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
Please read carefully all of this leaflet before taking this medicine because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• Contact your doctor or pharmacist if you have any questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Kleder is and what it is 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 Kleder is and what it is used for

What Kleder is
Kleder contains the active substance lenalidomide. This medicine belongs to a group of medicines that affect the function of the immune system.
What Kleder is used for
Kleder is used in adults for the treatment of:

• 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 cells called plasma cells. These cells accumulate in the bone marrow and divide uncontrollably. This may lead to damage of bones and kidneys.
Multiple myeloma is generally incurable, but it is possible to achieve temporary significant reduction or elimination of signs and symptoms of the disease. This is called a “response”.
Newly diagnosed multiple myeloma in patients after bone marrow transplantation
In this indication, Kleder is used alone as maintenance therapy after achieving an adequate response following transplantation.
Newly diagnosed multiple myeloma – in patients for whom treatment involving bone marrow transplantation is not possible
Kleder is taken in combination with other medicines. These may include:

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

If the patient is 75 years of age or older, or has moderate to severe kidney impairment, the doctor will perform thorough assessments before starting treatment.
Multiple myeloma – in previously treated patients
Kleder is taken in combination with an anti-inflammatory medicine called “dexamethasone”.
Kleder may stop the progression of signs and symptoms of multiple myeloma. 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 disorders. Abnormal blood cells are present that do not function properly. Patients may experience various subjective and objective symptoms, including low number of red blood cells (anaemia), need for blood transfusions, and risk of infection.
Kleder, used as monotherapy, is indicated for the treatment of adult patients diagnosed with MDS if all of the following conditions are met:

• the patient requires regular blood transfusions due to low red blood cell count (“transfusion-dependent anaemia”);
• the patient has an abnormality in bone marrow cells called “isolated cytogenetic abnormality with deletion 5q”. This means the patient’s body does not produce enough healthy blood cells;
• previous treatments used for the patient have proven inappropriate or insufficiently effective.

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 required blood transfusions. It may be possible that transfusions will no longer be needed.

Mantle cell lymphoma (MCL)
MCL is a cancer affecting part of the immune system (lymphatic tissue). It attacks a certain type of white blood cells called B-lymphocytes or B-cells. Mantle cell lymphoma is a disease characterised by uncontrolled growth of B-lymphocytes, resulting in their accumulation in lymphatic tissue, bone marrow, or blood.
Kleder, used as monotherapy, is indicated for the treatment of adult patients who have been previously treated with other medicines.
Follicular lymphoma (FL)
Follicular lymphoma (FL) is a slowly growing malignant tumour affecting B-lymphocytes. These are a type of white blood cells that help the body fight infections. In patients with FL, excessive numbers of B-lymphocytes may accumulate in the blood, bone marrow, lymph nodes, and spleen.
Kleder is taken together with another medicine called “rituximab” for the treatment of adult patients with previously treated follicular lymphoma.
How Kleder works
Kleder works by affecting the function of the immune system and directly attacking cancer cells. The medicine works in several different ways:

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

2. Important information before taking Kleder
Before starting treatment with Kleder, carefully read the leaflets of all medicinal products taken in combination with Kleder.
When not to use Kleder:

• If the patient is pregnant, suspects she is pregnant, or plans to become pregnant, because 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 she uses all required contraceptive measures (see section 2 “Pregnancy, breastfeeding and contraception – information for women and men”). If the patient may become pregnant, the doctor will always document that necessary measures have been taken and ensure the patient is informed.
• 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 your doctor for advice.

If any of these points apply to the patient, Kleder must not be used. In case of doubt, consult your doctor.
Warnings and precautions
Before starting to take Kleder, consult your doctor, pharmacist, or nurse if:

• you have previously had blood clots – this means an increased risk of developing blood clots in veins and arteries during treatment;
• you have any signs of infection, such as cough or fever;
• you currently have or have previously had a viral infection, particularly hepatitis B virus, varicella-zoster virus (chickenpox and shingles), or HIV. In case of doubt, consult your doctor. Treatment with Kleder may cause reactivation of the virus in patients who are carriers, leading to recurrence of infection. Your doctor will check whether you have previously had hepatitis B;
• you have kidney problems – your doctor may adjust the dose of Kleder;
• you have had a heart attack (myocardial infarction), have ever had a blood clot, smoke, have high blood pressure, or high cholesterol levels;
• you experienced allergic reactions while taking thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or breathing difficulties;
• you have previously had a combination of any of the following symptoms: widespread rash, skin redness, 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 reaction 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 apply to you, 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 walking pattern or balance disturbances, persistent numbness, reduced sensation or loss of sensation, memory loss or disorientation, inform your doctor or nurse immediately. These may be symptoms of a severe and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML). If you had such symptoms before treatment with lenalidomide, inform your doctor about any changes in these symptoms.
• shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or swelling of the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Tests and examinations
Regular blood tests will be performed before and during treatment with Kleder. This is because Kleder may cause a decrease in blood cells involved in fighting infections (white blood cells) and blood clotting (platelets).
Your doctor will request blood tests:

