Lenalidomide gedeon richter: detailed information

Package leaflet: Information for the user

Lenalidomide Gedeon Richter, 2.5 mg, hard capsules
Lenalidomide Gedeon Richter, 5 mg, hard capsules
Lenalidomide Gedeon Richter, 7.5 mg, hard capsules
Lenalidomide Gedeon Richter, 10 mg, hard capsules
Lenalidomide Gedeon Richter, 15 mg, hard capsules
Lenalidomide Gedeon Richter, 20 mg, hard capsules
Lenalidomide Gedeon Richter, 25 mg, hard capsules
Lenalidomidum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, 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.

Contents of the leaflet

What Lenalidomide Gedeon Richter is and what it is used for
What you need to know before taking Lenalidomide Gedeon Richter
How to take Lenalidomide Gedeon Richter
Possible side effects
How to store Lenalidomide Gedeon Richter
Contents of the pack and other information

1. What Lenalidomide Gedeon Richter is and what it is used for

What Lenalidomide Gedeon Richter is
Lenalidomide Gedeon Richter contains the active substance "lenalidomide". This medicine belongs to a group of medicines that affect the immune system.
What Lenalidomide Gedeon Richter is used for
Lenalidomide Gedeon Richter is used in adult patients for the treatment of:

multiple myeloma,
myelodysplastic syndromes,
mantle cell lymphoma,
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 bone and kidney damage.
Multiple myeloma is generally 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 undergoing stem cell transplantation
In this indication, Lenalidomide Gedeon Richter is used alone as maintenance therapy following achievement of an adequate response after stem cell transplantation.
Newly diagnosed multiple myeloma – in patients who are not eligible for stem cell transplantation
Lenalidomide Gedeon Richter is taken in combination 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 initiated with additional medicines, followed by continuation with Lenalidomide Gedeon Richter alone.

If you are 75 years of age or older, or have moderate to severe kidney problems, your doctor will perform careful assessments before starting treatment.
Multiple myeloma – in previously treated patients
Lenalidomide Gedeon Richter is taken in combination with an anti-inflammatory medicine called "dexamethasone".
Lenalidomide Gedeon Richter 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 that 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 Gedeon Richter is used as monotherapy for the treatment of adult patients diagnosed with MDS, if 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 Gedeon Richter 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 result in a reduced need for blood transfusions. It may even become possible to discontinue transfusions altogether.

Mantle cell lymphoma (MCL)
MCL is a cancer affecting part of the immune system (lymphatic tissue). It attacks a certain type of white blood cells called B-lymphocytes or B-cells. Mantle cell lymphoma is characterized by uncontrolled growth of B-lymphocytes, leading to their accumulation in lymphatic tissue, bone marrow, or blood.
Lenalidomide Gedeon Richter, used as monotherapy, is indicated for the treatment of adult patients who have been previously treated with other medicines.

Follicular lymphoma (FL)
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 Gedeon Richter is taken in combination with another medicine called "rituximab" for the treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide Gedeon Richter works
Lenalidomide Gedeon Richter works by affecting the immune system and directly attacking cancer cells. The medicine acts in several different ways:

by inhibiting the growth of cancer cells,
by inhibiting the development of blood vessels in the tumour,
by stimulating part of the immune system to attack cancer cells.

2. Important information before taking Lenalidomide Gedeon Richter

Before starting treatment with Lenalidomide Gedeon Richter, carefully read the package leaflets of all medicinal products taken in combination with Lenalidomide Gedeon Richter.
When not to take Lenalidomide Gedeon Richter:

if the patient is pregnant, suspects she is pregnant, or plans to become pregnant, because Lenalidomide Gedeon Richter is expected to be harmful to the unborn child (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men").
if the patient could become pregnant, unless she uses all required contraceptive measures (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men"). If the patient could become pregnant, the doctor will always document that necessary precautions have been taken and confirm this with the patient.
if the patient is allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). If an allergy is suspected, consult a doctor for advice.

