KLEDER

Patient Information Leaflet: Information for the Patient

KLEDER 2.5 mg hard capsules, 5 mg hard capsules, 7.5 mg hard capsules, 10 mg hard capsules, 15 mg hard capsules, 20 mg hard capsules, 25 mg hard capsules

Lenalidomide
Generic medicine
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What KLEDER is and what it is used for
2. What you need to know 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 functioning of the immune system.
What KLEDER is used for
KLEDER is used in adults for the treatment of:

• Multiple myeloma
• 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 can damage bones and kidneys.
Multiple myeloma is generally incurable. However, signs and symptoms can be significantly reduced or
disappear for a certain period. This outcome is called a "response".
Newly diagnosed multiple myeloma in patients who have undergone bone marrow transplantation
KLEDER is used alone as maintenance therapy in patients who have adequately recovered after bone marrow transplantation.
Newly diagnosed multiple myeloma – in patients who cannot undergo bone marrow transplantation
KLEDER is taken in combination with other medicines: These include:

• a chemotherapy medicine called "bortezomib",
• an anti-inflammatory medicine called "dexamethasone",
• a chemotherapy medicine called "melphalan", and
• an immunosuppressive medicine called "prednisone".
  You will take these other medicines at the beginning of treatment and then continue taking KLEDER alone. If you are aged 75 years or older or have moderate to severe kidney problems, your doctor will closely monitor you before starting treatment.

Multiple myeloma – in patients who have been previously treated
KLEDER is taken together with an anti-inflammatory medicine called "dexamethasone".
KLEDER can stop the worsening of signs and symptoms of multiple myeloma. It has also been shown to delay the return of multiple myeloma after treatment.
Follicular lymphoma (FL)
FL is a slow-growing form of cancer that affects B-lymphocytes, a type of white blood cell that helps the body fight infections. In FL, an excessive number of these 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 on the body's immune system and directly on the tumour in several ways:

• by stopping the growth of tumour cells
• by stopping the growth of blood vessels in the tumour
• by stimulating part of the immune system to attack tumour cells

2. What you should know before taking KLEDER

Before starting treatment with KLEDER, you must read the package leaflet of all the medicines you are
taking in combination with KLEDER.
Do not take KLEDER:

• if you are pregnant, think you may be pregnant, or are planning a pregnancy, because KLEDER is expected to be harmful to the fetus (see section 2, 'Pregnancy, breastfeeding and contraception – information for women and men').
• if there is any possibility of becoming pregnant unless you follow all necessary measures to avoid pregnancy (see section 2 'Pregnancy, breastfeeding and contraception – information for women and men'). If there is any possibility of becoming pregnant, your doctor will record and confirm at each prescription that the necessary measures to prevent pregnancy have been taken.
• if you are allergic to lenalidomide or to any of the other ingredients of this medicine listed in section 6. If you think you may be allergic, consult your doctor.

If you think any of these situations apply to you, do not take KLEDER. If in doubt, consult your doctor.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking KLEDER if:

• you have previously experienced episodes of blood clots – because the risk of developing blood clots in veins and arteries increases during treatment;
• you have any signs of infection, such as cough or fever;
• you have or have previously had a viral infection, particularly: hepatitis B infection, varicella-zoster, or HIV. If in doubt, consult your doctor. Treatment with KLEDER may cause reactivation of the virus in patients who carry the virus, leading to recurrence of the infection. Your doctor must check whether you have previously had a hepatitis B infection;
• you have kidney problems – your doctor may adjust the dose of KLEDER;
• you have had a heart attack, blood clots, or if you smoke, have high blood pressure, or high cholesterol levels;
• you previously had an allergic reaction during treatment with thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing;
• you have previously experienced any combination of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes; these are signs of a serious 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 these conditions apply to you, inform your doctor, pharmacist, or nurse before starting treatment.

