Lenalidomide Sandoz

Package Leaflet: Information for the Patient

Lenalidomide Sandoz, 2.5 mg, hard capsules
Lenalidomide

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

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 pack 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 arises from the proliferation of a certain type of white blood cell called plasma cells. These cells accumulate in the bone marrow and divide uncontrollably. This can lead to bone and kidney damage. Multiple myeloma is generally incurable. However, it is possible to achieve significant temporary relief or remission of the disease symptoms. This condition is called "remission". Newly diagnosed multiple myeloma - in patients after bone marrow transplantation Lenalidomide Sandoz is used alone in maintenance treatment in patients who have achieved a suitable condition after bone marrow transplantation. Newly diagnosed multiple myeloma - in patients who cannot undergo bone marrow transplantation Lenalidomide Sandoz is taken with other medicines, including:

• a chemotherapy medicine called "bortezomib"
• a medicine with anti-inflammatory effects called "dexamethasone"
• a chemotherapy medicine called "melphalan" and
• a medicine that suppresses the immune system called "prednisone".

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 of age or older or has moderate or severe kidney function impairment, the doctor will perform thorough examinations before starting Lenalidomide Sandoz treatment. Multiple myeloma - in patients who have received previous treatment Lenalidomide Sandoz is taken with the anti-inflammatory medicine dexamethasone. Lenalidomide Sandoz may prevent 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 in the treatment of adult patients with MDS, if all of the following conditions are met:

• the patient has a low number of red blood cells and needs regular blood transfusions ("transfusion-dependent anemia")
• the patient has a genetic abnormality in bone marrow cells called "isolated cytogenetic deletion 5q". This means that the patient's body does not produce enough healthy blood cells
• the patient has previously used other treatments that have been ineffective or insufficient.

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 decrease 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 part 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 in the treatment of adult patients who have previously been treated with 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" in the treatment of 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 process of forming new blood vessels in the tumor
• 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 package leaflets of all medicines taken in combination with Lenalidomide Sandoz.

When not to take Lenalidomide Sandoz

If any of the above situations apply to you, do not take Lenalidomide Sandoz. If in doubt, consult your 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 signs of infection, such as cough or fever
• you have had a viral infection, especially hepatitis B virus infection, varicella-zoster virus infection, or HIV. If in doubt, consult your doctor. Taking Lenalidomide Sandoz may cause the virus to reactivate, leading to infection recurrence. Your doctor should check if you have had hepatitis B virus infection.
• you have kidney function impairment - your doctor may adjust your 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, skin redness, high body temperature, flu-like symptoms, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes - these are symptoms of a severe skin reaction called drug rash with eosinophilia and systemic symptoms, also known as "DRESS" or "drug hypersensitivity syndrome" (see also section 4 "Possible side effects").

If any of the above situations apply to you, tell your doctor, pharmacist, or nurse before starting treatment. You should immediately consult your doctor, pharmacist, or nurse if you experience 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 walking or balance disturbances, persistent numbness, decreased sensation, or loss of sensation.

These may be symptoms of a severe and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If you have had such symptoms before treatment with lenalidomide, inform your 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 examinations
Before starting Lenalidomide Sandoz treatment and during treatment, you 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).
Your doctor will order blood tests:

• before treatment
• every week for the first 8 weeks of treatment
• then at least once a month.

Patient with MDS taking Lenalidomide Sandoz
If you have myelodysplastic syndrome, 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, your doctor may perform tests and check for symptoms that can better predict the risk of acute myeloid leukemia during treatment with Lenalidomide Sandoz.
Patient with MCL taking Lenalidomide Sandoz
Your doctor will ask you to have 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.

Patient with follicular lymphoma taking Lenalidomide Sandoz
Your doctor will ask you to have 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 lenalidomide treatment and during treatment, you may undergo an assessment for circulation and respiratory problems.
Your doctor may perform a test to check if you have a large amount of tumor tissue in your body, including in the bone marrow. This can lead to a condition where the tumor tissue breaks down, causing abnormal increases in various chemicals in the blood and potentially leading to kidney failure (this condition is called "tumor lysis syndrome").
Your doctor may examine your skin to check for changes, such as red spots or rash.
Your doctor may adjust your dose of Lenalidomide Sandoz or interrupt treatment based on your blood test results and overall condition. If the disease has been recently diagnosed, your doctor may also assess treatment considering your age and other conditions you have.

Blood donation

Do not donate blood during treatment and for at least 7 days after treatment has stopped.

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 you are 75 years of age or older or have moderate or severe kidney function impairment, your 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.
Particularly, 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

Pregnancy
Information 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, women of childbearing age must use effective contraception methods (see "Contraception").
• If you become pregnant while taking Lenalidomide Sandoz, you must stop treatment immediately and inform your doctor.

Information for men taking Lenalidomide Sandoz

• If your partner becomes pregnant, you must immediately inform your doctor. It is recommended that your partner consult a doctor.
• You must also use effective contraception methods (see "Contraception").