If any of these points apply to the patient, Lenalidomide Gedeon Richter must not be used. In case of doubt, consult a doctor.
Warnings and precautions
Before starting treatment with Lenalidomide Gedeon Richter, discuss with a doctor, pharmacist or nurse if the patient:

has previously had blood clots – this means an increased risk of developing blood clots in veins and arteries during treatment
has any signs of infection, such as cough or fever
currently has or has previously had a viral infection, particularly hepatitis B, varicella zoster virus (chickenpox and shingles) (Varicella Zoster), or HIV. In case of doubt, consult a doctor. Treatment with Lenalidomide Gedeon Richter may reactivate viruses in patients previously infected, leading to recurrence of infection. The doctor will check whether the patient has previously had hepatitis B
has kidney problems – the doctor may adjust the dose of Lenalidomide Gedeon Richter
has had a heart attack, ever had a blood clot, smokes, has high blood pressure or high cholesterol levels
experienced allergic reactions while taking thalidomide (another drug used in the treatment of multiple myeloma), such as rash, itching, swelling, dizziness or breathing difficulties
previously experienced any combination of the following symptoms: widespread rash, skin redness, high fever, flu-like symptoms, increased liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes – these are symptoms of a severe skin reaction called drug rash with eosinophilia and systemic symptoms, also known as “DRESS” (Drug Reaction with Eosinophilia and Systemic Symptoms) or “drug hypersensitivity syndrome” (see also section 4 “Possible side effects”).

If any of the above apply to the patient, consult a doctor, pharmacist or nurse before starting treatment.
At any time during or after treatment, the patient should immediately inform the doctor or nurse if any of the following occur:

vision disturbances, loss of vision or double vision, difficulty speaking, weakness in the arm or leg, change in gait or balance problems, persistent numbness, reduced sensation or loss of sensation, memory loss or disorientation. These may be symptoms of a serious and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML). If the patient had such symptoms 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 known as pulmonary hypertension (see section 4).

Tests and examinations
Before and during treatment with Lenalidomide Gedeon Richter, regular blood tests will be performed because Lenalidomide Gedeon Richter may reduce the number of blood cells that help fight infection (white blood cells) and help blood to clot (platelets).
The doctor will schedule 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 Gedeon Richter
If the patient has myelodysplastic syndromes (MDS), there is an increased likelihood of developing a serious disease called acute myeloid leukaemia. Furthermore, it is not known how Lenalidomide Gedeon Richter affects the risk of developing acute myeloid leukaemia. Therefore, the doctor may perform tests and check for signs that could better predict the risk of acute myeloid leukaemia during treatment with Lenalidomide Gedeon Richter.
Patients with MCL taking Lenalidomide Gedeon Richter
The doctor will request blood tests:

before treatment
weekly for the first 8 weeks (2 cycles) of treatment
thereafter every 2 weeks during cycles 3 and 4 (more information in section 3 "Treatment cycle")
then at the beginning of each cycle and
at least once a month.

Patients with FL taking Lenalidomide Gedeon Richter
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 tumour tissue in the body, including in the bone marrow. This may lead to a situation where tumour tissue begins to die and causes an abnormal increase in the concentration of various substances in the blood, potentially leading to kidney failure (a condition known as tumour lysis syndrome).
The doctor may examine the patient for skin changes such as red spots or rash.
The doctor may change the dose of Lenalidomide Gedeon Richter or interrupt treatment based on the patient's blood test results and general condition. If the disease was recently diagnosed, the doctor may also assess treatment considering the patient's age and other conditions the patient may have had in the past.
Blood donation
During treatment and for at least 7 days after treatment ends, the patient must not donate blood.
Children and adolescents
Lenalidomide Gedeon Richter is not recommended for use in children and adolescents under 18 years of age.
Elderly patients and patients with kidney problems
If the patient is 75 years of age or older, or has moderate to severe kidney problems, the doctor will perform thorough examinations before starting treatment.
Lenalidomide Gedeon Richter and other medicines
Inform the doctor or nurse about all medicines currently taken or recently taken. This is necessary because Lenalidomide Gedeon Richter may affect the action of other medicines. Likewise, other medicines may affect the action of Lenalidomide Gedeon Richter.
In particular, inform the doctor or nurse if the patient is taking the following medicines:

certain contraceptives, such as oral contraceptives, because they may stop working
certain medicines used for heart problems – such as digoxin
certain medicines used to thin the blood – such as warfarin.

