Package leaflet: Information for the user

Lenalidomide Krka 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, 25 mg hard capsules

lenalidomide
Read all of this leaflet carefully before you start taking this medicine because 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What Lenalidomide Krka is
Lenalidomide Krka contains the active substance “lenalidomide”. This medicine belongs to a group of medicines that affect the functioning of the immune system.
What Lenalidomide Krka is used for
Lenalidomide Krka is used in adults for:

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 can damage the bones and kidneys.
Multiple myeloma is generally incurable. However, signs and symptoms can be significantly reduced or disappear for a certain period. This outcome is called a “response”.
Newly diagnosed multiple myeloma: in patients undergoing bone marrow transplant
Lenalidomide Krka 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 Krka 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 immunosuppressive medicine called “prednisone”. You will take these other medicines at the beginning of treatment and then continue taking Lenalidomide Krka alone.

If you are 75 years of age or older or have moderate to severe kidney problems, your doctor will closely monitor you before starting treatment.
Multiple myeloma: in patients previously treated
Lenalidomide Krka is taken together with an anti-inflammatory medicine called “dexamethasone”.
Lenalidomide Krka can stop the worsening of signs and symptoms of multiple myeloma. It has also been shown to delay the return of multiple myeloma after treatment.
Myelodysplastic syndromes (MDS)
MDS are a group of different blood and bone marrow diseases. Blood cells become abnormal and do not function properly. Patients may experience various signs and symptoms, including a low number of red blood cells (anaemia), the need for blood transfusions, and risk of infection.
Lenalidomide Krka alone is used to treat adult patients diagnosed with MDS who meet all of the following conditions:

if they require regular blood transfusions to treat low levels of red blood cells (“transfusion-dependent anaemia”)
if they have an abnormality in bone marrow cells called “isolated del(5q) cytogenetic abnormality”. This means that their body does not produce enough healthy blood cells
if previous treatments have not been suitable or have not been effective enough.

Lenalidomide Krka can increase the number of healthy red blood cells produced by the body, reducing the number of abnormal cells:

this may reduce the number of blood transfusions needed. You may no longer require any transfusions.

Mantle cell lymphoma (MCL)
MCL is a cancer of part of the immune system (lymphatic tissue). It affects a type of white blood cells called B-lymphocytes, or B-cells. In MCL, B-lymphocytes grow uncontrollably and accumulate in lymphatic tissue, bone marrow, or blood.
Lenalidomide Krka is used alone to treat adult patients previously treated with other medicines.
Follicular lymphoma (FL)
FL is a slow-growing form of cancer that affects B-lymphocytes, a type of white blood cells that help the body fight infections. In FL, an excessive number of these B-lymphocytes may accumulate in the blood, bone marrow, lymph nodes, and spleen.
Lenalidomide Krka is taken together with another medicine called “rituximab” for the treatment of adult patients with previously treated follicular lymphoma.
How Lenalidomide Krka works
Lenalidomide Krka acts on the body's immune system and directly on the tumour in several ways:

by stopping the development of tumour cells
by stopping the growth of blood vessels that supply blood to tumour cells
by stimulating part of the immune system so that it attacks tumour cells.

2. What you should know before taking Lenalidomide Krka

Before starting treatment with Lenalidomide Krka, you must read the package leaflet of all
medicines that you are required to take in combination with Lenalidomide Krka.
Do not take Lenalidomide Krka

If you are pregnant, think you may be pregnant, or if you are planning a pregnancy, because Lenalidomide Krka is expected to be harmful to the unborn baby (see section 2, 'Pregnancy, breastfeeding and contraception – information for women and men').
If there is any possibility that you may become pregnant unless you follow all necessary measures to avoid pregnancy (see section 2 'Pregnancy, breastfeeding and contraception – information for women and men'). If there is any possibility of becoming pregnant, your doctor will record and confirm at each prescription that the necessary measures to prevent pregnancy have been taken.
If you are allergic to lenalidomide or to any of the other ingredients of this medicine (listed in section 6). If you think you are allergic, consult your doctor.

