Lenalidomide Krka 15 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Lenalidomida Krka 2.5 mg hard capsules EFG

Lenalidomida Krka 5 mg hard capsules EFG

Lenalidomida Krka 7.5 mg hard capsules EFG

Lenalidomida Krka 10 mg hard capsules EFG

Lenalidomida Krka 15 mg hard capsules EFG

Lenalidomida Krka 20 mg hard capsules EFG

Lenalidomida Krka 25 mg hard capsules EFG

lenalidomide

Read the entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

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

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

What Lenalidomida Krka is

Lenalidomida Krka contains the active substance "lenalidomida". 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
• Myelodysplastic 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 cells in the blood, called plasma cells. These cells accumulate in the bone marrow and multiply uncontrollably. This can damage bones and kidneys.

Multiple myeloma generally has no cure. However, signs and symptoms can be greatly reduced or may disappear for a period of time. This is called "remission."

Newly diagnosed multiple myeloma: in patients undergoing bone marrow transplant, Lenalidomida Krka is used as maintenance treatment after adequately recovering from the 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";
• an anti-inflammatory medicine called "dexamethasone";
• a chemotherapy medicine called "melphalan"; and
• an immunosuppressant called "prednisone".

You will take these medicines at the beginning of treatment and then continue taking Lenalidomida Krka alone.

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

Multiple myeloma: in previously treated patients

Lenalidomida Krka is taken together with an anti-inflammatory medicine called "dexamethasone".

Lenalidomida Krka may slow down 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 a variety of signs and symptoms, including low red blood cell count (anemia), the need for blood transfusions, and an increased risk of infection.

Lenalidomida Krka is used to treat adult patients diagnosed with MDS when all of the following apply:

• requires periodic blood transfusions to treat low red blood cell levels (“transfusion-dependent anemia”);
• has an abnormality in bone marrow cells called “isolated 5q cytogenetic abnormality”. This means that the body does not produce a sufficient number of healthy blood cells;
• previous treatments used have not been suitable or have not worked well enough.

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

• this may reduce the number of blood transfusions required. It may even become possible to no longer require transfusions.

Mantle cell lymphoma (MCL)

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

Lenalidomida Krka is used as monotherapy to treat adult patients who have previously received 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. In individuals with FL, excessive numbers of these B-lymphocytes may accumulate in the blood, bone marrow, lymph nodes, and spleen.

Lenalidomide Krka is used in combination with another medicine called "rituximab" for the treatment of adult patients who have received prior therapy for follicular lymphoma.

How Lenalidomide Krka works

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

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

2. What you need to know before starting Lenalidomide Krka

You must read the package leaflet of any other medicines you will be taking in combination with Lenalidomide Krka before starting treatment with Lenalidomide Krka.

Do not take Lenalidomide Krka

• if you are pregnant, think you might be pregnant, or plan to become pregnant, as Lenalidomide Krka is expected to harm the unborn baby (see section 2, "Pregnancy, breastfeeding and contraception: information for women and men");
• if you are able to become pregnant, unless you follow all the necessary precautions to prevent pregnancy (see section 2, "Pregnancy, breastfeeding and contraception: information for women and men"). If you are able to become pregnant, your doctor will document with each prescription that all necessary precautions have been taken and will provide you with this confirmation;
• if you are allergic to lenalidomide or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor.

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Lenalidomide Krka if:

• you have ever had blood clots; during treatment, your risk of developing blood clots in veins and arteries is increased;
• you have any signs of infection, such as cough or fever;
• you have or have previously had a viral infection, especially hepatitis B, shingles (herpes zoster), or HIV. If in doubt, consult your doctor. Treatment with Lenalidomide Krka may reactivate the virus in patients who carry it, leading to recurrence of the infection. Your doctor should check whether you have ever had hepatitis B infection;
• you have kidney problems; your doctor may adjust your dose of Lenalidomide Krka;
• you have had a heart attack, previously had a blood clot, or if you smoke, have high blood pressure, or high cholesterol levels;
• you have had an allergic reaction while taking thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or breathing difficulties;
• you have previously experienced a combination of any of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), or swollen lymph nodes (signs of a serious skin reaction known as 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, double vision, difficulty speaking, weakness in one arm or leg, change in walking pattern or balance problems, persistent numbness, decreased sensation, or loss of sensation, memory loss, or confusion. These may be symptoms of a serious and potentially life-threatening brain disease known as progressive multifocal leukoencephalopathy (PML). If you have any of these symptoms before starting treatment with Lenalidomide Krka, inform your doctor if you notice any changes in these symptoms.
• shortness of breath, fatigue, dizziness, chest pain, faster heartbeat, or swelling in the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Monitoring 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 blood cells that help fight infections (white blood cells) and in those involved in blood clotting (platelets).

