Kleder

Package Leaflet: Information for the Patient

Kleder, 5 mg, hard capsules
Kleder, 10 mg, hard capsules
Kleder, 15 mg, hard capsules
Kleder, 20 mg, hard capsules
Kleder, 25 mg, hard capsules
Lenalidomide

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Kleder and what is it used for
• 2. Important information before taking Kleder
• 3. How to take Kleder
• 4. Possible side effects
• 5. How to store Kleder
• 6. Contents of the pack and other information

1. What is Kleder and what is it used for

What is Kleder

Kleder contains the active substance lenalidomide. This medicine belongs to a group of medicines that affect the immune system.

What is Kleder used for

Kleder is used to treat adults with:

• multiple myeloma,
• myelodysplastic syndromes,
• mantle cell lymphoma,
• follicular lymphoma.

Multiple Myeloma

Multiple myeloma is a type of cancer that affects a certain type of white blood cell called plasma cells. These cells accumulate in the bone marrow and undergo uncontrolled divisions. This can lead to bone and kidney damage.
In principle, multiple myeloma is incurable, but it is possible to achieve significant temporary relief or removal of signs and symptoms of the disease. We call this "response".
Newly diagnosed multiple myeloma in patients after bone marrow transplantation
In this indication, Kleder is used without other medicines as maintenance treatment after achieving a suitable condition after transplantation.
Newly diagnosed multiple myeloma - in patients who are not eligible for bone marrow transplantation treatment
Kleder is taken with other medicines. These may include:

• a chemotherapy medicine called "bortezomib";
• an anti-inflammatory medicine called "dexamethasone";
• a chemotherapy medicine called "melphalan" and
• an immunosuppressant medicine called "prednisone". The patient starts treatment with additional medicines and then continues with Kleder alone.

If the patient is 75 years or older, or has moderate to severe kidney problems, the doctor will perform thorough examinations before starting treatment.
Multiple myeloma - in patients who have received previous treatment
Kleder is taken in combination with an anti-inflammatory medicine called "dexamethasone".
Kleder may stop the progression of multiple myeloma symptoms and signs. It has also been shown to delay the recurrence of multiple myeloma after treatment.
Myelodysplastic Syndromes (MDS)
Myelodysplastic syndromes (MDS) are a group of different blood and bone marrow diseases. There are abnormal blood cells that do not function properly. Patients may experience various subjective and objective symptoms, including low red blood cell count (anemia), the need for blood transfusions, and the risk of infection.
Kleder is used alone to treat adult patients with MDS, if all of the following conditions are met:

• the patient has a low red blood cell count and needs regular blood transfusions ("transfusion-dependent anemia");
• the patient has a genetic abnormality in bone marrow cells called "isolated cytogenetic deletion 5q". This means that the patient's body does not produce enough healthy blood cells;
• the patient has previously used other treatments that have been ineffective or insufficient.

Taking Kleder may lead to an increase in the number of healthy blood cells produced by the body, by reducing the number of abnormal cells:

• this may lead to a reduction in the number of blood transfusions required. It is possible that transfusions will no longer be needed.

Mantle Cell Lymphoma (MCL)

MCL is a cancer of part of the immune system (lymphoid tissue). It affects a certain type of white blood cell called B lymphocytes or B cells. Mantle cell lymphoma is a disease characterized by uncontrolled growth of B lymphocytes, resulting in their accumulation in lymphoid tissue, bone marrow, or blood.
Kleder is used alone to treat adult patients who have previously been treated with other medicines.
Follicular Lymphoma (FL)
Follicular lymphoma (FL) is a slow-growing malignant tumor that affects B lymphocytes. It is a type of white blood cell that helps the body fight infections. In patients with FL, there may be an accumulation of too many B lymphocytes in the blood, bone marrow, lymph nodes, and spleen.
Kleder is taken with another medicine called "rituximab" to treat adult patients with previously treated follicular lymphoma.

