Patient Information Leaflet: Product Characteristics

Lenalidomida Krka 2.5mg Hard Capsules EFG

Lenalidomida Krka 5mg Hard Capsules EFG

Lenalidomida Krka 7.5mg Hard Capsules EFG

Lenalidomida Krka 10mg Hard Capsules EFG

Lenalidomida Krka 15mg Hard Capsules EFG

Lenalidomida Krka 20mg Hard Capsules EFG

Lenalidomida Krka 25mg Hard Capsules EFG

lenalidomida

Please read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Contents of the Leaflet

1. What Lenalidomida Krka is and what it is used for
2. What you need to know before you start taking Lenalidomida Krka
3. How to take Lenalidomida Krka
4. Possible side effects
5. Storage of Lenalidomida Krka
6. Contents of the pack and additional information

What is Lenalidomida Krka

Lenalidomida Krka contains the active ingredient “lenalidomide”. This medicine belongs to a group of medicines that affect how the immune system works.

What Lenalidomida Krka is used for

Lenalidomida Krka is used in adults for:

• Multiple myeloma
• Myleodysplastic syndromes (MDS)
• mantle cell lymphoma (MCL)
• Follicular lymphoma

Multiple myeloma

Multiple myeloma is a type of cancer that affects a specific type of white blood cell in the blood, called plasma cells. These cells accumulate in the bone marrow and multiply, becoming uncontrolled. This can damage bones and kidneys.

Multiple myeloma usually does not have a cure. However, the symptoms and signs can be greatly reduced or disappear for a period of time. This is called “remission”.

Newly diagnosed multiple myeloma: in patients who have undergone a bone marrow transplantLenalidomida Krka is used as maintenance treatment after recovering adequately from a bone marrow transplant.

Newly diagnosed multiple myeloma: in patients who cannot be treated with a bone marrow transplant

Lenalidomida Krka is taken with other medicines, including:

• a chemotherapy medicine called “bortezomib”;
• a corticosteroid called “dexamethasone”;
• a chemotherapy medicine called “melfalan”; and
• a immunosuppressant called “prednisone”.

You will take these medicines when starting treatment and then continue taking Lenalidomida Krka alone.

If you are 75 years or older or have moderate to severe kidney problems, your doctor will closely monitor you before starting treatment.

Multiple myeloma: in previously treated patients

Lenalidomida Krka is taken with a corticosteroid called “dexamethasone”.

Lenalidomida Krka can slow the worsening of multiple myeloma symptoms. It has also been shown to delay the recurrence of multiple myeloma after treatment.

Myleodysplastic syndromes (MDS)

MDS are a group of many different blood and bone marrow diseases. Blood cells become abnormal and do not function correctly. Patients may experience a variety of symptoms, including low red blood cell count (anemia), the need for blood transfusions, and the risk of infection.

Lenalidomida Krka is used to treat adult patients diagnosed with MDS, when all the following points are applicable:

• you need periodic blood transfusions to treat low red blood cell levels (“transfusion-dependent anemia”);
• you have a bone marrow cell abnormality called “isolated deletion 5q cytogenetic anomaly”. This means your body does not produce enough healthy blood cells;
• other treatments you have used previously are not suitable or do not work well enough.

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

• this can reduce the number of blood transfusions needed. It may be possible that no transfusions are needed.

Mantle cell lymphoma (MCL)

MCL is a cancer of a part of the immune system (lymphoid tissue). It affects a type of white blood cell in the blood called “B lymphocytes” or B cells. MCL is a disease in which B cells grow uncontrollably and accumulate in lymphoid tissue, bone marrow, or blood.

Lenalidomida Krka is used in monotherapy to treat adult patients who have received previous treatment with other medicines.

Follicular lymphoma (FL)

FL is a slow-growing cancer that affects B lymphocytes. These are a type of white blood cell that helps the body fight infections. When a person has FL, they may store too many of these B lymphocytes in the blood, bone marrow, lymph nodes, and spleen.

Lenalidomida Krka is used with another medicine called “rituximab” for the treatment of adult patients who have received previous treatment for follicular lymphoma.

How Lenalidomida Krka works

Lenalidomida Krka works by affecting the body's immune system and directly attacking cancer. It acts in several ways:

• it stops the development of cancer cells;
• it stops the growth of blood vessels in the cancer;
• it stimulates part of the immune system to attack cancer cells.

