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.

• You should keep this leaflet, so you can read it again if you need to.
• You should consult your doctor or pharmacist if you have any doubts.
• This medicine has been prescribed specifically for you. 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 possible side effects not listed in the leaflet, 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 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 tests 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 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 received other treatments that have been ineffective or not effective enough.

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 received 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 you are pregnant, think you may be pregnant, or plan 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 you can become pregnant, unless you use all required pregnancy prevention measures (see section 2 "Pregnancy, breastfeeding, and contraception - information for women and men"). If you can become pregnant, your doctor will always check that the necessary measures have been taken and 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, consult your doctor for advice.

If any of these points apply to you, do not take Kleder. If you are unsure, consult your doctor.

Warnings and precautions

Before starting Kleder, consult your doctor, pharmacist, or nurse in the following cases:

• you have had blood clots in the past - this means you have an increased risk of developing 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 you are unsure, consult your doctor. Treatment with Kleder may cause the virus to reactivate in patients who are carriers. This can lead 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 had a blood clot, smoke, have high blood pressure, or high cholesterol levels;
• you have had allergic reactions 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, 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 rash with eosinophilia and systemic symptoms (DRESS) or drug hypersensitivity syndrome (see also section 4 "Possible side effects").

If any of these 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 in the arm or leg, change in walking or balance disturbances, persistent numbness, decreased sensation, or loss of sensation, memory loss, or disorientation, tell your doctor or nurse immediately. 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, 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 infection (white blood cells) and help the blood to 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 treatment with lenalidomide and during treatment, you may undergo an assessment for cardiovascular and respiratory diseases.
Patients with MDS taking Kleder
If you have myelodysplastic syndromes, there is an increased risk 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 can better predict the risk of acute myeloid leukemia during treatment with Kleder.
Patients 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 (see section 3 "Treatment cycle" for more information);
• then at the beginning of each cycle and
• at least once a month.

Patients 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 to 4 (see section 3 "Treatment cycle" for more information);
• 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 can lead to a situation where the tumor tissue starts to die and causes abnormal levels 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 adjust 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 assess treatment based on your age and other conditions 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 or older, or have moderate to severe kidney problems, your doctor will perform thorough tests before starting treatment.

Kleder and other medicines

Tell your doctor or nurse about all medicines you are taking, or have recently taken. This is necessary because Kleder may affect the way other medicines work. Also, some other medicines may affect the way Kleder works.
In particular, tell your doctor or nurse if you are taking:

• certain medicines to prevent pregnancy, such as oral contraceptives, as they may stop working;
• certain medicines for heart problems - such as digoxin;
• certain medicines to thin the blood - such as warfarin.

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

Pregnancy

For women taking Kleder

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

For men taking Kleder

• If your partner becomes pregnant while you are taking Kleder, she should inform her doctor immediately. Your 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 your doctor about the possibility of becoming pregnant, even if you think it is unlikely.
Women who can 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 sealed to prevent the egg from entering the uterus (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 is present in human semen. If a woman is pregnant or can 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

Do not drive or operate machinery if you experience dizziness, fatigue, drowsiness, balance disturbances due to dizziness, or blurred vision after taking Kleder.
Kleder contains lactose and sodium.
Kleder contains lactose. If you have been diagnosed with intolerance to some sugars, consult your 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 a healthcare professional who has 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".

Take Kleder exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
If you are taking Kleder with other medicines, read the package leaflet that comes with them to get information about their use and effects.

Treatment cycle

Kleder is taken on specific days during a 3-week period (21 days).

• Each 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 4-week period (28 days).
• Each 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 to take

Before starting treatment, your doctor will tell you:

• how much Kleder to take;
• how much of any other medicines to take in combination with Kleder, if other medicines are required;
• 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 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. Remove the gloves carefully to avoid skin exposure, place them in a sealed plastic bag, and dispose of them according to local regulations. Then, wash your hands with soap and water. Pregnant or potentially pregnant women should not handle the blister or capsule.
• The capsules can be taken with or without food.
• Take Kleder at approximately the same time each day when it 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 taken in treatment cycles; each cycle lasts 21 or 28 days (see above "Treatment cycle"). Treatment cycles should be continued until the doctor stops treatment.

What to do if you take more Kleder than you should

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

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

If you have any further questions about taking Kleder, 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 serious side effects, stop taking Kleder and tell your doctor immediately - you may need urgent medical 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;
• 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.

Tell your doctor immediately if you experience any of the following serious side effects:

• 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 the 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, your doctor should carefully weigh the benefits and risks of prescribing Kleder to you.
Very common side effects(may affect more than 1 in 10 people):

• decrease in the number of red blood cells, which can 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 levels of potassium, calcium, or sodium in the blood;
• underactive thyroid function;
• leg pain (which may be a sign of thrombosis), chest pain, or shortness of breath (which may be a sign of 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 levels;
• changes in blood proteins, leading to blood vessel inflammation (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 mouth inflammation, dry mouth;
• dehydration.

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

• red blood cell breakdown (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 levels of uric acid in the blood;
• skin rashes, redness, cracking, peeling, 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 sign of heart failure);
• erectile dysfunction;
• stroke, fainting, dizziness (inner ear disturbances that cause a feeling of spinning), loss of consciousness;
• chest pain that spreads to the arms, neck, jaw, back, or stomach, 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 levels of phosphate or magnesium 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 can lead to injury.

Uncommon side effects(may affect 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, 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 due to 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. 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 a painful rash 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 possible side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje 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 will help to gather more information on the safety of this 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 this medicine.
Do not use this medicine if you notice any damage or signs of opening 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 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), 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.
PVC/ACLAR/Aluminum blisters containing 7 capsules, in a carton box.
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:

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