If any of these conditions apply to you, do not take Lenalidomide Krka. If you have any doubts, consult your
doctor.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before taking Lenalidomide Krka if:

you have previously experienced episodes of blood clots, as the risk of developing blood clots in veins and arteries increases during treatment
you have any signs of infection, such as cough or fever
you currently have or have previously had a viral infection, particularly: hepatitis B infection, varicella-zoster, or HIV. If you have any doubts, consult your doctor. Treatment with Lenalidomide Krka may cause reactivation of the virus in patients who carry the virus, leading to recurrence of the infection. Your doctor must check whether you have previously had a hepatitis B infection
you have kidney problems – your doctor may adjust the dose of Lenalidomide Krka
you have had a heart attack, blood clots, or if you smoke, have high blood pressure, or high cholesterol levels
you have previously had an allergic reaction during treatment with thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing
you have previously experienced any combination of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), or 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, inform your doctor, pharmacist, or nurse before starting
treatment.
At any time during or after treatment, inform your doctor or nurse immediately if:

you experience blurred vision, loss of vision, double vision, difficulty speaking, weakness in one arm or leg, changes in walking or balance problems, persistent numbness, reduced sensation, 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 Krka, inform 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 monitoring
Before and during treatment with Lenalidomide Krka, you will undergo regular blood tests.
This is because Lenalidomide Krka may cause a reduction in blood cells that protect you
against infections (white blood cells) and those that help blood clot (platelets). Your
doctor will ask you to have blood tests:

before starting treatment
weekly for the first 8 weeks of treatment
then at least once a month thereafter.

You may be evaluated for signs of cardiopulmonary problems before and during treatment
with lenalidomide.
For patients with MDS taking Lenalidomide Krka
If you have MDS, you have a higher risk of developing a more advanced disease called
acute myeloid leukaemia (AML). Furthermore, the role of Lenalidomide Krka in the risk of
developing AML is not known. Your doctor may request certain tests to monitor signs that
could more accurately predict your risk of developing AML during treatment with
Lenalidomide Krka.
For patients with MCL taking Lenalidomide Krka
Your doctor will ask you to have a blood test:

before starting treatment
once a week for the first 8 weeks (2 cycles) of treatment
then every 2 weeks during cycles 3 and 4 (for further information see section 3 “Treatment cycle”)
subsequently at the beginning of each cycle and
at least once a month.

For patients with FL taking Lenalidomide Krka
Your doctor will ask you to have a blood test:

before starting treatment
once a week for the first 3 weeks (1 cycle) of treatment
then every 2 weeks during cycles 2 to 4 (for further information see section 3 “Treatment cycle”)
subsequently at the beginning of each cycle and at least once a month.

Your doctor may check whether you have a high tumour burden throughout the body, including in the bone
marrow. This could lead to a condition in which tumours break down and cause abnormally high levels of
chemicals in the blood, which may result in kidney failure (this condition is called “tumour lysis syndrome”).
Your doctor may monitor for skin changes, such as red spots or rashes.
Your doctor may decide to adjust the dose of Lenalidomide Krka or stop treatment depending on the results of blood tests and your general condition. If you are a newly diagnosed patient, your doctor may also consider treatment based on your age and other pre-existing conditions.
Blood donation
You must not donate blood during treatment with lenalidomide and for at least 7 days after
stopping treatment.
Children and adolescents
The use of Lenalidomide Krka is not recommended in children and adolescents under 18 years of age.
Elderly and patients with kidney problems
In patients aged 75 years or older, or with moderate or severe kidney problems, your doctor
will perform careful monitoring before starting treatment.
Other medicines and Lenalidomide Krka
Inform your doctor or nurse if you are taking, have recently taken, or might take any other
medicines. This is because Lenalidomide Krka may affect the action of other
medicines and other medicines may affect the action of Lenalidomide Krka.
In particular, inform your doctor or nurse if you are taking any of the following medicines:

certain medicines used to prevent pregnancy, such as oral contraceptives, because they may become less effective
certain medicines used for heart problems, such as digoxin
certain medicines used to thin the blood, such as warfarin.

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

You must not take Lenalidomide Krka if you are pregnant, as this medicine is expected to be harmful to the unborn baby.
During treatment with Lenalidomide Krka, you must not become pregnant. If there is any possibility of becoming pregnant, you must use effective contraceptive methods (see the section “Contraception”).
If you become pregnant during treatment with Lenalidomide Krka, you must stop treatment immediately and inform your doctor.

