LENALIDOMIDE 2.5 mg Hard capsules

Зміст інструкції

1. Lenalidomide Grindeks 2.5 mg hard capsules, 5 mg hard capsules, 7.5 mg hard capsules, 10 mg hard capsules, 15 mg hard capsules, 20 mg hard capsules
   1. What is Lenalidomide Grindeks and what it is used for
   2. What you need to know before taking Lenalidomide Grindeks
   3. How to take Lenalidomide Grindeks
   4. Possible side effects
   5. How to store Lenalidomide Grindeks
   6. Content of the pack and other information

Lenalidomide Grindeks 2.5 mg hard capsules, 5 mg hard capsules, 7.5 mg hard capsules, 10 mg hard capsules, 15 mg hard capsules, 20 mg hard capsules

Lenalidomide Grindeks 25 mg hard capsules
lenalidomide
generic medicine

Read this leaflet carefully before you start taking 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 you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Lenalidomide Grindeks is and what it is used for
• 2. What you need to know before you take 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 is Lenalidomide Grindeks and what it is used for

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

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

• Multiple Myeloma
• 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 collect in the bone marrow and divide uncontrollably.
This can damage the bones and kidneys.
Multiple myeloma is usually incurable. However, the signs and symptoms can be
significantly reduced or disappear for a period of time. This result is called “response”.
Newly diagnosed multiple myeloma: in patients undergoing bone marrow transplant
Lenalidomide Grindeks is used alone as maintenance therapy in patients who have
adequately recovered after bone marrow transplant.
Newly diagnosed multiple myeloma: in patients who cannot undergo bone marrow
transplant
Lenalidomide Grindeks is taken with other medicines, which may include:

• a chemotherapy medicine called “bortezomib”.
• an anti-inflammatory medicine called “dexamethasone”.
• a chemotherapy medicine called “melphalan” and
• an immunosuppressant medicine called “prednisone”. You will take these other medicines at the beginning of treatment and then continue to take Lenalidomide Grindeks alone. If you are 75 years of age or older or have moderate to severe kidney problems, your doctor will monitor you closely before starting treatment. Multiple myeloma: in patients already treated Lenalidomide Grindeks is taken together with an anti-inflammatory medicine called “dexamethasone”.

Lenalidomide Grindeks can stop the worsening of the signs and symptoms of multiple
myeloma. It has also been shown to delay the return of multiple myeloma after
treatment.

Follicular Lymphoma (FL)
FL is a slow-growing form of cancer that affects B lymphocytes. These are a type of white blood
cells that help the body fight infections. In the presence of FL, too many
of these B lymphocytes can 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 on the body's immune system and directly on the tumor,
in several ways:

• stopping the development of cancer cells
• stopping the growth of blood vessels that carry blood to cancer cells
• stimulating part of the immune system to attack cancer cells.

2. What you need to know before taking Lenalidomide Grindeks

about all the medicines you are taking in combination with Lenalidomide Grindeks.
Do not take Lenalidomide Grindeks

• If you are pregnant, think you may be pregnant, or are planning a pregnancy, because Lenalidomide Grindeks is expected to harm the fetus(see section 2, ‘Pregnancy, breastfeeding and contraception - information for women and men’).
• If there is a possibility of becoming pregnant unless you follow all the necessary measures to avoid pregnancy (see section 2 ‘Pregnancy, breastfeeding and contraception - information for women and men’). If there is a possibility of becoming pregnant, on each prescription the doctor will make a note and confirm to you that the necessary measures to avoid pregnancy have been taken.
• If you are allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice.