Your doctor will request blood tests:

• before starting treatment;
• weekly during the first 8 weeks of treatment;
• thereafter, at least once a month.

You may be evaluated for signs of cardiopulmonary problems before and during lenalidomide treatment.

For patients with MDS taking Lenalidomida Krka

If you have MDS, you may be more likely to develop an advanced disease called acute myeloid leukaemia (AML). In addition, it is unknown how Lenalidomida Krka affects your risk of developing AML. Therefore, your doctor may perform blood tests to detect signs that could better predict the likelihood of developing AML during treatment with Lenalidomida Krka.

For patients with MCL taking Lenalidomida Krka

Your doctor will request blood tests:

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

For patients with FL taking Lenalidomida Krka

Your doctor will request blood tests:

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

Your doctor may check whether you have a high overall tumor burden in the body, including in the bone marrow. This could lead to a condition in which tumors break down and release unusual levels of chemicals into the blood, which in turn may cause kidney failure (this condition is called "tumour lysis syndrome").

Your doctor may examine you to check for changes in your skin, such as red spots or skin rashes.

Your doctor may adjust the dose of Lenalidomida Krka or interrupt your treatment, depending on the results of your blood tests and your overall condition. If you are a newly diagnosed patient, your doctor may also consider your age and any other pre-existing medical conditions when evaluating your treatment.

Blood donation

You must not donate blood during treatment or for at least 7 days after completion of treatment.

Children and adolescents

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

Elderly patients and patients with kidney problems

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

Other medicines and Lenalidomida Krka

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

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

• certain medicines used to prevent pregnancy, such as oral contraceptives, as they may become ineffective;
• 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

Women taking Lenalidomida Krka

• You must not take Lenalidomida Krka if you are pregnant, as it is expected to be harmful to the unborn baby.
• You must not become pregnant while taking Lenalidomida Krka. Therefore, you must use effective contraceptive methods if there is any possibility that you could 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 advisable that your partner seeks medical advice.
• You must also use effective contraceptive methods (see “Contraception”).

Breast-feeding

You must not breast-feed 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 whether you are capable of becoming pregnant, even if you think this is unlikely.

If you are able to become pregnant:

• you will undergo medically supervised pregnancy tests (before each treatment cycle, at least every 4 weeks during treatment, and for at least 4 weeks after stopping treatment), unless it has been confirmed that your fallopian tubes are permanently blocked (tubal ligation), preventing eggs from reaching the uterus;

And

• you must use effective contraceptive methods starting at least 4 weeks before beginning treatment, throughout treatment, and for at least 4 weeks after treatment ends. Your doctor will advise you on the most appropriate contraceptive methods.

For men taking Lenalidomida Krka

Lenalidomida Krka is present in human semen. If your partner is pregnant or could become pregnant and is not using an effective contraceptive method, you must use condoms during treatment and for at least 7 days after stopping treatment, even if you have had a vasectomy.

Driving and operating machinery

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

3. How to take Lenalidomida Krka

Lenalidomida Krka must be administered by a healthcare professional experienced in the treatment of multiple myeloma, MDS, CLL, or FL.

• When Lenalidomida Krka is used for the treatment of multiple myeloma in patients who cannot undergo bone marrow transplantation or who have received prior treatments, it is taken in combination with other medicines (see section 1 “What Lenalidomida Krka is used for”).
• When Lenalidomida Krka is used for the treatment of multiple myeloma in patients who have undergone bone marrow transplantation or for the treatment of patients with MDS or CLL, it is taken alone.
• When Lenalidomida Krka is used for the treatment of follicular lymphoma, it is taken together with another medicine called "rituximab".

Always follow exactly the administration instructions for Lenalidomida Krka provided by your doctor. If in doubt, consult your doctor or pharmacist.