Pregnancy and breastfeeding and contraception – information for women and men
Pregnancy
For women taking Lenalidomide Gedeon Richter

Do not use Lenalidomide Gedeon Richter if the patient is pregnant, because it is expected to be harmful to the unborn child.
Women must not become pregnant while taking Lenalidomide Gedeon Richter. Therefore, women who could become pregnant must use an effective method of contraception (see “Contraception”).
If the patient becomes pregnant during treatment with Lenalidomide Gedeon Richter, treatment must be stopped immediately and the doctor informed.

For men taking Lenalidomide Gedeon Richter

If the male patient’s partner becomes pregnant while he is being treated with Lenalidomide Gedeon Richter, she must immediately inform the doctor. The partner should seek medical advice.
Men must also use an effective method of contraception (see “Contraception”).

Breastfeeding
Do not breastfeed while taking Lenalidomide Gedeon Richter, because it is not known whether Lenalidomide Gedeon Richter passes into human milk.
Contraception
Women taking Lenalidomide Gedeon Richter
Before starting treatment, ask the doctor about the possibility of becoming pregnant, even if the patient considers it unlikely.
Women who could become pregnant:

will have pregnancy tests performed under the doctor’s supervision (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends), except in cases where the fallopian tubes have been cut and sealed to prevent the egg from reaching the uterus (tubal sterilisation) AND
must use effective methods of contraception 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 Gedeon Richter
Lenalidomide Gedeon Richter passes into human sperm. If a woman is pregnant or could become pregnant and is not using effective contraception, her partner should use a condom during treatment and for at least 7 days after treatment ends. This applies also to men who have had a vasectomy. During treatment and for at least 7 days after treatment ends, the patient must not donate semen or sperm.
Driving and using machines
Do not drive or operate machinery if the patient experiences dizziness, fatigue, drowsiness, balance disturbances due to dizziness, or blurred vision after taking Lenalidomide Gedeon Richter.
Lenalidomide Gedeon Richter contains lactose, tartrazine, sunset yellow and allura red.
Lenalidomide Gedeon Richter contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking Lenalidomide Gedeon Richter.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, meaning the medicine is considered "sodium-free".
[ Dose 2.5 mg ]
Lenalidomide Gedeon Richter contains allura red (E 129), which may cause allergic reactions.
[ Dose 5 mg and 7.5 mg ]
Lenalidomide Gedeon Richter contains sunset yellow (E 110), which may cause allergic reactions.
[ Dose 10 mg ]
Lenalidomide Gedeon Richter contains tartrazine (E 102), sunset yellow (E110) and allura red (E129), which may cause allergic reactions.
[ Dose 15 mg ]
Lenalidomide Gedeon Richter contains tartrazine (E 102) and allura red (E 129), which may cause allergic reactions.
[ Dose 20 mg ]
Lenalidomide Gedeon Richter contains allura red (E 129), which may cause allergic reactions.

3. How to take Lenalidomide Gedeon Richter
Lenalidomide Gedeon Richter must be administered by healthcare professionals experienced in the treatment of multiple myeloma, myelodysplastic syndromes (MDS), mantle cell lymphoma (MCL) or follicular lymphoma (FL).

When Lenalidomide Gedeon Richter is used to treat multiple myeloma in patients who are not eligible for bone marrow transplantation or who have previously received other treatment, the medicine is used in combination with other drugs (see section 1 “Why Lenalidomide Gedeon Richter is used”).
When Lenalidomide Gedeon Richter is used to treat multiple myeloma in patients after bone marrow transplantation, the medicine should be used as monotherapy.
When Lenalidomide Gedeon Richter is used to treat follicular lymphoma, it is taken together with another medicine called “rituximab”.