For men taking Lenalidomide Krka

If your partner becomes pregnant while you are taking Lenalidomide Krka, inform your doctor immediately. It is also recommended that your partner contacts her doctor.
In addition, you must use effective contraceptive methods (see the section “Contraception”).

Breastfeeding
You must not breastfeed while taking Lenalidomide Krka, as it is not known whether this medicine passes
into breast milk.
Contraception
For women taking Lenalidomide Krka
Before starting treatment, ask your doctor whether there is any possibility that you could become pregnant, even if you think it is unlikely.
If there is any possibility of becoming pregnant

you will need to 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 stopping treatment), except in cases where it has been confirmed that your fallopian tubes have been cut and sealed to prevent eggs from reaching the uterus (sterilisation 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 necessary information regarding appropriate contraceptive methods.

For men taking Lenalidomide Krka
Lenalidomide Krka is present in human semen. If there is any possibility that your partner is pregnant or could become pregnant and she is not using effective contraceptive methods, you must use condoms during treatment and for at least 7 days after stopping treatment, even if you have had a vasectomy. You must not donate semen or sperm during treatment with lenalidomide and for at least 7 days after stopping treatment.
Driving and using machines
Do not drive or operate machinery if you experience dizziness, fatigue, drowsiness, vertigo, or blurred vision
after taking Lenalidomide Krka.

3. How to take Lenalidomide Krka

Lenalidomide Krka must be prescribed by healthcare professionals experienced in the treatment of
multiple myeloma, MDS, MCL, or FL.

When Lenalidomide Krka is used to treat multiple myeloma in patients who cannot undergo bone marrow transplantation or who have previously received other treatments, it is taken in combination with other medicines (see section 1 “What Lenalidomide Krka is and what it is used for”).
When Lenalidomide Krka is used to treat multiple myeloma in patients who have undergone bone marrow transplantation, or to treat patients with MDS or MCL, it is taken alone.
When Lenalidomide Krka is used to treat follicular lymphoma, it is taken in combination with another medicine called "rituximab".

Always take Lenalidomide Krka exactly as instructed by your doctor. If you have any doubts, consult
your doctor or pharmacist.
If you are taking Lenalidomide Krka in combination with other medicines, please refer to the package leaflet
of those medicines for further information on their use and side effects.

Treatment cycle
Lenalidomide Krka is taken on certain days within a 3-week period (21 days).

Each 21-day period is called a "treatment cycle".
Depending on the day of the cycle, you will take one or more medicines. However, on some days you will not take any medicine.
After completing each 21-day cycle, you should start a new "cycle" within the following 21 days. OR

Lenalidomide Krka is taken on certain days within a 4-week period (28 days).

Each 28-day period is called a "treatment cycle".
Depending on the day of the cycle, you will take one or more medicines. However, on some days you will not take any medicine.
After completing each 28-day cycle, you should start a new "cycle" within the following 28 days.

Dose of Lenalidomide Krka to be taken
Before starting treatment, your doctor will inform you:

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

How and when to take Lenalidomide Krka

swallow the capsules whole, preferably with water.
do not break, open, or chew the capsules. If the powder from a broken Lenalidomide Krka capsule comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
healthcare providers, 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 bag, and disposed of according to local regulations. Hands should then be washed thoroughly with soap and water. Pregnant women, or those who suspect they may be pregnant, must not handle the blister pack or capsule.
the capsules may be taken with or without food.
you must take Lenalidomide Krka on the scheduled days at approximately the same time each day.

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

Hold the blister by the edges and separate one end of the blister from the rest by gently tearing along the perforations around it.
Lift the edge of the foil and completely peel back the foil.
Push the capsule out into your hand.
Swallow the capsule whole, preferably with water.

Four numbered illustrations show the steps for opening a package, removing the seal, detaching the cap, and withdrawing the contents

Duration of treatment with Lenalidomide Krka
Lenalidomide Krka 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.

