Lenalidomide Grindeks contains the active substance “lenalidomide”. This medicine belongs to a group of medicines that can affect the way your immune system works.

What is Lenalidomide Grindeks used for?
Lenalidomide Grindeks is used in adults for:
• Multiple myeloma
• Myelodysplastic syndromes
• Mantle cell lymphoma
• Follicular lymphoma

Multiple myeloma:
Multiple myeloma is a type of cancer that affects a type of white blood cell called plasma cells. These cells collect in the bone marrow and multiply uncontrollably. This can damage the bones and kidneys.
Multiple myeloma cannot generally be cured. However, the signs and symptoms can be greatly reduced or disappear for a period of time. This is called a “response.”
Newly diagnosed multiple myeloma – in patients who have had a bone marrow transplant Lenalidomide Grindeks is used as maintenance therapy after patients have recovered sufficiently from a bone marrow transplant.
Newly diagnosed multiple myeloma – in patients who are not eligible for bone marrow transplantation Lenalidomide Grindeks is used together with other medicines. These may include:
• A chemotherapy medicine called “bortezomib”
• with an anti-inflammatory medicine called “dexamethasone”
• with a chemotherapy medicine called “melphalan”
• and an immunosuppressant drug called "prednisone".

You will take these other medicines at the start of treatment, and then continue to take Lenalidomide Grindeks alone.
If you are 75 years of age or older or have moderate to severe kidney problems - your doctor will check you carefully before starting treatment.
Multiple myeloma – in patients who have received prior treatment
Lenalidomide Grindeks is given in combination with an anti-inflammatory medicine called 'dexamethasone'. Lenalidomide Grindeks can stop the signs and symptoms of multiple myeloma getting worse. Lenalidomide has also been shown to delay the recurrence of multiple myeloma following treatment.

Myelodysplastic syndromes (MDS)
MDS is a group of several different blood and bone marrow disorders. Blood cells become abnormal and stop working properly. Patients may experience a variety of signs and symptoms, including low red blood cell counts (anemia), the need for a blood transfusion, and an increased risk of infection.

Lenalidomide Grindeks is used on its own in the treatment of adult patients who have been diagnosed with MDS, if all of the following conditions are met:
• you need regular blood transfusions to treat low red blood cell counts (“transfusion-dependent anemia”)
• you have an abnormality of the cells in your bone marrow called “isolated 5q deletion cytogenetic abnormality”. This means that your body does not produce enough healthy blood cells.
• other treatments have been used previously, are not appropriate or do not work well enough.
Lenalidomide Grindeks can increase the number of healthy red blood cells your body produces by decreasing the number of abnormal cells:
• this may reduce the number of transfusions needed. Transfusions may not be necessary at all.

Mantle cell lymphoma (MCL)
MCL is a cancer of a component of the immune system (lymph tissue), affecting a type of white blood cell called “B lymphocytes” or B cells. MCL is a disease in which B lymphocytes grow uncontrollably and accumulate in the lymph tissue, bone marrow or blood.
Lenalidomide Grindeks is used on its own for the treatment of adult patients who have received
previously other medications.

Follicular lymphoma (FL)
LF is a slow-growing cancer that affects B lymphocytes. These are a type of white blood cell that helps your body fight infection. When you have LF, too many of these B lymphocytes can build up in your blood, bone marrow, lymph nodes, and spleen.
Lenalidomide Grindeks is taken together with another medicine called 'rituximab' for the treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide Grindeks works:
Lenalidomide Grindeks works by affecting your body's immune system and directly attacking the cancer. It works in a few different ways:
• stops the development of cancer cells
• stops the growth of blood vessels in cancer-affected tissue
• stimulates part of the immune system to attack cancer cells.

Do not take Lenalidomide Grindeks
• if you are pregnant, think you may be pregnant or are planning to become pregnant, as Lenalidomide Grindeks is expected to have harmful effects on the unborn baby (see section 2, “Pregnancy, breast-feeding and contraception – information for men and women”).
• if you could become pregnant, unless you take all necessary precautions to avoid becoming pregnant (see section 2, “Warnings and precautions” and “Pregnancy, breast-feeding and contraception”).
– information for men and women”). If it is possible for you to become pregnant, with each prescription of the medicine, your doctor will record that the necessary measures have been taken and will give you this confirmation.
• if you are allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, talk to your doctor for advice.
recommendations.
If any of these apply to you, do not take Lenalidomide Grindeks.
Ask your doctor if you are not sure.

Lenalidomide Grindeks must be given to you by healthcare professionals.

Lenalidomide Grindeks 10 mg capsules:
• The active substance is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to lenalidomide 10 mg.
• The other components are:
o The capsule contains: lactose (see section 2), microcrystalline cellulose, croscarmellose sodium and magnesium stearate;
o The other ingredients are: Capsule shell: gelatin, titanium dioxide (E171), brilliant blue FCF – FD&C Blue 1 (E133) and yellow iron oxide (E172)
o Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) and concentrated ammonia solution (E527).

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

10 capsules