How Kleder works

Kleder works by affecting the immune system and directly attacking cancer cells. The medicine works in several ways:

• by inhibiting the growth of cancer cells,
• by inhibiting the growth of blood vessels in the tumor,
• by stimulating part of the immune system to attack cancer cells.

2. Important information before taking Kleder

Before starting treatment with Kleder, read the package leaflets of all medicines taken in combination with Kleder.

When not to take Kleder:

• If the patient is pregnant, suspects pregnancy, or plans to become pregnant, as Kleder is expected to be harmful to the unborn child(see section 2 "Pregnancy, breastfeeding, and contraception - information for women and men").
• If the patient may become pregnant, unless all required contraceptive measures are taken (see section 2 "Pregnancy, breastfeeding, and contraception - information for women and men"). If the patient may become pregnant, the doctor will always make a note when prescribing the medicine that the necessary measures have been taken and will inform the patient about this.
• If the patient is allergic to lenalidomide or any of the other ingredients of this medicine listed in section 6. In case of suspected allergy, consult a doctor.

If any of these points apply to the patient, do not take Kleder. In case of doubt, consult a doctor.

Warnings and precautions

Before starting treatment with Kleder, consult a doctor, pharmacist, or nurse in the following cases:

• there have been blood clots in the past - this means an increased risk of blood clots in the veins and arteries during treatment;
• there are any signs of infection, such as cough or fever;
• there is a current or past viral infection, especially hepatitis B, chickenpox, and shingles. In case of doubt, consult a doctor. Treatment with Kleder may cause reactivation of the virus in patients who are carriers. This can lead to recurrence of the infection. The doctor will check if the patient has had hepatitis B in the past.
• there are kidney problems - the doctor may adjust the dose of Kleder;
• there has been a heart attack, blood clot, smoking, high blood pressure, or high cholesterol;
• the patient has had allergic reactions when taking thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing;
• there has been a combination of any of the following symptoms: widespread rash, redness of the skin, high body temperature, flu-like symptoms, increased liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes - these are symptoms of a severe skin reaction called drug rash with eosinophilia and systemic symptoms (DRESS) or drug hypersensitivity syndrome (see also section 4 "Possible side effects").

If any of the above apply to the patient, consult a doctor, pharmacist, or nurse.
If at any time during or after treatment the patient experiences:

• vision disturbances, loss of vision, or double vision, difficulty speaking, weakness of the arm or leg, change in gait or balance disturbances, persistent numbness, reduced sensation, or loss of sensation, memory loss, or disorientation, tell the doctor or nurse immediately. These may be symptoms of a severe and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If the patient has had such symptoms before treatment with lenalidomide, inform the doctor about any changes in these symptoms.
• shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or swelling of the feet or ankles. These may be symptoms of a severe condition called pulmonary hypertension (see section 4).

Tests and examinations

Before and during treatment with Kleder, regular blood tests will be performed. This is because Kleder may cause a decrease in the number of blood cells that fight infection (white blood cells) and help blood to clot (platelets).
The doctor will ask for blood tests:

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

Before starting treatment with lenalidomide and during treatment, the patient may undergo an assessment for cardiovascular and respiratory diseases.
Patients with MDS taking Kleder
If the patient has myelodysplastic syndromes, there is an increased chance of developing a severe disease called acute myeloid leukemia. Additionally, it is not known how Kleder affects the likelihood of developing acute myeloid leukemia. Therefore, the doctor may perform tests and check for signs that can better predict the risk of acute myeloid leukemia during treatment with Kleder.
Patients with MCL taking Kleder
The doctor will ask for a blood test:

• before treatment;
• every week for the first 8 weeks (2 cycles) of treatment;
• then every 2 weeks in cycles 3 and 4 (more information is provided in section 3 "Treatment cycle");
• then at the beginning of each cycle and
• at least once a month.

Patients with FL taking Kleder
The doctor will ask for blood tests:

• before treatment;
• every week for the first 3 weeks (1 cycle) of treatment;
• then every 2 weeks in cycles 2 to 4 (more information is provided in section 3 "Treatment cycle");
• then at the beginning of each cycle and
• at least once a month.