If you are taking Lenalidomida Krka together with other medicines, you should consult the package leaflet of those other medicines for additional information about their use and effects.

Treatment cycle

Lenalidomida Krka is taken on certain days during a 3-week period (21 days).

• A "treatment cycle" consists of 21 days.
• 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 must start a new "cycle" for the following 21 days.

Or

Lenalidomida Krka is taken on certain days during a 4-week period (28 days).

• A "treatment cycle" consists of 28 days.
• 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 must start a new "cycle" for the following 28 days.

How much Lenalidomida Krka to take

Before starting treatment, your doctor will instruct you:

• how much Lenalidomida Krka you should take;
• how much of the other medications you should take together with Lenalidomida Krka, if applicable;
• on which days of the treatment cycle you should take each medicine.

How and when to take Lenalidomida Krka

• Swallow the capsules whole, preferably with water.
• Do not break, open, or chew the capsules. If the powder from a broken Lenalidomida Krka capsule comes into contact with the skin, wash the skin immediately and thoroughly with water and soap.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Afterwards, gloves should be carefully removed to avoid skin exposure, placed into a sealable polyethylene plastic bag, and disposed of according to local requirements. Hands should then be thoroughly washed with water and soap. 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 should take Lenalidomida Krka at approximately the same time each day on the scheduled days.

Taking this medicine

To remove the capsule from the blister:

1. Hold the blister by the edges and separate one blister cavity from the rest of the blister by gently tearing along the perforations surrounding it.
2. Lift the edge of the aluminum layer and completely remove it.
3. Tilt the capsule into your hand.
4. Swallow the capsule whole, preferably with water.

Duration of Treatment with Lenalidomide Krka

Lenalidomide Krka is taken in treatment cycles, each lasting 21 or 28 days (see "Treatment Cycle" above). You must continue the treatment cycles until your doctor instructs you to stop the treatment.

If you take more Lenalidomida Krka than you should

If you take more Lenalidomida Krka than prescribed, inform your doctor immediately.

If you forget to take Lenalidomida Krka

If you forget to take Lenalidomida 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 the following day at your usual time.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

If you experience any of the following serious adverse effects, stop treatment with Lenalidomida Krka immediately and seek medical attention right away, as you may require emergency 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 anaphylactic reaction.
• Severe allergic reaction that may start as a rash in one area but spreads, causing extensive skin loss throughout the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and effects on other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome). See also section 2.

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

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection including in the bloodstream (sepsis)
• Bleeding or bruising not due to injury
• Chest (thoracic) pain or leg pain
• Difficulty breathing
• Bone pain, muscle pain, confusion, or fatigue, which 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 reduce blood cells that help blood to clot (platelets), which may lead to bleeding disorders such as nosebleeds and bruising. Lenalidomida Krka may also cause blood clots in the veins (thrombosis).

Other adverse effects

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

Very common adverse effects (may affect more than 1 in 10 people):

• A decrease in the number of red blood cells, which may cause anemia leading to fatigue and weakness
• Skin 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 burning sensation in the skin, pain in hands or feet, dizziness, tremor
• Decreased appetite, changes in taste
• Increased pain, size, or redness around the tumor
• Weight loss
• Constipation, diarrhea, nausea, vomiting, stomach pain, heartburn
• Low levels of potassium, calcium, and/or sodium in the blood
• Reduced thyroid function
• Leg pain (which could be a symptom of thrombosis), chest pain or difficulty breathing (which could be a symptom of blood clots in the lungs, called pulmonary embolism)
• Infections of any type, including infection of the sinuses around the nose (sinusitis), lung infection, and upper respiratory tract infections
• Difficulty breathing
• Blurred vision
• Clouding of the eye (cataracts)
• Kidney problems including kidneys not functioning properly or unable to maintain normal function
• Abnormal results in liver function tests
• High results in liver function tests
• Changes in a blood protein which 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
• A general feeling of discomfort, feeling unwell
• Painful inflammation of the mouth, dry mouth
• Dehydration