At any time during or after treatment, inform your doctor or nurse immediately if:

• you experience blurred vision, loss of vision, double vision, difficulty speaking, weakness in one arm or leg, changes in walking or balance problems, persistent numbness, reduced sensation, or loss of sensation, memory loss, or confusion. These may be symptoms of a serious brain condition that can be fatal, known as progressive multifocal leukoencephalopathy (PML). If you had these symptoms before starting treatment with lenalidomide, inform your doctor of any changes in these symptoms;
• you experience shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or swelling in the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Tests and monitoring
Before and during treatment with KLEDER, you will undergo regular blood tests. This is because
KLEDER may cause a reduction in blood cells that protect you from infections (white blood cells) and those that help blood clot (platelets). Your doctor will ask you to have blood tests:

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

You may be evaluated for signs of heart or lung problems before and during treatment with lenalidomide.
For patients with MDS taking KLEDER
If you have MDS, you have a higher risk of developing a more advanced disease called acute myeloid leukemia (AML). In addition, the role of KLEDER in the risk of developing AML is not known. Your doctor may request certain tests to monitor signs that could more accurately predict your risk of developing AML during treatment with KLEDER.
For patients with MCL taking KLEDER
Your doctor will ask you to have a blood test:

• before starting treatment;
• once a week for the first 8 weeks (2 cycles) of treatment;
• then every 2 weeks during cycles 3 and 4 (for further information see section 3 “Treatment cycle”);
• subsequently at the beginning of each cycle and
• at least once a month.

For patients with FL taking KLEDER
Your doctor will ask you to have blood tests:

• before starting treatment;
• weekly for the first 3 weeks (1 cycle) of treatment;
• then every 2 weeks during cycles 2 to 4 (for further information see section 3 “Treatment cycle”);
• subsequently at the beginning of each cycle and
• at least once a month.

Your doctor may check whether you have a high tumor burden throughout your body, including in the bone marrow.
This could lead to a condition in which tumors break down and cause abnormal levels of chemicals in the blood, potentially leading to kidney failure (this condition is called “tumor lysis syndrome”).
Your doctor may check for skin changes, such as red spots or rashes.
Depending on the results of blood tests and your overall condition, your doctor may decide to adjust the dose of KLEDER or stop treatment. If you are a newly diagnosed patient, your doctor may also consider treatment based on your age and any other pre-existing conditions.
Blood donation
You must not donate blood during treatment and for one week after stopping treatment.
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 aged 75 years or older or have moderate to severe kidney problems, your doctor will carefully monitor you before starting treatment.
Other medicines and KLEDER
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines. This is because KLEDER may affect how other medicines work. Some other medicines may also affect how KLEDER works.
In particular, inform your doctor or nurse if you are taking any of the following medicines:

• certain medicines used to prevent pregnancy, such as oral contraceptives, because they may become less effective;
• 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
For women taking KLEDER

• You must not take KLEDER if you are pregnant, because this medicine is expected to be harmful to the fetus.
• During treatment with KLEDER, you must not become pregnant. If there is any possibility of becoming pregnant, you must use effective contraceptive methods (see the section “Contraception”).
• If you become pregnant during treatment with KLEDER, you must stop treatment immediately and inform your doctor.

For men taking KLEDER

• If your partner becomes pregnant while you are taking KLEDER, inform your doctor immediately. It is also recommended that your partner contacts her doctor.
• In addition, you must use effective contraceptive methods (see the section “Contraception”).

Breastfeeding
You must not breastfeed while taking KLEDER, as it is not known whether KLEDER passes into breast milk.
Contraception
For women taking KLEDER
Before starting treatment, ask your doctor whether there is any possibility of you becoming pregnant, even if you think it is unlikely.
If there is any possibility of becoming pregnant:

• you must undergo pregnancy tests under your doctor’s supervision (before each treatment cycle, at least every 4 weeks during treatment, and at least 4 weeks after stopping treatment), unless it has been confirmed that your fallopian tubes have been cut and sealed to prevent eggs from reaching the uterus (sterilization by tubal ligation), AND
• you must use effective contraceptive methods for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after stopping treatment. Your doctor will provide you with full guidance on appropriate contraceptive methods.

