Lenalidomide Grindeks 5 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: 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

lenalidomide

Read the 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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. How to store Lenalidomida Grindeks
6. Contents of the pack and other information

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

What Lenalidomide Grindeks is

This medicine contains the active substance "lenalidomide". This medicine belongs to a group of medicines that affect how the immune system works.

What Lenalidomide Grindeks is used for

Lenalidomide is used in adults for:

• Multiple myeloma
• Myelodysplastic syndromes
• 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 uncontrollably. This can damage bones and kidneys.

Multiple myeloma is generally not curable. However, signs and symptoms can be greatly reduced or may disappear for a period of time. This is called "remission".

Newly diagnosed myeloma: in patients who have undergone a bone marrow transplant, lenalidomide is used as maintenance treatment after adequately recovering from the bone marrow transplant.

Newly diagnosed multiple myeloma: in patients who cannot be treated with a bone marrow transplant

Lenalidomide Grindeks is taken with other medicines, including:

• a chemotherapy medicine called "bortezomib";
• an anti-inflammatory medicine called "dexamethasone";
• a chemotherapy medicine called "melphalan"; and
• an immunosuppressant called "prednisone".

You will take these medicines at the beginning of treatment and then continue taking Lenalidomide Grindeks alone.

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

Multiple myeloma: in previously treated patients

Lenalidomide is taken together with an anti-inflammatory medicine called "dexamethasone".

Lenalidomide may slow down the worsening of signs and symptoms of multiple myeloma. It has also been shown to delay the return of multiple myeloma after treatment.

Myelodysplastic syndromes (MDS)

MDS are a group of very varied diseases affecting the blood and bone marrow. Blood cells become abnormal and do not function properly. Patients may experience a range of signs and symptoms, including low red blood cell counts (anemia), the need for blood transfusions, and risk of infection.

Lenalidomide Grindeks is used as monotherapy to treat adult patients diagnosed with MDS when all of the following conditions are met:

• They require periodic blood transfusions to treat low red blood cell counts ("transfusion-dependent anemia").
• Bone marrow cells are abnormal, known as "cytogenetic abnormality with isolated deletion of chromosome 5q arm". This means the body does not produce enough healthy blood cells.
• Previous treatments have been used, are not suitable, or have not worked sufficiently.

Lenalidomide Grindeks can increase the number of healthy red blood cells the body produces by reducing the number of abnormal cells:

• This may reduce the number of blood transfusions needed. Blood transfusions may no longer be required.

Follicular lymphoma (FL)

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

Lenalidomide Grindeks is used in combination with another medicine called "rituximab" for the treatment of adult patients who have received prior therapy for follicular lymphoma.

How Lenalidomida Grindeks works

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

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

2. What you need to know before starting to take Lenalidomida Grindeks

You must read the package leaflet of all medicines you are going to take in combination with Lenalidomide 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 Lenalidomide is expected to be harmful to the fetus (see section 2, "Pregnancy, breastfeeding and contraception: information for women and men");
• if you are capable of becoming pregnant, unless you follow all necessary measures to prevent it (see section 2, "Pregnancy, breastfeeding and contraception: information for women and men"). If you are capable of becoming pregnant, your doctor will document with each prescription that all necessary precautions have been taken and will provide you with this confirmation;
• if you are allergic to lenalidomide or to any of the other ingredients of this medicine (listed 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. If in doubt, consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting Lenalidomide if:

• you have ever had blood clots; during treatment, you have an increased risk of developing blood clots in veins and arteries;
• you have any signs of infection, such as cough or fever;
• you have or have previously had a viral infection, especially hepatitis B, varicella zoster, or HIV. If in doubt, consult your doctor. Treatment with lenalidomide may reactivate the virus in patients who carry it, leading to a recurrence of the infection. Your doctor should check whether you have ever had hepatitis B infection;
• you have kidney problems; your doctor may adjust your dose of Lenalidomida Grindeks;
• 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 taking thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or breathing difficulties;
• you have previously experienced a combination of any of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes (these are signs of a serious 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 conditions 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, double vision, difficulty speaking, weakness in one arm or leg, change in walking pattern or balance problems, persistent numbness, reduced sensation, or loss of sensation, memory loss, or confusion. These may be symptoms of a serious and potentially life-threatening brain disorder known as progressive multifocal leukoencephalopathy (PML). If you have any of these symptoms before starting lenalidomide treatment, inform your doctor if you notice any change in these symptoms.
• Shortness of breath, fatigue, dizziness, chest pain, faster heartbeat, or swelling in the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Blood tests and monitoring

