LENALIDOMIDE KRKA 2.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Lenalidomide Krka 2.5mg hard capsulesEFG

Lenalidomide Krka 5mg hard capsulesEFG

Lenalidomide Krka 7.5mg hard capsulesEFG

Lenalidomide Krka 10mg hard capsulesEFG

Lenalidomide Krka 15mg hard capsulesEFG

Lenalidomide Krka 20mg hard capsulesEFG

Lenalidomide Krka 25mg hard capsulesEFG

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Lenalidomide Krka and what is it used for
2. What you need to know before you take 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 is Lenalidomide Krka and what is it used for

What is Lenalidomide Krka

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

What Lenalidomide Krka is used for

Lenalidomide Krka is used in adults to:

• Multple myeloma
• Myelodysplastic syndromes (MDS)
• Mantle cell lymphoma (MCL)
• Follicular lymphoma

Multple myeloma

Multple myeloma is a type of cancer that affects a specific type of white blood cell called plasma cells. These cells build up in the bone marrow and multiply out of control. This can damage the bones and kidneys.

Multple myeloma usually cannot be cured. However, the signs and symptoms can be greatly reduced or may disappear for a period of time. This is called “remission”.

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

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

Lenalidomide Krka is taken with other medicines, including:

• a chemotherapy medicine called “bortezomib”;
• an anti-inflammatory called “dexamethasone”;
• a chemotherapy medicine called “melphalan”;
• an immunosuppressant called “prednisone”.

You will take these medicines when you start treatment and then continue to take Lenalidomide Krka alone.

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

Multple myeloma: in patients previously treated

Lenalidomide Krka is taken with an anti-inflammatory called “dexamethasone”.

Lenalidomide Krka can delay the worsening of multple myeloma signs and symptoms. It has also been shown to delay the return of multple myeloma after treatment.

Myelodysplastic syndromes (MDS)

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

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

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

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

• this can reduce the number of blood transfusions needed. You may not need transfusions at all.

Mantle cell lymphoma (MCL)

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

Lenalidomide Krka is used alone to treat adult patients who have previously been treated 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 infection. When someone has FL, they may have too many of these B lymphocytes in their blood, bone marrow, lymph nodes, and spleen.

Lenalidomide Krka is used with another medicine called “rituximab” to treat adult patients who have previously been treated for follicular lymphoma.

How Lenalidomide Krka works

Lenalidomide Krka works by affecting the immune system and directly attacking cancer cells. It works in several ways:

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

2. What you need to know before you take Lenalidomide Krka

You must read the package leaflet of all medicines you will take in combination with Lenalidomide Krka before you start treatment with Lenalidomide Krka.

Do not take Lenalidomide Krka

as Lenalidomide Krka is expected to be harmful to the fetus(see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”);

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

Warnings and precautions

Tell your doctor, pharmacist or nurse before you start taking Lenalidomide Krka if:

• you have ever had blood clots; during treatment, you have a higher risk of getting blood clots in your veins and arteries;
• you have any signs of infection, such as cough or fever;
• you have or have had a viral infection, especially hepatitis B, varicella zoster or HIV. If in doubt, consult your doctor. Treatment with Lenalidomide Krka may cause the virus to become active again in patients who carry the virus. This can lead to the infection coming back. Your doctor should check if you have ever had a hepatitis B infection;
• you have kidney problems; your doctor may adjust your dose of Lenalidomide Krka;
• 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 multple myeloma), such as skin rash, itching, swelling, dizziness or breathing problems;
• you have experienced in the past a combination of any of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, elevated 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) (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, tell your doctor or nurse immediately if you:

• have blurred vision, loss of vision or double vision, difficulty speaking, weakness in an arm or leg, a change in the way you walk or balance problems, numbness, decreased sensitivity or loss of sensitivity, memory loss or confusion. These can be symptoms of a serious and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If you have any of these symptoms before starting treatment with Lenalidomide Krka, tell your doctor if you notice any change in these symptoms.
• have shortness of breath, tiredness, dizziness, chest pain, faster heart rate or swelling in your legs or ankles. These can be symptoms of a serious condition called pulmonary hypertension (see section 4).