For men taking KLEDER
KLEDER passes into human seminal fluid. If there is any possibility that your partner is pregnant or could become pregnant and she is not using effective contraception, you must use condoms during treatment and for at least 7 days after stopping treatment, even if you have had a vasectomy.
Driving and using machines
Do not drive or operate machinery if you experience dizziness, fatigue, drowsiness, vertigo, or blurred vision after taking KLEDER.
KLEDER contains lactose and sodium
KLEDER contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially 'sodium-free'.
[For the 2.5 mg dosage]
KLEDER contains Allura Red AC
KLEDER contains Allura Red AC (E129), which may cause allergic reactions.
[For the 5 mg dosage]
KLEDER contains Sunset Yellow FCF
KLEDER contains Sunset Yellow FCF (E110), which may cause allergic reactions.
[For the 7.5 mg dosage]
KLEDER contains Sunset Yellow FCF
KLEDER contains Sunset Yellow FCF (E110), which may cause allergic reactions.
[For the 10 mg dosage]
KLEDER contains tartrazine, Sunset Yellow FCF and Allura Red AC
KLEDER contains tartrazine (E102), Sunset Yellow FCF (E110), and Allura Red AC (E129), which may cause allergic reactions.
[For the 15 mg dosage]
KLEDER contains tartrazine and Allura Red AC
KLEDER contains tartrazine (E102) and Allura Red AC (E129), which may cause allergic reactions.
[For the 20 mg dosage]
KLEDER contains Allura Red AC
KLEDER contains Allura Red AC (E129), which may cause allergic reactions.

3. How to take KLEDER

KLEDER must be administered by healthcare professionals experienced in the treatment of multiple myeloma and FL.

• When KLEDER is used for the treatment of multiple myeloma in patients who cannot undergo bone marrow transplantation or who have previously received other treatments, it is taken in combination with other medicines (see section 1 “What KLEDER is used for”).
• When KLEDER is used for the treatment of multiple myeloma in patients who have undergone bone marrow transplantation, it is taken alone.
• When KLEDER is used to treat follicular lymphoma, it is taken in combination with another medicine called "rituximab". Always take KLEDER exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.

If you are taking KLEDER in combination with other medicines, please refer to the package leaflet of those medicines for further information on their use and side effects.
Treatment cycle
KLEDER is taken on certain days within 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 of the medicines. However, there will be some days when you will not take any medicine.
• After completing each 21-day cycle, you must start a new “cycle” within the next 21 days. Alternatively, KLEDER may be taken on certain days within 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 of the medicines. However, there will be some days when you will not take any medicine.
• After completing each 28-day cycle, you must start a new “cycle” within the next 28 days.

How much KLEDER to take
Before starting treatment, your doctor will inform you:

• of the dose of KLEDER to take
• of the dose of other medicines to take in combination with KLEDER, if prescribed
• on which days of the treatment cycle to take each medicine.

How and when to take KLEDER

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

Instructions for taking the medicine
To remove the capsule from the blister:

• Press on one side of the capsule only, pushing it through the aluminium foil.
• Do not press in the center of the capsule, as this may cause it to break.

Duration of treatment with KLEDER
KLEDER is taken in treatment cycles, each lasting either 21 or 28 days (see above “Treatment cycle”). You must continue the treatment cycles until your doctor tells you to stop.
If you take more KLEDER than you should
If you have taken more KLEDER than prescribed, inform your doctor immediately.
If you forget to take KLEDER
If you forget to take KLEDER at the usual time and

• less than 12 hours have passed – take the missed capsule immediately.
• more than 12 hours have passed – do not take the missed capsule; instead, take the next capsule at the usual time the following day. If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking KLEDER and contact your doctor immediately if you experience any of the following serious
side effects – urgent medical treatment may be required:

• Hives, skin rash, swelling of the eyes, mouth or face, difficulty breathing or itching, which may be symptoms of severe types of allergic reactions called angioedema and anaphylactic reaction.
• Severe allergic reaction, which may start as a rash in one area but spread with extensive skin loss over the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• Widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.