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

• Destruction of red blood cells (hemolytic anemia)
• Certain types of skin tumors
• Bleeding from 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 protein indicating inflammation in the body
• Darkening of skin color; skin discoloration due to internal bleeding, usually caused by bruising; skin inflammation due to blood accumulation; bruising (hematoma)
• Increased uric acid levels in the blood
• Skin rashes, redness of the skin, cracked skin, skin peeling or flaking, hives
• Increased sweating, night sweats
• Difficulty swallowing, sore throat, difficulty maintaining voice quality or voice changes
• Runny nose
• Marked increase or decrease in urine volume compared to usual, or inability to control urination
• Blood in the urine
• Difficulty breathing, especially when lying down (which could be a symptom of heart failure)
• Difficulty achieving an erection
• Stroke, fainting, dizziness (inner ear disorder causing a sensation that everything is spinning), temporary loss of consciousness
• Chest pain spreading to arms, neck, jaw, back, or stomach, accompanied by 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
• Swelling of joints
• Slowed or blocked bile flow from the liver
• Low levels of phosphate or magnesium in the blood
• Difficulty speaking
• Liver damage
• Loss of balance, difficulty with movement
• Deafness, ringing in the ears (tinnitus)
• Nerve pain, abnormal and unpleasant sensation, especially upon touch
• Excess iron in the body
• Thirst
• Confusion
• Tooth pain
• Falls that may result in injury

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

• Bleeding inside the skull
• Circulatory problems
• Loss of vision
• Loss of sexual desire (libido)
• Excretion of large amounts of urine accompanied by bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)
• Yellow pigmentation of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itchy skin, skin rash, stomach pain or swelling; these may be symptoms of liver damage (liver failure)
• Stomach pain, abdominal swelling, or diarrhea, which may be symptoms of inflammation of the large intestine (called colitis or typhlitis)
• Damage to kidney tubule cells (called renal tubular necrosis)
• Changes in skin color, sensitivity to sunlight
• Tumor lysis syndrome – metabolic complications may occur during cancer treatment and sometimes even without treatment. These complications result from the breakdown products of dying tumor cells and may include: changes in blood chemistry, high levels of potassium, phosphorus, 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 supplying the lungs (pulmonary hypertension)

Adverse effects with unknown frequency (cannot be estimated from available data):

• Sudden or mild pain in the upper abdomen and/or back that worsens and lasts for several days, possibly accompanied by nausea, vomiting, fever, and rapid pulse. These symptoms may be due to inflammation of the pancreas.
• Whistling or wheezing when breathing, difficulty breathing, or dry cough, which may be symptoms caused by inflammation of lung tissue.
• Rare cases of muscle breakdown (muscle pain, weakness, or swelling) have been observed, which may lead to kidney problems (rhabdomyolysis), some of them occurring when Lenalidomida Krka is administered with a statin (a type of cholesterol-lowering medicine).
• A skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis).
• Perforation of the stomach or intestinal wall. This may lead to a severe infection. Inform your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in the stool, 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, nausea, or feeling unwell).
• Rejection of solid organ transplants (such as kidney or heart).

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Lenalidomida Krka

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine and its packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lenalidomide Krka

• 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 maize starch, tartaric acid (E334), and glyceryl dibehenate.

• The other components in the capsule shell are:

Lenalidomide Krka 2.5 mg hard capsules:
hypromellose, carrageenan (E407), potassium chloride (E508), titanium dioxide (E171), yellow iron oxide (E172), indigotine (E132), printing ink (shellac (E904), black iron oxide (E172)).

Lenalidomide Krka 5 mg hard capsules:
hypromellose, carrageenan (E407), potassium chloride (E508), titanium dioxide (E171), indigotine (E132), printing ink (shellac (E904), black iron oxide (E172)).

Lenalidomide Krka 7.5 mg 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)).

Lenalidomide Krka 10 mg hard capsules:
hypromellose, carrageenan (E407), potassium chloride (E508), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), indigotine (E132), printing ink (shellac (E904), povidone, titanium dioxide (E171)).

Lenalidomide Krka 15 mg hard capsules:
hypromellose, carrageenan (E407), potassium chloride (E508), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), indigotine (E132), printing ink (shellac (E904), black iron oxide (E172)).

Lenalidomide Krka 20 mg hard capsules:
hypromellose, carrageenan (E407), potassium chloride (E508), titanium dioxide (E171), yellow iron oxide (E172), indigotine (E132), printing ink (shellac (E904), black iron oxide (E172)).

