Lenalidomide Sandoz

Package Leaflet: Information for the Patient

Lenalidomide Sandoz, 15 mg, Hard Capsules

Lenalidomide

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet. You may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. 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 package leaflet, 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 Package 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 medications 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. In principle, multiple myeloma is incurable. However, it is possible to achieve significant temporary relief or removal of disease symptoms. This condition is called "remission". Newly diagnosed multiple myeloma – in patients after bone marrow transplantation Lenalidomide Sandoz is used as maintenance therapy in patients who have achieved a satisfactory condition after bone marrow transplantation. Newly diagnosed multiple myeloma – in patients who are not eligible for bone marrow transplantation Lenalidomide Sandoz is taken with other medications, including:

• a chemotherapy medication called "bortezomib",
• an anti-inflammatory medication called "dexamethasone",
• a chemotherapy medication called "melphalan", and
• an immunosuppressive medication called "prednisone".

The patient starts treatment by taking Lenalidomide Sandoz with additional medications, and then continues treatment with Lenalidomide Sandoz alone. If the patient is 75 years 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 medication dexamethasone. Lenalidomide Sandoz may delay 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 disorders. 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 as monotherapy 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 requires regular blood transfusions ("transfusion-dependent anemia");
• the patient has a cytogenetic abnormality in bone marrow cells called "isolated deletion 5q". This means that the patient's body does not produce enough healthy blood cells;
• the patient has previously used other treatments that were ineffective or not sufficiently effective.

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 affects 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 as monotherapy in the treatment of adult patients who have previously been treated with other medications.

Follicular Lymphoma (FL)

Follicular lymphoma is a slow-growing malignant tumor that affects 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 medication called "rituximab" in the treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide Sandoz Works

The medication 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
• 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 Medications 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. In case of doubts, 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 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 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 in the past.
• you have kidney function impairment - your doctor may adjust your dose of Lenalidomide Sandoz;
• you have had a heart attack, had a blood clot, smoke, have high blood pressure, or high cholesterol levels;
• you have had an allergic reaction after taking thalidomide (another medication 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, 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 gait or balance, 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 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 legs 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, you will undergo regular blood tests, as this medication 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,
• weekly for the first 8 weeks of treatment,
• then at least once a month.

Patients with MDS taking Lenalidomide Sandoz If you have 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, your 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 Your doctor will ask you to have a blood test:

• before treatment,
• weekly 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 Your doctor will ask you to have a blood test:

• before treatment,
• weekly 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, 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 an abnormal increase in the levels of various chemicals in the blood and potentially leading to kidney failure (a condition 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 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 Renal Impairment

If you are 75 years or older or have moderate or severe kidney function impairment, your doctor will perform thorough examinations before starting treatment.

Lenalidomide Sandoz and Other Medications

Tell your doctor or nurse about all medications you are currently taking or have recently taken, as Lenalidomide Sandoz and some other medications may interact with each other. In particular, tell your doctor or nurse if you are taking any of the following medications or products:

• certain contraceptives, such as oral contraceptives, as they may lose their effectiveness
• certain heart medications, such as digoxin
• certain blood-thinning medications, 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 potential must not become pregnant while taking Lenalidomide Sandoz. Therefore, women of childbearing potential must use effective contraception methods (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, you should ask your doctor if you can become pregnant, even if you think it is unlikely. If you are of childbearing potential:

• 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 egg cells from reaching the uterus (tubal 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 completion. Your doctor will recommend appropriate 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 completion, even if you have had a vasectomy. During treatment and for at least 7 days after treatment completion, 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 medication. The medication contains less than 1 mmol (23 mg) of sodium per capsule, which means it 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 are not eligible for bone marrow transplantation or have received previous treatment, the medication is taken with other medications (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 medication is taken alone (as monotherapy).
• If Lenalidomide Sandoz is used to treat follicular lymphoma, it is taken with another medication called "rituximab".