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

If you forget to take Lenalidomide Krka
If you forget to take Lenalidomide Krka at your usual time and:

less than 12 hours have passed: take your capsule immediately
more than 12 hours have passed: do not take the missed capsule; instead, take the next capsule at the usual time the following day.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Lenalidomide Krka and contact your doctor immediately if you experience any of the
following serious side effects – urgent medical treatment may be required:

Hives, skin rash, swelling of the eyes, mouth or face, difficulty breathing or itching, which may be symptoms of serious types of allergic reactions called angioedema and anaphylactic reaction.
Severe allergic reaction, which may start as a rash in one area but spreads with extensive skin loss over 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 involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.

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

Fever, chills, sore throat, cough, mouth ulcers or any other sign of infection, including 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 high levels of calcium in the blood.

Lenalidomide Krka may reduce the number of white blood cells that fight infections and also the blood
cells that help blood clot (platelets), which may lead to bleeding disorders such as nosebleeds and
bruising. Lenalidomide Krka may 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 this
risk may possibly increase with treatment with Lenalidomide Krka. Therefore, your doctor must
carefully evaluate the benefits and risks when prescribing Lenalidomide Krka to you.
Very common (may affect more than 1 in 10 people):

Decrease in the number of red blood cells, which may cause anaemia and lead to fatigue and weakness
Rash, itching
Muscle cramps, muscle weakness, acute muscle pain, muscle ache, bone pain, joint pain, back pain, pain in limbs
Generalised swelling, including swelling of arms and legs
Weakness, fatigue
Fever and flu-like symptoms, including fever, muscle pain, headache, earache, cough and chills
Numbness, tingling or burning sensation on the skin, pain in hands or feet, dizziness, tremor
Loss of appetite, altered sense of taste
Increase in pain, size of tumour or redness around tumour
Loss of body weight
Constipation, diarrhoea, nausea, vomiting, stomach pain, heartburn
Low levels of potassium or calcium and/or sodium in the blood
Underactive thyroid gland
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 type, including infections of the sinuses around the nose, lungs and upper respiratory tract
Shortness of breath
Blurred vision
Clouding of the vision (cataract)
Kidney problems, including impaired kidney function or inability of the kidneys to maintain normal function
Abnormal liver function test results
Increase in liver function test values
Changes in a protein in the blood that may cause swelling of the arteries (vasculitis)
Increased blood sugar levels (diabetes)
Decreased blood sugar levels
Headache
Nosebleeds
Dry skin
Depression, mood changes, difficulty sleeping
Cough
Low blood pressure
Vague feeling of physical discomfort, malaise
Inflammation of the mouth, dry mouth
Dehydration

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

Destruction of red blood cells in the blood (haemolytic anaemia)
Certain types of skin cancer
Bleeding from gums, stomach or intestine
Increased blood pressure, slow, fast or irregular heartbeat
Increase in a substance resulting from normal and abnormal breakdown of red blood cells
Increase in a type of protein indicating inflammation in the body
Darkening of the skin; skin colour changes due to bleeding under the skin, typically caused by bruising; skin swelling due to blood; bruising
Increased uric acid levels in the blood
Skin rashes, redness of the skin, skin cracking, peeling or flaking, hives
Increased sweating, night sweats
Difficulty swallowing, sore throat, voice quality problems or voice changes
Runny nose
Urine output much greater or less than usual, or inability to control the urge to urinate
Presence of blood in the urine
Shortness of breath, especially when lying down (which may be a symptom of heart failure)
Difficulty achieving an erection
Stroke, fainting, dizziness (inner ear problem causing a spinning sensation), temporary loss of consciousness
Chest pain radiating to arms, neck, jaw, back or stomach, feeling of sweating and breathlessness, feeling of discomfort or vomiting, which may be symptoms of a heart attack (myocardial infarction)
Muscle weakness, lack of energy
Neck pain, chest pain
Chills
Swelling of joints
Slowing or blockage of bile flow 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 touch
Excess iron in the blood
Thirst
Confusion
Toothache
Falls, which may result in injury

