmacist.

Warnings and precautions

Before starting to use Levofloxacin Genoptim, consult a doctor or pharmacist if:

• the patient is 60 years old or more
• the patient is using corticosteroids, sometimes called steroids (see "Levofloxacin Genoptim and other medicines")
• the patient has had an organ transplant
• the patient has had seizures (epileptic fits) in the past
• the patient has had brain damage in the past due to a stroke or other brain injury
• the patient has kidney disease
• the patient has a diagnosed "glucose-6-phosphate dehydrogenase deficiency". The patient may be more prone to developing serious blood disorders while using this medicine
• the patient has had mental health problems in the past
• the patient has had heart problems: caution should be exercised when using this medicine if the patient has a congenital prolongation of the QT interval (visible in an ECG, i.e., an electrical activity test of the heart), the patient has electrolyte disturbances in the blood (especially low potassium or magnesium levels in the blood), the patient has a slow heart rate (bradycardia), the patient's heart function is impaired (heart failure), the patient has had a heart attack (myocardial infarction) in the past, the patient is a woman or an elderly person or is taking other medicines that cause abnormal changes in the ECG recording (see "Levofloxacin Genoptim and other medicines")
• the patient has diabetes
• the patient has had liver problems in the past
• the patient suffers from myasthenia
• the patient has nerve damage (peripheral neuropathy)
• the patient has an enlarged large blood vessel (aortic or large peripheral artery aneurysm)
• the patient has had an aortic dissection (tear in the aortic wall) in the past
• the patient has been diagnosed with heart valve leakage
• there have been cases of aortic aneurysm or aortic dissection or congenital heart valve disease, or other risk factors or conditions predisposing to it (e.g., connective tissue diseases

such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome (an autoimmune inflammatory disease) or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or confirmed atherosclerosis, rheumatoid arthritis (joint disease) or endocarditis (heart infection))

• the patient has ever experienced a severe skin rash or skin peeling, blistering, and (or) ulcers after using levofloxacin.

Severe skin reactions

Severe skin reactions have been reported during levofloxacin treatment, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS).

• SJS or TEN may initially appear as red, target-like, or circular patches, often with blisters in the center on the torso. They may also cause ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin rashes are often preceded by fever and (or) flu-like symptoms. These rashes can lead to widespread skin peeling, which can be life-threatening or fatal.
• In DRESS syndrome, flu-like symptoms and a rash on the face initially occur, followed by a widespread rash with high body temperature, elevated liver enzymes, and an increased white blood cell count (eosinophilia), as well as swollen lymph nodes and other body organs.

If a severe rash or any of these skin symptoms occur, discontinue levofloxacin and consult a doctor or seek immediate medical attention. Do not take antibacterial medicines containing fluoroquinolones or quinolones, including levofloxacin, if the patient has experienced any severe adverse reaction while taking a quinolone or fluoroquinolone in the past. In such a case, inform the doctor as soon as possible.

If the patient is using this medicine:

• In case of sudden severe abdominal, back, or chest pain, which may be a sign of an aortic aneurysm or dissection, seek emergency medical attention immediately. The risk of these changes may be higher in patients treated with systemic corticosteroids.
• In case of sudden shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or palpitations (feeling of rapid or irregular heartbeat), consult a doctor immediately.
• If the following occur: sudden, involuntary muscle twitches, muscle tremors, or muscle spasms, seek medical attention immediately, as they may be symptoms of myoclonus. The doctor may decide to discontinue levofloxacin and initiate appropriate treatment.
• If the following occur: fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat, and significant deterioration of health or feeling of reduced resistance to infections - seek medical attention immediately, as they may be symptoms of blood disorders. The doctor should monitor the patient's blood test results. If abnormalities are found in the blood test results, the doctor may decide to discontinue treatment.

