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 using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine 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 of bones and kidneys.
Generally, multiple myeloma is incurable. However, it is possible to achieve temporary significant reduction or disappearance of signs and symptoms of the disease. This is called “remission”.

Newly diagnosed multiple myeloma – in patients who have undergone bone marrow transplantation
Lenalidomide Grindeks is used alone as maintenance therapy in patients who have responded adequately after bone marrow transplantation.

Newly diagnosed multiple myeloma – in patients who are 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 is started with Lenalidomide Grindeks together 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 or severe kidney problems, 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 the recurrence of multiple myeloma after treatment.

Myelodysplastic syndromes (MDS)
Myelodysplastic syndromes (MDS) are a group of different blood and bone marrow disorders. Abnormal blood cells are present and do not function properly. Patients may experience various subjective and objective symptoms, including low number of red blood cells (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 called “isolated cytogenetic abnormality with deletion 5q”. This means the patient’s body does not produce enough healthy blood cells;
• the patient has previously been treated with other therapies that were inappropriate or insufficiently effective.

Taking Lenalidomide Grindeks may lead to an increase in the number of healthy blood cells produced by the body by reducing the number of abnormal cells.

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

Follicular lymphoma (FL)
Follicular lymphoma (FL) is a slowly growing malignant cancer affecting B-lymphocytes. These are a type of white blood cells that help the body fight infections. In patients with FL, excessive numbers of B-lymphocytes 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 the tumour,
• 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 used in combination with Lenalidomide Grindeks.
When not to take Lenalidomide Grindeks

• if the patient is pregnant, 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 could become pregnant unless she uses all required contraceptive measures (see "Pregnancy, breastfeeding and contraception – information for women and men" in section 2). If the patient could 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 he or she may be allergic, medical advice should be sought.

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 a doctor,
pharmacist, or nurse if:

• the patient has previously had blood clots, as there is an increased risk of developing venous and arterial thrombosis 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, or HIV. If in doubt, consult a doctor. Treatment with Lenalidomide Grindeks may reactivate the virus, leading to recurrence of infection. The doctor should check whether the patient has ever had hepatitis B.
• the patient has kidney function impairment – the doctor may adjust the dose of Lenalidomide Grindeks;
• the patient has had a heart attack, has had blood clots, smokes, 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 a combination of any of the following symptoms: widespread rash, skin redness, high fever, flu-like symptoms, elevated liver enzymes, blood abnormalities (eosinophilia), or swollen lymph nodes – these are symptoms of a severe skin reaction known as "drug rash with eosinophilia and systemic symptoms" (DRESS) or "drug hypersensitivity syndrome" (see also section 4 "Possible side effects"). If any of the above apply, inform the doctor, pharmacist, or nurse before starting treatment.

Contact a 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, double vision, difficulty speaking, muscle weakness in arms or legs, changes in walking 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 treatment with lenalidomide, inform the doctor of 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 known as 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 involved in blood clotting (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
In patients with myelodysplastic syndromes (MDS), there is an increased risk of developing a serious disease called acute myeloid leukemia. Furthermore, it is not known how Lenalidomide Grindeks affects the likelihood of developing acute myeloid leukemia. Therefore, the doctor may perform tests to check for signs that help better predict the risk of acute myeloid leukemia 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,
• thereafter 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 tumor tissue in the body, including in the bone marrow. This may lead to a condition in which tumor tissue begins to die, causing abnormal increases in various substances in the blood and potentially leading to kidney failure (this condition is known as "tumor 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 was 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 impairment
If the patient is 75 years of age or older or has moderate to severe kidney function impairment, the doctor will perform thorough evaluations before starting treatment.
Lenalidomide Grindeks and other medicines
Inform the doctor or nurse about all medicines currently or recently taken. 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 the doctor or nurse if any of the following medicines are being used:

• certain medicines used to prevent pregnancy, such as oral contraceptives, as they may become ineffective;
• certain medicines used for heart conditions – such as digoxin;
• certain medicines used to thin the blood – 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 could become pregnant must use effective contraceptive methods (see "Contraception"). If the patient becomes pregnant while taking Lenalidomide Grindeks, treatment must be stopped immediately and the doctor informed.

For men taking Lenalidomide Grindeks

• If the male patient's partner becomes pregnant while he is taking Lenalidomide Grindeks, inform the doctor immediately. It is recommended that the partner seek medical advice.
• The patient must also use effective contraception methods (see below "Contraception").

Breastfeeding
Do not breastfeed while taking Lenalidomide Grindeks, as it is not known whether it passes into human milk.
Contraception
Women taking Lenalidomide Grindeks
Before starting treatment, the patient should ask the doctor whether she could become pregnant, even if she considers it unlikely.
If the patient could 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 and occlusion to prevent the passage of egg cells to the uterus (tubal sterilization) AND
• 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 is present in human semen. If the patient's partner is pregnant or could 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, he or she should consult a doctor before using 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 prescribed and administered by medical professionals experienced in the treatment of multiple myeloma, MDS or FL.

• If Lenalidomide Grindeks is used for the treatment of 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 is Lenalidomide Grindeks used?"). If Lenalidomide Grindeks is used for the treatment of multiple myeloma in patients after bone marrow transplantation or for the treatment of patients with MDS, it is used as monotherapy. If Lenalidomide Grindeks is used for the treatment of 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, please consult your doctor or pharmacist.