Before starting and during treatment with Lenalidomide, you will have regular blood tests. This is because Lenalidomide may cause a decrease in blood cells that help fight infections (white blood cells) and those involved in blood clotting (platelets).

Your doctor will request that you have blood tests:

• before starting treatment;
• every week during the first 8 weeks of treatment;
• thereafter, at least once a month.

You may be evaluated for signs of cardiopulmonary problems before and during lenalidomide treatment.

Patients with MDS taking Lenalidomida Grindeks

If you have MDS, you may have an increased risk of developing an advanced disease called acute myeloid leukemia (AML). In addition, it is not known how Lenalidomida Grindeks affects the likelihood of developing AML. Therefore, your doctor may perform tests to check for signs that could better predict your risk of developing AML during treatment with Lenalidomida Grindeks.

For patients with FL taking Lenalidomida Grindeks

Your doctor will request that you have blood tests:

• before treatment;
• every week during the first 3 weeks (one cycle) of treatment;
• thereafter, every two weeks during Cycles 2–4 (see section 3 for more information);
• after this, at the beginning of each cycle; and
• at least once a month.

Your doctor may assess whether you have a high overall tumor burden in the body, including in the bone marrow. This could lead to a condition in which tumors break down and release unusual levels of chemicals into the blood, which in turn may cause kidney failure (this condition is called “tumor lysis syndrome”).

Your doctor may examine your skin for any changes, such as red spots or rashes.

Your doctor may adjust the dose of Lenalidomide or interrupt your treatment, depending on the results of your blood tests and your general condition. If you are a newly diagnosed patient, your doctor may also consider your age and any other existing medical conditions when evaluating your treatment.

Blood donation

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

Children and adolescents

The use of Lenalidomide is not recommended in children and adolescents under 18 years of age.

Elderly patients and patients with renal problems

If you are 75 years of age or older, or have moderate to severe renal problems, your doctor will carefully evaluate you before starting treatment.

Other medicines and Lenalidomida Grindeks

Tell your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines. This is because Lenalidomida Grindeks may affect how other medicines work. In addition, some medicines may affect how 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, breastfeeding and contraception: information for women and men Pregnancy

Women taking Lenalidomida Grindeks

• You must not take Lenalidomida if you are pregnant, as it is expected to be harmful to the fetus.
• You must not become pregnant while taking Lenalidomida. Therefore, you must use effective contraceptive methods if there is any possibility that you could 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 advisable that your partner seeks medical advice.
• You must also use effective contraceptive methods (see “Contraception”).

Breast-feeding

You must not breast-feed while taking Lenalidomide, as it is unknown whether Lenalidomide passes into breast milk.

Contraception

For women taking Lenalidomida Grindeks

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

If you are capable of becoming pregnant:

• you will undergo physician-supervised pregnancy testing (before each treatment cycle, at least every 4 weeks during treatment, and for at least 4 weeks after completion of treatment), unless surgical sterilization has been confirmed by tubal ligation to prevent ova from reaching the uterus;

And

• you must use effective contraceptive methods starting at least 4 weeks before beginning treatment, throughout treatment, and for at least 4 weeks after stopping treatment. Your doctor will advise you on the most appropriate contraceptive methods.

For men taking Lenalidomida Grindeks

Lenalidomide is present in human semen. If your partner is pregnant or could become pregnant and is not using an effective contraceptive method, you must use condoms during treatment and for at least 7 days after stopping treatment, even if you have had a vasectomy. You must not donate semen or sperm during treatment or for at least 7 days after stopping treatment.