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

Bleeding within the skull
Circulatory problems
Loss of vision
Loss of sexual desire (libido)
Abundant urine flow with pain and bone weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)
Yellowing of the skin, mucous membranes or eyes (jaundice), pale stools, dark urine, itchy skin, rash, stomach pain or swelling. These may be symptoms of liver damage (liver failure).
Stomach pain, swelling or diarrhoea, which may be symptoms of inflammation of the large intestine (called colitis or typhlitis)
Damage to kidney cells (called renal tubular necrosis)
Changes in skin colour, sensitivity to sunlight
Tumour lysis syndrome: metabolic complications that may occur during anti-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 parameters with high levels of potassium, phosphate and uric acid, and low calcium levels, leading to changes in kidney function and heart rhythm, seizures and, sometimes, death.
Increased blood pressure in the blood vessels leading to the lungs (pulmonary hypertension).

Not known (frequency cannot be estimated from the available data):

Sudden, or mild but worsening, upper abdominal and/or back pain lasting for several days, possibly accompanied by 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 (muscle pain, weakness or swelling), which may lead to kidney problems (rhabdomyolysis), some of which occurred when Lenalidomide Krka was administered with a statin (a type of cholesterol-lowering medicine).
A skin disease caused by inflammation of small blood vessels, with joint pain and fever (leukocytoclastic vasculitis).
Deterioration of the stomach or intestinal wall, which may lead to severe infections. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in stools or changes in bowel habits.
Viral infections, including herpes zoster (also known as shingles, a viral disease causing a painful rash with blisters) and reactivation of hepatitis B infection (which may cause yellowing of the skin and eyes, dark brown urine, stomach pain on the right side, fever and nausea or vomiting).
Rejection of solid organ transplant (such as kidney, heart)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or
pharmacist. You can also report side effects directly via the national reporting system listed in
Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Lenalidomide Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after
"Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lenalidomide Krka contains

The active substance is lenalidomide. Each hard capsule contains lenalidomide hydrochloride monohydrate equivalent to 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, or 25 mg of lenalidomide.
The other components of the capsule contents are: mannitol (E421), microcrystalline cellulose (E460), pregelatinized corn starch, tartaric acid (E334), and glyceryl dibehenate.
The other components of the capsule coating are:

Lenalidomide Krka 2.5 mg hard capsules:
hypromellose, carrageenan (E 407), potassium chloride (E 508), titanium dioxide (E 171), yellow iron oxide (E 172), indigotine (E 132), printing ink (shellac (E 904), black iron oxide (E 172)).
Lenalidomide Krka 5 mg hard capsules:
hypromellose, carrageenan (E 407), potassium chloride (E 508), titanium dioxide (E 171), indigotine (E 132), printing ink (shellac (E 904), black iron oxide (E 172)).
Lenalidomide Krka 7.5 mg hard capsules:
hypromellose, carrageenan (E 407), potassium chloride (E 508), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172), printing ink (shellac (E 904), povidone, titanium dioxide (E 171)).
Lenalidomide Krka 10 mg hard capsules:
hypromellose, carrageenan (E 407), potassium chloride (E 508), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172), indigotine (E 132), printing ink (shellac (E 904), povidone, titanium dioxide (E 171)).
Lenalidomide Krka 15 mg hard capsules:
hypromellose, carrageenan (E 407), potassium chloride (E 508), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172), indigotine (E 132), printing ink (shellac (E 904), black iron oxide (E 172)).
Lenalidomide Krka 20 mg hard capsules:
hypromellose, carrageenan (E 407), potassium chloride (E 508), titanium dioxide (E 171), yellow iron oxide (E 172), indigotine (E 132), printing ink (shellac (E 904), black iron oxide (E 172)).
Lenalidomide Krka 25 mg hard capsules:
hypromellose, carrageenan (E 407), potassium chloride (E 508), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172), printing ink (shellac (E904), povidone, titanium dioxide (E 171)).

Description of the appearance of Lenalidomide Krka and contents of the pack

Lenalidomide Krka 2.5 mg hard capsules (capsules):
The cap of the capsule is green, the body of the capsule is green with a black mark imprinted "2.5". The capsule contents are white to off-white or white to light brown powder. Size of the hard capsule: 4, length 14 ± 1 mm.

Lenalidomide Krka 5 mg hard capsules (capsules):
The cap of the capsule is blue, the body of the capsule is blue with a black mark imprinted "5". The capsule contents are white to off-white or white to light brown powder. Size of the hard capsule: 2, length 18 ± 1 mm.