If any of these conditions apply to you, do not take Lenalidomide Grindeks. If you have doubts, consult your
doctor.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Lenalidomide Grindeks
if:

• you have had episodes of blood clot formation in the past, as the risk of blood clots forming in the veins and arteries increases during treatment
• you have any signs of infection, such as cough or fever
• you have or have had a viral infection in the past, in particular: hepatitis B infection, shingles, HIV. If you have doubts, consult your doctor. Treatment with Lenalidomide Grindeks may cause the virus to reactivate in patients carrying the virus. This causes the infection to reappear. The doctor must check if you have had a hepatitis B infection in the past
• you have kidney problems - the doctor may adjust the dose of Lenalidomide Grindeks
• you have had a heart attack, have had a blood clot, or if you smoke, have high blood pressure or high cholesterol levels
• you have had an allergic reaction during treatment with thalidomide (another medicine for the treatment of multiple myeloma), such as rash, itching, swelling, dizziness or difficulty breathing
• you have had in the past any combination 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 or drug hypersensitivity syndrome (see also section 4 “Possible side effects”). If any of these conditions apply to you, tell your doctor, pharmacist or nurse before starting treatment.

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

• you experience blurred vision, loss of vision or double vision, difficulty speaking, weakness in an arm or leg, changes in the way you walk or problems with balance, persistent numbness, decreased sensitivity or loss of sensation, memory loss or confusion. These may be symptoms of a serious brain condition that can be fatal, known as progressive multifocal leukoencephalopathy (PML). If you had these symptoms before treatment with lenalidomide, tell your doctor of any changes in these symptoms.
• you experience shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat or swelling in the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Tests and checks
Before and during treatment with Lenalidomide Grindeks you will undergo regular blood tests. This is because Lenalidomide Grindeks can cause a decrease in blood cells
that defend you from infections (white blood cells) and those that promote blood clotting
(platelets). The doctor will ask you to undergo blood tests:

• before treatment
• every week for the first 8 weeks of treatment
• then at least once a month afterwards.

You may be evaluated for signs of cardiopulmonary problems before and during
treatment with lenalidomide.
For patients with follicular lymphoma who are taking Lenalidomide Grindeks
The doctor will ask you to have a blood test:

• before treatment
• every week for the first 3 weeks (1 cycle) of treatment
• then every 2 weeks in cycles 2 to 4 (see Section 3 "Treatment Cycle" for more information)
• subsequently, it will occur at the beginning of each cycle and
• at least every month.

The doctor may check if you have a high tumor burden throughout the body, including in the
bone marrow. This may cause a condition in which tumors break down and cause the
presence of abnormal levels of chemicals in the blood, which can lead to kidney failure (this condition is called “tumor lysis syndrome”).
The doctor may check for changes on the skin, such as red spots or rashes.
The doctor may decide to adjust the dose of Lenalidomide Grindeks or stop the
treatment depending on the results of the blood tests and your general condition. If you are
a newly diagnosed patient, the doctor may also evaluate the treatment based on your age and
other conditions you may already have.

Blood donation
You must not donate blood during therapy with lenalidomide and for at least 7 days after
stopping treatment.

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

Elderly and people with kidney problems
In patients aged 75 years or older, or with moderate or severe kidney problems, the doctor
will perform careful checks before starting treatment.

Other medicines and Lenalidomide Grindeks
Tell your doctor or nurse if you are taking or have recently taken any other
medicines. This is because Lenalidomide Grindeks can affect the action of other medicines and
other medicines can affect the action of Lenalidomide Grindeks.
In particular, tell your doctor or nurse if you are taking any of the following
medicines:

• some medicines used to prevent pregnancy, such as oral contraceptives, because they may no longer be effective
• 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
For women taking Lenalidomide Grindeks

• You must not take Lenalidomide Grindeks if you are pregnant, as this medicine is expected to harm the fetus.
• During treatment with Lenalidomide Grindeks, you must not start a pregnancy. If there is a possibility of becoming pregnant, you must use effective contraceptive methods (see the “Contraception” section).
• If you become pregnant during treatment with Lenalidomide Grindeks, you must stop treatment immediately and inform your doctor. For men taking Lenalidomide Grindeks
• If your partner becomes pregnant while you are taking Lenalidomide Grindeks, immediately inform your doctor. It is also recommended that your partner contact the doctor.
• In addition, you must use effective contraceptive methods (see the “Contraception” section).

Breastfeeding
You must not breastfeed while taking Lenalidomide Grindeks, as it is not known whether this medicine
passes into breast milk.

