Lenalidomide Sandoz

Package Leaflet: Information for the Patient

Lenalidomide Sandoz, 20 mg, Hard Capsules

Lenalidomide

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication 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 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 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 removal of 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 drug called "bortezomib"
• an anti-inflammatory drug called "dexamethasone"
• a chemotherapy drug called "melphalan" and
• an immunosuppressive drug 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 of age 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 drug 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 disorders. Abnormal blood cells are present 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 a low number of red blood cells and requires regular blood transfusions ("transfusion-dependent anemia")
• the patient has a cytogenetic abnormality in the 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 received 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 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 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 alone to treat adult patients who have previously received 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 drug called "rituximab" to treat adult patients with previously treated follicular lymphoma.

How Lenalidomide Sandoz Works

The drug 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 Medicines Taken in Combination with Lenalidomide Sandoz.

When Not to Take Lenalidomide Sandoz

• if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, as Lenalidomide Sandoz may harm the fetus (see "Pregnancy, Breastfeeding, and Contraception - Information for Women and Men" in section 2)
• if the patient is of childbearing age, unless she follows all necessary measures to prevent pregnancy (see "Pregnancy, Breastfeeding, and Contraception - Information for Women and Men" in section 2). If the patient is a woman of childbearing age, the doctor will check at each control visit that the necessary measures have been taken and will provide the patient with confirmation.
• if the patient is allergic to lenalidomide or any of the excipients of this medicine (listed in section 6). If the patient suspects she may be allergic, she should consult a doctor.

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

Warnings and Precautions

Before taking Lenalidomide Sandoz, discuss with your doctor, pharmacist, or nurse if:

• the patient has had blood clots in the past, as there is an increased risk of blood clots in veins and arteries
• the patient has any symptoms of infection, such as cough or fever
• the patient has or has 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.
• the patient has kidney function impairment - the doctor may adjust the dose of Lenalidomide Sandoz
• the patient has had a heart attack, has had a blood clot, smokes, has high blood pressure, or high cholesterol levels
• the patient has had an allergic reaction to thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing
• the patient has 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 enzymes, 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
• 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 risk 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 respiratory 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 where the tumor tissue breaks down, causing abnormal increases in various chemical substances in the blood and potentially leading to kidney failure (a condition 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 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 Renal Impairment

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 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:

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

Information for Men Taking Lenalidomide Sandoz

• If your partner becomes pregnant, you must inform your doctor immediately. It is recommended that your partner consult a doctor.
• You must also use effective contraception (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 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 has confirmed that you have been sterilized by tubal ligation and
• you must use effective contraception 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 contraceptive methods.

Information for Men Taking Lenalidomide Sandoz Lenalidomide Sandoz is present in human semen. If your partner is pregnant or may become pregnant, and she 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, you should 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 a healthcare professional with experience 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 medicine 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 medicine is taken alone (as monotherapy).
• If Lenalidomide Sandoz is used to treat follicular lymphoma, it is taken with another medicine called "rituximab".

This medicine should always be taken exactly as prescribed by your doctor. 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 these medicines to obtain information on 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 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. Remove the gloves carefully to avoid skin exposure, place them in a sealed plastic bag, and dispose of them 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 the Medicine

To remove a capsule from the blister:

• press the capsule only from 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 the doctor recommends stopping 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 forget to take 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 on the use of this medicine, ask 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), 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, feeling of confusion, or fatigue that may be due to high levels of calcium 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 can lead to bleeding disorders, such as nosebleeds and bruising. Lenalidomide Sandoz may also cause blood clots in the 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 this is increased 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 can 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
• intensification of pain, increase in 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
• 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, usually caused by bruising
• increased levels of uric acid 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 changes
• runny nose (rhinitis)
• passing much more or much less urine than normal, or inability to control the timing of 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, 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 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
• feeling of confusion
• toothache
• fall that may cause injury

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

• bleeding in the brain
• circulatory 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 inflammation of the large intestine (colitis)
• 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, heart rhythm disturbances, seizures, and sometimes death
• high blood pressure in the blood vessels that lead to 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 that 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 inflammation of the lung tissue
• breakdown of muscle tissue (muscle pain, weakness, or swelling) that 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 shingles (a viral disease that causes a painful rash with blisters) and reactivation of hepatitis B virus (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, please inform 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

Keep this 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 precautions. Do not use this 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 Package and Other Information

What Lenalidomide Sandoz Contains

• The active substance is lenalidomide. Each capsule contains 20 mg of lenalidomide.
• The other ingredients are lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate. Capsule 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 Package

The capsule has a matte blue to light blue body and a matte green to light green cap, approximately 21.7 mm in length, with the marking "L9NL" and "20". The hard capsules are packaged in OPA/Aluminum/PVC/Aluminum blisters. Package 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 More Information on This Medicine and Its Authorized Names in the European Economic Area Member States, 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 Sandoz Logo