Rarely, pain and swelling of the joints and tendon inflammation or rupture may occur. The risk is increased in elderly patients (over 60 years old), after organ transplantation, in patients with kidney problems, or during corticosteroid treatment. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after discontinuing Levofloxacin Genoptim. After the first symptoms of pain or tendon inflammation appear (e.g., in the ankle, wrist, elbow, shoulder, or knee), discontinue Levofloxacin Genoptim, consult a doctor, and rest the affected area. Avoid excessive strain, as it may increase the risk of tendon rupture. The patient may rarely experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness, and (or) weakness, especially in the feet and legs and hands and arms. In such a case, discontinue Levofloxacin Genoptim and inform the doctor immediately to prevent the development of potentially irreversible disease.

Long-term, disabling, and potentially irreversible serious side effects

Fluoroquinolone and quinolone antibacterial medicines, including Levofloxacin Genoptim, have been associated with very rare but serious side effects. Some of these have been long-term (lasting for months or years), disabling, or potentially irreversible. These include: tendon pain, muscle pain, and joint pain in the upper and lower limbs, walking difficulties, abnormal sensations, such as tingling, burning, itching, numbness, or prickling (paresthesia), sensory disturbances, including vision, taste, and smell and hearing disorders, depression, memory impairment, severe fatigue, and severe sleep disturbances. If any of these side effects occur after taking Levofloxacin Genoptim, consult a doctor before continuing treatment. The patient and doctor will decide whether to continue treatment, also considering antibiotics from another group.

Levofloxacin Genoptim and other medicines

Inform the doctor or pharmacist about all medicines currently being taken and recently taken, including those available without a prescription. This is because Levofloxacin Genoptim may affect the action of other medicines. Also, some medicines may affect the way Levofloxacin Genoptim works. It is especially important to inform the doctor about the medicines listed below, as their concurrent use with Levofloxacin Genoptim may increase the risk of side effects.

• Corticosteroids, sometimes called steroids, used to treat inflammation. The patient may be more prone to tendon inflammation and (or) rupture.
• Warfarin, which reduces blood clotting. The patient may be more prone to bleeding. The doctor may order regular blood clotting tests.
• Theophylline, used to treat breathing problems. Concurrent use of Levofloxacin Genoptim with this medicine may increase the risk of seizures (epileptic fits).
• Non-steroidal anti-inflammatory medicines (NSAIDs) used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, and indomethacin. The patient may be more prone to seizures (epileptic fits) when taking Levofloxacin Genoptim.
• Cyclosporine, used after organ transplantation. The patient may be more prone to cyclosporine side effects.
• Medicines that affect heart function. These include medicines used to treat heart rhythm disorders (anti-arrhythmic medicines, such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), depression (tricyclic antidepressants, such as amitriptyline and imipramine), mental disorders (antipsychotic medicines), and bacterial infections (macrolide antibiotics, such as erythromycin, azithromycin, and clarithromycin).

Inform the doctor if any of the above points apply to the patient.

Do not take Levofloxacin Genoptim at the same time as the following medicines, as they may affect the action of Levofloxacin Genoptim:

• Medicines containing iron (used for anemia), zinc preparations, antacids containing magnesium or aluminum (used for acidity or heartburn), didanosine, or sucralfate (used for stomach ulcers). See section 3 below "If the patient is already taking medicines containing iron, zinc preparations, antacids, didanosine, or sucralfate".

Tests for detecting opioids in urine

The results of tests for detecting strong painkillers called opioids in urine may be falsely positive in patients taking Levofloxacin Genoptim. If the doctor has ordered a urine test, the patient should inform the doctor that they are taking this medicine.

Tests for tuberculosis

This medicine may give false-negative results in some laboratory tests used to detect tuberculosis-causing bacteria.

Pregnancy and breastfeeding

Do not use this medicine if:

• the patient is pregnant, may become pregnant, or is suspected to be pregnant
• the patient is breastfeeding or plans to breastfeed

Driving and using machines

After using this medicine, side effects such as dizziness, drowsiness, feeling of spinning, or vision disturbances may occur. Some of these side effects may impair concentration and reaction speed. In such a case, do not drive vehicles or perform any work that requires a high level of attention.

3. How to use Levofloxacin Genoptim

Levofloxacin Genoptim should always be used as directed by the doctor. In case of doubts, consult a doctor or pharmacist.

Using the medicine

• The medicine is taken orally.
• Swallow the tablets whole with water.
• Tablets can be taken during meals or at any time between meals.