You should read the leaflet accompanying all the medicines you are going to take in combination with Lenalidomida Krka before starting treatment with Lenalidomida Krka.

Do not take Lenalidomida Krka

• if you are pregnant, think you may be pregnant or intend to become pregnant, as Lenalidomida Krka is expected to be harmful to the fetus (see section 2, “Pregnancy, lactation and contraception: information for women and men”);since Lenalidomida Krka is expected to be harmful to the fetus(see section 2, “Pregnancy, lactation and contraception: information for women and men”);
• if you can become pregnant, unless you follow all the necessary measures to avoid it (see section 2, “Pregnancy, lactation and contraception: information for women and men”). If you can become pregnant, your doctor will note on each prescription that all necessary measures have been taken and will provide you with this confirmation;
• if you are allergic to lenalidomide or to any of the other components of this medicine (including in section 6). If you think you may be allergic, consult your doctor.

If any of these conditions apply to you, do not take Lenalidomida Krka. If in doubt, consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Lenalidomida Krka if:

• you have ever had blood clots; during treatment, you have a higher risk of developing blood clots in veins and arteries;
• you have any signs of infection, such as cough or fever;
• you have or have previously had a viral infection, especially hepatitis B infection, varicella zoster or HIV. If in doubt, consult your doctor. Treatment with Lenalidomida Krka may make the virus become active again in patients who are carriers of the virus. This leads to the reappearance of the infection. Your doctor must check if you have ever had a hepatitis B infection;
• you have kidney problems; your doctor may adjust your Lenalidomida Krka dose;
• you have had a heart attack, have ever had a blood clot, or if you smoke, have high blood pressure or high cholesterol levels;
• you have had an allergic reaction while using thalidomide (another medicine used to treat multiple myeloma), such as skin rash, itching, swelling, dizziness or respiratory problems;
• you have experienced in the past a combination of any of the following symptoms: generalised rash, skin redness, high body temperature, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes (these are signs of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome) (see also section 4 “Possible side effects”).

If any of the above 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 or double vision, difficulty speaking, weakness in one arm or leg, a change in the way you walk or balance problems, persistent numbness, decreased sensitivity or loss of sensitivity, memory loss or confusion. All of these may be symptoms of a serious and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If you experience any of these symptoms before starting treatment with Lenalidomida Krka, inform your doctor if you notice any change in these symptoms.
• shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat or swelling in the legs or ankles. These may be symptoms of a serious condition called pulmonary hypertension (see section 4).

Analysis and tests

Before starting treatment with Lenalidomida Krka and during treatment, you will have regular blood tests. This is because Lenalidomida Krka may cause a decrease in the white blood cells that help fight infections and platelets that participate in blood clotting.

Your doctor will ask you to have a blood test:

• before treatment;
• every week for the first 8 weeks of treatment;
• subsequently, at least once a month.

You may be evaluated to detect signs of cardiopulmonary problems before and during treatment with lenalidomide.

For patients with SMD who take Lenalidomida Krka

If you have SMD, you may be more prone to developing a more advanced disease called acute myeloid leukemia (AML). Additionally, it is unknown how Lenalidomida Krka affects the likelihood of developing AML. Your doctor may perform tests to detect signs that may better predict the likelihood of developing AML during treatment with Lenalidomida Krka.

For patients with MCL who take Lenalidomida Krka

Your doctor will ask you to have a blood test:

• before treatment;
• every week for the first 8 weeks (2 cycles) of treatment;
• subsequently, every 2 weeks in cycles 3 and 4 (see section 3 “Treatment cycle” for more information);
• then at the start of each cycle;
• at least once a month.

For patients with LF who take Lenalidomida Krka

Your doctor will ask you to have a blood test:

• before treatment;
• every week for the first 3 weeks (1 cycle) of treatment;
• subsequently, every 2 weeks in cycles 2 to 4 (see section 3 “Treatment cycle” for more information).
• then at the start of each cycle and at least once a month.

Your doctor may check if you have a high total tumor burden in the body, including the bone marrow. This could lead to a disease in which the tumors break down and produce unusual levels of chemical substances in the blood that, in turn, may cause kidney failure (this disease is called tumor lysis syndrome).