Lenalidomide Gedeon Richter should always be taken as directed by the doctor. In case of doubt, consult the doctor or pharmacist.
If the patient is taking Lenalidomide Gedeon Richter together with other medicines, they should read the package leaflet included with those medicines to obtain information about their use and action.
Treatment cycle
Lenalidomide Gedeon Richter is taken on specific days over a period of 3 weeks (21 days).

Each 21-day period is called a 'treatment cycle'.
Depending on the day of the cycle, the patient will take one or more medicines. However, on some days the patient will not take any medicines.
After completing each 21-day cycle, the patient should start a new 21-day 'cycle'. OR Lenalidomide Gedeon Richter is taken on specific days over a period of 4 weeks (28 days).
Each 28-day period is called a 'treatment cycle'.
Depending on the day of the cycle, the patient will take one or more medicines. However, on some days the patient will not take any medicines.
After completing each 28-day cycle, the patient should start a new 28-day 'cycle'.

Recommended dose of Lenalidomide Gedeon Richter
Before starting treatment, the doctor will inform the patient:

how much Lenalidomide Gedeon Richter to take
how much of other medicines to take in combination with Lenalidomide Gedeon Richter, if other medicines are required
on which days of the cycle to take which medicines.

How and when to take Lenalidomide Gedeon Richter

swallow the capsule whole, preferably with water.
do not break, open or chew the capsules. If powder from a damaged Lenalidomide Gedeon Richter 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. Hands should then be washed thoroughly with soap and water. Pregnant women or women who suspect they may be pregnant should not touch the blister pack or capsule.
capsules may be taken with or without food.
Lenalidomide Gedeon Richter should be taken approximately at the same time each day when scheduled.

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 the middle of the capsule, as this may damage it.

Hands and fingers showing step by step the process of removing a black, oval tablet from a plastic blister pack from left to right

Duration of treatment with Lenalidomide Gedeon Richter
Lenalidomide Gedeon Richter is used in treatment cycles; each cycle lasts 21 or 28 days (see above “Treatment cycle”). Treatment cycles should be continued until the doctor advises stopping.
Taking more than the recommended dose of Lenalidomide Gedeon Richter
If more than the prescribed dose of Lenalidomide Gedeon Richter is taken, inform the doctor immediately.
Missing a dose of Lenalidomide Gedeon Richter
If a dose of Lenalidomide Gedeon Richter is missed at the scheduled time and

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

If further doubts arise regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur, stop taking Lenalidomide Gedeon Richter
immediately and contact your doctor straight away – 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 over the entire body and associated with significant skin peeling (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
Widespread rash, high fever, 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 serious adverse reactions occur:

Fever, chills, sore throat, cough, mouth ulcers or any other signs of infection, including blood infections (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 Gedeon Richter 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 Gedeon Richter may also cause blood clots in the veins (thrombosis).
Other adverse reactions
Please note that in a small number of patients, other types of cancer may develop, and this risk may potentially increase with treatment with Lenalidomide Gedeon Richter. Therefore, your doctor should carefully assess the benefits and risks before prescribing Lenalidomide Gedeon Richter.
Very common adverse reactions (may occur in more than 1 in 10 people):