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

• Fever, chills, sore throat, cough, mouth ulcers or any other sign of infection (including within the bloodstream (sepsis));
• Bleeding or bruising without injury;
• Chest or leg pain;
• Shortness of breath;
• Bone pain, muscle weakness, confusion or fatigue, which may be due to high levels of calcium in the blood. KLEDER may reduce the number of white blood cells that fight infections and also the number of 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 side effects
It is important to note that a small number of patients may develop other types of cancer, and this risk may possibly increase with treatment with KLEDER. Therefore, your doctor must carefully evaluate the risk/benefit ratio when prescribing KLEDER to you.
Very common side effects (may affect more than 1 in 10 people):

• Decrease in red blood cells, which may cause anaemia and consequently fatigue and weakness;
• Skin rashes, itching;
• Muscle cramps, muscle weakness, muscle pain, muscle tenderness, bone pain, joint pain, back pain, limb pain;
• Generalised swelling, including swelling of arms and legs;
• Weakness, fatigue;
• Fever and flu-like symptoms, including fever, muscle pain, headache, earache, cough and chills;
• Numbness, tingling or burning sensation on the skin, pain in hands or feet, dizziness, tremor;
• Loss of appetite, altered taste;
• Increased pain, tumour size or redness around the tumour;
• Weight loss;
• Constipation, diarrhoea, nausea, vomiting, stomach ache, heartburn;
• Low levels of potassium, calcium and/or sodium in the blood;
• Underactive thyroid gland;
• 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, so-called pulmonary embolism);
• Infections of any type, including infections of the sinuses around the nose, lungs and upper respiratory tract;
• Shortness of breath;
• Blurred vision;
• Clouding of vision (cataract);
• Kidney problems, including impaired kidney function or inability of the kidneys to maintain normal function;
• Abnormal results in liver function tests;
• Increased values in liver function tests;
• Changes in a protein in the blood that may cause swelling of the arteries (vasculitis);
• Increased blood sugar levels (diabetes);
• Reduced blood sugar levels;
• Headache;
• Nosebleeds;
• Dry skin;
• Depression, mood changes, difficulty sleeping;
• Cough;
• Drop in blood pressure;
• Vague feeling of physical discomfort, malaise;
• Inflammation of the mouth, dry mouth;
• Dehydration.

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

• Destruction of red blood cells in the blood (haemolytic anaemia);
• Certain types of skin tumours;
• Bleeding from gums, stomach or intestine;
• Increased blood pressure, slow, fast or irregular heartbeat;
• Increased levels of a substance resulting from normal and abnormal breakdown of red blood cells;
• Increase in a type of protein indicating inflammation in the body;
• Darkening of the skin; change in skin colour due to bleeding under the skin, typically caused by bruising; skin swelling due to blood; bruising;
• Increased uric acid levels in the blood;
• Skin rashes, redness of the skin, cracked skin, peeling or flaking, hives;
• Increased sweating, night sweats;
• Difficulty swallowing, sore throat, voice quality problems or voice changes;
• Runny nose;
• Urine output much greater or less than usual, or inability to control the urge to urinate;
• Presence of blood in the urine;
• Shortness of breath, especially when lying down (which may be a symptom of heart failure);
• Difficulty achieving an erection;
• Stroke, fainting, vertigo (inner ear problem causing a sensation that everything is spinning), temporary loss of consciousness;
• Chest pain radiating to arms, neck, jaw, back or stomach, with 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;
• Swelling of joints;
• Slowing or blockage of bile flow from the liver;
• Low levels of phosphate or magnesium in the blood;
• Difficulty speaking;
• Liver damage;
• Balance disorders, difficulty moving;
• Hearing loss, ringing in the ears (tinnitus);
• Nerve pain, altered sensation, especially touch;
• Excess iron in the blood;
• Thirst;
• Confusion;
• Toothache;
• Falls, which may lead to injury.