Tests and examinations

Before you start treatment with Lenalidomide Krka and during treatment, you will have regular blood tests. This is because Lenalidomide Krka can cause a decrease in the blood cells that help fight infections (white blood cells) and those that help the blood to clot (platelets).

Your doctor will ask you to have a blood test:

• before treatment;
• every week, during the first 8 weeks of treatment;
• then at least every month.

You may be evaluated for signs of heart and lung problems before and during treatment with lenalidomide.

For patients with MDS taking Lenalidomide Krka

If you have MDS, you may be more likely to develop a more advanced disease called acute myeloid leukemia (AML). Additionally, it is not known how Lenalidomide Krka affects the chances of developing AML. Your doctor may therefore have you undergo tests to detect signs that may predict a better chance 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 treatment;
• every week during the first 8 weeks (2 cycles) of treatment;
• then every 2 weeks in cycles 3 and 4 (see section 3 “Treatment cycle” for more information);
• after that, at the start of each cycle;
• at least once a month.

For patients with FL taking Lenalidomide Krka

Your doctor will ask you to have a blood test:

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

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

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

Your doctor may adjust your dose of Lenalidomide Krka or stop 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 evaluate your treatment based on your age and any other conditions you already have.

Blood donation

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

Children and adolescents

Lenalidomide Krka is not recommended for use in children and adolescents under 18 years.

Elderly and patients with kidney problems

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

Other medicines and Lenalidomide Krka

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This is because Lenalidomide Krka can affect how other medicines work. Also, some medicines can affect how Lenalidomide Krka works.

In particular, tell 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 for heart problems, such as digoxin;
• some medicines used to thin the blood, such as warfarin.

Pregnancy, breastfeeding and contraception: information for women and men

Pregnancy

Women taking Lenalidomide Krka

• Do not take Lenalidomide Krka if you are pregnant, as it is expected to be harmful to the fetus.
• Do not become pregnant while taking Lenalidomide Krka. You must use effective contraception if you can become pregnant (see “Contraception”).
• If you become pregnant during treatment with Lenalidomide Krka, stop treatment and tell your doctor immediately.

Men taking Lenalidomide Krka

• If your partner becomes pregnant while you are taking Lenalidomide Krka, tell your doctor immediately. It is recommended that your partner seeks medical advice.
• You must also use effective contraception (see “Contraception”).

Breastfeeding

Do not breastfeed while taking Lenalidomide Krka, as it is not known if lenalidomide passes into breast milk.

Contraception

For women taking Lenalidomide Krka

Before you start treatment, ask your doctor if you are able to become pregnant, even if you 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 the end of treatment) unless you have had your fallopian tubes blocked (tubal ligation);

And

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

For men taking Lenalidomide Krka

Lenalidomide Krka passes into human semen. If your partner is pregnant or can become pregnant and does not use effective contraception, you must use condoms during treatment and for at least 7 days after the end of treatment, even if you have had a vasectomy.

Driving and using machines

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

3. How to take Lenalidomida Krka

Lenalidomida Krka should be administered by a healthcare professional with experience in the treatment of multiple myeloma, MDS, MCL, or FL.

• When Lenalidomida 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 Lenalidomida Krka is used for").
• When Lenalidomida Krka is used for the treatment of multiple myeloma in patients who have received a bone marrow transplant or to treat patients with MDS or MCL, it is taken alone.
• When Lenalidomida Krka is used for the treatment of follicular lymphoma, it is taken with another medication called "rituximab".

Follow the administration instructions for Lenalidomida Krka exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist.

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

Treatment cycle

Lenalidomida Krka is taken on certain days during a 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, on some days you will not take any medication.
• After completing each 21-day cycle, you should start a new "cycle" during the following 21 days.

Or

Lenalidomida Krka is taken on certain days during a 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, on some days you will not take any medication.
• After completing each 28-day cycle, you should start a new "cycle" during the following 28 days.

How much Lenalidomida Krka to take

Before starting treatment, your doctor will tell you:

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

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 carefully with water and soap.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister or capsule. Afterwards, they should carefully remove the gloves to avoid skin exposure, place them in a sealable polyethylene plastic bag, and dispose of them according to local requirements. Then, they should wash their hands well with water and soap. Pregnant women or those who suspect they may be pregnant should not handle the blister or capsule.
• The capsules can be taken with or without food.
• You should take Lenalidomida Krka approximately at the same time on the scheduled days.

