Product Information for the User

Lenalidomida Grindeks 2.5 mg Hard Capsules EFG

Lenalidomida Grindeks 5 mg Hard Capsules EFG

Lenalidomida Grindeks 7.5 mg Hard Capsules EFG

Lenalidomida Grindeks 10 mg Hard Capsules EFG

Lenalidomida Grindeks 15 mg Hard Capsules EFG

Lenalidomida Grindeks 20 mg Hard Capsules EFG

Lenalidomida Grindeks 25 mg Hard Capsules EFG

Lenalidomida

Read this entire leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Lenalidomida Grindeks is and what it is used for

2. What you need to know before taking Lenalidomida Grindeks

3. How to take Lenalidomida Grindeks

4. Possible side effects

5. Storage of Lenalidomida Grindeks

6. Contents of the pack and additional information

What isLenalidomida Grindeks

This medication contains the active ingredient “lenalidomida”. This medication belongs to a group of medications that affect how the immune system works.

What is Lenalidomida Grindeks used forLenalidomida Grindeks

Lenalidomida is used in adults for:

• Multiple myeloma
• Follicular lymphoma

Multiple myeloma

Multiple myeloma is a type of cancer that affects a specific type of white blood cells in the blood, called plasma cells. These cells accumulate in the bone marrow and multiply, becoming uncontrolled. This can damage bones and kidneys.

Multiple myeloma is generally incurable. However, the symptoms and signs can be greatly reduced or disappear for a period of time. This is called “remission”.

Multiple myeloma: new diagnosis; in patients who have undergone a bone marrow transplantLenalidomida is used as maintenance treatment after recovering adequately from a bone marrow transplant.

Multiple myeloma: new diagnosis; in patients who cannot be treated with a bone marrow transplant

Lenalidomida Grindeks is taken with other medications, including:

• A chemotherapy medication called “bortezomib”;
• An anti-inflammatory medication called “dexametasona”;
• A chemotherapy medication called “melfalán”; and
• An immunosuppressant medication called “prednisona”.

You will take these medications when starting treatment and then continue taking Lenalidomida Grindeks alone.

If you are 75 years or older or have moderate to severe kidney problems, your doctor will closely monitor you before starting treatment.

Multiple myeloma: in previously treated patients

Lenalidomida is taken with an anti-inflammatory medication called “dexametasona”.

Lenalidomida can slow the progression of multiple myeloma symptoms. It has also been shown to delay the recurrence of multiple myeloma after treatment.

Follicular lymphoma (FL)

FL is a slow-growing cancer that affects lymphocytes B. These are a type of white blood cell that helps the body fight infections. When a person has FL, they may store too many of these lymphocytes B in the blood, bone marrow, lymph nodes, and spleen.

Lenalidomida Grindeks is used with another medication called “rituximab” in the treatment of adult patients who have received previous treatment for follicular lymphoma.

How Lenalidomida Grindeks works

Lenalidomida works by affecting the body's immune system and directly attacking cancer. It acts in several ways:

• It stops the development of cancer cells;
• It stops the growth of blood vessels in the cancer;
• It stimulates part of the immune system to attack cancer cells.

You must read the leaflet for all the medicines you are going to take in combination with Lenalidomida before starting treatment with this medicine.

Do not take Lenalidomida Grindeks:

• if you are pregnant, think you may be pregnant or intend to become pregnant, as it is expected to be harmful to the fetus (see section 2, “Pregnancy, lactation and contraception: information for women and men”);
• if you can become pregnant, unless you follow all the necessary measures to avoid it (see section 2, “Pregnancy, lactation and contraception: information for women and men”). If you can become pregnant, your doctor will note with each prescription that all necessary measures have been taken and will provide you with this confirmation;
• if you are allergic to lenalidomida or to any of the other components of this medicine (including in section 6). If you think you may be allergic, consult your doctor.