Driving and using machines

Do not drive or operate machinery if you feel dizzy, tired, drowsy, have vertigo, or blurred vision after taking Lenalidomide Grindeks.

Lenalidomida Grindeks contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with your doctor before taking this medicine.

Lenalidomida Grindeks contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; i.e., essentially "sodium-free".

3. How to take Lenalidomide Grindeks

Lenalidomide must be prescribed and managed by a healthcare professional experienced in the treatment of multiple myeloma, MDS, or FL.

• When lenalidomide is used for the treatment of multiple myeloma in patients who cannot undergo a bone marrow transplant or who have received prior treatments, it is taken in combination with other medicines (see section 1 “What Lenalidomide Grindeks is used for”).
• When lenalidomide is used for the treatment of multiple myeloma in patients who have undergone a bone marrow transplant or patients with MDS, it is taken alone.
• When lenalidomide is used for the treatment of follicular lymphoma, it is taken together with another medicine called “rituximab”.

Always follow exactly the dosing instructions for Lenalidomide provided by your doctor. If you have any doubts, consult your doctor or pharmacist again.

If you are taking lenalidomide together with other medicines, you should read the package leaflet of those other medicines for additional information about their use and possible effects.

Treatment cycle

Lenalidomide is taken on specific days during a 3-week period (21 days).

• A "treatment cycle" consists of 21 days.
• Depending on the day of the cycle, you will take one or more medicines. However, on some days you will not take any medicine.
• After completing each 21-day cycle, you must start a new "cycle" for the next 21 days.

Or

Lenalidomide is taken on specific days during a 4-week period (28 days).

• A "treatment cycle" consists of 28 days.
• Depending on the day of the cycle, you will take one or more medicines. However, on some days you will not take any medicine.
• After completing each 28-day cycle, you must start a new "cycle" for the next 28 days.

How much Lenalidomide Grindeks to take

Before starting treatment, your doctor will tell you:

• how much lenalidomide you should take;
• how much of any other medicines you should take together with lenalidomide, if applicable;
• on which days of the treatment cycle you should take each medicine.

How and when to take Lenalidomide Grindeks

• Swallow the capsules whole, preferably with water.
• Do not break, open, or chew the capsules. If the powder from a broken lenalidomide capsule comes into contact with the skin, wash the skin immediately and thoroughly with water and soap.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Gloves should then be carefully removed to avoid skin exposure, placed into a sealable polyethylene plastic bag, and disposed of according to local requirements. Afterwards, hands should be thoroughly washed with water and soap. Pregnant women or women who may be pregnant must not handle the blister pack or capsule.
• The capsules may be taken with or without food.
• You should take lenalidomide at approximately the same time each day on the scheduled days.

How to take this medicine

To remove the capsule from the blister pack:

• Press only one end of the capsule so it comes 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 must continue the treatment cycles until your doctor tells you to stop the treatment.

If you take more Lenalidomida 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 Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Lenalidomida 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 the following day at your usual time.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you experience any of the following serious adverse effects, stop treatment with Lenalidomida Grindeks immediately and seek medical help right away, as you may require urgent medical treatment:

• Hives, rash, swelling of the eyes, mouth or face, difficulty breathing or itching, which may be symptoms of serious types of allergic reactions called angioedema and anaphylactic reaction.
• A severe allergic reaction that may start as a rash in one area but spreads with extensive skin loss throughout the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as «DRESS syndrome» or «drug-induced hypersensitivity syndrome»). See also section 2.

Contact your doctor immediately if you notice any of the following serious adverse effects:

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection including in the bloodstream (sepsis)
• Bleeding (haemorrhage) or bruising (haematoma) not due to injury
• Chest (thoracic) or leg pain
• Difficulty breathing
• Bone pain, muscle weakness, confusion or fatigue, which may be due to high levels of calcium in the blood.