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

Before starting lenalidomide treatment and during treatment, you may be evaluated for cardiovascular and respiratory disorders.
Patients with MDS taking Kleder
If you have myelodysplastic syndromes, there is an increased chance of developing a severe disease called acute myeloid leukaemia. Furthermore, it is not known how Kleder affects the likelihood of developing acute myeloid leukaemia. Therefore, your doctor may perform tests and check for signs that may better predict the risk of acute myeloid leukaemia during treatment with Kleder.
Patients with MCL taking Kleder
Your doctor will request blood tests:

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

Patients with FL taking Kleder
Your doctor will request blood tests:

• before treatment;
• weekly for the first 3 weeks (1 cycle) of treatment;
• thereafter every 2 weeks during cycles 2 to 4 (more information 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 determine whether you have a large amount of tumour tissue in your body, including bone marrow. This may lead to a situation where tumour tissue begins to die and causes an abnormal increase in various substances in the blood, potentially leading to kidney failure (a condition known as tumour lysis syndrome).
Your doctor may examine you to check for skin changes such as red spots or rash.
Your doctor may adjust the dose of Kleder or discontinue treatment based on your blood test results and overall condition. If the disease has been recently diagnosed, your doctor may also assess treatment based on your age and other pre-existing conditions.
Blood donation
During treatment and for at least 7 days after treatment ends, you must not donate blood.
Children and adolescents
Kleder is not recommended for use in children and adolescents under 18 years of age.
Elderly patients and patients with kidney problems
If you are 75 years of age or older, or have moderate to severe kidney impairment, your doctor will perform thorough assessments before starting treatment.
Kleder and other medicines
Inform 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. Likewise, some other medicines may affect how Kleder works.
In particular, inform your doctor or nurse if you are taking the following medicines:

• certain contraceptives, such as oral contraceptives, as they may become ineffective;
• certain medicines used for heart problems – such as digoxin;
• certain medicines used to thin the blood – such as warfarin.

Pregnancy, breastfeeding and contraception – information for women and men
Pregnancy
Applies to women taking Kleder

• Do not use Kleder if you are pregnant, as it is expected to be harmful to the unborn child.
• Women must not become pregnant while taking Kleder.
• Therefore, women of childbearing potential must use an effective method of contraception (see “Contraception”).
• If you become pregnant while being treated with Kleder, you must stop treatment immediately and inform your doctor.

Applies to men taking Kleder

• If the female partner of a man undergoing treatment with Kleder becomes pregnant, she should immediately inform her doctor. The patient’s partner should seek medical advice.
• Men must also use an effective method of contraception (see “Contraception”).

Breastfeeding
Do not breastfeed while taking Kleder, as it is not known whether Kleder passes into human milk.
Contraception
Applies to women taking Kleder
Before starting treatment, ask your doctor about the possibility of becoming pregnant, even if you consider it unlikely.
Women of childbearing potential:

• will undergo pregnancy tests performed under medical supervision (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends), except in cases where the fallopian tubes have been cut and blocked to prevent the egg from reaching the uterus (tubal sterilization)
  AND

• must use effective methods of contraception for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after treatment ends. Your doctor will advise you on appropriate contraceptive methods.

Applies to men taking Kleder
Kleder passes into human semen. If a woman is pregnant or may become pregnant and does not use an effective method of contraception, her partner must use a condom during treatment and for at least 7 days after treatment ends. This applies also to men who have undergone vasectomy. During treatment and for at least 7 days after treatment ends, you must not donate semen.
Driving and using machines
Do not drive or operate machinery if you experience dizziness, fatigue, drowsiness, balance disturbances due to vertigo, or blurred vision after taking Kleder.
Kleder contains lactose and sodium.
Kleder contains lactose. If you have been previously diagnosed with intolerance to certain sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered “sodium-free”.

3. How to take Kleder

Kleder must be administered by medical personnel experienced in the treatment of 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 previously received other treatment, the medicine is given in combination with other drugs (see section 1 "Why is Kleder used").
• 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 as monotherapy.
• When Kleder is used to treat follicular lymphoma, it is taken together with another medicine called "rituximab".

Kleder should always be taken exactly as prescribed by the doctor. In case of doubt, consult your doctor or pharmacist.
If you are taking Kleder together with other medicines, you should read the package leaflet included with those medicines to obtain information about their use and effects.