If any of these conditions apply to you, do not take this medicine. In case of doubt, consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Lenalidomidaif:

• you have ever had blood clots; during treatment, you have a higher risk of presenting blood clots in veins and arteries;
• you have any sign of infection, such as cough or fever;
• you have or have had previously a viral infection, especially hepatitis B infection, varicella zoster or HIV. In case of doubt, consult your doctor. Treatment with lenalidomida may make the virus become active again in patients who are carriers of the virus. This leads to the reappearance of the infection. Your doctor must check if you have ever had a hepatitis B infection;
• you have kidney problems; your doctor may adjust your Lenalidomida Grindeks dose;
• you have had a heart attack, have ever had a blood clot, or if you smoke, have high blood pressure or high cholesterol levels;
• you have had an allergic reaction while using thalidomide (another medicine used to treat multiple myeloma), such as skin rash, itching, swelling, dizziness or respiratory problems;
• you have experienced in the past a combination of any of the following symptoms: generalised rash, skin redness, high body temperature, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes (these are signs of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome) (see also section 4 “Possible side effects”).

If any of the above alterations apply to you, inform your doctor, pharmacist or nurse before starting treatment.

At any time, during or after treatment, inform your doctor or nurse immediately if you experience:

• blurred vision, loss of vision or double vision, difficulty speaking, weakness in one arm or leg, a change in the way you walk or balance problems, persistent numbness, decreased sensitivity or loss of sensitivity, memory loss or confusion. All of them may be symptoms of a serious and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML). If you have any of these symptoms before starting treatment with lenalidomida, inform your doctor if you notice any change in these symptoms.
• shortness of breath, fatigue, dizziness, chest pain, faster heart rate or swelling in the legs or ankles. These may be symptoms of a serious condition called pulmonary hypertension (see section 4).

Analysis and tests

Before starting treatment with Lenalidomida and during the same, blood tests will be done regularly. This is because Lenalidomida may cause a decrease in the blood cells that help fight infections (white blood cells) and those that participate in coagulation (platelets).

Your doctor will ask you to have a blood test:

• before treatment;
• every week, during the first 8 weeks of treatment;
• later, at least every month.

You may be evaluated to detect signs of cardiopulmonary problems before and during treatment with lenalidomida.

For patients with MM who take Lenalidomida Grindeks

Your doctor will ask you to have a blood test:

•before treatment;

•every week during the first 3weeks (a cycle) of treatment;

•later, every 2 weeks in cycles2-4 (see section3 for more information);

•after that, at the start of each cycle; and

•at least every month.

Your doctor may check if you have a high total tumor burden in the body, including the bone marrow. This could lead to a disease in which the tumors break down and produce unusual levels of chemical substances in the blood that, in turn, may cause kidney failure (this disease is called “tumor lysis syndrome”).

Your doctor may examine you to check if any changes have occurred in your skin, such as red spots or skin rashes.

Your doctor may adjust the dose of Lenalidomida or interrupt your treatment, depending on the results of your blood tests and your overall condition. If you are a newly diagnosed patient, your doctor may also evaluate your treatment based on your age and any other conditions you already have.

Blood donation

You should not donate blood during treatment or for at least 7 days after the end of treatment.

Children and adolescents

Lenalidomida is not recommended for use in children and adolescents under 18 years old.

Older people and people with kidney problems

If you are 75 years old or more or have moderate to severe kidney problems, your doctor will examine you carefully before starting treatment.

Other medicines and Lenalidomida Grindeks

Inform your doctor or nurse if you are taking, have taken recently or may need to take any other medicine. This is because Lenalidomida Grindeks may affect the way other medicines work. In addition, some medicines may affect the way Lenalidomida works.

Specifically, inform your doctor or nurse if you are taking any of the following medicines:

• some medicines used to prevent pregnancy, such as oral contraceptives, as they may stop working;
• some medicines used for heart problems, such as digoxin;
• some medicines used to thin the blood, such as warfarin.

Pregnancy, lactation and contraception: information for women and men Pregnancy

Women taking Lenalidomida Grindeks

• You should not take Lenalidomida if you are pregnant, as it is expected to be harmful to the fetus.
• You should not become pregnant while taking Lenalidomida. Therefore, you must use effective contraceptive methods if there is a possibility that you may become pregnant (see “Contraception”).
• If you become pregnant during treatment with Lenalidomida, you must stop treatment and inform your doctor immediately.