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

Other adverse effects

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

Very common adverse effects (may affect more than 1 in 10 people):

• A decrease in the number of red blood cells, which may cause anaemia leading to tiredness and weakness.
• Rash, itching
• Muscle cramps, muscle weakness, muscle pain, muscle soreness, bone pain, joint pain, back pain, pain in the limbs
• Generalised swelling, including swelling of the arms and legs
• Weakness, fatigue
• Fever and flu-like symptoms, including fever, muscle pain, headache, earache, cough and chills
• Numbness, tingling or burning sensation in the skin, pain in the hands or feet, dizziness, tremor
• Decreased appetite, changes in taste
• Increased pain, size or redness around the tumour
• Weight loss
• Constipation, diarrhoea, nausea, vomiting, stomach pain, heartburn
• Low levels of potassium or calcium and/or sodium in the blood
• Underactive thyroid function
• Leg pain (which could be a symptom of thrombosis), chest pain or difficulty breathing (which could be a symptom of blood clots in the lungs, called pulmonary embolism)
• Infections of any kind, including sinus infection, lung infection and upper respiratory tract infection
• Difficulty breathing
• Blurred vision
• Clouding of the eye (cataracts)
• Kidney problems, including insufficient kidney function or kidneys unable to maintain normal function
• Abnormal liver function test results
• High values in liver function tests
• Changes in a blood protein that may cause swelling of the arteries (vasculitis)
• Increased blood sugar levels (diabetes)
• Decreased blood sugar levels
• Headache
• Nosebleeds
• Dry skin
• Mood changes, difficulty sleeping
• Cough
• Drop in blood pressure
• A vague feeling of general discomfort, feeling unwell
• Painful, inflamed mouth, dry mouth
• Dehydration

Common adverse effects (may affect up to 1 in 10 people):

• Destruction of red blood cells (haemolytic anaemia)
• Certain types of skin tumours
• Bleeding from the gums, stomach or intestines
• Increase or decrease in blood pressure, slow, fast or irregular heartbeat
• Increase in the amount of a substance produced following normal or abnormal breakdown of red blood cells
• Increase in a type of protein indicating inflammation in the body
• Darkening of the skin, skin discolouration due to internal bleeding (often seen as bruising), skin inflammation caused by blood accumulation, bruising
• Increased uric acid levels in the blood
• Skin rashes, redness of the skin, cracked skin, skin peeling or exfoliation, hives
• Increased sweating, night sweats
• Difficulty swallowing, sore throat, difficulty maintaining voice quality or changes in voice
• Runny nose
• Marked increase or decrease in urine output compared to normal or inability to control urination
• Blood in the urine
• Difficulty breathing, especially when lying down (which could be a symptom of heart failure)
• Difficulty achieving an erection
• Stroke, fainting, dizziness (a disorder of the inner ear causing a sensation of spinning), temporary loss of consciousness
• Chest pain spreading to the arms, neck, jaw, back or stomach, sweating, shortness of breath, feeling unwell or vomiting, which may be symptoms of a heart attack (myocardial infarction)
• Muscle weakness, lack of energy
• Neck pain, chest pain
• Chills
• Swelling of the joints
• Slowed or blocked bile flow from the liver
• Low levels of phosphate or magnesium in the blood
• Liver damage
• Loss of balance, movement difficulties
• Deafness
• Ringing in the ears (tinnitus)
• Excess iron in the body
• Thirst
• Confusion
• Toothache
• Falls that may cause injury

Uncommon adverse effects (may affect up to 1 in 100 people):

• Bleeding inside the skull
• Circulatory problems
• Loss of vision
• Loss of sexual desire (libido)
• Excretion of large amounts of urine with bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)
• Yellowish pigmentation of the skin, mucous membranes or eyes (jaundice), pale stools, dark-coloured urine, itchy skin, rash, stomach pain or swelling (these symptoms may indicate liver damage [liver failure])
• Stomach pain, abdominal swelling or diarrhoea, which may be symptoms of inflammation of the large intestine (called colitis or typhlitis)
• Damage to kidney cells (called renal tubular necrosis)
• Changes in skin colour, sensitivity to sunlight
• Tumour lysis syndrome: metabolic complications may occur during cancer treatment and sometimes even without treatment. These complications result from the breakdown products of dying tumour cells and may include: changes in blood biochemistry, high levels of potassium, phosphate and uric acid, and low calcium levels, which in turn may lead to changes in kidney function and heart rhythm, seizures and, occasionally, death
• Increased blood pressure in the blood vessels supplying the lungs (pulmonary hypertension)

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

• Sudden or mild pain in the upper abdomen and/or back that worsens over several days, possibly accompanied by nausea, vomiting, fever and a rapid pulse. These symptoms may be due to inflammation of the pancreas.

