Lenalidomide Sandoz

Leaflet accompanying the packaging: patient information

Lenalidomide Sandoz, 7.5 mg, hard capsules
Lenalidomide

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lenalidomide Sandoz and what is it used for
• 2. Important information before taking Lenalidomide Sandoz
• 3. How to take Lenalidomide Sandoz
• 4. Possible side effects
• 5. How to store Lenalidomide Sandoz
• 6. Contents of the packaging and other information

1. What is Lenalidomide Sandoz and what is it used for

What is Lenalidomide Sandoz

Lenalidomide Sandoz contains the active substance lenalidomide and belongs to a group of medicines that affect the immune system.

What is Lenalidomide Sandoz used for

Lenalidomide Sandoz is used in adults to treat:

• multiple myeloma,
• myelodysplastic syndromes,
• mantle cell lymphoma,
• follicular lymphoma.

Multiple myeloma

Multiple myeloma is a type of cancer that occurs when a certain type of white blood cell, called plasma cells, grows uncontrollably. These cells accumulate in the bone marrow and divide uncontrollably. This can lead to bone and kidney damage. In principle, multiple myeloma is incurable. However, it is possible to significantly alleviate or eliminate the symptoms of the disease for a time. This condition is called "remission". New multiple myeloma - in patients after bone marrow transplantation Lenalidomide Sandoz is used alone (without other medicines) for maintenance treatment in patients who have achieved a suitable condition after bone marrow transplantation. New multiple myeloma - in patients who cannot undergo bone marrow transplantation Lenalidomide Sandoz is taken with other medicines, including: bortezomib (a chemotherapy medicine), dexamethasone (an anti-inflammatory medicine), melphalan (a chemotherapy medicine), and prednisone (an immunosuppressive medicine). The patient starts treatment by taking Lenalidomide Sandoz with additional medicines, and then continues treatment with Lenalidomide Sandoz alone. If the patient is 75 years old or older, or has moderate or severe kidney function impairment, the doctor will perform thorough examinations before starting Lenalidomide Sandoz. Multiple myeloma - in patients receiving previous treatment Lenalidomide Sandoz is taken with the anti-inflammatory medicine dexamethasone. Lenalidomide Sandoz may stop the worsening of multiple myeloma symptoms. It has also been shown to delay the recurrence of multiple myeloma after treatment.

Myelodysplastic syndromes (MDS)

Myelodysplastic syndromes (MDS) are a group of different blood and bone marrow diseases. There are abnormal blood cells that do not function properly. Patients may experience various subjective and objective symptoms, including a low number of red blood cells (anemia), the need for blood transfusions, and the risk of infections. Lenalidomide Sandoz is used alone to treat adult patients with MDS, if all of the following conditions are met: the patient has anemia that requires regular blood transfusions ("transfusion-dependent anemia"); the patient has a cytogenetic abnormality in the bone marrow cells called "isolated deletion 5q", which means that the patient's body does not produce enough healthy blood cells; the patient has previously received other treatments that were not effective or were not suitable. Taking Lenalidomide Sandoz may lead to an increase in the number of healthy blood cells produced by the body, by reducing the number of abnormal cells. This may lead to a reduction in the number of blood transfusions required. It is possible that transfusions will no longer be needed.

Mantle cell lymphoma (MCL)

MCL is a cancer of the immune system (lymphoid tissue). It attacks a type of white blood cell called B lymphocytes or B cells. Mantle cell lymphoma is a disease characterized by uncontrolled growth of B lymphocytes, resulting in their accumulation in lymphoid tissue, bone marrow, or blood. Lenalidomide Sandoz is used alone to treat adult patients who have previously received other medicines.

Follicular lymphoma (FL)

Follicular lymphoma is a slow-growing malignant tumor that attacks B lymphocytes. It is a type of white blood cell that helps the body fight infections. In patients with follicular lymphoma, there may be an accumulation of too many B lymphocytes in the blood, bone marrow, lymph nodes, and spleen. Lenalidomide Sandoz is taken with another medicine called "rituximab" to treat adult patients with previously treated follicular lymphoma.