Men taking Lenalidomida Grindeks

• If your partner becomes pregnant while you are taking Lenalidomida, you must inform your doctor immediately. It is recommended that your partner seek medical advice.
• You should also use effective contraceptive methods (see “Contraception”).

Lactation

You should not breastfeed while taking Lenalidomida, as it is unknown whether Lenalidomida passes into breast milk.

Contraception

For women taking Lenalidomida Grindeks

Before starting treatment, ask your doctor if you are capable of becoming pregnant, although you may think this is unlikely.

If you can become pregnant:

• you will have pregnancy tests under medical supervision (before each treatment, at least every 4 weeks during treatment and for at least 4 weeks after treatment ends) except that tubal ligation has been confirmed so that the eggs do not reach the uterus;

And

• you must use effective contraceptive methods from at least 4 weeks before starting treatment, during treatment and for at least 4 weeks after treatment ends. Your doctor will advise you on the most suitable contraceptive methods.

For men taking Lenalidomida Grindeks

Lenalidomida passes into human semen. If your partner becomes pregnant or may become pregnant and does not use any effective contraceptive method, you must use condoms during treatment and for at least 7 days after treatment ends, even if you have undergone a vasectomy.

Driving and operating machines

You should not drive or operate machines if you feel dizzy, tired, drowsy, have vertigo or blurred vision after taking Lenalidomida Grindeks.

Lenalidomida Grindeks contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Lenalidomida Grindeks contains sodium

This medicine contains less than 23mg of sodium (1mmol) per capsule; this is, essentially “sodium-free”.

Lenalidomide should be administered by a healthcare professional with experience in the treatment of multiple myeloma or lymphoma follicular.

• When Lenalidomide is used for the treatment of multiple myeloma in patients who cannot be treated with a bone marrow transplant or have been treated with other treatments before, it is taken with other medications (see section 1 “What Lenalidomide Grindeks is used for”).
• When Lenalidomide is used for the treatment of multiple myeloma in patients who have received a bone marrow transplant, it is taken alone.
• When Lenalidomide is used for the treatment of lymphoma follicular, it is taken with another medication called “rituximab”.

Follow exactly the administration instructions of Lenalidomide indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

If you are taking Lenalidomide with other medications, you should consult the leaflet of those other medications to obtain additional information on their use and effects.

Treatment cycle

Lenalidomide is taken on certain days during the period of 3 weeks (21 days).

• A “treatment cycle” consists of 21 days.
• Depending on the day of the cycle, you will take one or more medications. However, some days you will not take any medication.
• After completing each cycle of 21 days, you must start a new “cycle” during the following 21 days.

Or

Lenalidomide is taken on certain days during the period of 4 weeks (28 days).

• A “treatment cycle” consists of 28 days.
• Depending on the day of the cycle, you will take one or more medications. However, some days you will not take any medication.
• After completing each cycle of 28 days, you must start a new “cycle” during the following 28 days.

How much Lenalidomide Grindeks to take

Before starting treatment, your doctor will indicate:

• what amount of Lenalidomide you should take;
• what amount of the other medications you should take with Lenalidomide, if applicable;
• what days of the treatment cycle you should take each medication.

How and when to take Lenalidomide Grindeks

• Swallow the capsules whole, preferably with water.
• Do not break, open, or chew the capsules. In the event that the powder from a broken Lenalidomide capsule comes into contact with the skin, wash the skin immediately and carefully with water and soap.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Subsequently, they should carefully remove the gloves to avoid skin exposure, place them in a plastic polyethylene bag, and dispose of them in accordance with local requirements. They should then wash their hands thoroughly with water and soap. Pregnant women or women who may be pregnant should not handle the blister pack or capsule.
• The capsules can be taken with or without food.
• You should take Lenalidomide approximately at the same time on the scheduled days.

Administration of this medication

To remove the capsule from the blister pack:

• Press only one end of the capsule to allow it to come out through the foil.
• Do not press in the center of the capsule as it may break.