Lenalidomide Krka 25 mg 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 container

Lenalidomide Krka 2.5 mg hard capsules (capsules):
The capsule cap is green, the capsule body is green, and bears a black imprint "2.5". The capsule contains a white to off-white or white-brownish powder. Size of hard capsule: 4, length 14 ± 1 mm.

Lenalidomide Krka 5 mg hard capsules (capsules):
The capsule cap is blue, the capsule body is blue, and bears a black imprint "5". The capsule contains a white to off-white or white-brownish powder. Size of hard capsule: 2, length 18 ± 1 mm.

Lenalidomide Krka 7.5 mg hard capsules (capsules):
The capsule cap is brown, the capsule body is brown, and bears a white imprint "7.5". The capsule contains a white to off-white or white-brownish powder. Size of hard capsule: 1, length 19 ± 1 mm.

Lenalidomide Krka 10 mg hard capsules (capsules):
The capsule cap is green, the capsule body is brown, and bears a white imprint "10". The capsule contains a white to off-white or white-brownish powder. Size of hard capsule: 0, length 21 ± 1 mm.

Lenalidomide Krka 15 mg hard capsules (capsules):
The capsule cap is brown, the capsule body is blue, and bears a black imprint "15". The capsule contains a white to off-white or white-brownish powder. Size of hard capsule: 2, length 18 ± 1 mm.

Lenalidomide Krka 20 mg hard capsules (capsules):
The capsule cap is green, the capsule body is blue, and bears a black imprint "20". The capsule contains a white to off-white or white-brownish powder. Size of hard capsule: 1, length 19 ± 1 mm.

Lenalidomide Krka 25 mg hard capsules (capsules):
The capsule cap is brown, the capsule body is brown, and bears a white imprint "25". The capsule contains a white to off-white or white-brownish powder. Size of hard capsule: 0, length 21 ± 1 mm.

Lenalidomide Krka is available in packs containing 7 x 1 or 21 x 1 hard capsule in pre-scored, peelable unit-dose blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer responsible

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

Further information on this medicinal product is available upon request by contacting the local representative of the marketing authorization holder:

Belgium/Belgium/Belgium KRKA Belgium, SA. Tel/Tel: + 32 (0) 487 50 73 62	Lithuania UAB KRKA Lietuva Tel: + 370 5 236 27 40
Bulgaria KRKA Bulgaria EOOD Tel: + 359 (02) 962 34 50	Luxembourg/Luxembourg KRKA Belgium, SA. Tél/Tel: + 32 (0) 487 50 73 62 (BE)
Czech Republic KRKA CR, s.r.o. Tel: + 420 (0) 221 115 150	Hungary KRKA Magyarország Kereskedelmi Kft. Tel.: + 36 (1) 355 8490
Denmark KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE)	Malta J. Busuttil Ltd. Tel: + 356 21 445 885
Germany TAD Pharma GmbH Tel: + 49 (0) 4721 606-0	Netherlands KRKA Belgium, SA. Tel: + 32 (0) 487 50 73 62 (BE)
Estonia KRKA, d.d., Novo mesto Estonia branch Tel: + 372 (0) 6 671 658	Norway KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE)
Greece BIANEX S.A. Tel: +30 210 8009111	Austria KRKA Pharma GmbH, Vienna Tel: + 43 (0)1 66 24 300
Spain KRKA Farmacéutica, S.L. Tel: + 34 911 61 03 80	Poland KRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7500
France KRKA France Eurl Tél: + 33 (0)1 57 40 82 25	Portugal KRKA Farmacêutica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 650
Croatia KRKA - FARMA d.o.o. Tel: + 385 1 6312 100	Romania KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 05
Ireland KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3710	Slovenia KRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 100
Iceland LYFIS ehf. Sími: + 354 534 3500	Slovakia KRKA Slovensko, s.r.o. Tel: + 421 (0) 2 571 04 501
Italy KRKA Farmaceutici Milano S.r.l. Tel: + 39 02 3300 8841	Finland KRKA Finland Oy Puh/Tel: + 358 20 754 5330
Cyprus KI.PA. (PHARMACAL) LIMITED Tel: + 357 24 651 882	Sweden KRKA Sverige AB Tel: + 46 (0)8 643 67 66 (SE)
Latvia KRKA Latvija SIA Tel: + 371 6 733 86 10	United Kingdom (Northern Ireland) KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3710

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Other sources of information

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