How Lenalidomide Sandoz works

The medicine works by affecting the immune system and directly attacking cancer cells. Its mechanism of action includes: inhibiting the growth of cancer cells, inhibiting the formation of blood vessels in the tumor, and stimulating part of the immune system to attack cancer cells.

2. Important information before taking Lenalidomide Sandoz

Before starting treatment with Lenalidomide Sandoz, read the leaflets of all medicines taken in combination with Lenalidomide Sandoz.

When not to take Lenalidomide Sandoz

If any of the above situations apply to the patient, she should not take Lenalidomide Sandoz. In case of doubts, consult a doctor.

Warnings and precautions

Before taking Lenalidomide Sandoz, discuss with your doctor, pharmacist, or nurse if: you have had blood clots in the past, as you have an increased risk of developing blood clots in veins and arteries; you have any symptoms of infection, such as cough or fever; you have or have had a viral infection, especially hepatitis B virus, varicella-zoster virus, or HIV. If in doubt, consult a doctor. Taking Lenalidomide Sandoz may cause the virus to reactivate, leading to a recurrence of the infection. The doctor should check if the patient has had hepatitis B virus in the past. you have kidney function impairment - the doctor may adjust the dose of Lenalidomide Sandoz; you have had a heart attack, have had a blood clot, smoke, have high blood pressure, or high cholesterol levels; you have had an allergic reaction after taking thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing; you have had a combination of any of the following symptoms in the past: widespread rash, redness of the skin, high body temperature, flu-like symptoms, elevated liver enzyme activity, blood abnormalities (eosinophilia), enlarged lymph nodes - these are symptoms of a severe skin reaction called drug rash with eosinophilia and systemic symptoms (DRESS) or "drug hypersensitivity syndrome" (see also section 4 "Possible side effects").

If any of the above situations apply to the patient, she should tell her doctor, pharmacist, or nurse before starting treatment. The patient should immediately consult a doctor, pharmacist, or nurse if she experiences any of the following at any time during or after treatment: vision disturbances, loss of vision, or double vision, difficulty speaking, weakness in the arm or leg, change in gait, or balance disturbances, persistent numbness, decreased sensation, or loss of sensation, memory loss, or disorientation. These may be symptoms of a severe and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If the patient has had such symptoms before treatment with lenalidomide, she should inform her doctor of any changes. shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or swelling of the feet or ankles. These may be symptoms of a severe condition called pulmonary hypertension (see section 4).

Tests and examinationsBefore starting treatment with Lenalidomide Sandoz and during treatment, the patient will undergo regular blood tests, as this medicine may cause a decrease in the number of blood cells that help fight infection (white blood cells) and those that help blood clot (platelets). The doctor will order blood tests: before treatment, every week for the first 8 weeks of treatment, and then at least once a month. Patients with MDS taking Lenalidomide Sandoz If the patient has myelodysplastic syndromes, there is an increased risk of developing a severe disease called acute myeloid leukemia. Additionally, it is not known how Lenalidomide Sandoz affects the likelihood of developing acute myeloid leukemia. Therefore, the doctor may perform tests and check for symptoms that can help predict the risk of acute myeloid leukemia during treatment with Lenalidomide Sandoz. Patients with MCL taking Lenalidomide Sandoz The doctor will ask for a blood test: before treatment, every week for the first 8 weeks (2 cycles) of treatment, then every 2 weeks in cycles 3 and 4 (more information is provided in section 3 "Treatment cycle"), then at the beginning of each cycle, and at least once a month. Patients with follicular lymphoma taking Lenalidomide Sandoz The doctor will ask for a blood test: before treatment, every week for the first 3 weeks (1 cycle) of treatment, then every 2 weeks in cycles 2 to 4 (more information is provided in section 3 "Treatment cycle"). Then at the beginning of each cycle, and at least once a month. Before starting treatment with lenalidomide and during treatment, the patient may undergo an assessment for circulation and breathing problems. The doctor may perform a test to check if the patient has a large amount of tumor tissue in the body, including in the bone marrow. This can lead to a condition in which the tumor tissue breaks down, causing an abnormal increase in the levels of various chemicals in the blood and potentially leading to kidney failure (this condition is called "tumor lysis syndrome"). The doctor may examine the patient's skin to check for changes, such as red spots or rash. The doctor may adjust the dose of Lenalidomide Sandoz or interrupt treatment based on the results of the patient's blood tests and overall condition. If the disease has been recently diagnosed, the doctor may also assess treatment taking into account the patient's age and other existing conditions.

