Kleder

Leaflet accompanying the packaging: patient information

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the 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 packaging 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 functioning of the immune system.

What is Kleder used for

Kleder is used in adults to treat:

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

Multiple myeloma

Multiple myeloma is a type of cancer that attacks 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 temporarily significantly alleviate or eliminate the 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 in 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. They 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 old or older, or has moderate to severe kidney problems, the doctor will perform thorough tests before starting treatment.
Multiple myeloma - in patients who have undergone 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 a low number of red blood cells (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 anemia that requires regular blood transfusions ("transfusion-dependent anemia");
• the patient has a cytogenetic abnormality in bone marrow cells called "isolated 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 proven to be ineffective or insufficient.

Taking Kleder may lead to an increase in the number of healthy blood cells produced by the body, by limiting 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 attacks 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 attacks 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 functioning of 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, you should carefully read the leaflets of all medicinal products taken in combination with Kleder.

When not to take Kleder:

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

If any of these points apply to you, you should not take Kleder. In case of doubts, you should consult your doctor.
Before starting Kleder treatment, you should consult your doctor, pharmacist, or nurse in the following cases:

• you have had blood clots in the past - this means an increased risk of blood clots in the veins and arteries during treatment;
• you have any symptoms of infection, such as cough or fever;
• you have a current or past viral infection, especially hepatitis B, chickenpox, and shingles. If in doubt, you should consult your doctor. Kleder treatment may cause the virus to reactivate in patients who are its carriers. This leads to a recurrence of the infection. Your doctor will check if you have had hepatitis B in the past.
• you have kidney problems - your doctor may adjust the dose of Kleder;
• you have had a heart attack, have ever had a blood clot, if you smoke, have high blood pressure, or high cholesterol levels;
• you have had allergic symptoms when taking thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing;
• you have had a combination of any of the following symptoms in the past: 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, also known as "DRESS" or "drug hypersensitivity syndrome" (see also section 4 "Possible side effects").

If any of the above applies to you, you should consult your doctor, pharmacist, or nurse.
If at any time during or after treatment you experience:

• vision disturbances, loss of vision, or double vision, difficulty speaking, weakness of the arm or leg, change in gait, or balance disturbances, persistent numbness, decreased sensation, or loss of sensation, memory loss, or disorientation, you should immediately tell your doctor or nurse. These may be symptoms of a severe and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If you have had such symptoms before treatment with lenalidomide, you should inform your 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 infections (white blood cells) and help blood clot (platelets).
Your doctor will ask you to have blood tests:

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

Before starting lenalidomide treatment and during treatment, you may be evaluated for cardiovascular and respiratory diseases.
Patient with MDS taking Kleder
If you have myelodysplastic syndrome, 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, your doctor may perform tests and check for signs that will help better predict the risk of acute myeloid leukemia during Kleder treatment.
Patient with MCL taking Kleder
Your doctor will ask you to have blood tests:

• 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.

Patient with FL taking Kleder
Your doctor will ask you to have blood tests:

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

Your doctor may perform a test to check if you have a large amount of tumor tissue in your body, including bone marrow. This may 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).
Your doctor may perform a test to check if you have any skin changes, such as red spots or rash.
Your doctor may change the dose of Kleder or stop treatment based on the results of your blood tests and your overall condition. If the disease is newly diagnosed, your doctor may also evaluate treatment based on your age and other diseases you already have.

Blood donation

During treatment and for at least 7 days after stopping treatment, you 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 you are 75 years old or older, or have moderate to severe kidney problems, your doctor will perform thorough tests before starting treatment.

Kleder and other medicines

You should tell your doctor or nurse about all medicines you are currently taking or have recently taken. This is necessary because Kleder may affect the action of other medicines. Also, some other medicines may affect how Kleder works.
In particular, you should inform your doctor or nurse if you are taking the following medicines:

• 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

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

For men taking Kleder

• If your partner becomes pregnant while you are taking Kleder, she should immediately inform her doctor. Your partner should consult a doctor.
• Men should also use effective contraception (see "Contraception").

Breastfeeding

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

Contraception

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

• will have pregnancy tests performed under medical supervision (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after stopping treatment), unless you have had your fallopian tubes cut and unblocked (tubal sterilization)

AND

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

For men taking Kleder
Kleder passes into 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, you must not donate semen.

Driving and using machines

You should not drive or operate machinery if you experience dizziness, fatigue, drowsiness, balance disturbances caused by dizziness, or blurred vision after taking Kleder.
Kleder contains lactose and sodium.
Kleder contains lactose. If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "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 undergone previous treatment, the medicine 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, the medicine is used alone.
• When Kleder is used to treat follicular lymphoma, it is taken with another medicine called "rituximab".

