LENALIDOMIDE GRINDEKS

Package leaflet: Information for the patient

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
lenalidomide
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Lenalidomide Grindeks is and what it is used for
2. Important information before taking Lenalidomide Grindeks
3. How to take Lenalidomide Grindeks
4. Possible side effects
5. How to store Lenalidomide Grindeks
6. Contents of the pack and other information

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

What Lenalidomide Grindeks is
Lenalidomide Grindeks contains the active substance ‘lenalidomide’. This medicine belongs to a group of medicines that affect the function of the immune system.

What Lenalidomide Grindeks is used for
Lenalidomide Grindeks is used in adults to treat:

• multiple myeloma,
• myelodysplastic syndromes,
• follicular lymphoma.

Multiple myeloma
Multiple myeloma is a type of cancer that affects a certain type of white blood cells called plasma cells. These cells accumulate in the bone marrow and divide uncontrollably. This may lead to damage to bones and kidneys.
Generally, multiple myeloma is incurable. However, it is possible to achieve temporary significant reduction or elimination of signs and symptoms of the disease. This is called “remission”.

Newly diagnosed multiple myeloma – in patients after bone marrow transplantation
Lenalidomide Grindeks is used alone (without other medicines) as maintenance therapy in patients who have responded adequately after bone marrow transplantation.

Newly diagnosed multiple myeloma – in patients not eligible for bone marrow transplantation
Lenalidomide Grindeks is taken together with other medicines, including:

• a chemotherapy medicine called ‘bortezomib’;
• an anti-inflammatory medicine called ‘dexamethasone’;
• a chemotherapy medicine called ‘melphalan’; and
• an immunosuppressive medicine called ‘prednisone’.
  Treatment starts with Lenalidomide Grindeks in combination with additional medicines, followed by continued treatment with Lenalidomide Grindeks alone.

If you are 75 years of age or older, or if you have moderate to severe kidney function impairment, your doctor will perform careful assessments before starting treatment.

Multiple myeloma – in previously treated patients
Lenalidomide Grindeks is taken together with an anti-inflammatory medicine called ‘dexamethasone’.
Lenalidomide Grindeks may stop the progression of signs and symptoms of multiple myeloma. It has also been shown to delay relapse 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 and do not function properly. Patients may experience various subjective and objective symptoms, including low red blood cell count (anaemia), need for blood transfusions, and risk of infection.

Lenalidomide Grindeks, used as monotherapy, is indicated for the treatment of adult patients with MDS when all of the following conditions are met:

• the patient requires regular blood transfusions due to low red blood cell count (“transfusion-dependent anaemia”);
• the patient has an abnormality in bone marrow cells known as “isolated cytogenetic abnormality with deletion 5q”. This means the patient’s body does not produce enough healthy blood cells;
• the patient has previously received other treatments that were inappropriate or insufficiently effective.

Taking Lenalidomide Grindeks may increase the production of healthy blood cells by the body by reducing the number of abnormal cells.

• This may lead to a reduction in the number of required blood transfusions. It may even become possible to discontinue blood transfusions altogether.

Follicular lymphoma (FL)
Follicular lymphoma (FL) is a slowly growing malignant cancer affecting B-cells. These are a type of white blood cells that help the body fight infections. In patients with FL, excessive numbers of B-cells may accumulate in the 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 the body’s immune system and directly attacking cancer cells. Its mechanism of action includes:

• inhibition of cancer cell growth;
• inhibition of blood vessel formation in tumours;
• stimulation of part of the immune system to attack cancer cells.

2. Important information before taking Lenalidomide Grindeks

Before starting treatment with Lenalidomide Grindeks, carefully read the package leaflets of all medicinal products being used in combination with Lenalidomide Grindeks.
When not to take Lenalidomide Grindeks

• if the patient is pregnant or suspects she may be pregnant, or plans to become pregnant, because Lenalidomide Grindeks may harm the unborn child (see "Pregnancy, breastfeeding and contraception – information for women and men" in section 2).
• if the patient may become pregnant, unless she is using all required contraceptive measures (see "Pregnancy, breastfeeding and contraception – information for women and men" in section 2). If the patient may become pregnant, the doctor will document at each follow-up visit that necessary precautions have been taken and will confirm this with the patient.
• if the patient is allergic to lenalidomide or to any of the other ingredients of this medicine (listed in section 6). If the patient suspects an allergy, she should consult her doctor for advice.