Blood donation

Do not donate blood during treatment and for at least 7 days after its completion.

Children and adolescents

Lenalidomide Sandoz is not recommended for use in children and adolescents under 18 years of age.

Elderly and patients with kidney function impairment

If the patient is 75 years old or older, or has moderate or severe kidney function impairment, the doctor will perform thorough examinations before starting treatment.

Lenalidomide Sandoz and other medicines

Tell your doctor or nurse about all medicines you are taking or have recently taken, as Lenalidomide Sandoz and some other medicines may affect each other's action. In particular, tell your doctor or nurse if you are taking any of the following medicines or products: certain contraceptives, such as oral contraceptives, as they may lose their effectiveness; certain heart medicines, such as digoxin; certain blood-thinning medicines, such as warfarin.

Pregnancy, breastfeeding, and contraception - information for women and men

PregnancyInformation for women taking Lenalidomide Sandoz Do not take Lenalidomide Sandoz if you are pregnant, as it may harm the fetus. Women of childbearing age must not become pregnant while taking Lenalidomide Sandoz. Therefore, they must use effective methods of contraception (see "Contraception"). If you become pregnant while taking Lenalidomide Sandoz, stop treatment immediately and inform your doctor. Information for men taking Lenalidomide Sandoz If your partner becomes pregnant, inform your doctor immediately. It is recommended that your partner consult a doctor. You must also use effective contraception methods (see "Contraception").

BreastfeedingDo not breastfeed while taking Lenalidomide Sandoz, as it is not known whether it passes into breast milk. ContraceptionInformation for women taking Lenalidomide Sandoz Before starting treatment, ask your doctor if you can become pregnant, even if you think it is unlikely. If you are of childbearing age: you will have pregnancy tests under medical supervision (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after treatment completion), unless your doctor confirms that your fallopian tubes have been cut and blocked to prevent eggs from reaching the uterus (tubal sterilization) AND you must use effective methods of contraception for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after treatment completion. Your doctor will recommend appropriate contraception methods. Information for men taking Lenalidomide Sandoz Lenalidomide Sandoz passes into human semen. If your partner is pregnant or may become pregnant and is not using effective contraception, you must use condoms during treatment and for at least 7 days after treatment completion, even if you have had a vasectomy. During treatment and for at least 7 days after treatment completion, you must not donate sperm.

Driving and using machines

If you experience dizziness, fatigue, drowsiness, a feeling of spinning, or blurred vision after taking Lenalidomide Sandoz, do not drive or operate machinery.

Lenalidomide Sandoz contains lactose and sodium

If you have been told that you have an intolerance to some sugars, consult your doctor before taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which is considered "sodium-free".

3. How to take Lenalidomide Sandoz

Lenalidomide Sandoz must be administered by medical personnel experienced in the treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma, or follicular lymphoma.