Taking this medication

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 foil and remove it completely.
3. Tilt the capsule into your hand.
4. Swallow the capsule whole, preferably with water.

Duration of treatment with Lenalidomida Krka

Lenalidomida 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 tells 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 next day at the usual time.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone may experience them.

If you experience any of the following serious side effects, stop treatment with Lenalidomida Krka and see a doctor immediately, as you may need urgent medical treatment:

• Hives, rash, swelling of the eyes, mouth, or face, difficulty breathing or itching, which can be symptoms of severe allergic reactions called angioedema and anaphylactic reaction
• A severe allergic reaction that can start as a rash in one area but spreads, causing significant skin loss throughout 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 effects on other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.

Consult your doctor immediately if you notice any of the following serious side effects:

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

Lenalidomida Krka may reduce the number of white blood cells that fight infections and also the blood cells that help blood to clot (platelets), which can cause bleeding disorders such as nosebleeds and bruising. Lenalidomida 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 increase with treatment with Lenalidomida Krka. Therefore, your doctor should carefully evaluate the benefits and risks when prescribing Lenalidomida Krka.

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

• A decrease in the number of red blood cells, which can cause anemia, leading to fatigue and weakness
• Skin rash, itching
• Muscle cramps, muscle weakness, muscle pain, muscle discomfort, bone pain, joint pain, back pain, pain in the limbs
• 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 a sensation of burning in the skin, pain in the hands or feet, dizziness, tremors
• Decreased appetite, changes in taste
• Increased pain, tumor size, or redness around the tumor
• Weight loss
• Constipation, diarrhea, nausea, vomiting, stomach pain, heartburn
• Low levels of potassium, calcium, or sodium in the blood
• Underactive thyroid function
• Pain in the legs (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 all kinds, including infection of the sinuses surrounding the nose (sinusitis), lung infection, and upper respiratory tract infection
• Difficulty breathing
• Blurred vision
• Eye opacity (cataracts)
• Kidney problems, including kidneys that do not function properly or are unable to maintain normal function
• Abnormal liver test results
• High liver test results
• Changes in a blood protein that can cause swelling of the arteries (vasculitis)
• Increased blood sugar levels (diabetes)
• Low blood sugar levels
• Headache
• Nosebleeds
• Dry skin
• Depression, mood changes, difficulty sleeping
• Cough
• Low blood pressure
• A vague feeling of discomfort in the body, feeling unwell
• Painful inflammation of the mouth, dry mouth
• Dehydration

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

• Destruction of red blood cells (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 protein that indicates inflammation in the body
• Darkening of skin color; change in skin color due to internal bleeding, usually caused by bruising; skin inflammation caused by blood accumulation; bruising
• Increased uric acid levels in the blood
• Skin rash, redness of the skin, cracked skin, skin peeling or exfoliation, hives
• Increased sweating, night sweats
• Difficulty swallowing, sore throat, difficulty maintaining voice quality or changes in voice
• Rhinorrhea
• Strong increase or decrease in urine output 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 having an erection.
• Stroke, fainting, vertigo (inner ear disorder that causes a sensation of everything spinning), temporary loss of consciousness
• Chest pain that spreads to the arms, neck, jaw, back, or stomach, sensation of sweating and shortness of breath, nausea or vomiting, which can be symptoms of a heart attack (myocardial infarction)
• Muscle weakness, lack of energy
• Cervical pain, chest pain
• Chills
• Joint swelling
• Slower or blocked bile flow from the liver
• Low levels of phosphate or magnesium in the blood
• Difficulty speaking
• Liver damage
• Balance disturbance, difficulty moving
• Deafness, ringing in the ears (tinnitus)
• Nerve pain, abnormal and unpleasant sensation, especially when touched
• Excess iron in the body
• Thirst
• Confusion
• Toothache
• Fall that can cause injury