If the patient is already taking medicines containing iron, zinc preparations, antacids, didanosine, or sucralfate

• Do not take these medicines at the same time as Levofloxacin Genoptim. Take them at least 2 hours before or 2 hours after taking Levofloxacin Genoptim.

What dose to use

• The doctor will decide what dose of Levofloxacin Genoptim to use.
• The dose of the medicine depends on the type and location of the infection.
• The duration of treatment depends on the severity of the infection.
• If the patient feels that the effect of the medicine is too weak or too strong, do not change the dose themselves, but consult a doctor.

Adults and elderly patients

Sinusitis

two Levofloxacin Genoptim 250 mg tablets, once a day, or one Levofloxacin Genoptim 500 mg tablet, once a day.

Lung infections in patients with chronic breathing difficulties

two Levofloxacin Genoptim 250 mg tablets, once a day, or one Levofloxacin Genoptim 500 mg tablet, once a day.

Pneumonia

two Levofloxacin Genoptim 250 mg tablets, once or twice a day, or one Levofloxacin Genoptim 500 mg tablet, once or twice a day.

Urinary tract infections, including kidney or bladder infections

one or two Levofloxacin Genoptim 250 mg tablets, once a day, or half or one Levofloxacin Genoptim 500 mg tablet, once a day.

Prostate infections

two Levofloxacin Genoptim 250 mg tablets, once a day, or one Levofloxacin Genoptim 500 mg tablet, once a day.

Skin and subcutaneous tissue infections, including muscle infections

two Levofloxacin Genoptim 250 mg tablets, once or twice a day, or one Levofloxacin Genoptim 500 mg tablet, once or twice a day.

Adults and elderly patients with kidney function disorders

The doctor may prescribe a lower dose of the medicine.

Children and adolescents

Do not use this medicine in children and adolescents.

Protecting the skin from sunlight

During and for 2 days after using this medicine, avoid direct exposure to sunlight. This is because the patient's skin will become more sensitive to the sun, which can lead to sunburn, tingling, and the formation of large blisters on the skin if the following precautions are not taken:

• use UV filters with a high protection factor
• always wear a hat and clothing that covers the arms and legs
• avoid using a sunbed.

Using a higher than recommended dose of Levofloxacin Genoptim

In case of accidental ingestion of a higher number of tablets than recommended, consult a doctor or seek other medical advice immediately. Take the medicine packaging with you so that the doctor knows what medicine was used. The following symptoms may occur: seizures, confusion, dizziness, disturbances of consciousness, muscle tremors, and heart rhythm disturbances, including irregular heartbeat, as well as nausea (nausea) or heartburn.

Missing a dose of Levofloxacin Genoptim

In case of a missed dose, take it as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for the missed dose.

Discontinuing Levofloxacin Genoptim

Do not stop taking Levofloxacin Genoptim, even if the patient's condition improves. It is essential to complete the entire treatment cycle prescribed by the doctor. If treatment is discontinued prematurely, the infection may recur, the patient's condition may worsen, or the bacteria may become resistant to the medicine. In case of any further doubts about using the medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These side effects are usually mild or moderate and often disappear within a short time.

Discontinue Levofloxacin Genoptim and consult a doctor or go to the hospital immediately if the following side effects occur:

Very rare(may occur less frequently than in 1 in 10,000 patients)

• Allergic reaction. Symptoms may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

Discontinue Levofloxacin Genoptim and consult a doctor immediately if any of the following serious side effects occur - immediate treatment may be necessary:

Rare(may occur less frequently than in 1 in 1,000 patients)