Duration of treatment with Lenalidomide Grindeks

Lenalidomide is taken in treatment cycles, each cycle lasting 21 or 28 days (see “Treatment cycle” above). You should continue the treatment cycles until your doctor informs you to stop treatment.

If you take more Lenalidomide Grindeks than you should

If you take more Lenalidomide than prescribed, inform your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Lenalidomide Grindeks

If you forget to take Lenalidomide at your usual time and

• less than 12 hours have passed: take the capsule immediately;
• more than 12 hours have passed: do not take the capsule. Take the next capsule at the usual time the next day.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following severe side effects, stop taking Lenalidomida Grindeks and seek immediate medical attention because you may require emergency medical treatment:

• Hives, rashes, swelling of the eyes, mouth, or face, difficulty breathing or itching, which may be symptoms of severe types of allergic reactions calledangioedemaandanaphylactic reaction.
• A severe allergic reaction that can start as a rash in one area, but spreads with significant skin loss throughout the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Generalized rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and effects on other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known as "DRESS" or "drug-induced hypersensitivity syndrome"). See also section2.

Seek immediate medical attention if you notice any of the following severe side effects:

• Fever, chills, sore throat, cough, mouth ulcers, or any other symptom of infection, including sepsis.
• Bleeding (hemorrhage) or hematoma (bruise) not due to injury.
• Chest pain (thoracic) or leg pain.
• Difficulty breathing.
• Bone pain, muscle weakness, confusion, or fatigue, which may be due to elevated calcium levels in the blood.

Lenalidomida Grindeks may reduce the number of white blood cells that fight infections and also the blood cells that help blood clotting (platelets), which can cause bleeding disorders, such as nosebleeds and petechiae. Lenalidomida Grindeks may also cause blood clots in the veins (thrombosis).

Other side effects

It is essential to note that a reduced number of patients may develop other types of cancer, and this risk may increase with lenalidomide treatment. Therefore, your doctor must carefully evaluate the benefits and risks of prescribing lenalidomide to you.

Side effectsvery common(may affect more than 1 in 10 people):

• A decrease in the number of red blood cells, which can cause anemia leading to fatigue and weakness.
• Rashes, itching
• Muscle cramps, muscle weakness, muscle pain, muscle soreness, bone pain, joint pain, back pain, limb pain
• Generalized swelling, including swelling of the arms and legs
• Weakness, fatigue
• Fever and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough, and chills
• Numbness, tingling, or burning sensation in the skin, hand or foot pain, dizziness, tremors
• Decreased appetite, changes in the taste of things.
• Increased pain, tumor size, or redness around the tumor
• Weight loss
• Constipation, diarrhea, nausea, vomiting, stomach pain, heartburn
• Low levels of potassium, calcium, or sodium in the blood.
• Low thyroid function.
• Leg pain (which may be a symptom of thrombosis), chest pain, or difficulty breathing (which may be a symptom of pulmonary embolism).
• All types of infections, including sinusitis, pneumonia, and upper respiratory tract infections.
• Difficulty breathing.
• Blurred vision.
• Cataracts.
• Kidney problems, including insufficient kidney function or kidneys that cannot maintain normal function.
• Abnormal liver test results.
• High levels in liver test results.
• Changes in a blood protein that can cause swelling of the arteries (vasculitis).
• Increased blood sugar levels (diabetes).
• Decreased blood sugar levels.
• Headache.
• Nosebleeds
• Dry skin.
• Changes in mood, difficulty sleeping.
• Cough
• Blood pressure drop.
• A vague feeling of bodily discomfort, feeling unwell.
• Inflamed, painful mouth, dry mouth.
• Dehydration.