Treatment cycle
Kleder is taken on specific days within a period of three weeks (21 days).

• Each 21-day period is referred to as 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 within a period of four weeks (28 days).
• Each 28-day period is referred to as 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 should be taken
Before starting treatment, the doctor will inform the patient:

• how much Kleder should be taken;
• how much of other medicines should be taken in combination with Kleder, if necessary;
• on which days of the cycle each medicine should be taken.

How and when to take Kleder

• Swallow the capsule whole, preferably with water.
• Do not crush, open, or chew the capsules. If the powder from a damaged Kleder capsule comes into contact with the skin, wash the skin thoroughly with soap and water immediately.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsules. Gloves should then be carefully removed to avoid skin exposure, placed in a sealed polyethylene plastic bag, and disposed of according to local regulations. Hands should then be washed thoroughly with soap and water. Pregnant women or women who suspect they may be pregnant should not handle the blister pack or capsules.
• Capsules may be taken with or without food.
• Kleder should be taken at approximately the same time each day when a dose is scheduled.

How to take Kleder
To remove the capsule from the blister:

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

Duration of treatment with Kleder
Kleder is administered in treatment cycles; each cycle lasts 21 or 28 days (see above, "Treatment cycle"). Treatment cycles should continue until the doctor decides to discontinue the treatment.

Overdose of Kleder
If you have taken more Kleder than prescribed, inform your doctor immediately.

Missed dose of Kleder
If you missed taking Kleder at the scheduled time and

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

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur, stop taking Kleder immediately and seek medical help – immediate treatment may be required:

• urticaria, rash, swelling of the eyes, lips or face, breathing difficulties or itching, which may be symptoms of severe allergic reactions known as angioedema and anaphylactic reaction;
• severe allergic reaction possibly starting as a rash in one area, spreading over the entire body and associated with significant skin peeling (Stevens-Johnson syndrome and/or toxic epidermal necrolysis);
• widespread rash, high body temperature, 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.

Immediately inform your doctor if any of the following serious adverse reactions 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, which may result from high calcium levels in the blood.

Kleder may reduce the number of white blood cells that fight infection, as well as blood cells that help blood clot (platelets), which may lead to bleeding disorders, such as nosebleeds and bruising. Kleder may also cause blood clots in veins (thrombosis).
Other adverse reactions
It should be noted that in a small number of patients, other types of tumours may develop and it is possible that this risk may increase due to treatment with Kleder. Therefore, the prescribing doctor should carefully assess the benefits and risks before prescribing Kleder to a patient.
Very common adverse reactions (may occur in more than 1 in 10 people):

• reduced number of red blood cells, which may cause anaemia leading to fatigue and weakness;
• rashes, itching;
• muscle cramps, muscle weakness, muscle pain, tenderness in muscles, bone pain, joint pain, back pain, limb pain;
• generalised swelling, including swelling of hands and feet;
• weakness, fatigue;
• fever and flu-like symptoms, including fever, muscle pain, headache, earache, cough and chills;
• numbness, tingling or burning sensation of the skin, pain in hands or feet, dizziness, tremor;
• decreased appetite, altered taste;
• increased pain, enlargement or redness around a tumour;
• weight loss;
• constipation, diarrhoea, nausea, vomiting, abdominal pain, heartburn;
• low levels of potassium or calcium and (or) sodium 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 symptoms of blood clots in the lungs, so-called pulmonary embolism);
• all types of infections, including sinus infection, lung infection 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 function test values;
• changes in blood proteins leading to swelling of arteries (vasculitis);
• increased blood sugar levels (diabetes);
• decreased blood sugar levels;
• headache;
• nosebleeds;
• dry skin;
• depression, mood changes, sleep problems;
• cough;
• low blood pressure;
• vague feeling of physical discomfort, malaise;
• painful inflammation of the mouth, dry mouth;
• dehydration.

Common adverse reactions (may occur in up to 1 in 10 people):

• breakdown of red blood cells (haemolytic anaemia);
• certain types of skin tumours;
• bleeding from gums, stomach or intestines;
• increased blood pressure, slow, fast or irregular heartbeat;
• increased levels of substances resulting from normal and abnormal breakdown of red blood cells;
• increased levels of a protein indicating inflammation in the body;
• darkening of the skin, skin discolouration due to bleeding under the skin, usually caused by bruising; skin swelling filled with blood, bruising;
• increased levels of uric acid in the blood;
• skin eruptions, redness of the skin, cracking, peeling or flaking of the skin, urticaria;
• excessive sweating, night sweats;
• difficulty swallowing, sore throat, problems with voice quality or voice changes;
• rhinitis (nasal inflammation);
• passing significantly more or significantly less urine than normal or inability to control the timing of urination;
• blood in the urine;
• shortness of breath, especially when lying down (which may be a sign of heart failure);
• problems with erection;
• stroke, fainting, dizziness (inner ear disorder causing a sensation that everything is spinning), transient loss of consciousness;
• chest pain spreading to arms, neck, jaw, back or abdomen, sweating and breathlessness, 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 blockage of bile flow from the liver;
• low levels of phosphates or magnesium in the blood;
• difficulty speaking;
• liver damage;
• balance disorders, difficulty moving;
• deafness, tinnitus (ringing in the ears);
• nerve pain, unpleasant abnormal sensations, especially in response to touch;
• excess iron in the body;
• thirst;
• confusion;
• toothache;
• falls that may lead to injury.