• Watery diarrhea with blood, with possible stomach cramps and high fever. These symptoms may indicate severe bowel disorders.
• Pain and inflammation of the tendons or ligaments, which can lead to rupture. This most often affects the Achilles tendon.
• Seizures (epileptic fits).
• Seeing or hearing things that do not exist (hallucinations, paranoia).
• Feeling depressed, mentally disturbed, anxious (agitation), sleepy, trembling, or feeling of spinning (vertigo).
• Widespread rash, high body temperature, elevated liver enzymes, abnormal blood count (eosinophilia), swollen lymph nodes, and other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.
• Syndrome associated with abnormal water excretion and low sodium levels (SIADH).
• Low blood sugar levels (hypoglycemia) or low blood sugar levels leading to coma (hypoglycemic coma). This is important in patients with diabetes. Very rare(may occur less frequently than in 1 in 10,000 patients)
• Burning, tingling, pain, or numbness. These may be symptoms of "neuropathy". Frequency not known(frequency cannot be estimated from the available data)
• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear as red, target-like, or circular patches, often with blisters in the center on the torso, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms. See also section 2.
• Lack of appetite, yellowing of the skin and eyes, dark urine, itching, liver tenderness (abdominal pain). These may be symptoms of liver function disorders, including liver failure, which can be fatal.
• Changes in opinion and thought (psychotic reactions) with a risk of suicidal thoughts or attempts.

If the patient experiences vision disturbances or any changes in the eyes while using Levofloxacin Genoptim, consult an ophthalmologist immediately. The use of quinolone and fluoroquinolone antibiotics, in some cases regardless of existing risk factors, has very rarely caused long-term (lasting for months or years) or permanent drug side effects, such as tendonitis, tendon rupture, muscle pain, joint pain in the upper and lower limbs, walking difficulties, abnormal sensations, such as tingling, burning, itching, numbness, or prickling (paresthesia), sensory disturbances, including vision, taste, and smell and hearing disorders, depression, memory impairment, severe fatigue, and severe sleep disturbances. If any of these side effects occur after taking Levofloxacin Genoptim, consult a doctor before continuing treatment. Patients taking fluoroquinolones have reported cases of aortic enlargement or aortic wall damage (aortic aneurysm and dissection), which can end in rupture and be fatal, as well as cases of heart valve leakage. See also section 2.

Consult a doctor if any of the following side effects worsen or persist for more than a few days:

Common(may occur less frequently than in 1 in 10 patients)

• Sleep disturbances.
• Headache, dizziness.
• Nausea (nausea), vomiting, and diarrhea.
• Elevated activity of some liver enzymes in the blood.

Uncommon(may occur less frequently than in 1 in 100 patients)

Changes in the number of other bacteria or fungi, fungal infections, which may require treatment. Changes in the number of white blood cells shown in the results of some blood tests (leukopenia, eosinophilia). Anxiety, confusion, nervousness, sleepiness, tremors, feeling of spinning (vertigo). Shortness of breath (dyspnea). Changes in taste, loss of appetite, stomach upset or indigestion, stomach pain, bloating with gas, or constipation. Itching and skin rash, severe itching or hives, excessive sweating. Joint or muscle pain. Abnormal liver or kidney function test results (elevated bilirubin or creatinine levels). General weakness. Rare(may occur less frequently than in 1 in 1,000 patients)

Elevated tendency to bruise and bleed due to a decrease in platelet count (thrombocytopenia). Decreased white blood cell count (neutropenia). Excessive immune response (hypersensitivity). Feeling of tingling in the hands and feet (paresthesia). Hearing or vision problems (tinnitus or blurred vision). Abnormal rapid heartbeat (tachycardia) or low blood pressure (hypotension). Muscle weakness. This is important in patients with myasthenia (a rare nervous system disease). Changes in kidney function and sometimes kidney failure, which may be caused by an allergic reaction in the kidneys called interstitial nephritis. Fever. Clearly defined, red, blistering patches that develop within hours of taking levofloxacin. They usually resolve with post-inflammatory hyperpigmentation. When levofloxacin is administered again, these patches usually recur in the same location on the skin or mucous membranes. Memory disturbances. Frequency not known(frequency cannot be estimated from the available data)