Side effectscommon(may affect up to 1 in 10 people):

• Red blood cell destruction (hemolytic anemia).
• Determined types of skin tumors.
• Bleeding from the gums, stomach, or intestines.
• Increased or decreased blood pressure, slow, fast, or irregular heartbeat.
• Increased levels of a substance produced after normal or abnormal destruction of red blood cells.
• Increased levels of a type of protein indicating the presence of inflammation in the body.
• Darkening of the skin, skin discoloration due to internal bleeding and usually caused by petechiae, skin inflammation caused by blood accumulation, petechiae.
• Increased uric acid levels in the blood.
• Rashes, skin redness, skin cracking, peeling, or exfoliation.
• Increased sweating, nocturnal sweating.
• Difficulty swallowing, sore throat, difficulty maintaining voice quality or changes in voice.
• Cough.
• Significant increase or decrease in urine production or inability to control urination.
• Blood in the urine.
• Difficulty breathing, especially when lying down (which may be a symptom of heart failure).
• Difficulty achieving an erection.
• Stroke, fainting, vertigo (a disorder of the inner ear that causes the sensation of everything spinning), temporary loss of consciousness.
• Chest pain that spreads to the arms, neck, jaw, back, or stomach, sensation of sweating and shortness of breath, sensation of illness or vomiting, which may be symptoms of a heart attack (myocardial infarction).
• Muscle weakness, lack of energy.
• Cervical pain, chest pain.
• Chills.
• Joint swelling.
• Slower or blocked bile flow from the liver.
• Low levels of phosphate or magnesium in the blood.
• Liver damage.
• Balance problems, difficulty moving.
• Deafness.
• Tinnitus in the ears.
• Excess iron in the body.
• Thirst.
• Confusion.
• Toothache.
• Cuts that can cause injuries.

Side effectsuncommon(may affect up to 1 in 100 people):

• Brain hemorrhage.
• Circulatory problems.
• Loss of vision.
• Loss of libido (sex drive).
• Expulsion of large amounts of urine with bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome).
• Yellowing of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching, rash, stomach pain, or swelling (these symptoms may indicate liver damage [hepatic insufficiency]).
• Stomach pain, abdominal swelling, or diarrhea, which may be symptoms of inflammation of the large intestine (colitis or typhlitis).
• Damage to kidney cells (necrotizing renal tubulopathy).
• Changes in skin color, sensitivity to sunlight.
• Tumor lysis syndrome: complications may occur during cancer treatment, and sometimes even without treatment. These complications occur as a result of the breakdown products of tumor cells that die and may include the following: changes in blood biochemistry, high levels of potassium, phosphorus, and uric acid, and low levels of calcium, which, as a result, cause changes in kidney function and heart rhythm, crises, and sometimes death.
• Increased blood pressure within the blood vessels that supply the lungs (pulmonary hypertension).

Frequency not known(cannot be estimated from available data):

• Sudden, or mild pain that worsens in the upper stomach and/or back, lasting several days, possibly accompanied by nausea, vomiting, fever, and a rapid pulse. These symptoms may be due to pancreatitis.
• Whistling or ringing in the lungs, difficulty breathing, or dry cough, which may be symptoms caused by inflammation of the lung tissue.
• Rare cases of muscle degradation (pain, weakness, or swelling) that may lead to kidney problems (rhabdomyolysis), some of which occur when lenalidomide is administered with a statin (a type of medication to reduce cholesterol).
• A disease that affects the skin caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis).
• Perforation of the stomach or intestine wall. This can lead to a very serious infection. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel habits.
• Viruses, including herpes zoster (also known as shingles, a viral disease that causes painful skin rash with blisters) and the reactivation of hepatitis B infection (which can cause yellowing of the skin and eyes, dark urine, stomach pain on the right side, fever, and nausea or feeling unwell).
• Generalized rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and effects on other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug-induced hypersensitivity syndrome). Stop using lenalidomide if you develop these symptoms and contact your doctor or seek immediate medical attention. See also section 2.

• Rejection of solid organ transplants (such as kidney, heart).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and the box after “CAD”/“EXP”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Do not use this medication if you observe visible signs of deterioration or signs of improper handling.

Medications should not be disposed of through drains or in the trash. Return unused medication to your pharmacist. This will help protect the environment.

Composition of Lenalidomide Grindeks

Lenalidomide Grindeks2.5 mg hard capsules:

• The active substance is lenalidomide. Each capsule containsammonium chloride of lenalidomide, which is equivalent to 2.5mg of lenalidomide
• The other components are:

• Content of the capsules: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capsule coating: gelatin, titanium dioxide (E171), brilliant blue FCF - FD&C Blue1 E133 and iron oxide yellow (E172).
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), iron oxide black (E172) and concentrated ammonia solution (E527).