Contraception
For women taking Lenalidomide Grindeks
Before starting treatment, ask your doctor if there is a possibility for you to become
pregnant, even if you think it is unlikely.
If there is a possibility of becoming pregnant

• you must undergo pregnancy tests under the supervision of your doctor (before each treatment, at least every 4 weeks during treatment and at least 4 weeks after the end of treatment) except in cases where it has been confirmed that the fallopian tubes have been cut and closed to prevent eggs from reaching the uterus (sterilization by tubal ligation) AND
• you must use effective contraceptive methods for at least 4 weeks before starting treatment, during treatment and for at least 4 weeks after stopping treatment. Your doctor will provide you with all the information on appropriate contraceptive methods.

For men taking Lenalidomide Grindeks
Lenalidomide Grindeks passes into human seminal fluid. If there is a possibility that your partner
is pregnant or becomes pregnant and she does not use effective contraception, you
must use condoms during treatment and for at least 7 days after stopping treatment,
even if you have undergone a vasectomy.

Driving and using machines
Do not drive or use machines if you experience dizziness, fatigue, drowsiness, vertigo or blurred vision
after taking Lenalidomide Grindeks.

Lenalidomide Grindeks contains lactose
Lenalidomide Grindeks contains lactose. If your doctor has diagnosed you with intolerance to some
sugars, contact him before taking this medicine.

Lenalidomide Grindeks contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially
“sodium-free”.

3. How to take Lenalidomide Grindeks

Lenalidomide Grindeks must be administered by healthcare professionals experienced in the treatment of
multiple myeloma or follicular lymphoma.

• When Lenalidomide Grindeks is used for the treatment of multiple myeloma in patients who are not eligible for bone marrow transplantation or who have received other

treatments previously, it is taken with other medicines (see section 1 “What Lenalidomide Grindeks is and what it is used for”).

• When Lenalidomide Grindeks is used for the treatment of multiple myeloma in patients who have undergone bone marrow transplantation, it is taken alone.
• When Lenalidomide Grindeks is used for the treatment of follicular lymphoma, it is taken with another medicine called 'rituximab'

Take Lenalidomide Grindeks exactly as your doctor has told you. If you have any doubts
ask your doctor or pharmacist.
If you are taking Lenalidomide Grindeks in combination with other medicines, read the
package leaflet of those medicines for further information on their use and their effects.

Treatment cycle
Lenalidomide Grindeks is taken on some days over a 3-week (21-day) period.

• Each 21-day period is called a “treatment cycle”.
• Depending on the day of the cycle, you will take one or more of the medicines. However, on some days you will not take any medicine.
• Once each 21-day cycle is completed, you will start a new “cycle” over the next 21 days. OR Lenalidomide Grindeks is taken on some days over a 4-week (28-day) period.
• Each 28-day period is called a “treatment cycle”.
• Depending on the day of the cycle, you will take one or more of the medicines. However, on some days you will not take any medicine.
• Once each 28-day cycle is completed, you will start a new “cycle” over the next 28 days.

Dose of Lenalidomide Grindeks to be taken
Before starting treatment, your doctor will tell you:

• the dose of Lenalidomide Grindeks to be taken
• the dose of the other medicines to be taken in combination with Lenalidomide Grindeks, if prescribed
• on which days of the treatment cycle to take each medicine.

How and when to take Lenalidomide Grindeks

• the capsules should be swallowed whole, preferably with water.
• do not break, open or chew the capsules. If the powder from a broken Lenalidomide Grindeks capsule comes into contact with the skin, wash the skin immediately and thoroughly with water and soap.
• healthcare professionals, caregivers and family members must wear disposable gloves when handling the blister or the capsule. The gloves should then be carefully removed to prevent skin exposure, placed in sealable polyethylene plastic bags and disposed of in accordance with local regulations. Hands should then be washed thoroughly with water and soap. Pregnant women or women suspecting pregnancy should not handle the blister or the capsule.
• the capsules can be taken with or without food.
• you must take Lenalidomide Grindeks on the established days at more or less the same time.

Taking this medicine
To remove the capsule from the blister:

• press on one side of the capsule only, pushing it through the aluminum foil
• do not press on the center of the capsule, otherwise there is a risk of breaking it.