Side effects uncommon(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 with bone pain and weakness, which can be symptoms of a kidney disorder (Fanconi syndrome)
• Yellowing of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching of the skin, rash, pain or swelling of the stomach; these can be symptoms of liver damage (liver failure)
• Stomach pain, abdominal swelling, or diarrhea, which can be symptoms of inflammation of the large intestine (called colitis or typhlitis)
• Kidney cell damage (called tubular necrosis)
• Changes in skin color, sensitivity to sunlight
• Tumor lysis syndrome - metabolic complications can occur during cancer treatment and sometimes even without treatment. These complications occur as a result of the breakdown products of dying cancer cells and can include: changes in blood biochemistry, high levels of potassium, phosphorus, uric acid, and low levels of calcium, which can cause changes in kidney function and heart rhythm, seizures, and sometimes death.
• Increased blood pressure in the blood vessels that supply the lungs (pulmonary hypertension).

Side effects of unknown frequency(cannot be estimated from the available data):

• Sudden, mild, or severe pain in the upper abdomen and/or back that lasts for several days, possibly accompanied by nausea, vomiting, fever, and rapid pulse. These symptoms can be due to pancreatitis.
• Wheezing or whistling when breathing, difficulty breathing, or dry cough, which can be symptoms caused by inflammation of the lung tissue.
• Rare cases of muscle breakdown (pain, weakness, or swelling of the muscles) have been observed, which can lead to kidney problems (rhabdomyolysis), some of them when Lenalidomida Krka is administered with a statin (a type of medication to lower cholesterol).
• A disease that affects the skin caused by inflammation of the small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis).
• Rupture of the stomach or intestine wall. This can 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.
• Viral infections, including herpes zoster (also known as shingles, a viral disease that causes a painful rash with blisters) and the recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark urine, stomach pain on the right side, fever, and nausea or feeling sick).
• Rejection of solid organ transplants (such as kidney, heart).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Lenalidomida Krka

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

Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Lenalidomida Krka

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

• The other ingredients of the capsule content are mannitol (E421), microcrystalline cellulose (E460), pregelatinized corn starch, tartaric acid (E334) and glycerol dibehenate.

• The other ingredients in the capsule shell are:

Lenalidomida 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)).

Lenalidomida Krka 5 mg hard capsules:

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

Lenalidomida 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)).

Lenalidomida 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)).

Lenalidomida 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)).

Lenalidomida 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)).

Lenalidomida 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 and packaging of the product

Lenalidomida Krka 2.5 mg hard capsules (capsules):

The cap of the capsule is green, the body of the capsule is green and bears the black imprint 2.5. The capsule contains a white to off-white or light brown powder. Size of the hard capsule: 4, length 14 ± 1 mm.

Lenalidomida Krka 5 mg hard capsules (capsules):

The cap of the capsule is blue, the body of the capsule is blue and bears the black imprint 5. The capsule contains a white to off-white or light brown powder. Size of the hard capsule: 2, length 18 ± 1 mm.

Lenalidomida Krka 7.5 mg hard capsules (capsules):

The cap of the capsule is brown, the body of the capsule is brown and bears the white imprint 7.5. The capsule contains a white to off-white or light brown powder. Size of the hard capsule: 1, length 19 ± 1 mm.

Lenalidomida Krka 10 mg hard capsules (capsules):

The cap of the capsule is green, the body of the capsule is brown and bears the white imprint 10. The capsule contains a white to off-white or light brown powder. Size of the hard capsule: 0, length 21 ± 1 mm.

Lenalidomida Krka 15 mg hard capsules (capsules):

The cap of the capsule is brown, the body of the capsule is blue and bears the black imprint 15. The capsule contains a white to off-white or light brown powder. Size of the hard capsule: 2, length 18 ± 1 mm.

Lenalidomida Krka 20 mg hard capsules (capsules):

The cap of the capsule is green, the body of the capsule is blue and bears the black imprint 20. The capsule contains a white to off-white or light brown powder. Size of the hard capsule: 1, length 19 ± 1 mm.

Lenalidomida Krka 25 mg hard capsules (capsules):

The cap of the capsule is brown, the body of the capsule is brown and bears the white imprint 25. The capsule contains a white to off-white or light brown powder. Size of the hard capsule: 0, length 21 ± 1 mm.

Lenalidomida Krka is available in boxes containing 7 x 1 or 21 x 1 hard capsules in unit dose precut blisters.

Only some 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:

Date of last revision of this prospectus:

Other sources of information

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