• Wheezing or whistling when breathing, difficulty breathing or dry cough, which may be symptoms caused by inflammation of the lung tissue.

• Rare cases of muscle breakdown (muscle pain, weakness or swelling) have been observed, which may lead to kidney problems (rhabdomyolysis), some of them occurring when lenalidomide is administered together with a statin (a type of medicine used to lower cholesterol).

• A skin condition caused by inflammation of small blood vessels, accompanied by joint pain and fever (leucocytoclastic vasculitis).

• Perforation of the stomach or intestinal wall. This may lead to a severe infection. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in the stools or changes in bowel habits.

• Viral infections, including herpes zoster (also known as “shingles”, a viral disease causing a painful skin rash with blisters) and reactivation of hepatitis B infection (which may cause yellowing of the skin and eyes, dark brown urine, stomach pain on the right side, fever and nausea or feeling unwell).

• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and effects on other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). Stop taking 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 of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lenalidomida Grindeks

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 following "CAD"/"EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any visible signs of deterioration or evidence of improper handling.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This helps protect the environment.

6. Pack contents and other information

Composition of Lenalidomida Grindeks

Lenalidomida Grindeks 2.5 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 2.5 mg of lenalidomide.

• The other components are:

• Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.

• Capsule shell: gelatin, titanium dioxide (E171), brilliant blue FCF - FD&C Blue No. 1 (E133) and yellow iron oxide (E172).

• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) and concentrated ammonia solution (E527).

Lenalidomida Grindeks 5 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 5 mg of lenalidomide.

• The other components are:

• Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.

• Capsule shell: gelatin and titanium dioxide (E171).

• Printing ink: shellac (E-904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) and concentrated ammonia solution (E527).

Lenalidomida Grindeks 7.5 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 7.5 mg of lenalidomide.

• The other components are:

• Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.

• Capsule shell: gelatin, titanium dioxide (E171) and yellow iron oxide (E172).

• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) and concentrated ammonia solution (E527).

Lenalidomida Grindeks 10 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 10 mg of lenalidomide.

• The other components are:

• Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.

• Capsule shell: gelatin, titanium dioxide (E171), brilliant blue FCF - FD&C Blue No. 1 (E133), and yellow iron oxide (E172).

• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) and concentrated ammonia solution (E527).

Lenalidomida Grindeks 15 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 15 mg of lenalidomide.

• The other components are:

• Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.

• Capsule shell: gelatin, titanium dioxide (E171) and brilliant blue FCF - FD&C Blue No. 1 (E133).

• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) and concentrated ammonia solution (E527).

Lenalidomida Grindeks 20 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 20 mg of lenalidomide.

• The other components are:

• Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.

• Capsule shell: gelatin, titanium dioxide (E171), brilliant blue FCF - FD&C Blue No. 1 (E133) and yellow iron oxide (E172).

• Printing ink: shellac (E-904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) and concentrated ammonia solution (E527).

Lenalidomida Grindeks 25 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 25 mg of lenalidomide.

• The other components are:

• Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.

• Capsule shell: gelatin and titanium dioxide (E171).

• Printing ink: shellac (E-904), propylene glycol (E1520), potassium hydroxide (E-525), black iron oxide (E172) and concentrated ammonia solution (E-527).

Appearance of the product and contents of the pack

Lenalidomide Grindeks 2.5 mg hard capsules are size 4, light green/white capsules, with the imprint «L2.5».