If any of the above situations apply, Lenalidomide Grindeks must not be taken. If in doubt, consult a doctor.

Warnings and precautions
Before starting treatment with Lenalidomide Grindeks, discuss with your doctor,
pharmacist or nurse if:

• the patient has previously had blood clots, as there is an increased risk of developing blood clots in veins and arteries during treatment;
• the patient has any signs of infection, such as cough or fever;
• the patient has or has ever had a viral infection, especially: hepatitis B virus, varicella-zoster virus (chickenpox and shingles), or HIV. If in doubt, consult a doctor. Treatment with Lenalidomide Grindeks may cause reactivation of the virus in carriers, leading to recurrence of infection. The doctor should check whether the patient has ever had hepatitis B.
• the patient has kidney function disorders – the doctor may adjust the dose of Lenalidomide Grindeks;
• the patient has had a heart attack, has ever had a blood clot, smokes tobacco, has high blood pressure or high cholesterol levels;
• the patient experienced an allergic reaction after taking thalidomide (another medicine used in the treatment of multiple myeloma), such as rash, itching, swelling, dizziness or difficulty breathing;
• the patient has previously experienced any combination of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes – these are symptoms of a severe skin reaction known as "drug reaction with eosinophilia and systemic symptoms" (DRESS) or "drug hypersensitivity syndrome" (see also section 4 "Possible side effects"). If any of the above applies, inform the doctor, pharmacist or nurse before starting treatment.

Contact your doctor or nurse immediately if at any time during or after treatment
the patient experiences any of the following symptoms:

• blurred vision, loss of vision or double vision, difficulty speaking, muscle weakness in arms or legs, change in walking pattern or balance problems, persistent numbness, reduced sensation or loss of sensation, memory loss or disorientation. All these symptoms may indicate a serious and potentially fatal brain disease known as progressive multifocal leukoencephalopathy (PML). If the above symptoms occurred before starting lenalidomide treatment, inform the doctor about any changes in these symptoms.

• shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or swelling of the legs or ankles. These may be symptoms of a serious condition called pulmonary hypertension (see section 4).

Tests and examinations
Before starting treatment with Lenalidomide Grindeks and during treatment, the patient will undergo regular blood tests, as this medicine may reduce 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,
• weekly for the first 8 weeks of treatment,
• thereafter at least once a month.

Before starting lenalidomide treatment and during treatment, the patient may be evaluated for circulatory and respiratory problems.

Patients with MDS taking Lenalidomide Grindeks
If the patient has myelodysplastic syndromes (MDS), there is an increased risk of developing a serious disease called acute myeloid leukaemia. Furthermore, it is not known how Lenalidomide Grindeks affects the likelihood of developing acute myeloid leukaemia. Therefore, the doctor may perform tests and check for signs that help better predict the risk of acute myeloid leukaemia during treatment with Lenalidomide Grindeks.

Patients with FL taking Lenalidomide Grindeks
The doctor will request blood tests:

• before treatment,
• weekly for the first 3 weeks (1 cycle) of treatment,
• then every 2 weeks during cycles 2 to 4 (more information in section 3 "Treatment cycle"),
• then at the beginning of each cycle, and
• at least once a month.

The doctor may perform a test to determine whether the patient has a large amount of tumour tissue in the body, including in the bone marrow. This may lead to a condition in which tumour tissue begins to break down, causing abnormal increases in various substances in the blood and potentially leading to kidney failure (this condition is known as "tumour lysis syndrome").

The doctor may examine the patient to check for skin changes such as red spots or rash.

The doctor may adjust the dose of Lenalidomide Grindeks or discontinue treatment based on blood test results and the patient's overall condition. If the disease has been recently diagnosed, the doctor may also consider the patient's age and other pre-existing conditions when evaluating treatment.

Blood donation
Do not donate blood during treatment and for at least 7 days after treatment ends.

Children and adolescents
Lenalidomide Grindeks is not recommended for use in children and adolescents under 18 years of age.

Elderly patients and patients with kidney function disorders
If the patient is 75 years of age or older, or has moderate to severe kidney function impairment, the doctor will perform thorough assessments before starting treatment.

Lenalidomide Grindeks and other medicines
Inform your doctor or nurse about all medicines currently taken or recently used. This is necessary because Lenalidomide Grindeks may affect the action of other medicines. Likewise, other medicines may affect the action of Lenalidomide Grindeks.