Your doctor may examine you to check if any changes have occurred in your skin, such as red spots or skin rashes.

Your doctor may adjust your Lenalidomida Krka dose or interrupt your treatment, depending on the results of your blood tests and your overall condition. If you are a new diagnosis patient, your doctor may also evaluate your treatment based on your age and any other conditions you already have.

Blood donation

You should not donate blood during treatment or for at least 7 days after the end of treatment.

Children and adolescents

The use of Lenalidomida Krka is not recommended in children and adolescents under 18 years of age.

Older people and people with kidney problems

If you are 75 years of age or older or have moderate to severe kidney problems, your doctor will carefully examine you before starting treatment.

Other medicines and Lenalidomida Krka

Inform your doctor or nurse if you are taking, have recently taken or may need to take any other medicine. This is because Lenalidomida Krka may affect how other medicines work. Additionally, some medicines may affect how Lenalidomida Krka works.

In particular, inform your doctor or nurse if you are taking any of the following medicines:

• some medicines used to prevent pregnancy, such as oral contraceptives, as they may stop working;
• some medicines used to treat heart problems, such as digoxin;
• some medicines used to thin the blood, such as warfarin.

Pregnancy, lactation and contraception: information for women and men

Pregnancy

Women taking Lenalidomida Krka

• You should not take Lenalidomida Krka if you are pregnant, as it is expected to be harmful to the fetus.
• You should not become pregnant while taking Lenalidomida Krka. Therefore, you must use effective contraceptive methods if there is a possibility that you may become pregnant (see “Contraception”).
• If you become pregnant during treatment with Lenalidomida Krka, you must stop treatment and inform your doctor immediately.

Men taking Lenalidomida Krka

• If your partner becomes pregnant while you are taking Lenalidomida Krka, you must inform your doctor immediately. It is recommended that your partner seek medical advice.
• You should also use effective contraceptive methods (see “Contraception”).

Lactation

You should not breastfeed while taking Lenalidomida Krka, as it is unknown whether Lenalidomida Krka passes into breast milk.

Contraception

For women taking Lenalidomida Krka

Before starting treatment, ask your doctor if you are capable of becoming pregnant, although you may think this is unlikely.

If you can become pregnant:

• you will have pregnancy tests under medical supervision (before each treatment, at least every 4 weeks during treatment and for at least 4 weeks after completing treatment) except that you have had a tubal ligation so that the eggs do not reach the uterus (tubal ligation);

And

• you must use effective contraceptive methods from at least 4 weeks before starting treatment, during treatment and for at least 4 weeks after completing treatment. Your doctor will advise you on the most suitable contraceptive methods.

For men taking Lenalidomida Krka

Lenalidomida Krka passes into human semen. If your partner becomes pregnant or may become pregnant and does not use any effective contraceptive method, you must use condoms during treatment and for at least 7 days after completing treatment, even if you have had a vasectomy.

Driving and operating machinery

You should not drive or operate machinery if you feel dizzy, tired, drowsy, have vertigo or blurred vision after taking Lenalidomida Krka.

Lenalidomide Krka should be administered by a healthcare professional with experience in the treatment of multiple myeloma, SMD, LCM, or LF.

• When Lenalidomide Krka is used for the treatment of multiple myeloma in patients who cannot be treated with a bone marrow transplant or have undergone other treatments before, it is taken with other medications (see section 1 “What Lenalidomide Krka is used for”).
• When Lenalidomide Krka is used for the treatment of multiple myeloma in patients who have received a bone marrow transplant or to treat patients with SMD or LCM, it is taken alone.
• When Lenalidomide Krka is used for the treatment of follicular lymphoma, it is taken with another medication called “rituximab”.

Follow exactly the administration instructions for Lenalidomide Krka indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

If you are taking Lenalidomide Krka with other medications, you should consult the leaflet of those other medications to obtain additional information on their use and effects.

Treatment cycle

Lenalidomide Krka is taken on certain days during the period of 3 weeks (21 days).

• A “treatment cycle” consists of 21 days.
• Depending on the day of the cycle, you will take one or more medications. However, some days you will not take any medication.
• After completing each cycle of 21 days, you should start a new “cycle” during the following 21 days.