The doctor may perform a test to check if the patient has a large amount of tumor tissue in the body, including bone marrow. This can lead to a situation where the tumor tissue starts to die and causes abnormal growth of various substances in the blood, which can lead to kidney failure (a condition called tumor lysis syndrome).
The doctor may perform a test to check if the patient has any skin changes, such as red spots or rash.
The doctor may change the dose of Kleder or stop treatment based on the results of the patient's blood tests and overall condition. If the disease is newly diagnosed, the doctor may also assess treatment based on the patient's age and other diseases that already exist.

Blood donation

During treatment and for at least 7 days after stopping treatment, the patient must not donate blood.

Children and adolescents

Kleder is not recommended for use in children and adolescents under 18 years of age.

Elderly and patients with kidney problems

If the patient is 75 years or older, or has moderate to severe kidney problems, the doctor will perform thorough examinations before starting treatment.

Kleder and other medicines

Tell the doctor or nurse about all medicines the patient is taking, or has recently taken. This is necessary because Kleder may affect the action of other medicines. Also, some other medicines may affect the action of Kleder.
In particular, inform the doctor or nurse if the patient is taking:

• certain contraceptives, such as oral contraceptives, as they may stop working;
• certain heart medicines, such as digoxin;
• certain blood-thinning medicines, such as warfarin.

Pregnancy, breastfeeding, and contraception - information for women and men

Pregnancy

For women taking Kleder

• Do not take Kleder if pregnant, as it is expected to be harmful to the unborn child.
• Do not become pregnant while taking Kleder.
• Therefore, women who may become pregnant must use effective contraception (see "Contraception").
• If the patient becomes pregnant while taking Kleder, stop treatment immediately and inform the doctor.

For men taking Kleder

• If the partner of a man taking Kleder becomes pregnant, she should inform the doctor immediately. The partner should consult a doctor.
• Men should also use effective contraception (see "Contraception").

Breastfeeding

Do not breastfeed while taking Kleder, as it is not known whether Kleder passes into human milk.

Contraception

For women taking Kleder
Before starting treatment, ask the doctor about the possibility of becoming pregnant, even if it seems unlikely.
Women who may become pregnant:

• will undergo pregnancy tests under medical supervision (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after stopping treatment), unless the patient has had their fallopian tubes cut and unblocked (tubal sterilization)

AND

• must use effective contraceptive methods for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after stopping treatment. The doctor will recommend the appropriate contraceptive methods.

For men taking Kleder
Kleder is present in human semen. If a woman is pregnant or may become pregnant and is not using effective contraception, her partner should use a condom during treatment and for at least 7 days after stopping treatment. This also applies to men who have had a vasectomy. During treatment and for at least 7 days after stopping treatment, the patient must not donate semen.

Driving and using machines

Do not drive or operate machinery if the patient experiences dizziness, fatigue, drowsiness, balance disturbances due to dizziness, or blurred vision after taking Kleder.
Kleder contains lactose and sodium.
Kleder contains lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to take Kleder

Kleder must be administered by medical personnel who have experience in treating multiple myeloma, MDS, MCL, or FL.

• •When Kleder is used to treat multiple myeloma in patients who are not eligible for bone marrow transplantation or who have received previous treatment, it is taken with other medicines (see section 1 "What is Kleder used for").
• When Kleder is used to treat multiple myeloma in patients after bone marrow transplantation or to treat patients with MDS or MCL, it is used alone.
• When Kleder is used to treat follicular lymphoma, it is taken with another medicine called "rituximab".

Kleder should always be taken as directed by the doctor. In case of doubt, consult a doctor or pharmacist.
If the patient is taking Kleder with other medicines, they should read the package leaflet of those medicines to get information about their use and effects.

Treatment cycle

Kleder is taken on specific days during a period of three weeks (21 days).