• If Lenalidomide Sandoz is used to treat multiple myeloma in patients who cannot undergo bone marrow transplantation or have received previous treatment, the medicine is taken with other medicines (see section 1 "What is Lenalidomide Sandoz used for").
• If Lenalidomide Sandoz is used to treat multiple myeloma in patients after bone marrow transplantation or to treat myelodysplastic syndromes or mantle cell lymphoma, the medicine is taken alone (as monotherapy).
• If Lenalidomide Sandoz is used to treat follicular lymphoma, it is taken with another medicine called "rituximab".

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. If you are taking Lenalidomide Sandoz with other medicines, read the leaflets of those medicines to learn about their use and action.

Treatment cycle

Lenalidomide Sandoz is taken on specific days during a 3-week period (21 days).

• Each 21-day period is called a "treatment cycle".
• Depending on the day of the cycle, you will take one or more medicines. However, on some days, you will not take any medicines.
• After completing each 21-day cycle, you should start a new 21-day cycle.

OR Lenalidomide Sandoz is taken on specific days for 4 weeks (28 days).

• Each 28-day period is called a "treatment cycle".
• Depending on the day of the cycle, you will take one or more medicines. However, on some days, you will not take any medicines.
• After completing each 28-day cycle, you should start a new 28-day cycle.

How much Lenalidomide Sandoz to take

Before starting treatment, your doctor will tell you: how much Lenalidomide Sandoz to take; how many other medicines (if any) to take with Lenalidomide Sandoz; on which days of the cycle to take each of these medicines.

How and when to take Lenalidomide Sandoz

• Swallow the capsule whole, preferably with water.
• Do not break, open, or chew the capsule. If the powder from a damaged Lenalidomide Sandoz capsule comes into contact with your skin, wash the skin immediately with soap and water.
• Healthcare professionals, caregivers, and family members should wear single-use gloves when handling the blister or capsule. Remove the gloves carefully to avoid skin exposure, place them in a sealed plastic bag, and dispose of them according to local regulations. Then wash your hands with soap and water. Pregnant or potentially pregnant women should not touch the blister or capsule.
• The capsules can be taken with or without food.
• Take the medicine at the designated times, approximately at the same time each day.

Taking this medicine

To remove a capsule from the blister: press the capsule only on one side and push it through the foil; do not press on the center of the capsule, as this may damage it.

Duration of treatment with Lenalidomide Sandoz

Lenalidomide Sandoz is used in treatment cycles, each lasting 21 or 28 days (see above "Treatment cycle"). Treatment should be continued until the doctor recommends stopping it.

Taking more Lenalidomide Sandoz than prescribed

If you have taken more capsules than you should, consult your doctor immediately.

Missing a dose of Lenalidomide Sandoz

If you miss a dose of Lenalidomide Sandoz at the usual time: if it has been less than 12 hours since then, take the capsule immediately; if it has been more than 12 hours since then, do not take the missed capsule. Take the next dose at the usual time the next day.

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lenalidomide Sandoz can cause side effects, although not everybody gets them.

If you experience any of the following severe side effects, stop taking Lenalidomide Sandoz and consult your doctor immediately - you may need urgent medical attention:

• Hives, rash, swelling of the eyes, lips, or face, difficulty breathing, or itching, which may be symptoms of severe allergic reactions called angioedema and anaphylaxis;
• A severe allergic reaction that starts as a rash in one area and spreads to the whole body, accompanied by a significant loss of skin (Stevens-Johnson syndrome and/or toxic epidermal necrolysis);
• Widespread rash, high body temperature, elevated liver enzyme activity, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs (drug rash with eosinophilia and systemic symptoms, also known as DRESS or "drug hypersensitivity syndrome") (see also section 2).

Tell your doctor immediately if you experience any of the following severe side effects:

• Fever, chills, sore throat, cough, mouth sores, or any other signs of infection (including blood infections (sepsis));
• Bleeding or bruising without injury;
• Chest pain or leg pain;
• Shortness of breath;
• Bone pain, muscle weakness, feeling of confusion, or fatigue that may be due to high calcium levels in the blood.