Lenalidomide Krka 7.5 mg hard capsules (capsules):
The cap of the capsule is brown, the body of the capsule is brown with a white mark imprinted "7.5". The capsule contents are white to off-white or white to light brown powder. Size of the hard capsule: 1, length 19 ± 1 mm.

Lenalidomide Krka 10 mg hard capsules (capsules):
The cap of the capsule is green, the body of the capsule is brown with a white mark imprinted "10". The capsule contents are white to off-white or white to light brown powder. Size of the hard capsule: 0, length 21 ± 1 mm.

Lenalidomide Krka 15 mg hard capsules (capsules):
The cap of the capsule is brown, the body of the capsule is blue with a black mark imprinted "15". The capsule contents are white to off-white or white to light brown powder. Size of the hard capsule: 2, length 18 ± 1 mm.

Lenalidomide Krka 20 mg hard capsules (capsules):
The cap of the capsule is green, the body of the capsule is blue with a black mark imprinted "20". The capsule contents are white to off-white or white to light brown powder. Size of the hard capsule: 1, length 19 ± 1 mm.

Lenalidomide Krka 25 mg hard capsules (capsules):
The cap of the capsule is brown, the body of the capsule is brown with a white mark imprinted "25". The capsule contents are white to off-white or white to light brown powder. Size of the hard capsule: 0, length 21 ± 1 mm.

Lenalidomide Krka is available in packs containing 7 x 1 or 21 x 1 hard capsules in peelable blisters, divided into single-dose units in calendar packaging.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA – FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
KRKA Belgium, SA. UAB KRKA Lietuva
Tél/Tel: + 32 (0) 487 50 73 62 Tel: + 370 5 236 27 40

България Luxembourg/Luxemburg
КРКА България ЕООД KRKA Belgium, SA.
Teл.: + 359 (02) 962 34 50 Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika Magyarország
KRKA ČR, s.r.o. KRKA Magyarország Kereskedelmi Kft.
Tel: + 420 (0) 221 115 150 Tel.: + 36 (1) 355 8490

Danmark Malta
KRKA Sverige AB E. J. Busuttil Ltd.
Tlf: + 46 (0)8 643 67 66 (SE) Tel: + 356 21 445 885

Deutschland Nederland
TAD Pharma GmbH KRKA Belgium, SA.
Tel: + 49 (0) 4721 606-0 Tel: + 32 (0) 487 50 73 62 (BE)

Eesti Norge
KRKA, d.d., Novo mesto Eesti filiaal KRKA Sverige AB
Tel: + 372 (0) 6 671 658 Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα Österreich
ΒΙΑΝΕΞ Α.Ε. KRKA Pharma GmbH, Wien
Τηλ: +30 210 8009111 Tel: + 43 (0)1 66 24 300

España Polska
KRKA Farmacéutica, S.L. KRKA-POLSKA Sp. z o.o.
Tel: + 34 911 61 03 80 Tel.: + 48 (0)22 573 7500

France Portugal
KRKA France Eurl KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tél: + 33 (0)1 57 40 82 25 Tel: + 351 (0)21 46 43 650

Hrvatska România
KRKA - FARMA d.o.o. KRKA Romania S.R.L., Bucharest
Tel: + 385 1 6312 101 Tel: + 4 021 310 66 05

Ireland Slovenija
KRKA Pharma Dublin, Ltd. KRKA, d.d., Novo mesto
Tel: + 353 1 413 3710 Tel: + 386 (0) 1 47 51 100

Ísland Slovenská republika
LYFIS ehf. KRKA Slovensko, s.r.o.
Sími: + 354 534 3500 Tel: + 421 (0) 2 571 04 501

Italia Suomi/Finland
KRKA Farmaceutici Milano S.r.l. KRKA Finland Oy
Tel: + 39 02 3300 8841 Puh/Tel: + 358 20 754 5330

Κύπρος Sverige
KI.PA. (PHARMACAL) LIMITED KRKA Sverige AB
Τηλ: + 357 24 651 882 Tel: + 46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA): https://www.ema.europa.eu.