Take this medication exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. If you are taking Lenalidomide Sandoz with other medications, read the package leaflets of those medications 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 medications. However, on some days, you will not take any medications.
• 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 medications. However, on some days, you will not take any medications.
• 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 medications (if any) to take with Lenalidomide Sandoz;
• on which days of the cycle to take each of these medications.

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 disposable 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 handle the blister or capsule.
• The capsules can be taken with or without food.
• Take the medication at the designated times, approximately at the same time each day.

Taking the Medication

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 taken in treatment cycles, each lasting 21 or 28 days (see above "Treatment Cycle"). Treatment should be continued until your doctor recommends stopping it.

Taking More Lenalidomide Sandoz Than Prescribed

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

Missing a Dose of Lenalidomide Sandoz

If you forget to take Lenalidomide Sandoz at the usual time:

• and it has been less than 12 hours since then, take the capsule immediately,
• 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 doubts about taking this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, 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 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 anaphylactic reaction;

severe allergic reaction that can start as a rash in one area and spread to the entire body, accompanied by significant skin peeling (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 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 increased during treatment with Lenalidomide Sandoz. Therefore, before prescribing this medication, 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 hands or feet, 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 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 physical discomfort, malaise;
• Painful inflammation of the mouth, dry mouth;
• Dehydration. Commonside effects (may affect less than 1 in 10 people)
• Breakdown of red blood cells (hemolytic anemia);
• Certain types of skin tumors;
• Bleeding from the gums, stomach, or intestines;
• Increased blood pressure, slow, fast, or irregular heartbeat;
• Increased levels of a substance produced by the breakdown of 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; skin swelling filled with blood, bruising;
• Increased uric acid levels in the blood;
• Skin rashes, redness of the skin, peeling, cracking, or flaking of the skin, hives;
• Excessive sweating, night sweats;
• Difficulty swallowing, sore throat, voice problems, or changes in voice;
• Rhinitis (runny nose);
• Urinating much more or much less than usual, or loss of control over urination;
• Blood in the urine;
• Shortness of breath, especially when lying down (which may be a sign of heart failure);
• Difficulty getting an erection;
• Stroke, fainting, dizziness (inner ear disorders that cause a feeling of spinning), 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 of bile flow from the liver;
• Low levels of phosphorus or magnesium in the blood;
• Difficulty speaking;
• Liver damage;
• Balance disorders, difficulty walking;
• Deafness, ringing in the ears (tinnitus);
• Nerve pain, unpleasant abnormal sensations, especially in response to touch;
• Excessive iron in the body;
• Thirst;
• Confusion;
• Toothache;
• Falling, which can lead to injury

Uncommonside effects (may affect less than 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 - metabolic complications 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 leading to the lungs (pulmonary hypertension).

Rareside effects (may affect less than 1 in 1,000 people)

• Sudden or mild but worsening abdominal pain and/or back pain that persists 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 (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 administered with a statin (a cholesterol-lowering medication)
• A skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis)
• Breakdown of the stomach or intestine wall, which can lead to a very serious 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 (a viral disease that causes a painful skin 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, etc.).

Not Knownfrequency of side effects (frequency cannot be estimated from available data)

• Other side effects not listed above

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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 medication.

5. How to Store Lenalidomide Sandoz

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

6. Contents of the Package and Other Information

What Lenalidomide Sandoz Contains

• The active substance is lenalidomide. One capsule contains 15 mg of lenalidomide.
• Other ingredients are lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate. Capsule Shell:gelatin, titanium dioxide (E171), indigo carmine, lake (E 132) Printing Ink: shellac, propylene glycol, potassium hydroxide, iron oxide black (E 172).

What Lenalidomide Sandoz Looks Like and Contents of the Package

The capsule has a matte white body and a matte blue to light blue cap, approximately 21.7 mm in length, with the inscription "L9NL" and "15". The hard capsules are packaged in blisters of OPA/Aluminum/PVC/Aluminum foil. Package 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 on the Medication and Its Names in the Member States of 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 Package Leaflet:06/2023 Sandoz Logo