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

Read this entire 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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you specifically. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Lenalidomide Gedeon Richter is and what it is used for
Important information 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 function of 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 (MDS),
mantle cell lymphoma (MCL),
follicular lymphoma (FL).

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 autologous stem cell transplantation
In this indication, Lenalidomide Gedeon Richter is used as monotherapy for maintenance treatment following achievement of an adequate response after autologous stem cell transplantation.

Newly diagnosed multiple myeloma in patients 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 thorough 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 and do not function properly. Patients may experience various subjective and objective symptoms, including low red blood cell count (anaemia), need for blood transfusions, and risk of infection.

Lenalidomide Gedeon Richter, as monotherapy, is used to treat adult patients diagnosed with MDS if all 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 increase the production of healthy blood cells 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.

Mantle cell lymphoma (MCL)
MCL is a cancer affecting part of the immune system (lymphatic tissue). It attacks a 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, as monotherapy, is used in 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 together 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 tumours,
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). In case of suspected allergy, 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 the doctor, pharmacist or nurse if the patient:

has previously had blood clots – this increases the 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). 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 (heart attack), has ever had a blood clot, if the patient smokes, has high blood pressure or high cholesterol levels
experienced allergic reactions while taking thalidomide (another medicine used in the treatment of multiple myeloma), such as rash, itching, swelling, dizziness or difficulty breathing
previously experienced a combination of any of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, increased liver enzyme activity, blood abnormalities (eosinophilia), enlarged 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 the 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 disturbances, 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 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 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. In addition, it is unknown how Lenalidomide Gedeon Richter affects the risk of developing acute myeloid leukaemia. Therefore, the doctor may perform tests and check for signs that help better predict the risk of acute myeloid leukaemia during treatment with Lenalidomide 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
then 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
then every 2 weeks during cycles 2 to 4 (more information in section 3 “Treatment cycle”)
then at the beginning of each cycle and
at least once a month.

The doctor may perform an examination 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, causing abnormal increases in various substances in the blood, which may lead to kidney failure (a condition called tumour lysis syndrome).
The doctor may examine the patient to check for skin changes such as red spots or rash.
The doctor may adjust the dose of Lenalidomide Gedeon Richter or discontinue treatment based on blood test results and the patient's general condition. If the disease was recently diagnosed, the doctor may also assess treatment based on the patient's age and other conditions that may have occurred 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
Tell the doctor or nurse about all medicines the patient is currently taking or has recently taken. This is necessary because Lenalidomide Gedeon Richter may affect the action of other medicines. Other medicines may also 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, as 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

Lenalidomide Gedeon Richter must not be used 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 female partner of a man undergoing treatment with Lenalidomide Gedeon Richter becomes pregnant, she must inform the doctor immediately. The partner should seek medical advice.
Men must also use an effective method of contraception (see “Contraception”).

Breastfeeding
Breastfeeding must not be done 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 medical 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 must 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, imbalance 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 of 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 in the treatment of 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 medicines (see section 1 “Why is Lenalidomide Gedeon Richter used?”).
When Lenalidomide Gedeon Richter is used in the treatment of multiple myeloma in patients after bone marrow transplantation, the medicine should be used as monotherapy.
When Lenalidomide Gedeon Richter is used in the treatment of follicular lymphoma, it is taken together with another medicine called “rituximab”.

Lenalidomide Gedeon Richter should always be taken according to the doctor's instructions. 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 on their use and action.
Treatment cycle
Lenalidomide Gedeon Richter is taken on specific days within a 3-week period (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 within a 4-week period (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 many 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 crush, 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 thoroughly washed 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 at approximately the same time each day on which it is 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 on the centre of the capsule, as this may damage it.

Hands and fingers demonstrating step by step the process of removing a black, oval cap from a white, flat medical device

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 there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If any of the following serious side effects occur, stop taking
Lenalidomide Gedeon Richter and contact your doctor immediately – you may
need urgent medical treatment:

Hives, rash, swelling of the eyes, lips or face, difficulty breathing or itching, which may be symptoms of serious allergic reactions called angioedema and anaphylactic reaction.
Severe allergic reaction that may start as a rash in one area and spread over the entire body, accompanied by 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 side effects 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 calcium levels in the blood.