Lenalidomide Grindeks 5 mg hard capsules are size 4, white capsules, with the imprint «L5».

Lenalidomide Grindeks 7.5 mg hard capsules are size 3, light yellow/white capsules, with the imprint «L7.5».

Lenalidomide Grindeks 10 mg hard capsules are size 2, light green/pale yellow capsules, with the imprint «L10».

Lenalidomide Grindeks 15 mg hard capsules are size 1, blue/white capsules, with the imprint «L15».

Lenalidomide Grindeks 20 mg hard capsules are size 0, light green/blue capsules, with the imprint «L20».

Lenalidomide Grindeks 25 mg hard capsules are size 0, white capsules, with the imprint «L25».

The capsules are supplied in packs containing 7 or 21 capsules per pack.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible

AS GRINDEKS. Krustpils iela 53, Riga, LV-057, Latvia Tel: +371 67083205 Fax: +371 67083505 e-mail:[email protected]

Further information about this medicinal product is available by contacting the local representative of the Marketing Authorization Holder

Grindeks Kalceks España, S.L.

C/ José Abascal, 58 – 2º Dcha.

Madrid, 28003, Spain

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

Netherlands	Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg, hard capsules
Austria	Lenalidomid Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hard capsules
Belgium	Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsules
Bulgaria	Леналидомид Гриндекс 2,5 mg, 5 mg, 7,5 mg, 10 mg, 15 mg, 20 mg, 25 mg твърди капсули Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hard capsules
Czech Republic	Lenalidomide Grindeks
Croatia	Lenalidomid Grindeks 2.5 mg hard capsules Lenalidomid Grindeks 5 mg hard capsules Lenalidomid Grindeks 7.5 mg hard capsules Lenalidomid Grindeks 10 mg hard capsules Lenalidomid Grindeks 15 mg hard capsules Lenalidomid Grindeks 20 mg hard capsules Lenalidomid Grindeks 25 mg hard capsules
Cyprus	Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg σκληρά καψύλια
Denmark	Lenalidomide Grindeks
Estonia	Lenalidomide Grindeks
Finland	Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hard capsules
France	Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg, capsule
Germany	Lenalidomid Ethypharm 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hard capsules
Greece	Lenalidomide Grindeks 2.5 mg hard capsules Lenalidomide Grindeks 5 mg hard capsules Lenalidomide Grindeks 7.5 mg hard capsules Lenalidomide Grindeks 10 mg hard capsules Lenalidomide Grindeks 15 mg hard capsules Lenalidomide Grindeks 20 mg hard capsules Lenalidomide Grindeks 25 mg hard capsules
Hungary	Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hard capsules
Iceland	Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Capsules, hard
Ireland	Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Capsules, hard
Italy	Lenalidomide Grindeks
Latvia	Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hard capsules
Lithuania	Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hard capsules
Malta	Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Hard Capsules
Norway	Lenalidomide Grindeks
Poland	Lenalidomide Grindeks
Portugal	Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hard capsules
Romania	Lenalidomida Grindeks 2.5 mg capsule Lenalidomida Grindeks 5 mg capsule Lenalidomida Grindeks 7.5 mg capsule Lenalidomida Grindeks 10 mg capsule Lenalidomida Grindeks 15 mg capsule Lenalidomida Grindeks 20 mg capsule Lenalidomida Grindeks 25 mg capsule
Slovakia	Lenalidomid Grindeks 2.5 mg tvrdé kapsuly Lenalidomid Grindeks 5 mg tvrdé kapsuly Lenalidomid Grindeks 7.5 mg tvrdé kapsuly Lenalidomid Grindeks 10 mg tvrdé kapsuly Lenalidomid Grindeks 15 mg tvrdé kapsuly Lenalidomid Grindeks 20 mg tvrdé kapsuly Lenalidomid Grindeks 25 mg tvrdé kapsuly
Slovenia	Lenalidomid Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg trde kapsule
Spain	Lenalidomida Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hard capsule
Sweden	Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hårda kapslar
United Kingdom (Northern Ireland)	Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Capsules, hard

Date of the most recent review of this leaflet: 10/2025.

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).