• Each such 21-day period is called a treatment cycle.
• Depending on the day of the cycle, the patient will take one or more medicines. However, on some days, the patient will not take any medicines.
• After completing each 21-day cycle, the patient should start a new 21-day cycle. OR Kleder is taken on specific days during a period of four weeks (28 days).
• Each such 28-day period is called a treatment cycle.
• Depending on the day of the cycle, the patient will take one or more medicines. However, on some days, the patient will not take any medicines.
• After completing each 28-day cycle, the patient should start a new 28-day cycle.

What dose of Kleder to take

Before starting treatment, the doctor will inform the patient:

• how much Kleder to take;
• how much of other medicines to take in combination with Kleder, if other medicines are necessary;
• on which days of the cycle to take each medicine.

How and when to take Kleder

• Swallow the capsule whole, preferably with water.
• Do not break, open, or chew the capsules. If the powder from a damaged Kleder capsule comes into contact with the skin, wash the skin immediately with soap and water.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister or capsule. The gloves should then be carefully removed to avoid skin exposure, placed in a sealed plastic bag, and disposed of in accordance with local regulations. Then, wash hands thoroughly with soap and water. Pregnant women or those who suspect they are pregnant should not handle the blister or capsule.
• The capsules can be taken with or without food.
• Kleder should be taken at approximately the same time every day, on the days when the medicine is scheduled.

How to take Kleder

To remove a capsule from the blister:

• press the capsule only on one side and push it through the foil;
• do not press the center of the capsule, as this may damage it.

Duration of treatment with Kleder

Kleder is used in treatment cycles; each cycle lasts 21 or 28 days (see above "Treatment cycle"). Treatment cycles should be continued until the doctor stops the treatment.

Overdose of Kleder

If a higher dose of Kleder than prescribed is taken, inform the doctor immediately.

Missed dose of Kleder

If a dose of Kleder is missed and

• less than 12 hours have passed since the scheduled time: take the capsule immediately;
• more than 12 hours have passed since the scheduled time: do not take the capsule. Take the next capsule at the scheduled time the next day.

In case of any further doubts about taking the medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Kleder can cause side effects, although not everybody gets them.

If any of the following serious side effects occur, stop taking Kleder and consult a doctor immediately - immediate treatment may be necessary:

• hives, rash, swelling of the eyes, lips, or face, difficulty breathing, or itching, which may be symptoms of severe allergic reactions called angioedema and anaphylaxis;
• severe allergic reaction that starts as a rash in one area and spreads to the whole body, and is accompanied by a significant loss of skin (Stevens-Johnson syndrome and/or toxic epidermal necrolysis);
• widespread rash, high fever, increased liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (drug rash with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.

Tell the doctor immediately if any of the following serious side effects occur:

• fever, chills, sore throat, cough, mouth ulcers, or any other signs of infection (including blood infections (sepsis));
• bleeding or bruising without injury;
• chest pain or leg pain;
• shortness of breath;
• bone pain, muscle weakness, confusion, or fatigue that may be due to high calcium levels in the blood.

Kleder may decrease the number of white blood cells that fight infection and the cells that help blood to clot (platelets), which can lead to bleeding disorders, such as nosebleeds and bruising. Kleder may also cause blood clots in the veins (thrombosis).

Other side effects

Note that in a small number of patients, Kleder may cause the development of other types of cancer, and it is possible that this risk may increase due to treatment with Kleder. Therefore, the treating doctor should carefully assess the benefits and risks of prescribing Kleder to the patient.
Very common side effects(may occur in more than 1 in 10 people):