Lenalidomide Sandoz may cause a decrease in the number of white blood cells that fight infection and platelets that help blood clot, which may lead to bleeding disorders, such as nosebleeds and bruising. Lenalidomide Sandoz may also cause blood clots in veins (thrombosis).

Other side effects

In a small number of patients, another type of cancer may develop, and it is possible that the risk of its development is higher during treatment with Lenalidomide Sandoz. Therefore, before prescribing this medicine, the doctor will carefully weigh the benefits and risks of treatment. Very commonside effects (may affect more than 1 in 10 people)

• Decrease in the number of red blood cells, which may cause anemia leading to fatigue and weakness;
• Rashes, itching;
• Muscle spasms, muscle weakness, muscle pain, muscle tenderness, bone pain, joint pain, back pain, limb pain;
• Generalized swelling, including swelling of the hands and feet;
• Weakness, fatigue;
• Fever, flu-like symptoms, including fever, muscle pain, headache, ear pain, cough, and chills;
• Numbness, tingling, or burning sensation of the skin, prickling sensation in the hands or feet, dizziness, trembling;
• Decreased appetite, changes in taste;
• Increased pain, increased tumor size, or redness around the tumor;
• Weight loss;
• Constipation, diarrhea, nausea, vomiting, abdominal pain, heartburn;
• Low levels of potassium, calcium, or sodium in the blood;
• Abnormal thyroid function;
• Leg pain (which may be a sign of thrombosis), chest pain, or shortness of breath (which may be symptoms of blood clots in the lungs, called pulmonary embolism);
• All types of infections, including sinusitis, pneumonia, and upper respiratory tract infections;
• Shortness of breath;
• Blurred vision;
• Blurred vision (cataract);
• Kidney problems, including abnormal kidney function or inability to maintain normal kidney function;
• Abnormal liver test results;
• Increased liver enzyme activity;
• Changes in blood proteins, leading to blood vessel inflammation (vasculitis)
• Increased blood sugar levels (diabetes);
• Decreased blood sugar levels;
• Headache;
• Nosebleeds;
• Dry skin;
• Depression, mood changes, sleep disturbances;
• Cough;
• Low blood pressure;
• General feeling of discomfort, malaise;
• Painful inflammation of the mouth, dry mouth;
• Dehydration.

Commonside effects (may affect up to 1 in 10 people)

• Breakdown of red blood cells (hemolytic anemia);
• Certain types of skin tumors;
• Bleeding from the gums, stomach, or intestines;
• High blood pressure, slow, fast, or irregular heartbeat;
• Increased levels of a substance produced by the breakdown of red and abnormal red blood cells;
• Increased levels of a protein that indicates inflammation in the body
• Darkening of the skin; discoloration of the skin due to bleeding under the skin, usually caused by bruising; swelling of the skin filled with blood, bruising;
• Increased uric acid levels in the blood;
• Skin rashes, redness of the skin, peeling, cracking, or shedding of the skin, hives;
• Increased sweating, night sweats;
• Difficulty swallowing, sore throat, voice problems, or voice changes;
• Rhinitis (runny nose);
• Passing much more or much less urine than normal, or inability to control urination;
• Blood in the urine;
• Shortness of breath, especially when lying down (which may be a sign of heart failure);
• Difficulty achieving an erection;
• Stroke, fainting, dizziness (inner ear disorders that cause a feeling of spinning), transient loss of consciousness;
• Chest pain radiating to the arms, neck, jaw, back, or abdomen, feeling of sweating and shortness of breath, nausea, or vomiting, which may be symptoms of a heart attack (myocardial infarction);
• Muscle weakness, lack of energy;
• Neck pain, chest pain;
• Chills;
• Joint swelling;
• Slowing or blocking the flow of bile from the liver;
• Low levels of phosphorus or magnesium in the blood;
• Difficulty speaking;
• Liver damage;
• Balance disturbances, difficulty walking;
• Deafness, ringing in the ears (tinnitus);
• Nerve pain, unpleasant abnormal sensations, especially in response to touch;
• Excessive iron in the body;
• Thirst;
• Feeling of confusion;
• Toothache;
• Fall that may cause injury