Or

Lenalidomide Krka is taken on certain days during the period of 4 weeks (28 days).

• A “treatment cycle” consists of 28 days.
• Depending on the day of the cycle, you will take one or more medications. However, some days you will not take any medication.
• After completing each cycle of 28 days, you should start a new “cycle” during the following 28 days.

How much Lenalidomide Krka to take

Before starting treatment, your doctor will indicate:

• what amount of Lenalidomide Krka you should take;
• what amount of the other medications you should take with Lenalidomide Krka, if applicable;
• which days of the treatment cycle you should take each medication.

How and when to take Lenalidomide Krka

• Swallow the capsules whole, preferably with water.
• Do not break, open, or chew the capsules. In the event that the powder from a broken Lenalidomide Krka capsule comes into contact with the skin, wash the skin immediately and carefully with water and soap.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Subsequently, they should carefully remove the gloves to avoid skin exposure, place them in a plastic polyethylene bag, and dispose of them in accordance with local requirements. They should then wash their hands thoroughly with water and soap. Pregnant women or those who suspect they may be pregnant should not handle the blister pack or capsule.
• The capsules can be taken with or without food.
• You should take Lenalidomide Krka approximately at the same time on the scheduled days.

Medication intake

To remove the capsule from the blister pack:

1.Hold the blister pack by the edges and separate one compartment from the rest of the blister pack by gently tearing along the perforations that surround it.

2.Lift the aluminum foil edge and remove it completely.

3.Incline the capsule towards your hand.

4.Swallow the capsule whole, preferably with water.

Treatment duration with Lenalidomide Krka

Lenalidomide Krka is taken in treatment cycles, each cycle lasting 21 or 28 days (see “Treatment cycle” above). You should continue the treatment cycles until your doctor informs you to stop treatment.

If you take more Lenalidomide Krka than you should

If you take 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 the capsule immediately;
• more than 12 hours have passed: do not take the capsule. Take the next capsule at the usual time the next day.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

If you experience any of the following serious side effects, stop taking Lenalidomida Krka and seek medical attention immediately, as it may require urgent medical treatment:

• Hives, rashes, swelling of the eyes, mouth, or face, difficulty breathing, or itching, which may be symptoms of severe types of allergic reactions called angioedema and anaphylaxis
• Severe allergic reaction that may start as a rash in one area, but spreads, causing significant skin loss throughout the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis)
• Generalized rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and effects on other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.

Seek immediate medical attention if you notice any of the following serious side effects:

• Fever, chills, sore throat, cough, mouth ulcers, or any other symptom of infection, including sepsis
• Bleeding (hemorrhage) or hematoma (bruise) not due to injury
• Chest pain (thoracic) or leg pain
• Difficulty breathing
• Bone pain, muscle pain, confusion, or fatigue that may be due to high levels of calcium in the blood

Lenalidomida Krka may reduce the number of white blood cells that fight infections and also the cells in the blood that help to clot (platelets), which can cause bleeding disorders such as nosebleeds and bruises. Lenalidomida Krka may also cause blood clots in the veins (thrombosis).

Other side effects

It is essential to note that a reduced number of patients may develop other types of cancer, and it is possible that this risk may increase with treatment with Lenalidomida Krka. Therefore, your doctor must carefully evaluate the benefits and risks when prescribing Lenalidomida Krka.

Side effectsvery common(may affect more than 1 in 10 people):

• Decreased red blood cell count, which can cause anemia leading to fatigue and weakness
• Rash, itching
• Muscle cramps, muscle weakness, muscle pain, muscle discomfort, bone pain, joint pain, back pain, limb pain
• Generalized swelling, including swelling of the arms and legs
• Weakness, fatigue
• Fever and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough, and chills
• Numbness, tingling, or prickling sensation in the skin, hand or foot pain, dizziness, tremor
• Decreased appetite, changes in the taste of things
• Increased pain, tumor size, or redness around the tumor
• Weight loss
• Constipation, diarrhea, nausea, vomiting, stomach pain, acid reflux
• Low levels of potassium, calcium, or sodium in the blood
• Decreased thyroid function
• Leg pain (which may be a symptom of thrombosis), chest pain, or difficulty breathing (which may be a symptom of blood clots in the lungs, called pulmonary embolism)
• Infections of all types, including sinusitis, pneumonia, and upper respiratory tract infections
• Difficulty breathing
• Blurred vision
• Cataracts
• Renal problems, including kidneys that do not function correctly or are unable to maintain normal function
• Abnormal liver test results
• High levels of liver test results
• Changes in a blood protein that can cause swelling of the arteries (vasculitis)
• Increased blood sugar levels (diabetes)
• Decreased blood sugar levels
• Headache
• Nosebleeds
• Dry skin
• Depression, changes in mood, difficulty sleeping
• Cough
• Low blood pressure
• A vague feeling of discomfort in the body, feeling unwell
• Inflammation of the mouth, dry mouth
• Dehydration