• decrease in red blood cell count, which may cause anemia leading to fatigue and weakness;
• rash, itching;
• muscle spasms, muscle weakness, pain in muscles, muscle tenderness, bone pain, joint pain, back pain, limb pain;
• generalized swelling, including swelling of the hands and feet;
• weakness, fatigue;
• fever and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough, and chills;
• numbness, tingling, or burning sensation of the skin, pain in hands or feet, dizziness, tremors;
• decreased appetite, altered taste;
• increased pain, tumor growth, or redness around the tumor;
• weight loss;
• constipation, diarrhea, nausea, vomiting, abdominal pain, heartburn;
• low potassium, calcium, or sodium levels in the blood;
• abnormally low thyroid function;
• leg pain (which may be a sign of thrombosis), chest pain, or shortness of breath (which may be a sign of blood clots in the lungs, called pulmonary embolism);
• infections, including sinusitis, pneumonia, and upper respiratory tract infections;
• shortness of breath;
• blurred vision;
• cloudy vision (cataract);
• kidney problems, including abnormal kidney function or inability to maintain normal kidney function;
• abnormal liver test results;
• increased liver enzyme activity;
• changes in blood proteins leading to swelling of blood vessels (vasculitis);
• high blood sugar levels (diabetes);
• low blood sugar levels;
• headache;
• nosebleeds;
• dry skin;
• depression, mood changes, sleep disturbances;
• cough;
• low blood pressure;
• general feeling of discomfort, malaise;
• painful inflammation of the mouth, dry mouth;
• dehydration.

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

• red blood cell destruction (hemolytic anemia);
• certain types of skin tumors;
• bleeding from the gums, stomach, or intestines;
• high blood pressure, slow, fast, or irregular heartbeat;
• increased levels of substances due to normal and abnormal breakdown of red blood cells;
• increased levels of a protein that indicates inflammation in the body;
• skin darkening, skin discoloration due to bleeding under the skin, usually caused by bruising; skin swelling filled with blood, bruising;
• high uric acid levels in the blood;
• skin rashes, redness of the skin, peeling, cracking, or shedding of the skin, hives;
• excessive sweating, night sweats;
• difficulty swallowing, sore throat, voice problems, or changes in voice;
• runny nose (rhinitis);
• passing much more or much less urine than normal, or inability to control urination;
• passing blood in urine;
• shortness of breath, especially when lying down (which may be a sign of heart failure);
• erectile dysfunction;
• stroke, fainting, dizziness (inner ear disturbances that cause a feeling of spinning), loss of consciousness;
• chest pain radiating to the arms, neck, jaw, back, or abdomen, feeling 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;
• slowing or blocking the flow of bile from the liver;
• low phosphate or magnesium levels in the blood;
• difficulty speaking;
• liver damage;
• balance disturbances, difficulty walking;
• hearing loss, ringing in the ears (tinnitus);
• nerve pain, unpleasant abnormal sensations, especially in response to touch;
• excessive iron in the body;
• thirst;
• confusion;
• toothache;
• fall that may lead to injury.

Uncommon side effects(may occur in up to 1 in 100 people):

• bleeding in the brain;
• circulatory problems;
• vision loss;
• loss of sex drive (libido);
• passing large amounts of urine, with accompanying bone pain and weakness, which may be a sign of kidney disease (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 abdomen - these may be symptoms of liver damage (liver failure);
• abdominal pain, bloating, or diarrhea, which may be symptoms of colon inflammation (colitis);
• kidney cell damage (renal tubular necrosis);
• skin color changes, sensitivity to sunlight;
• tumor lysis syndrome - a complication of metabolism that can occur during cancer treatment, and sometimes even without treatment. These complications are caused by the breakdown products of dying cancer cells and can include changes in blood chemistry; high levels of potassium, phosphate, uric acid, and low levels of calcium, leading to kidney dysfunction, irregular heartbeat, seizures, and sometimes death;
• high blood pressure in the blood vessels that lead to the lungs (pulmonary hypertension).

Rare side effects(frequency cannot be estimated from available data)

• sudden or gradual, but worsening, pain in the upper abdomen and/or back, lasting for several days, usually accompanied by nausea, vomiting, fever, and rapid heartbeat - these symptoms may occur with pancreatitis;
• wheezing, shortness of breath, or dry cough, which may be caused by lung inflammation;
• rare cases of muscle breakdown (pain, weakness, or swelling of muscles) that can lead to kidney problems (rhabdomyolysis), some of which occurred when Kleder was taken 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);
• rupture of the stomach or intestine wall; this can lead to a very serious infection. Tell the doctor if there is severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel movements;
• viral infections, including shingles (a viral disease that causes painful skin rash with blisters) and reactivation of hepatitis B virus (which can cause yellowing of the skin and eyes, dark urine, abdominal pain on the right side, fever, nausea, and vomiting);
• rejection of a transplanted organ (e.g., kidney, heart).