Uncommonside effects (may affect up to 1 in 100 people)

• Bleeding inside the skull;
• Circulation disorders;
• Loss of vision;
• Loss of sexual desire;
• Passing large amounts of urine with accompanying bone pain and weakness - these may be symptoms of kidney function disorders (Fanconi syndrome);
• Yellowing of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching of the skin, rash, pain, or swelling of the abdomen - these may be symptoms of liver damage (liver failure);
• Abdominal pain, bloating, or diarrhea, which may be symptoms of colon inflammation (colitis);
• Kidney cell damage (tubular necrosis);
• Changes in skin color, sensitivity to sunlight;
• Tumor lysis syndrome - a complication of metabolism that can occur during cancer treatment, as well as sometimes without treatment. These complications are caused by the breakdown products of dying cancer cells and can include changes in blood chemistry; high levels of potassium, phosphorus, uric acid, and low levels of calcium, leading to kidney function disorders, heart rhythm disturbances, seizures, and sometimes death;
• High blood pressure in the blood vessels that lead to the lungs (pulmonary hypertension).

Rareside effects (frequency cannot be estimated from available data)

• Sudden or mild but worsening abdominal or back pain that lasts for several days and may be accompanied by nausea, vomiting, fever, and rapid heartbeat. These symptoms may be caused by pancreatitis
• Wheezing, shortness of breath, or dry cough - these may be symptoms of lung tissue inflammation
• Rare cases of muscle breakdown (muscle pain, weakness, or swelling) that can lead to kidney function disorders (rhabdomyolysis), some of which occurred when lenalidomide was taken with a statin (a cholesterol-lowering medicine)
• A skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis)
• Rupture of the stomach or intestine wall, which can lead to a severe infection. Tell your doctor if you experience severe abdominal pain, fever, nausea, vomiting, blood in the stool, or changes in bowel habits
• Viral infections, including shingles (a viral disease that causes a painful rash with blisters) and hepatitis B virus reactivation (which can cause yellowing of the skin and eyes, dark urine, abdominal pain, fever, nausea, or vomiting)
• Rejection of a transplanted organ (such as a kidney, heart).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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.: +48 22 49 21 301, fax: +48 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 Lenalidomide Sandoz

Store the medicine out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month stated. There are no special storage precautions. Do not use the medicine if it is damaged or if the packaging is broken. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Lenalidomide Sandoz contains

• The active substance is lenalidomide. One capsule contains 7.5 mg of lenalidomide.
• The other ingredients are: lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate. Capsule shell:gelatin, titanium dioxide (E171), and yellow iron oxide (E172) Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).

What Lenalidomide Sandoz looks like and contents of the pack

The capsule has a matte white body and a matte yellow cap, approximately 18.0 mm in length, marked with "L9NL" and "7.5". The hard capsules are packaged in blisters of OPA/Aluminum/PVC/Aluminum foil. Pack sizes: blisters of OPA/Aluminum/PVC/Aluminum foil: packs containing 21 hard capsules. Single-dose blisters of OPA/Aluminum/PVC/Aluminum foil: packs containing 21 x 1 hard capsule.

Marketing authorization holder

Sandoz GmbH Biochemiestrasse 10 6250 Kundl, Austria

Manufacturer/Importer

Synthon Hispania, S.L. C/ Castelló no1, Pol. Las Salinas Sant Boi de Llobregat 08830 Barcelona, Spain Synthon BV Microweg 22 6545 CM Nijmegen, Netherlands Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben, Germany

For more information about this medicine and its authorized names in the European Economic Area, contact:

Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warsaw tel. 22 209 70 00 Date of last revision of the leaflet:06/2023 Sandoz logo