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

• Red blood cell destruction (hemolytic anemia)
• Certain types of skin tumors
• Bleeding from the gums, stomach, or intestines
• Increased blood pressure, slow, fast, or irregular heartbeat
• Increased levels of a substance released after normal or abnormal destruction of red blood cells
• Increased levels of a type of protein that indicates inflammation in the body
• Darkening of the skin; change in skin color due to internal bleeding, usually caused by hematomas; inflammation of the skin caused by the accumulation of blood; hematoma
• Increased uric acid levels in the blood
• Rashes, redness of the skin, dry skin, peeling or exfoliation of the skin, hives
• Increased sweating, nocturnal sweating
• Difficulty swallowing, sore throat, difficulty maintaining voice quality or changes in voice
• Nasal discharge
• Significant increase or decrease in urine output compared to normal or inability to control urination
• Blood in the urine
• Difficulty breathing, especially when lying down (which may be a symptom of heart failure)
• Difficulty achieving an erection
• Stroke, fainting, vertigo (inner ear disorder that causes the sensation of everything spinning), temporary loss of consciousness
• Chest pain that radiates to arms, neck, jaw, spine, or stomach, sensation of sweating and 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
• Slowed or blocked bile flow from the liver
• Low levels of phosphate or magnesium in the blood
• Difficulty speaking
• Liver damage
• Balance problems, difficulty moving
• Deafness, tinnitus (ringing in the ears)
• Nerve pain, abnormal and unpleasant sensation, especially when touched
• Excess iron in the body
• Thirst
• Confusion
• Toothache
• Fall that may cause injury

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

• Brain hemorrhage
• Circulatory problems
• Loss of vision
• Loss of libido (sex drive)
• Expulsion of large amounts of urine with bone pain and weakness, which may be symptoms of kidney disease (Fanconi syndrome)
• Yellow pigmentation in the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching skin, rash, stomach pain, or swelling; these may be symptoms of liver damage (hepatic insufficiency)
• Stomach pain, abdominal swelling, or diarrhea, which may be symptoms of inflammation of the large intestine (colitis or typhlitis)
• Damage to kidney cells (necrotizing renal tubular damage)
• Changes in skin color, sensitivity to sunlight
• Tumor lysis syndrome – complications may occur during cancer treatment and sometimes even without treatment. These complications occur as a result of the breakdown products of tumor cells that die and may include: changes in blood biochemistry, high levels of potassium, phosphorus, uric acid, and low levels of calcium, which generate changes in renal function and heart rhythm, seizures, and sometimes death.
• Increased blood pressure within the blood vessels that supply the lungs (pulmonary hypertension).

Side effectsof unknown frequency(cannot be estimated from available data):

• Sudden, severe, or worsening pain in the upper stomach and/or back, lasting several days, possibly accompanied by nausea, vomiting, fever, and a rapid pulse. These symptoms may be due to pancreatitis.
• Wheezing or ringing in the lungs, difficulty breathing, or dry cough, which may be symptoms caused by inflammation of the lung tissue.
• Rare cases of muscle degradation (pain, weakness, or swelling) that may lead to kidney problems (rhabdomyolysis), some of which occur when Lenalidomida Krka is administered with a statin (a type of medication to reduce cholesterol).
• A disease that affects the skin caused by inflammation of small blood vessels, accompanied by joint pain and fever (leucocytoclastic vasculitis).
• Perforation of the stomach or intestine wall. This may lead to a severe infection. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel habits.
• Viruses, including herpes zoster (also known as shingles, a viral disease that causes a painful rash with blisters) and the reactivation of hepatitis B infection (which may cause yellowing of the skin and eyes, dark urine, stomach pain on the right side, fever, and nausea or feeling unwell).
• Rejection of solid organ transplants (such as kidney, heart).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Lenalidomida Krka

• The active ingredient is lenalidomide. Each hard capsule contains lenalidomide hydrochloride hydrate equivalent to 2.5mg, 5mg, 7.5mg, 10mg, 15mg, 20mg or 25mg of lenalidomide.