Kleder should always be taken according to your doctor's instructions. If you have any doubts, you should consult your doctor or pharmacist.
If you are taking Kleder with other medicines, you should read the leaflet that comes with their packaging 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, you will take one or more medicines. However, on some days, you will not take any medicines.
• After completing each 21-day cycle, you 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, you will take one or more medicines. However, on some days, you will not take any medicines.
• After completing each 28-day cycle, you should start a new 28-day cycle.

What dose of Kleder should you take

Before starting treatment, your doctor will inform you:

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

How and when to take Kleder

• The capsule should be swallowed whole, preferably with water.
• Do not break, open, or chew the capsules. If you come into contact with the powder from a damaged Kleder capsule, wash your 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 according to local regulations. Then, wash your hands with soap and water. Pregnant women or those who suspect they are pregnant should not touch the blister or capsule.
• The capsules can be taken with or without food.
• Kleder should be taken at approximately the same time every day when the medicine is scheduled to be taken.

How to take Kleder

To remove the 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.

What to do if you take more Kleder than you should

If you take more Kleder than prescribed, you should immediately inform your doctor.

What to do if you miss a dose of Kleder

If you miss a dose of Kleder and

• it has been less than 12 hours since the scheduled time: you should take the capsule immediately;
• it has been more than 12 hours since the scheduled time: do not take the capsule. You should take the next capsule at the scheduled time the next day.

If you have any further doubts about taking the medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following severe side effects, you should stop taking Kleder and immediately consult your doctor – you may need urgent treatment:

• 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;
• a severe allergic reaction that starts as a rash in one area and spreads to the whole body, 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.

You should immediately inform your doctor about any of the following severe side effects:

• fever, chills, sore throat, cough, mouth ulcers, or any other symptoms 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 clot (platelets), which can lead to bleeding disorders, e.g., 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 Kleder treatment. Therefore, your doctor should carefully weigh the benefits and risks of prescribing Kleder to you.
Very common side effects(may occur in more than 1 in 10 people):

• decrease in the number of red blood cells, which may cause anemia leading to fatigue and weakness;
• rash, itching;
• muscle spasms, muscle weakness, muscle pain, 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 the 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 symptom of thrombosis), chest pain, or shortness of breath (which may be symptoms of blood clots in the lungs, called pulmonary embolism);
• infections of all kinds, 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 the arteries (vasculitis);
• increased blood sugar levels (diabetes);
• decreased blood sugar levels;
• headache;
• nosebleeds;
• dry skin;
• depression, mood changes, sleep disturbances;
• cough;
• low blood pressure;
• general feeling of physical discomfort, malaise;
• painful oral inflammation, dry mouth;
• dehydration.

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

• red blood cell breakdown (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 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;
• increased uric acid levels in the blood;
• skin rashes, redness of the skin, peeling, cracking, or flaking of the skin, hives;
• increased sweating, night sweats;
• difficulty swallowing, sore throat, voice changes, or hoarseness;
• runny nose (rhinitis);
• passing much more or much less urine than normal, or inability to control urination;
• passing blood in the urine;
• shortness of breath, especially when lying down (which may be a symptom of heart failure);
• erectile dysfunction;
• stroke, fainting, dizziness (inner ear disturbances that cause a feeling of spinning), transient 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 symptoms of kidney disease (Fanconi syndrome);
• yellowing of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching, 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 may include changes in blood chemistry; high levels of potassium, phosphate, uric acid, and low levels of calcium, leading to kidney dysfunction, heart rhythm disturbances, seizures, and sometimes death;
• increased 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, and rapid heartbeat - these symptoms may occur in association 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 the 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. You should tell your doctor if you experience 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 rashes with blisters) and hepatitis B reactivation (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 you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw, phone: 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 will help gather more information on the safety of the medicine.

5. How to store Kleder

The medicine should be stored out of 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 you notice any damage or signs of opening of the packaging.
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 packaging 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), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), and gelatin;
• printing ink: shellac, iron oxide black (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: iron oxide black (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), and gelatin;
• printing ink: shellac, iron oxide black (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: iron oxide black (E 172), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), and gelatin;
• printing ink: shellac, iron oxide black (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: iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172), titanium dioxide (E 171), and gelatin;
• printing ink: shellac, iron oxide black (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, iron oxide black (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 ink printing "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 ink printing "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 ink printing "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 ink printing "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 ink printing "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.
Kleder 5 mg, 10 mg, and 15 mg
Package size: 7 or 21 capsules. Not all package sizes may be marketed
Kleder 20 mg and 25 mg
Package 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:

Countries:

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