In particular, inform your doctor or nurse if the patient is taking any of the following medicines:

• certain contraceptives, such as oral contraceptives, as they may become ineffective;
• certain heart medications – such as digoxin;
• certain anticoagulants – such as warfarin.

Pregnancy, breastfeeding and contraception – information for women and men
Pregnancy
For women taking Lenalidomide Grindeks

• Do not take Lenalidomide Grindeks if the patient is pregnant, as it is expected to be harmful to the unborn child.
• Women must not become pregnant while taking Lenalidomide Grindeks. Therefore, women who may become pregnant must use effective contraceptive methods (see "Contraception"). If the patient becomes pregnant while taking Lenalidomide Grindeks, she must stop treatment immediately and inform her doctor.

For men taking Lenalidomide Grindeks

• If the female partner of a man taking Lenalidomide Grindeks becomes pregnant, inform the doctor immediately. It is recommended that the partner seek medical advice.
• The patient must also use effective contraception (see below "Contraception").

Breastfeeding
Do not breastfeed while taking Lenalidomide Grindeks, as it is not known whether the medicine passes into human milk.

Contraception
Women taking Lenalidomide Grindeks
Before starting treatment, the patient should ask her doctor whether she could become pregnant, even if she considers it unlikely.

If the patient may become pregnant:

• she will have pregnancy tests performed under medical supervision (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends), unless the doctor confirms tubal ligation (surgical sterilization of the fallopian tubes) OR
• she must use effective contraceptive methods for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after treatment ends. The doctor will advise the patient on appropriate contraceptive methods.

Men taking Lenalidomide Grindeks
Lenalidomide Grindeks passes into human semen. If the patient's partner is pregnant or may become pregnant and is not using effective contraception, the patient must use condoms during treatment and for at least 7 days after treatment ends, even if he has had a vasectomy. During treatment and for at least 7 days after treatment ends, the patient must not donate semen.

Driving and operating machinery
If the patient experiences dizziness, fatigue, drowsiness, imbalance due to dizziness or blurred vision after taking Lenalidomide Grindeks, he or she should not drive or operate machinery.

Lenalidomide Grindeks contains lactose
Lenalidomide Grindeks contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

Lenalidomide Grindeks contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per capsule, meaning the medicine is considered "sodium-free".

3. How to take Lenalidomide Grindeks

Lenalidomide Grindeks must be administered by healthcare professionals experienced in the treatment of multiple myeloma, MDS, or FL.

• If Lenalidomide Grindeks is used to treat multiple myeloma in patients who are not eligible for bone marrow transplantation or who have previously received other treatments, the medicine is given in combination with other drugs (see section 1, "Why Lenalidomide Grindeks is used"). If Lenalidomide Grindeks is used to treat multiple myeloma in patients after bone marrow transplantation or in patients with MDS, it is given as monotherapy. If Lenalidomide Grindeks is used to treat follicular lymphoma, it is taken together with another medicine called "rituximab". This medicine should always be taken exactly as prescribed by the doctor. In case of any doubts, consult your doctor or pharmacist.

If you are taking Lenalidomide Grindeks together with other medicines, you should read the package leaflets of those medicines to obtain information about their use and effects.

Treatment cycle
Lenalidomide Grindeks is taken on specific days for 3 weeks (21 days).

• Each 21-day period is called a "treatment cycle".

• Depending on the day of the cycle, you may take one or more medicines. However, on certain days you may not take any medicines.

• After completing each 21-day cycle, you should start a new 21-day cycle.
  OR
  Lenalidomide Grindeks 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 may take one or more medicines. However, on certain days you may not take any medicines.

• After completing each 28-day cycle, you should start a new 28-day cycle.

How much Lenalidomide Grindeks to take
Before starting treatment, your doctor will inform you:

• how much Lenalidomide Grindeks you should take;
• how much of any other medicines you should take in combination with Lenalidomide Grindeks, if other medicines are required;
• which medicines to take on which days of the cycle.

How and when to take Lenalidomide Grindeks

• Swallow the capsule whole, preferably with water.
• Do not break, open, or chew the capsule. If the powder from a damaged Lenalidomide Grindeks capsule comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
• 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 in a sealed polyethylene plastic bag, and disposed of according to local regulations. Afterwards, hands should be washed thoroughly with soap and water. Pregnant women or women who suspect they may be pregnant should not handle the blister pack or capsule.
• Capsules may be taken with or without food.
• Lenalidomide Grindeks should be taken on the designated days at approximately the same time each day.