• The other components of the capsule content are mannitol (E421), microcrystalline cellulose(E460), pregelatinized cornstarch, tartaric acid(E334)and dibehenato of glycerol.

• The other components in the capsule coating are:

Lenalidomida Krka 2.5mg hard capsules:

hypromellose, carrageenan (E407), potassium chloride (E508), titanium dioxide (E171), yellow iron oxide (E172), indigotin (E132), printing ink (shellac (E904), black iron oxide (E172)).

Lenalidomida Krka 5mg hard capsules:

hypromellose, carrageenan (E407), potassium chloride (E508), titanium dioxide (E171), indigotin (E132), printing ink (shellac (E904), black iron oxide (E172)).

Lenalidomida Krka 7.5mg hard capsules:

hypromellose, carrageenan (E407), potassium chloride (E508), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), printing ink (shellac (E904), povidone, titanium dioxide (E171)).

Lenalidomida Krka 10mg hard capsules:

hypromellose, carrageenan (E407), potassium chloride (E508), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), indigotin (E132), printing ink (shellac (E904), povidone, titanium dioxide (E171)).

Lenalidomida Krka 15mg hard capsules:

hypromellose, carrageenan (E407), potassium chloride (E508), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), indigotin (E132), printing ink (shellac (E904), black iron oxide (E172)).

Lenalidomida Krka 20mg hard capsules:

hypromellose, carrageenan (E407), potassium chloride (E508), titanium dioxide (E171), yellow iron oxide (E172), indigotin (E132), printing ink (shellac (E904), black iron oxide (E172)).

Lenalidomida Krka 25mg hard capsules:

hypromellose, carrageenan (E407), potassium chloride (E508), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), printing ink (shellac (E904), povidone, titanium dioxide (E171)).

Appearance of the product and contents of the package

Lenalidomida Krka 2.5mg hard capsules (capsules):

The cap of the capsule is green, the body of the capsule is green and has a black imprint 2.5. The capsule contains a white to light yellowish or light brown powder. Hard capsule size: 4, length 14 ± 1 mm.

Lenalidomida Krka 5mg hard capsules (capsules):

The cap of the capsule is blue, the body of the capsule is blue and has a black imprint 5. The capsule contains a white to light yellowish or light brown powder. Hard capsule size: 2, length 18 ± 1 mm.

Lenalidomida Krka 7.5mg hard capsules (capsules):

The cap of the capsule is brown, the body of the capsule is brown and has a white imprint 7.5. The capsule contains a white to light yellowish or light brown powder. Hard capsule size: 1, length 19 ± 1 mm.

Lenalidomida Krka 10mg hard capsules (capsules):

The cap of the capsule is green, the body of the capsule is brown and has a white imprint 10. The capsule contains a white to light yellowish or light brown powder. Hard capsule size: 0, length 21 ± 1 mm.

Lenalidomida Krka 15mg hard capsules (capsules):

The cap of the capsule is brown, the body of the capsule is blue and has a black imprint 15. The capsule contains a white to light yellowish or light brown powder. Hard capsule size: 2, length 18 ± 1 mm.

Lenalidomida Krka 20mg hard capsules (capsules):

The cap of the capsule is green, the body of the capsule is blue and has a black imprint 20. The capsule contains a white to light yellowish or light brown powder. Hard capsule size: 1, length 19 ± 1 mm.

Lenalidomida Krka 25mg hard capsules (capsules):

The cap of the capsule is brown, the body of the capsule is brown and has a white imprint 25. The capsule contains a white to light yellowish or light brown powder. Hard capsule size: 0, length 21 ± 1 mm.

Lenalidomida Krka is available in boxes containing 7 x 1 or 21 x 1 hard capsules in detachable, pre-cut, single-dose blisters.

Only some package sizes may be marketed.

Marketing Authorization 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 more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.