Decreased number of red blood cells, which may lead to anemia causing fatigue and weakness
Rash, itching
Muscle cramps, muscle weakness, muscle pain, muscle tenderness, bone pain, joint pain, back pain, limb pain
Generalized swelling, including swelling of hands and feet
Weakness, fatigue
Flu and flu-like symptoms, including fever, muscle pain, headache, earache, cough and chills
Numbness, tingling or burning sensation of the skin, pain in hands or feet, dizziness, tremor
Loss of appetite, altered taste sensation
Increased pain, enlargement or redness around a lump
Weight loss
Constipation, diarrhea, 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 indicate presence 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 abnormal kidney function or inability to maintain normal kidney function
Abnormal liver function tests
Increased liver function test values
Blood protein changes leading to blood vessel swelling (vasculitis)
Increased blood sugar levels (diabetes)
Decreased blood sugar levels
Headache
Nosebleeds
Dry skin
Depression, mood changes, sleep disturbances
Cough
Low blood pressure
Vague 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 (hemolytic anemia)
Certain types of skin tumors
Bleeding from gums, stomach or intestines
High blood pressure, slow, fast or irregular heartbeat
Increased levels of substances produced during normal and abnormal breakdown of red blood cells
Increased levels of a protein indicating inflammation in the body
Skin darkening; skin discoloration due to bleeding under the skin, usually caused by bruising; blood-filled skin swelling, bruises
Increased uric acid levels in the blood
Skin eruptions, skin redness, skin cracking, peeling or flaking, hives
Excessive sweating, night sweats
Difficulty swallowing, sore throat, voice quality problems or voice changes
Nasal inflammation (rhinitis)
Passing significantly more or significantly less urine than normal, or inability to control the timing of urination
Blood in the urine
Shortness of breath, especially when lying down (which may be a sign of heart failure)
Erectile dysfunction
Stroke, fainting, dizziness (inner ear disorder 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 signs of 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
Speech difficulties
Liver damage
Balance disorders, difficulty moving
Hearing loss, tinnitus (ringing in the ears)
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 problems
Loss of vision
Loss of sex drive (libido)
Passing large amounts of urine, accompanied by bone pain and weakness, which may be symptoms of kidney disease (Fanconi syndrome)
Yellowing of the skin, mucous membranes or eyes (jaundice), pale stools, dark urine, itchy skin, rash, abdominal pain or swelling – may be symptoms of liver damage (liver failure)
Abdominal pain, bloating or diarrhea, which may be symptoms of inflammation of the large intestine (colitis or typhlitis)
Kidney tubule cell damage (known as tubular necrosis)
Skin color changes, sensitivity to sunlight
Tumor lysis syndrome – metabolic complications that may occur during cancer treatment, and sometimes even without treatment. These complications are caused by products released from dying tumor 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 blood vessels leading to the lungs (pulmonary hypertension).

Adverse reactions of unknown frequency (frequency cannot be estimated from available data):

Sudden or mild but worsening pain in the upper abdomen and/or back, lasting for several days, usually accompanied by nausea, vomiting, fever and rapid pulse – these symptoms may occur in association with 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) leading to kidney problems (rhabdomyolysis) have been observed, some occurring when Lenalidomide Gedeon Richter was administered concomitantly with a statin (a type of medicine that lowers blood cholesterol levels).
Skin disease caused by inflammation of small blood vessels, associated 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 stomach pain, fever, nausea, vomiting, blood in stool or changes in bowel function.
Viral infections, including herpes zoster (a viral disease causing a painful skin rash with blisters) and reactivation of hepatitis B virus infection (which may cause yellowing of the skin and eyes, dark brown urine, pain in the right lower abdomen, fever, nausea and vomiting).
Rejection of solid organ transplant (e.g. kidney, heart).

Reporting of adverse reactions:
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Lenalidomide Gedeon Richter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after:
"EXP" or Expiry date (EXP). The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Do not use this medicine if you notice any damage or signs of tampering with the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the pack and other information

What Lenalidomide Gedeon Richter contains
Lenalidomide Gedeon Richter, 2.5 mg, hard capsules

The active substance is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
Other ingredients are:
Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
Capsule shell: brilliant blue (E 133), erythrosine (E 127), allura red (E 129) (see section 2), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), and gelatin
Printing ink: shellac, propylene glycol, ammonia, iron oxide black (E 172), and potassium hydroxide

Lenalidomide Gedeon Richter, 5 mg, hard capsules

The active substance is lenalidomide. Each capsule contains 5 mg of lenalidomide.
Other ingredients are:
Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
Capsule shell: brilliant blue (E 133), orange yellow (E 110) (see section 2), iron oxide black (E 172), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), and gelatin
Printing ink: shellac, propylene glycol, ammonia, iron oxide black (E 172), and potassium hydroxide

Lenalidomide Gedeon Richter, 7.5 mg, hard capsules

The active substance is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
Other ingredients are:
Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
Capsule shell: brilliant blue (E 133), erythrosine (E 127), orange yellow (E 110) (see section 2), titanium dioxide (E 171), and gelatin
Printing ink: shellac, propylene glycol, ammonia, iron oxide black (E 172), and potassium hydroxide