• Decreased red blood cell count (anemia): this may cause paleness or yellowing of the skin due to damage to red blood cells; decreased count of all blood cell types (pancytopenia).
• Cessation of new blood cell production by the bone marrow, which may cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow failure).
• Fever, sore throat, and general poor health that does not improve. This may be caused by a decreased white blood cell count (agranulocytosis).
• Circulatory arrest (anaphylactoid shock)
• Elevated blood sugar levels (hyperglycemia). This is important in patients with diabetes.
• Changes in smell, loss of smell or taste (olfactory hallucinations, anosmia, ageusia).
• Feeling of intense excitement, agitation, or enthusiasm (mania).
• Problems with movement and walking (dyskinesia, extrapyramidal disorders).
• Transient loss of consciousness or fainting (syncope).
• Transient loss of vision, eye inflammation.
• Hearing or vision disturbances.
• Abnormal heart rhythm, life-threatening irregular heartbeat, including cardiac arrest, change in heart rhythm (so-called "QT interval prolongation" visible in an ECG, i.e., an electrical activity test of the heart)
• Difficulty breathing or wheezing (bronchospasm).
• Allergic reactions in the lungs.
• Pancreatitis.
• Hepatitis.
• Increased skin sensitivity to sunlight and ultraviolet radiation (photosensitivity), discoloration (skin hyperpigmentation).
• Vasculitis due to an allergic reaction.
• Mouth mucosa inflammation (stomatitis).
• Muscle rupture and breakdown (rhabdomyolysis).
• Joint and muscle pain (arthritis).
• Pain, including back, chest, and limb pain.
• Sudden, involuntary muscle twitches, muscle tremors, and muscle spasms (myoclonus).
• Porphyria attacks in patients with porphyria (a very rare metabolic disorder).
• Persistent headache with blurred vision (benign intracranial hypertension).

Reporting side effects

If any side effects occur, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levofloxacin Genoptim

Store the medicine out of sight and reach of children. There are no special storage instructions for the medicine. Do not use Levofloxacin Genoptim after the expiry date stated on the carton and blister after the abbreviation: EXP. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Levofloxacin Genoptim contains

The active substance of the medicine is levofloxacin. Each film-coated tablet contains 250 mg or 500 mg of levofloxacin in the form of levofloxacin hemihydrate. The other ingredients of the medicine are:

• Tablet core: crospovidone (type A), hypromellose (15 cP), microcrystalline cellulose, and magnesium stearate.
• 250 mg Tablet coating: hypromellose (6 cP) (E 464), titanium dioxide (E 171), macrogol 400, iron oxide red (E 172), polysorbate 80 (E 433).
• 500 mg Tablet coating: hypromellose (6 cP) (E 464), titanium dioxide (E 171), macrogol 400, iron oxide yellow (E 172), iron oxide red (E 172), polysorbate 80 (E 433).

What Levofloxacin Genoptim looks like and contents of the pack

Levofloxacin Genoptim, 250 mg, film-coated tablets: pink, capsule-shaped, biconvex film-coated tablets with the inscription "ML" and "62" on both sides of a deep dividing line and a break line on the other side. The tablet can be divided into two equal parts if the doctor recommends using a half-tablet dose. Levofloxacin Genoptim, 250 mg is available in blisters containing 5, 7, or 10 tablets. Each carton contains one blister. Levofloxacin Genoptim, 500 mg, film-coated tablets: peach-colored, capsule-shaped, biconvex film-coated tablets with the inscription "ML" and "63" on both sides of a deep dividing line and a break line on the other side. The tablet can be divided into two equal parts if the doctor recommends using a half-tablet dose. Levofloxacin Genoptim, 500 mg is available in blisters containing 5, 7, 10, or 200 tablets. Packaging of 5, 7, 10 tablets - each carton contains one blister. Packaging of 200 tablets - each carton contains 20 blisters. Not all pack sizes may be marketed.

Marketing authorization holder

Synoptis Pharma Sp. z o.o., ul. Krakowiaków 65, 02-255 Warsaw

Importer

Synoptis Industrial Sp. z o.o., ul. Rabowicka 15, 62-020 Swarzędz, or Formula Pharmazeutische und chemische Entwicklungs GmbH, Goerzallee 305b, D-14167 Berlin, Germany

This medicinal product is authorized in the Member States of the EEA under the following names:

Germany

Levoflox-HEC 500 mg Filmtabletten

Poland

Levofloxacin Genoptim, 500 mg, film-coated tablets

Spain

Levofloxacino Macleods 500 mg comprimidos recubiertos con película

Date of last revision of the leaflet: 09.2024