Taking this medicine
To remove the capsule from the blister:

• press only on one side of the capsule 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 Grindeks
Lenalidomide Grindeks is administered in treatment cycles, each lasting either 21 or 28 days (see above, "Treatment cycle"). Treatment cycles should continue until your doctor advises stopping the medicine.

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

If you miss a dose of Lenalidomide Grindeks
If you forget to take Lenalidomide Grindeks at the scheduled time and:

• less than 12 hours have passed – take the capsule as soon as possible;
• more than 12 hours have passed – do not take the missed capsule. Take the next capsule at the scheduled time the following day.

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

4. Possible adverse reactions

Like all medicines, Lenalidomide Grindeks may cause adverse reactions, although they do not
occur in everyone.
If any of the following serious adverse reactions occur, stop taking Lenalidomide Grindeks and
seek immediate medical advice – immediate treatment may be required:

• hives, rash, swelling of the eyes, lips or face, difficulty breathing or itching, which may be symptoms of severe allergic reactions known as angioedema and anaphylactic reaction;
• severe allergic reaction possibly starting as a rash in one area, spreading across the entire body and progressing with significant skin peeling (Stevens-Johnson syndrome and/or toxic epidermal necrolysis);
• widespread rash, high body temperature, increased liver enzyme activity, abnormalities in blood tests (eosinophilia), swollen 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.

Immediately inform your doctor if any of the following serious adverse reactions occur:

• fever, chills, sore throat, cough, mouth ulcers or any other signs of infection, including blood infection (sepsis);
• bleeding or bruising without injury;
• chest pain or leg pain;
• shortness of breath;
• bone pain, muscle weakness, confusion or fatigue, which may result from high levels of calcium in the blood.

Lenalidomide Grindeks may reduce the number of white blood cells that fight infection, as well as
blood cells that help blood clot (platelets), which may lead to bleeding disorders such as nosebleeds
and bruising. Lenalidomide Grindeks may also cause blood clots in the veins (thrombosis).
Other adverse reactions
It should be noted that in a small number of patients, other types of cancer may develop, and
treatment with Lenalidomide Grindeks may possibly increase this risk.
For this reason, before prescribing Lenalidomide Grindeks, the doctor should carefully assess the benefits and risks associated with treatment.
Very common adverse reactions (may affect more than 1 in 10 people):

• Decreased number of red blood cells, which may lead to anaemia causing fatigue and weakness
• Rash, itching
• Muscle cramps, muscle weakness, muscle pain, bone pain, joint pain, back pain, limb pain
• Generalised swelling, including swelling of hands and feet
• Weakness, fatigue
• Fever and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough and chills
• Numbness, tingling or burning sensation of the skin, pain in hands or feet, dizziness, tremor
• Decreased appetite, altered taste sensation
• Worsening pain, swelling or redness around a tumour
• Weight loss
• Constipation, diarrhoea, nausea, vomiting, abdominal pain, heartburn
• Low levels of potassium or calcium and (or) sodium in the blood
• Underactive thyroid gland
• Leg pain (which may be a sign of thrombosis), chest pain or shortness of breath (which may be symptoms of a blood clot in the lungs, so-called pulmonary embolism)
• All types of infections, including sinus infection, lung infection 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 function test values
• Blood protein changes leading to arterial swelling (blood vessel inflammation)
• Increased blood sugar levels (diabetes)
• Decreased blood sugar levels
• Headache
• Dry skin
• Depression, mood changes, difficulty sleeping
• Cough
• Low blood pressure
• Vague physical discomfort, malaise
• Painful mouth inflammation, dry mouth
• Dehydration

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

• Breakdown of red blood cells (haemolytic anaemia)
• Certain types of skin tumours
• Bleeding from gums, stomach or intestines
• Increased blood pressure, slow, fast or irregular heartbeat
• Increased levels of substances resulting from normal and abnormal breakdown of red blood cells
• Increased levels of a protein indicating inflammation in the body
• Skin darkening, skin discolouration due to bleeding under the skin, usually caused by bruising, blood-filled skin swelling, bruising
• Increased uric acid levels in the blood
• Skin eruptions, skin redness, cracking, peeling or shedding of the skin, hives
• Excessive sweating, night sweats
• Difficulty swallowing, sore throat, voice quality problems or voice changes
• Nasal congestion
• Production of significantly more or significantly less urine than usual or inability to control the timing of urination
• Presence of blood in the urine
• Shortness of breath, especially when lying down (which may be a symptom of heart failure)
• Difficulty achieving erection
• Stroke, fainting, dizziness (inner ear disorders causing a sensation of spinning), transient loss of consciousness
• Chest pain spreading to arms, neck, jaw, back or abdomen, sweating, 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 blockage of bile flow from the liver
• Low levels of phosphates or magnesium in the blood
• Difficulty speaking
• Liver damage
• Balance disorders, difficulty moving
• Hearing loss
• Ringing in the ears (tinnitus)
• Nerve pain, unpleasant abnormal sensations, especially in response to touch
• Excess iron in the body
• Thirst
• Confusion
• Toothache
• Falls that may lead to injury