Duration of treatment with Lenalidomide Grindeks
Lenalidomide Grindeks is taken in treatment cycles, each lasting 21 or 28 days
(see above “Treatment cycle”). You must continue the treatment cycles until your
doctor tells you to stop treatment.

If you take more Lenalidomide Grindeks than you should
If you have taken more Lenalidomide Grindeks than you have been prescribed, inform your
doctor immediately.

If you forget to take Lenalidomide Grindeks
If you forget to take Lenalidomide Grindeks at the usual time and:

• less than 12 hours have passed: take your capsule immediately
• more than 12 hours have passed: do not take the forgotten capsule, but take the next capsule the following day at the usual time.

If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking Lenalidomide Grindeks and immediately consult a doctor if you notice any of the following serious side effects - you may need urgent medical attention:

• Hives, skin rash, swelling of the eyes, mouth or face, difficulty breathing, or itching, which may be symptoms of severe forms of allergic reactions called angioedema and anaphylactic reaction.
• A severe allergic reaction may start as a rash localized but spread with extensive skin loss throughout the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• Widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and other involvement of body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also paragraph 2.

Contact your doctor immediately if you experience any of the following serious side effects:

• Fever, chills, sore throat, cough, ulcers in the mouth, or any other symptom of infection, even in the bloodstream (sepsis)
• Bleeding or bruising without injury
• Chest or leg pain
• Shortness of breath
• Bone pain, muscle weakness, confusion, or fatigue, which may be due to a high level of calcium in the blood. Lenalidomide Grindeks can reduce the number of white blood cells that fight infections and also blood cells that promote blood clotting (platelets), which can

cause bleeding disorders such as nosebleeds and bruising. Lenalidomide Grindeks can also cause blood clots in the veins (thrombosis).

Other side effects
It is important to note that a small number of patients may develop other types of cancer and it is possible that this risk may increase with treatment with Lenalidomide Grindeks.
Therefore, the doctor must carefully evaluate the benefit and risk when prescribing Lenalidomide Grindeks.
Side effects very common(may affect more than 1 in 10 people):

• Decrease in the number of red blood cells, which can cause anemia leading to fatigue and weakness
• Rashes, itching
• Muscle cramps, muscle weakness, muscle pain, muscle aches, bone pain, joint pain, back pain, limb pain
• Generalized swelling, including swelling of the arms and legs
• Weakness, fatigue
• Fever and flu-like symptoms including fever, muscle pain, headache, ear pain, cough and chills
• Numbness, tingling, or burning sensation on the skin, pain in the hands or feet, dizziness, tremor
• Decreased appetite, altered sense of taste
• Increased pain, size of the tumor or redness around the tumor
• Weight loss Constipation, diarrhea, nausea, vomiting, stomach pain, heartburn
• Low levels of potassium or calcium and/or sodium in the blood
• Thyroid that works less than normal
• Leg pain (which may be a symptom of thrombosis), chest pain or shortness of breath (which may be symptoms of blood clots in the lungs, called pulmonary embolism)
• Infections of any kind including infections of the sinuses surrounding the nose, lung infection and upper respiratory tract infection
• Shortness of breath
• Blurred vision
• Clouding of the vision (cataract)
• Kidney problems including kidney malfunction or inability to maintain normal function
• Abnormal liver test results
• Increased values in liver function tests
• Changes in a protein in the blood that can cause inflammation of the arteries (vasculitis)
• Increased blood sugar levels (diabetes)
• Decreased blood sugar levels
• Headache
• Nosebleeds
• Dry skin
• Depression, mood changes, difficulty sleeping
• Cough
• Decreased blood pressure
• Vague sense of discomfort, malaise
• Inflammation of the oral cavity, dry mouth
• Dehydration