Lenalidomide Gedeon Richter may reduce the number of white blood cells that fight infection, as well as blood cells that help blood to clot (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 side effects
It should be noted that in a small number of patients, other types of cancer may develop, and treatment with Lenalidomide Gedeon Richter may possibly increase this risk. Therefore, your doctor should carefully assess the benefits and risks before prescribing Lenalidomide Gedeon Richter to you.
Very common side effects (may affect more than 1 in 10 people):

Decrease in red blood cells, which may cause anaemia leading to tiredness and weakness
Skin rashes, itching
Muscle cramps, muscle weakness, muscle pain, bone pain, joint pain, back pain, limb pain
General swelling, including swelling of hands and feet
Weakness, fatigue
Flu 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
Loss of appetite, altered taste sensation
Increased pain, swelling or redness around a tumour
Weight loss
Constipation, diarrhoea, nausea, vomiting, abdominal pain, heartburn
Low levels of potassium or calcium and/or sodium in the blood
Underactive thyroid gland
Leg pain (which may be a sign of thrombosis), chest pain or shortness of breath (which may be symptoms of blood clots in the lungs, known as pulmonary embolism)
All types of infections, including sinus infection, lung infection and upper respiratory tract infections
Shortness of breath
Blurred vision
Cloudy vision (cataract)
Kidney problems, including abnormal kidney function or inability to maintain normal kidney function
Abnormal liver function tests
Increased liver function test values
Changes in blood proteins leading to blood vessel inflammation (vasculitis)
Increased blood sugar levels (diabetes)
Decreased blood sugar levels
Headache
Nosebleeds
Dry skin
Depression, mood changes, sleep disturbances
Cough
Low blood pressure
Vague feeling of physical discomfort, malaise
Painful inflammation of the mouth, dry mouth
Dehydration.

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

Breakdown of red blood cells (haemolytic anaemia)
Certain types of skin tumours
Bleeding from gums, stomach or intestines
Increased blood pressure, slow, fast or irregular heartbeat
Increased levels of substances produced during 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 skin swelling, bruising
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
Rhinitis (runny nose)
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 difficulties
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, sweating, shortness of breath, nausea or vomiting, which may be symptoms of a heart attack (myocardial infarction)
Muscle weakness, lack of energy
Neck pain, chest pain
Chills
Joint swelling
Slowing or blockage of bile flow from the liver
Low levels of phosphates or magnesium in the blood
Speech difficulties
Liver damage
Loss of balance, 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 side effects (may affect 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-coloured stools, dark-coloured urine, itchy skin, rash, abdominal pain or swelling – may be symptoms of liver damage (liver failure)
Abdominal pain, bloating or diarrhoea, which may be symptoms of inflammation of the large intestine (colitis or diverticulitis)
Kidney tubular damage (known as tubular necrosis)
Skin colour changes, sensitivity to sunlight
Tumour lysis syndrome – metabolic complications that may occur during cancer treatment, and sometimes even without treatment. These complications are caused by the breakdown products of dying tumour cells and may include: changes in blood chemistry; high levels of potassium, phosphate and uric acid, and low calcium levels, leading to kidney dysfunction, irregular heart rhythm, seizures, and sometimes death
High blood pressure in the blood vessels leading to the lungs (pulmonary hypertension).

Side effects with 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 heartbeat – these symptoms may occur in connection with pancreatitis.
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) leading to kidney problems (rhabdomyolysis) have been observed, some of them 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, accompanied by 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 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 infection (which may cause yellowing of the skin and eyes, dark brown urine, pain in the right lower abdomen, fever, nausea and vomiting).
Solid organ transplant rejection (e.g. kidney, heart).

Reporting of side effects:
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects 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 .
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Lenalidomide Gedeon Richter

Keep this medicine out of 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 apply 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.
The 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.
The other ingredients are:
Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
Capsule shell: brilliant blue (E 133), sunset 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.
The 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), sunset 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.
The 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), sunset 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.
The 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.
The 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.
The 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 dark blue opaque cap and light orange opaque body, capsule size 4, 14-15 mm, with black print "LP" on the cap and "637" on the body.
Lenalidomide Gedeon Richter, 5 mg, hard capsules have green opaque cap and light brown opaque body, capsule size 2, 18-19 mm, with black print "LP" on the cap and "638" on the body.
Lenalidomide Gedeon Richter, 7.5 mg, hard capsules have violet opaque cap and pink opaque body, capsule size 1, 19-20 mm, with black print "LP" on the cap and "643" on the body.
Lenalidomide Gedeon Richter, 10 mg, hard capsules have yellow opaque cap and grey opaque body, capsule size 0, 21-22 mm, with black print "LP" on the cap and "639" on the body.
Lenalidomide Gedeon Richter, 15 mg, hard capsules have brown opaque cap and grey opaque body, capsule size 2, 18-19 mm, with black print "LP" on the cap and "640" on the body.
Lenalidomide Gedeon Richter, 20 mg, hard capsules have dark red opaque cap and light grey opaque body, capsule size 1, 19-20 mm, with black print "LP" on the cap and "641" on the body.
Lenalidomide Gedeon Richter, 25 mg, hard capsules have white opaque cap and white opaque body, capsule size 0, 21-22 mm, with black print "LP" on the cap and "642" on the body.
Carton pack containing a blister made of polyvinyl chloride (PVC)/ACLAR/aluminium, 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 for marketing in the European Economic Area under the following names:
Iceland Lenalidomide Gedeon Richter
Czech Republic Lenalidomide Gedeon Richter
Poland Lenalidomide Gedeon Richter