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

• Bleeding inside the skull
• Circulatory disorders
• Loss of vision
• Loss of sexual desire (libido)
• Excretion of large amounts of urine accompanied by bone pain and weakness, which may be symptoms of kidney dysfunction (Fanconi syndrome)
• Yellowing of the skin, mucous membranes or eyes (jaundice), pale-coloured stools, dark-coloured urine, itchy skin, rash, abdominal pain or swelling – these may be symptoms of liver damage (liver function disorders)
• Abdominal pain, bloating or diarrhoea, which may be symptoms of inflammation of the large intestine (so-called colitis or proctitis)
• Kidney tubular cell damage (called tubular necrosis)
• Skin colour changes, sensitivity to sunlight
• Tumour lysis syndrome – metabolic complications that may occur during cancer treatment, and sometimes even without treatment. These complications are caused by the breakdown products of dying tumour cells and may include: changes in blood chemistry; high levels of potassium, phosphate, uric acid and low calcium levels, leading to kidney dysfunction, heart rhythm disturbances, seizures, and sometimes death
• High blood pressure in the blood vessels leading to the lungs (pulmonary hypertension)

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

• Sudden or mild but worsening pain in the upper abdomen and/or back, persisting for several days and possibly accompanied by nausea, vomiting, fever and rapid pulse. These symptoms may be caused by pancreatitis.
• Wheezing, shortness of breath or dry cough, possibly due to inflammation of lung tissue.
• Rare cases of muscle breakdown (muscle pain, weakness or swelling) have been observed, which may lead to kidney dysfunction (rhabdomyolysis); some of these occurred when Lenalidomide Grindeks was administered with a statin (a type of cholesterol-lowering medicine).
• Skin disease caused by inflammation of small blood vessels, presenting with joint pain and fever (leukocytoclastic vasculitis).
• Perforation of the stomach or intestinal wall, which may lead to severe infection. Inform your doctor if you experience severe abdominal pain, fever, nausea, vomiting, blood in the stool or changes in bowel function.
• Viral infections, including shingles (a viral disease causing a painful skin rash with blisters) and reactivation of hepatitis B virus (which may cause yellowing of the skin and eyes, dark brown urine, pain in the right side of the abdomen, fever, nausea or vomiting).
• Rejection of transplanted solid organs (such as kidney, heart).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Lenalidomide Grindeks

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister and the cardboard box after 'Expiry date (EXP)'. The expiry date refers to the last day of the stated month.
• There are no special requirements for storage conditions of this medicine.
• Do not use this medicine if you notice any signs of damage or evidence of tampering with the packaging.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Doing so helps protect the environment.

6. Contents of the pack and other information

What Lenalidomide Grindeks contains
Lenalidomide Grindeks, 2.5 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide with ammonium chloride equivalent to 2.5 mg of lenalidomide.
• Other components are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
  • capsule shell: gelatin, titanium dioxide (E 171), Brilliant Blue FCF - FD&C Blue 1 (E 133), and yellow iron oxide (E 127)
  • printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), and concentrated ammonium hydroxide (E 527).

Lenalidomide Grindeks, 5 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide with ammonium chloride equivalent to 5 mg of lenalidomide.
• Other components are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
  • capsule shell: gelatin and titanium dioxide (E 171)
  • printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), and concentrated ammonium hydroxide (E 527).

Lenalidomide Grindeks, 7.5 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide with ammonium chloride equivalent to 7.5 mg of lenalidomide.
• Other components are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
  • capsule shell: gelatin, titanium dioxide (E 171), and yellow iron oxide (E 127)
  • printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), and concentrated ammonium hydroxide (E 527).