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

• Destruction of red blood cells (hemolytic anemia)
• Some types of skin cancer
• Bleeding from the gums, stomach or intestines
• Increased blood pressure, slow, rapid or irregular heartbeat
• Increased amount of a substance that comes from the normal and abnormal breakdown of red blood cells
• Increase in a type of protein that indicates inflammation in the body
• Darkening of the skin, discoloration of the skin resulting from underlying bleeding, typically caused by bruising, swelling of the skin filled with blood, bruising.
• Increased uric acid in the blood
• Skin rashes, redness of the skin, cracking, scaling or peeling, hives
• Increased sweating, night sweats
• Difficulty swallowing, sore throat, voice changes or changes in voice
• Runny nose
• Production of urine much more or less than usual or inability to control when to urinate
• Presence of blood in the urine.
• Shortness of breath, especially when lying down (which may be a symptom of heart failure)
• Difficulty having an erection
• Stroke, fainting, dizziness (inner ear problems leading to the sensation that everything is spinning) temporary loss of consciousness
• Chest pain that spreads to arms, neck, jaw, back or stomach, feeling of sweating and 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
• Swollen joints
• Slowed or blocked flow of bile from the liver
• Low levels of phosphate or magnesium in the blood
• Difficulty speaking
• Liver damage
• Balance disorders, difficulty moving
• Hearing loss
• Ringing in the ears (tinnitus)
• Nerve pain, altered sensation especially of touch
• Excess iron in the blood
• Thirst
• Confusion
• Toothache
• Falls that can lead to injury

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

• Bleeding inside the skull
• Circulatory problems
• Loss of vision
• Loss of sexual drive (libido)
• Abundant urine flow with pain and weakness in the bones, which may be symptoms of a kidney disorder (Fanconi syndrome)
• Yellowing of the skin, mucous membranes or eyes (jaundice), pale stools, dark urine, itching of the skin, pain or swelling of the stomach. These may be symptoms of liver damage (liver failure).
• Stomach pain, bloating or diarrhea, which may be symptoms of inflammation of the large intestine (called colitis or typhlitis)
• Damage to kidney cells (called tubular necrosis)
• Changes in skin color, sensitivity to sunlight
• Tumor lysis syndrome - metabolic complications that occur during cancer treatment and sometimes even without treatment. These complications are caused by the breakdown products of dying cancer cells and can include the following: changes in blood chemistry tests, elevated potassium, phosphorus, uric acid and decreased calcium leading to alterations in kidney function, heartbeat, seizures and sometimes death.
• Increased blood pressure in the vessels that carry blood to the lungs (pulmonary hypertension).

Side effects with frequency not known(frequency cannot be estimated on the basis of available data):

• Sudden, or mild but worsening, pain in the upper abdomen and/or back, which persists for several days, with possible nausea, vomiting, fever and rapid pulse; these symptoms may be due to inflammation of the pancreas.
• Wheezing, shortness of breath or dry cough, which may be symptoms caused by inflammation of lung tissue.
• Rare cases of muscle breakdown (pain, weakness or swelling of the muscles) have been observed, which can cause kidney problems (rhabdomyolysis), some of which when Lenalidomide Grindeks is administered with a statin (a type of drug that lowers cholesterol).
• A disease that affects the skin and is caused by inflammation of small blood vessels, with joint pain and fever (leukocytoclastic vasculitis).
• Deterioration of the wall of the stomach or intestine, which can cause very serious infections. Tell your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in your stool or changes in your bowel habits.
• Viral infections, including herpes zoster (also known as “shingles”, a viral disease that causes painful blistering rash) and recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown urine, pain in the right side of the stomach, fever and nausea or vomiting).
• Rejection of solid organ transplant (such as kidney, heart)

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lenalidomide Grindeks

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that is stated on the blister and the package after “Exp.”. The expiry date refers to the last day of that month.
• This medicine does not require any particular storage conditions.
• Do not use this medicine if you notice damaged packages or packages with signs of tampering.
• Do not dispose of any medicine in wastewater or household waste. Return any unused medicines to the pharmacist. This will help protect the environment.