Breastfeeding
Do not breastfeed while taking Lenalidomide Sandoz, as it is not known whether it passes into breast milk.
Contraception
Information for women taking Lenalidomide Sandoz
Before starting treatment, you should 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 has stopped), unless your doctor confirms that your fallopian tubes have been cut and sealed to prevent eggs from reaching the uterus (tubal ligation or sterilization) AND
• you must use effective contraception methods for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after treatment has stopped. Your doctor will recommend suitable contraception methods.

Information for men taking Lenalidomide Sandoz
Lenalidomide Sandoz is present in 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 has stopped, even if you have had a vasectomy. During treatment and for at least 7 days after treatment has stopped, you must not donate sperm or semen.

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 essentially "sodium-free".

3. How to take Lenalidomide Sandoz

Lenalidomide Sandoz must be administered by medical personnel with experience in treating 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, you should read the package leaflets of those medicines to learn about their use and effects.

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 inform 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 area thoroughly with soap and water.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister or capsule. Gloves should then be carefully removed to avoid skin exposure, placed in a sealed plastic bag, and disposed of in accordance with local regulations. Then, wash your hands thoroughly with soap and water. Pregnant or potentially pregnant women should not handle 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 your doctor decides to stop it.

Taking more Lenalidomide Sandoz than prescribed

If you take more capsules than you should, contact your doctor immediately.

Missing a dose of Lenalidomide Sandoz

If you miss a dose of Lenalidomide Sandoz at the usual time:

• and it has been less than 12 hours since then, take the capsule as soon as possible
• and 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 questions 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 serious side effects, stop taking Lenalidomide Sandoz and contact 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 anaphylactic reaction

severe allergic reaction that can start as a rash in one area and spread 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 enzymes, blood abnormalities (eosinophilia), swollen 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 serious 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, 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, leading 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, your 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
• rash, itching
• muscle spasms, muscle weakness, fatigue, muscle pain, 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 arms or legs, dizziness, tremors
• decreased appetite, changes in taste
• increased tumor pain, tumor swelling, 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
• cloudy vision (cataract)
• kidney problems, including abnormal kidney function or inability to maintain normal kidney function
• abnormal liver test results
• increased liver enzyme values
• 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 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, skin redness, peeling, cracking, or shedding of the skin, hives
• increased sweating, night sweats
• difficulty swallowing, sore throat, voice changes, or hoarseness
• runny nose (rhinitis)
• passing much more or much less urine than normal, or loss of control over urination
• passing blood in the urine
• shortness of breath, especially when lying down (which may be a sign of heart failure)
• erectile dysfunction
• stroke, fainting, dizziness (inner ear disturbances that cause a feeling of spinning), loss of consciousness
• chest pain radiating to the arms, neck, jaw, or back, or a 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 of bile flow from the liver
• low levels of phosphorus or magnesium in the blood
• difficulty speaking
• liver damage
• balance disturbances, difficulty walking
• hearing loss, ringing in the ears (tinnitus)
• nerve pain, unpleasant abnormal sensations, especially in response to touch
• excessive iron in the body
• thirst
• confusion
• toothache
• fall that may cause injury

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

• bleeding in the brain
• circulatory disorders
• vision loss
• loss of sex drive
• 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-colored stools, dark-colored urine, itching, 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 or proctitis)
• kidney cell damage (renal tubular necrosis)
• skin color changes, 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, irregular heartbeat, seizures, and sometimes death
• high blood pressure in the blood vessels that supply the lungs (pulmonary hypertension)

Rareside effects (may affect up to 1 in 1,000 people)

• sudden or mild but worsening abdominal pain and/or back pain, which persists for several days and may occur with 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 (interstitial lung disease)
• observed rare cases of muscle breakdown (muscle pain, weakness, or swelling), which can lead to kidney function disorders (rhabdomyolysis), some of which occurred when lenalidomide was given 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 movements
• viral infections, including varicella-zoster virus infection (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-colored urine, abdominal pain, fever, nausea, or vomiting)
• organ transplant rejection (such as kidney, heart, or liver transplant rejection)

Frequency not knownside effects (frequency cannot be estimated from available data)

• report side effects to your doctor, pharmacist, or nurse. Side effects can also 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.
  Reporting side effects will help gather more information on the safety of this medicine.

  5. How to store Lenalidomide Sandoz

  Keep the medicine out of the 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 requirements.
  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 pack and other information

  What Lenalidomide Sandoz contains

  • The active substance is lenalidomide. One capsule contains 2.5 mg of lenalidomide.
  • The other ingredients are lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate. Capusle shell:gelatin, titanium dioxide (E171), indigo carmine, lake (E 132), and iron oxide yellow (E 172) Printing ink: shellac, propylene glycol, potassium hydroxide, iron oxide black (E 172).

  What Lenalidomide Sandoz looks like and contents of the pack

  The capsule has a matte white body and a matte green to light green cap, approximately 14.3 mm in length, with the imprint "L9NL" and "2.5".
  Hard capsules are packaged in OPA/Aluminum/PVC/Aluminum blisters.
  Pack sizes:
  OPA/Aluminum/PVC/Aluminum blisters: packs containing 21 hard capsules.
  Single-dose OPA/Aluminum/PVC/Aluminum blisters: 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 further information on the medicine and its names in the Member States of the European Economic Area, please contact:

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