Lenalidomide Grindeks, 10 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide with ammonium chloride equivalent to 10 mg of lenalidomide.
• Other components are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
  • capsule shell: gelatin, titanium dioxide (E 171), Brilliant Blue FCF - FD&C Blue 1 (E 133), and yellow iron oxide (E 127)
  • printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), and concentrated ammonium hydroxide (E 527).

Lenalidomide Grindeks, 15 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide with ammonium chloride equivalent to 15 mg of lenalidomide.
• Other components are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
  • capsule shell: gelatin, titanium dioxide (E 171), and Brilliant Blue FCF - FD&C Blue 1 (E 133)
  • printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), and concentrated ammonium hydroxide (E 527).

Lenalidomide Grindeks, 20 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide with ammonium chloride equivalent to 20 mg of lenalidomide.
• Other components are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
  • capsule shell: gelatin, titanium dioxide (E 171), Brilliant Blue FCF - FD&C Blue 1 (E 133), and yellow iron oxide (E 127)
  • printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), and concentrated ammonium hydroxide (E 527).

Lenalidomide Grindeks, 25 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide with ammonium chloride equivalent to 25 mg of lenalidomide.
• Other components are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
  • capsule shell: gelatin and titanium dioxide (E 171)
  • printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), and concentrated ammonium hydroxide (E 527).

What Lenalidomide Grindeks looks like and contents of the pack
Lenalidomide Grindeks, 2.5 mg, hard capsules are light green/white capsules of size 4, marked with the letters "L2.5".
Lenalidomide Grindeks, 5 mg, hard capsules are white capsules of size 4, marked with the letters "L5".
Lenalidomide Grindeks, 7.5 mg, hard capsules are light yellow/white capsules of size 3, marked with the letters "L7.5".
Lenalidomide Grindeks, 10 mg, hard capsules are light green/light yellow capsules of size 2, marked with the letters "L10".
Lenalidomide Grindeks, 15 mg, hard capsules are blue/white capsules of size 1, marked with the letters "L15".
Lenalidomide Grindeks, 20 mg, hard capsules are light green/blue capsules of size 0, marked with the letters "L20".
Lenalidomide Grindeks, 25 mg, hard capsules are white capsules of size 0, marked with the letters "L25".
The capsules are supplied in packs containing 7 or 21 capsules in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53,
Riga, LV-1057,
Latvia
Tel.: +371 67083205

This medicinal product is authorised in the European Economic Area and 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
Latvia: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg cietās kapsulas
Lithuania: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg kietosios kapsulės
Estonia, Poland: Lenalidomide Grindeks
Czech Republic: Lenalidomid Grindeks
Hungary: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg kemény kapszula
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
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
Romania: Lenalidomidă Grindeks 2.5 mg capsule
     Lenalidomidă Grindeks 5 mg capsule
     Lenalidomidă Grindeks 7.5 mg capsule
     Lenalidomidă Grindeks 10 mg capsule
     Lenalidomidă Grindeks 15 mg capsule
     Lenalidomidă Grindeks 20 mg capsule
     Lenalidomidă Grindeks 25 mg capsule
Croatia: Lenalidomid Grindeks 2.5 mg tvrde kapsule
     Lenalidomid Grindeks 5 mg tvrde kapsule
     Lenalidomid Grindeks 7.5 mg tvrde kapsule
     Lenalidomid Grindeks 10 mg tvrde kapsule
     Lenalidomid Grindeks 15 mg tvrde kapsule
     Lenalidomid Grindeks 20 mg tvrde kapsule
     Lenalidomid Grindeks 25 mg tvrde kapsule
Austria: Lenalidomid Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Hartkapseln
Belgium: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg gélules
Cyprus: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg σκληρά καψάκια
Denmark: Lenalidomide Grindeks
Finland: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg kapselit, kovat
France: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg, Gélule
Germany: Lenalidomid Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Hartkapseln
Greece: Lenalidomide/Grindeks 2.5 mg καψάκια σκληρά
     Lenalidomide/Grindeks 5 mg καψάκια σκληρά
     Lenalidomide/Grindeks 7.5 mg καψάκια σκληρά
     Lenalidomide/Grindeks 10 mg καψάκια σκληρά
     Lenalidomide/Grindeks 15 mg καψάκια σκληρά
     Lenalidomide/Grindeks 20 mg καψάκια σκληρά
     Lenalidomide/Grindeks 25 mg καψάκια σκληρά
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
Malta: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Hard Capsules
Norway: Lenalidomide Grindeks
Portugal: Lenalidomida Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg cápsulas duras
Spain: Lenalidomida Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg cápsula dura
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