6. Content of the pack and other information

What contains Lenalidomide Grindeks
Lenalidomide Grindeks 2.5 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 2.5 mg of lenalidomide
• The other ingredients are:
• capsule content: lactose (see paragraph 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
• capsule shell: gelatin, titanium dioxide (E171), Brilliant Blue FCF - FD&C Blue 1 (E133) and yellow iron oxide (E172)
• inscription ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) and concentrated ammonia solution (E527). Lenalidomide Grindeks 5 mg hard capsules:
• The active ingredient is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 5 mg of lenalidomide
• The other ingredients are:
• capsule content: lactose (see paragraph 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
• capsule shell: gelatin and titanium dioxide (E171)
• inscription ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172), concentrated ammonia solution (E527). Lenalidomide Grindeks 7.5 mg hard capsules:
• The active ingredient is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 7.5 mg of lenalidomide.
• The other ingredients are:
• capsule content: lactose (see paragraph 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
• capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172)
• inscription ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) and concentrated ammonia solution (E527). Lenalidomide Grindeks 10 mg hard capsules:
• The active ingredient is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 10 mg of lenalidomide.
• The other ingredients are:
• capsule content: lactose (see paragraph 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
• capsule shell: gelatin, titanium dioxide (E171), Brilliant Blue FCF - FD&C Blue 1 (E133) and yellow iron oxide (E172)
• inscription ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) and concentrated ammonia solution (E527). Lenalidomide Grindeks 15 mg hard capsules:
• The active ingredient is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 15 mg of lenalidomide.
• The other ingredients are:
• capsule content: lactose (see paragraph 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
• capsule shell: gelatin, titanium dioxide (E171) and Brilliant Blue FCF - FD&C Blue 1 (E133).
• inscription ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) and concentrated ammonia solution (E527).

Lenalidomide Grindeks 20 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 20 mg of lenalidomide.
• The other ingredients are:
• capsule content: lactose (see paragraph 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
• capsule shell: gelatin, titanium dioxide (E171), Brilliant Blue FCF - FD&C Blue 1 (E133) and yellow iron oxide (E172)
• inscription ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) and concentrated ammonia solution (E527).

Lenalidomide Grindeks 25 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 25 mg of lenalidomide.
• The other ingredients are:
• capsule content: lactose (see paragraph 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
• capsule shell: gelatin and titanium dioxide (E171).
• inscription ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) and concentrated ammonia solution (E527).

Description of the appearance of Lenalidomide Grindeks and contents of the pack
Lenalidomide Grindeks 2.5 mg hard capsules are light green/white in colour, size 4,
with the inscription ‘L2.5’.
Lenalidomide Grindeks 5 mg hard capsules are white in colour, size 4, with the inscription
‘L5’.
Lenalidomide Grindeks 7.5 mg hard capsules are light yellow/white in colour, size 3,
with the inscription ‘L7.5’.
Lenalidomide Grindeks 10 mg hard capsules are light green/light yellow in colour,
size 2, with the inscription ‘L10’.
Lenalidomide Grindeks 15 mg hard capsules are blue/white in colour, size 1, with the
inscription ‘L15’.
Lenalidomide Grindeks 20 mg hard capsules are light green/blue in colour, size 0, with
the inscription ‘L20’.
Lenalidomide Grindeks 25 mg hard capsules are white in colour, size 0, with the inscription
‘L25’.
The capsules are supplied in packs of 7 capsules or 21 capsules.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
AS GRINDEKS.
Krustpils iela 53,
Rīga LV-1057,
Latvia

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) with the following names:
Netherlands: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg,
20 mg, 25 mg, harde capsules
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
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 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
Cyprus: Lenalidomide Grindeks 2,5 mg, 5 mg, 7,5 mg,
10 mg, 15 mg, 20 mg, 25 mg hard capsules
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 kapselit, kovat
France: Lenalidomide Grindeks 2,5 mg, 5 mg, 7,5 mg,
10 mg, 15 mg, 20 mg, 25 mg, Gélule
Germany: Lenalidomid Ethypharm 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
Hungary: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg,
20 mg, 25 mg kemény kapszula
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 cietās kapsulas
Lithuania: Lenalidomide Grindeks 2,5 mg, 5 mg, 7,5 mg, 10 mg, 15 mg,
20 mg, 25 mg kietosios kapsulės
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 cápsulas duras
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
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: Lenalidomide 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