Lenalidomide Gedeon Richter, 10 mg, hard capsules

The active substance is lenalidomide. Each capsule contains 10 mg of lenalidomide.
Other ingredients are:
Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
Capsule shell: brilliant blue (E 133), allura red (E 129) (see section 2), tartrazine (E 102) (see section 2), orange yellow (E 110) (see section 2), titanium dioxide (E 171), and gelatin
Printing ink: shellac, propylene glycol, ammonia, iron oxide black (E 172), and potassium hydroxide

Lenalidomide Gedeon Richter, 15 mg, hard capsules

The active substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.
Other ingredients are:
Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
Capsule shell: brilliant blue (E 133), allura red (E 129) (see section 2), tartrazine (E 102) (see section 2), iron oxide black (E 172), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), and gelatin
Printing ink: shellac, propylene glycol, ammonia, iron oxide black (E 172), and potassium hydroxide

Lenalidomide Gedeon Richter, 20 mg, hard capsules

The active substance is lenalidomide. Each capsule contains 20 mg of lenalidomide.
Other ingredients are:
Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
Capsule shell: brilliant blue (E 133), allura red (E 129) (see section 2), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), and gelatin
Printing ink: shellac, propylene glycol, ammonia, iron oxide black (E 172), and potassium hydroxide

Lenalidomide Gedeon Richter, 25 mg, hard capsules

The active substance is lenalidomide. Each capsule contains 25 mg of lenalidomide.
Other ingredients are:
Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
Capsule shell: titanium dioxide (E 171) and gelatin
Printing ink: shellac, propylene glycol, ammonia, iron oxide black (E 172), and potassium hydroxide

What Lenalidomide Gedeon Richter looks like and contents of the pack
Lenalidomide Gedeon Richter, 2.5 mg, hard capsules have a dark blue opaque cap and a light orange opaque body, capsule size 4, 14-15 mm, with black printing "LP" on the cap and "637" on the body.
Lenalidomide Gedeon Richter, 5 mg, hard capsules have a green opaque cap and a light brown opaque body, capsule size 2, 18-19 mm, with black printing "LP" on the cap and "638" on the body.
Lenalidomide Gedeon Richter, 7.5 mg, hard capsules have a violet opaque cap and a pink opaque body, capsule size 1, 19-20 mm, with black printing "LP" on the cap and "643" on the body.
Lenalidomide Gedeon Richter, 10 mg, hard capsules have a yellow opaque cap and a grey opaque body, capsule size 0, 21-22 mm, with black printing "LP" on the cap and "639" on the body.
Lenalidomide Gedeon Richter, 15 mg, hard capsules have a brown opaque cap and a grey opaque body, capsule size 2, 18-19 mm, with black printing "LP" on the cap and "640" on the body.
Lenalidomide Gedeon Richter, 20 mg, hard capsules have a dark red opaque cap and a light grey opaque body, capsule size 1, 19-20 mm, with black printing "LP" on the cap and "641" on the body.
Lenalidomide Gedeon Richter, 25 mg, hard capsules have a white opaque cap and a white opaque body, capsule size 0, 21-22 mm, with black printing "LP" on the cap and "642" on the body.
Cardboard box containing a blister made of polyvinyl chloride (PVC)/ACLAR/aluminum, each containing 7 hard capsules.
Lenalidomide Gedeon Richter, 2.5 mg and 5 mg
Pack size: 7 or 21 capsules. Not all pack sizes may be marketed.
Lenalidomide Gedeon Richter, 7.5 mg, 20 mg and 25 mg
Pack size: 21 capsules.
Lenalidomide Gedeon Richter, 10 mg and 15 mg
Pack size: 21 capsules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

Manufacturer/Importer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Adalvo Ltd.
Malta Life Sciences Park
Building 1, Level 4
Sir Temi Zammit Buildings
San Gwann SGN 3000, Malta

This medicinal product is authorised in the European Economic Area under the following names:
Iceland Lenalidomide Gedeon Richter
Czech Republic Lenalidomide Gedeon Richter
Poland Lenalidomide Gedeon Richter