Lenalidomide Grindeks5 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains cloruro amónico de lenalidomida, which is equivalent to 5mg of lenalidomide
• The other components are:

• Content of the capsules: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capsule coating: gelatin and titanium dioxide (E171).
• Printing ink: shellac (E-904), propylene glycol (E1520), potassium hydroxide (E525), iron oxide black (E172) and concentrated ammonia solution (E-527).

Lenalidomide Grindeks7.5 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains cloruro amónico de lenalidomida, which is equivalent to 7.5mg of lenalidomide.
• The other components are:

• Content of the capsules: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capsule coating: gelatin, titanium dioxide (E171) and iron oxide yellow (E172).
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), iron oxide black (E172) and concentrated ammonia solution (E527).

Lenalidomide Grindeks 10 mg hard capsules:

• The active substance is lenalidomide. Each capsule containsammonium chloride of lenalidomide, which is equivalent to 10mg of lenalidomide.
• The other components are:

• Content of the capsules: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capsule coating: gelatin, titanium dioxide (E171),brilliant blue FCF - FD&C Blue1 E133,and iron oxide yellow (E172).
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), iron oxide black (E172)and concentrated ammonia solution (E527).

Lenalidomide Grindeks 15 mg hard capsules:

• The active substance is lenalidomide. Each capsule containsammonium chloride of lenalidomide, which is equivalent to 15mg of lenalidomide.
• The other components are:

• Content of the capsules: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capsule coating: gelatin, titanium dioxide (E171) andbrilliant blue FCF - FD&C Blue1 E133.
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), iron oxide black (E172) and concentrated ammonia solution (E527).

Lenalidomide Grindeks 20 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains cloruro amónico de lenalidomida, which is equivalent to 20mg of lenalidomide.
• The other components are:

• Content of the capsules: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capsule coating: gelatin, titanium dioxide (E171), brilliant blue FCF - FD&C Blue1 E133and iron oxide yellow (E172).
• Printing ink: shellac (E-904), propylene glycol (E1520), potassium hydroxide (E525), iron oxide black (E172)and concentrated ammonia solution (E527).

Lenalidomide Grindeks 25 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains cloruro amónico de lenalidomida, which is equivalent to 25mg of lenalidomide.
• The other components are:

• Content of the capsules: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capsule coating: gelatin and titanium dioxide (E171).
• Printing ink: shellac (E-904), propylene glycol (E1520), potassium hydroxide (E-525), iron oxide black (E172) and concentrated ammonia solution (E-527).

Appearance of the product and contents of the pack

The hard capsules of Lenalidomide Grindeks 2.5 mg arecapsules of size 4, of greenish-white color, with the inscription«L2,5».

The hard capsules of Lenalidomide Grindeks 5 mg are capsules of size 4, of white color, with the inscription «L5».

The hard capsules of Lenalidomide Grindeks 7.5 mg are capsules of size 3, of yellowish-white color, with the inscription «L7,5».

The hard capsules of Lenalidomide Grindeks 10 mg are capsules of size 2, of greenish-yellowish color, with the inscription «L10».

The hard capsules of Lenalidomide Grindeks 15 mg are capsules of size 1, of blue-white color, with the inscription «L15».

The hard capsules of Lenalidomide Grindeks 20 mg are capsules of size 0, of greenish-blue color, with the inscription «L20».

The hard capsules of Lenalidomide Grindeks 25 mg are capsules of size 0, of white color, with the inscription «L25».

The capsules are presented in packs of 7 or 21 capsules per pack.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for the manufacture

AS GRINDEKS.
Krustpils iela 53, Riga, LV-1057, Latvia
Phone: +371 67083205
Fax: +371 67083505
Email:grindeks@grindeks.lv

Further information on this medicinal product can be obtained bycontacting the representative of the marketing authorization holder in your country

Grindeks Kalceks España, S.L.

C/ José Abascal, 58 – 2º Dcha.

Madrid, 28003, Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Last update of the summary of product characteristics: 02/2022

Other sources of information

The detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)