If you are taking Lenalidomide Grindeks together with other medicines, you should read the package leaflets of these 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 completion of 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 completion of 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 many other medicines you should take in combination with Lenalidomide Grindeks, if applicable;
• 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 thoroughly with soap and water immediately.
• Healthcare professionals, caregivers and family members should wear disposable gloves when handling the blister pack or capsule. Gloves should be carefully removed to avoid skin exposure, placed in a sealed polyethylene plastic bag, and disposed of according to local regulations. Hands should then be washed thoroughly with soap and water. Pregnant women or women who suspect they may be pregnant must not handle the blister pack or capsule.
• The capsules may be taken with or without food.
• Lenalidomide Grindeks should be taken on the designated days at approximately the same time each day.

How to take this medicine
To remove the capsule from the blister:

• press only on one side of the capsule to push it through the foil,
• do not press in the middle of the capsule, as this may damage it.

Duration of treatment with Lenalidomide Grindeks
Lenalidomide Grindeks is administered in treatment cycles, each lasting 21 or 28 days (see above, "Treatment cycle"). Treatment cycles should continue until your doctor advises you to stop taking the medicine.

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

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

• less than 12 hours have passed – take the missed dose as soon as possible;
• more than 12 hours have passed – do not take the missed dose. Take the next dose 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 not everyone will experience them.
If any of the following severe adverse reactions occur, treatment with Lenalidomide Grindeks should be discontinued immediately and medical advice should be sought urgently – immediate treatment may be required:

• urticaria, rash, swelling of the eyes, lips or face, breathing difficulties 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 over the entire body and associated with significant loss of the outer layer of skin (Stevens-Johnson syndrome and/or toxic epidermal necrolysis);
• widespread rash, high body temperature, increased liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction 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 severe 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 involved in blood clotting (platelets), which may lead to bleeding disorders such as nosebleeds and bruising. Lenalidomide Grindeks may also cause blood clots in veins (venous 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 increase this risk.
Therefore, before prescribing Lenalidomide Grindeks, the doctor should carefully assess the benefits and risks associated with treatment.

Very common adverse reactions (may occur in 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 of pain, enlargement 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 blood clots in the lungs, known as pulmonary embolism)
• All types of infections, including sinusitis, lung infection and upper respiratory tract infections
• Shortness of breath
• Blurred vision
• Cloudy vision (cataract)
• Kidney problems, including impaired kidney function or inability to maintain normal kidney function
• Abnormal liver function tests
• Increased liver function test results
• Changes in blood proteins leading to inflammation of arteries (vasculitis)
• Increased blood sugar levels (diabetes)
• Decreased blood sugar levels
• Headache
• Dry skin
• Depression, mood changes, difficulty sleeping
• Cough
• Low blood pressure
• Vague feeling of physical discomfort, malaise
• Painful inflammation of the mouth, dry mouth
• Dehydration

Common adverse reactions (may occur in 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
• Darkening of the skin, skin discolouration due to bleeding under the skin, usually caused by bruising, blood-filled swelling of the skin, bruising
• Increased levels of uric acid in the blood
• Skin eruptions, redness of the skin, cracking, peeling or shedding of the skin, urticaria
• Excessive sweating, night sweats
• Difficulty swallowing, sore throat, voice quality problems or voice changes
• Nasal congestion
• Production of significantly larger or smaller amounts of 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 disorder causing a sensation that everything is spinning), transient loss of consciousness
• Chest pain spreading to arms, neck, jaw, back or abdomen, accompanied by sweating, breathlessness, 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
• Deafness
• 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 occur in 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 dysfunction)
• Abdominal pain, bloating or diarrhoea, which may be symptoms of inflammation of the large intestine (so-called colitis or proctitis)
• Kidney tubular cell damage (known as tubular necrosis)
• Changes in skin colour, sensitivity to sunlight
• Tumour lysis syndrome – metabolic complications that may occur during cancer treatment, and sometimes even without treatment. These complications are caused by products released from dying tumour cells and may include: changes in blood chemistry; high levels of potassium, phosphate and uric acid, and low calcium levels, leading to impaired kidney function, heart rhythm disturbances, seizures, and sometimes death
• Increased blood pressure in blood vessels leading to the lungs (pulmonary hypertension)

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

• Sudden or mild but progressively worsening pain in the upper abdomen and/or back, lasting for several days and possibly accompanied by nausea, vomiting, fever and rapid pulse. These symptoms may be caused by inflammation of the pancreas.
• Wheezing, shortness of breath or dry cough, which may be caused by 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 drug).
• Skin disease caused by inflammation of small blood vessels, associated with joint pain and fever (leucocytoclastic vasculitis).
• Perforation of the stomach or intestine, 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 kidneys, 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 also be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 provide more information on the safety of this medicine.

5. How to store Lenalidomide Grindeks

• Keep the medicine out of the 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 storage conditions required for 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. These measures will help 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, size 4, marked with the letters "L2.5".
Lenalidomide Grindeks, 5 mg, hard capsules are white capsules, size 4, marked with the letters "L5".
Lenalidomide Grindeks, 7.5 mg, hard capsules are light yellow/white capsules, size 3, marked with the letters "L7.5".
Lenalidomide Grindeks, 10 mg, hard capsules are light green/light yellow capsules, size 2, marked with the letters "L10".
Lenalidomide Grindeks, 15 mg, hard capsules are blue/white capsules, size 1, marked with the letters "L15".
Lenalidomide Grindeks, 20 mg, hard capsules are light green/blue capsules, size 0, marked with the letters "L20".
Lenalidomide Grindeks, 25 mg, hard capsules are white capsules, 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 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
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 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
Hungary: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg kemény kapszula
Slovenia: Lenalidomid Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg trde kapsole
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