Uncommon adverse reactions (may occur in up to 1 in 100 people):

• bleeding inside the skull;
• circulatory problems;
• loss of vision;
• loss of sexual desire (libido);
• passing large amounts of urine, accompanied by bone pain and weakness, which may be symptoms of kidney disease (Fanconi syndrome);
• yellowing of the skin, mucous membranes or eyes (jaundice), pale-coloured stools, dark-coloured urine, itchy skin, rash, abdominal pain or swelling – may be symptoms of liver damage (liver failure);
• abdominal pain, bloating or diarrhoea, which may be symptoms of inflammation of the large intestine (so-called colitis or typhlitis);
• damage to kidney cells (called tubular necrosis);
• change in skin colour, sensitivity to sunlight;
• tumour lysis syndrome – metabolic complications that may occur during cancer treatment, and sometimes even without treatment. These complications are caused by products released from dying tumour cells and may include: changes in blood chemistry; high levels of potassium, phosphorus, uric acid and low calcium levels, leading to kidney dysfunction, irregular heart rhythm, seizures, and sometimes death;
• increased blood pressure in blood vessels leading to the lungs (pulmonary hypertension).

Unknown frequency adverse reactions (frequency cannot be determined from available data)

• sudden or mild but progressively 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 in association with pancreatitis;
• wheezing, shortness of breath or dry cough, which may be caused by inflammation of lung tissue;
• rare cases of muscle breakdown (pain, weakness or swelling of muscles) leading to kidney problems (rhabdomyolysis) have been observed, some of which occurred when Kleder was administered concomitantly with a statin (a type of medicine that lowers blood cholesterol levels);
• skin disease caused by inflammation of small blood vessels, associated with joint pain and fever (leucocytoclastic vasculitis);
• perforation of the stomach or intestinal wall; this may lead to a very serious infection. Inform your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in stool or changes in bowel habits;
• viral infections, including shingles (a viral disease causing a painful skin rash with blisters) and reactivation of hepatitis B virus infection (which may cause yellowing of the skin and eyes, dark brown urine, abdominal pain on the right side, fever, nausea and vomiting);
• rejection of solid organ transplant (e.g. kidney, heart).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Kleder

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the cardboard
box after the word "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Do not use this medicine if you notice any damage or signs of tampering with the packaging.
Medicines should not be disposed of via wastewater or household waste. Unused medicines should be returned to a pharmacy for proper disposal. 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.
• The 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.
• The 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.
• The 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 (E172), propylene glycol, and potassium hydroxide.

Kleder 20 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 20 mg of lenalidomide.
• The 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.
• The 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 have a green, opaque cap and a light brown, opaque body, capsule size 2, 18–19 mm, printed in black ink with "LP" on the cap and "638" on the body; the capsule is filled with white powder.
Kleder 10 mg, hard capsules have a yellow, opaque cap and a grey, opaque body, capsule size 0, 21–22 mm, printed in black ink with "LP" on the cap and "639" on the body; the capsule is filled with white powder.
Kleder 15 mg, hard capsules have a brown, opaque cap and a grey, opaque body, capsule size 2, 18–19 mm, printed in black ink with "LP" on the cap and "640" on the body; the capsule is filled with white powder.
Kleder 20 mg, hard capsules have a dark red, opaque cap and a light grey, opaque body, capsule size 1, 19–20 mm, printed in black ink with "LP" on the cap and "641" on the body; the capsule is filled with white powder.
Kleder 25 mg, hard capsules have a white, opaque cap and a white, opaque body, capsule size 0, 21–22 mm, printed in black ink with "LP" on the cap and "642" on the body; the capsule is filled with white powder.
Blister packs made of PVC/ACLAR/Aluminium containing 7 capsules in a cardboard carton.
Kleder 5 mg, 10 mg and 15 mg
Pack sizes: 7 or 21 capsules. Not all pack sizes may be marketed.
Kleder 20 mg and 25 mg
Pack size: 21 capsules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Stada Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel, Germany

Manufacturers/Importers
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 authorised for marketing in 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