Reporting side effects

If any side effects occur, including any not listed in this leaflet, tell the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website:
https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Kleder

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after the words "EXP". The expiry date refers to the last day of the month stated.
There are no special storage instructions for the medicine.
Do not use this medicine if the packaging is damaged or shows signs of opening.
Medicines should not be disposed of via wastewater or household waste. Unused medicines should be returned to a pharmacy that accepts them. This will help protect the environment.

6. Contents of the pack and other information

What Kleder contains

Kleder, 5 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 5 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: brilliant blue FCF (E 133), red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), and gelatin;
• printing ink: shellac, black iron oxide (E 172), propylene glycol, and potassium hydroxide.

Kleder, 10 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 10 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: black iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), and gelatin;
• printing ink: shellac, black iron oxide (E 172), propylene glycol, and potassium hydroxide.

Kleder, 15 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: black iron oxide (E 172), red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), and gelatin;
• printing ink: shellac, black iron oxide (E 172), propylene glycol, and potassium hydroxide.

Kleder, 20 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 20 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: red iron oxide (E 172), yellow iron oxide (E 172), black iron oxide (E 172), titanium dioxide (E 171), and gelatin;
• printing ink: shellac, black iron oxide (E 172), propylene glycol, and potassium hydroxide.

Kleder, 25 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 25 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: titanium dioxide (E 171) and gelatin;
• printing ink: shellac, black iron oxide (E 172), propylene glycol, and potassium hydroxide.

What Kleder looks like and contents of the pack

Kleder, 5 mg, hard capsules are green, opaque cap and light brown, opaque body, capsule size 2, 18-19 mm, with black printing ink "LP" on the cap and "638" on the body; capsule filled with white powder.
Kleder, 10 mg, hard capsules are yellow, opaque cap and gray, opaque body, capsule size 0, 21-22 mm, with black printing ink "LP" on the cap and "639" on the body; capsule filled with white powder.
Kleder, 15 mg, hard capsules are brown, opaque cap and gray, opaque body, capsule size 2, 18-19 mm, with black printing ink "LP" on the cap and "640" on the body; capsule filled with white powder.
Kleder, 20 mg, hard capsules are dark red, opaque cap and light gray, opaque body, capsule size 1, 19-20 mm, with black printing ink "LP" on the cap and "641" on the body; capsule filled with white powder.
Kleder, 25 mg, hard capsules are white, opaque cap and white, opaque body, capsule size 0, 21-22 mm, with black printing ink "LP" on the cap and "642" on the body; capsule filled with white powder.
Blisters of PVC/ACLAR/Aluminum containing 7 capsules, in a carton box.
Kleder 5 mg, 10 mg, and 15 mg
Pack size: 7 or 21 capsules. Not all pack sizes may be marketed
Kleder 20 mg and 25 mg
Pack size: 21 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder
Stada Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel, Germany
Manufacturer/Importer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Adalvo Ltd.
Malta Life Sciences Park
Building 1, Level 4
Sir Temi Zammit Buildings
San Gwann SGN 3000, Malta
STADA Arzneimittel AG
Stadastrasse 2 – 18
61118 Bad Vilbel
Germany
STADAPHARM GmbH
Feodor-Lynen-Str. 35
30625 Hannover,
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Iceland
Kleder 2.5 mg hard capsules
Kleder 5 mg hard capsules
Kleder 7.5 mg hard capsules
Kleder 10 mg hard capsules
Kleder 15 mg hard capsules
Kleder 20 mg hard capsules
Kleder 25 mg hard capsules
Italy, Poland
Kleder
Date of last revision of the leaflet:04/2024