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

• Bleeding inside the skull;
• Circulatory problems;
• Loss of vision;
• Loss of sex drive (libido);
• Abundant urine flow with bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome);
• Yellowing of the skin, mucous membranes or eyes (jaundice), pale stools, dark urine, skin itching, rash, stomach pain or swelling – these may be symptoms of liver damage (liver failure);
• Stomach pain, bloating or diarrhoea, which may be symptoms of inflammation of the large intestine (called colitis or typhlitis);
• Damage to kidney cells (called renal tubular necrosis);
• Changes 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 from the breakdown of dying tumour cells and may include: changes in blood parameters; high levels of potassium, phosphate and uric acid; and low calcium levels, leading to impaired kidney function, irregular heartbeat, seizures and sometimes death;
• Increased blood pressure in the blood vessels leading to the lungs (pulmonary hypertension).

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

• Sudden or mild but worsening pain in the upper abdomen and/or back, lasting for several days, possibly accompanied by nausea, vomiting, fever and rapid pulse; these symptoms may be due to inflammation of the pancreas;
• Wheezing, shortness of breath or dry cough, which may be symptoms caused by inflammation of lung tissue;
• Rare cases of muscle breakdown (muscle pain, weakness or swelling) have been observed, which may lead to kidney problems (rhabdomyolysis), some of which occurred when KLEDER was administered with a statin (a type of cholesterol-lowering medicine);
• A disease affecting the skin caused by inflammation of small blood vessels, with joint pain and fever (leukocytoclastic vasculitis);
• Deterioration of the stomach or intestinal wall, which may lead to severe infections. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in stools or changes in bowel habits;
• Viral infections, including herpes zoster (also known as "shingles", a viral disease causing a painful rash with blisters) and reactivation of hepatitis B infection (which may cause yellowing of the skin and eyes, dark brown urine, stomach pain on the right side, fever, nausea or vomiting);
• Rejection of solid organ transplant (such as kidney, heart).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store KLEDER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or on the carton after the word "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Return unused medicines to the pharmacist. This will help protect the environment.

6. Package contents and other information

What KLEDER contains
KLEDER 2.5 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
• The other components are:
• Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capsule shell: Brilliant Blue FCF (E133), Erythrosine (E127), Allura Red AC (E129) (see section 2), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171) and gelatin.
• Printing ink: shellac, propylene glycol (E1520), black iron oxide (E172) and potassium hydroxide.

KLEDER 5 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 5 mg of lenalidomide.
• The other components are:
• Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capsule shell: Brilliant Blue FCF (E133), Sunset Yellow FCF (E110) (see section 2), black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171) and gelatin.
• Printing ink: shellac, propylene glycol (E1520), black iron oxide (E172) and potassium hydroxide.

KLEDER 7.5 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
• The other components are:
• Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capsule shell: Brilliant Blue FCF (E133), Erythrosine (E127), Sunset Yellow FCF (E110) (see section 2), titanium dioxide (E171) and gelatin.
• Printing ink: shellac, propylene glycol (E1520), black iron oxide (E172) and potassium hydroxide.

KLEDER 10 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 10 mg of lenalidomide.
• The other components are:
• Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capsule shell: Brilliant Blue FCF (E133), Allura Red AC (E129) (see section 2), Tartrazine (E102) (see section 2), Sunset Yellow FCF (E110) (see section 2), titanium dioxide (E171) and gelatin.
• Printing ink: shellac, propylene glycol (E1520), black iron oxide (E172) and potassium hydroxide.

KLEDER 15 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• The other components are:
• Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capsule shell: Brilliant Blue FCF (E133), Allura Red AC (E129) (see section 2), Tartrazine (E102) (see section 2), black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171) and gelatin.
• Printing ink: shellac, propylene glycol (E1520), black iron oxide (E172) and potassium hydroxide.

KLEDER 20 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 20 mg of lenalidomide.
• The other components are:
• Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capsule shell: Brilliant Blue FCF (E133), Allura Red AC (E129) (see section 2), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171) and gelatin.
• Printing ink: shellac, propylene glycol (E1520), black iron oxide (E172) and potassium hydroxide.

KLEDER 25 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 25 mg of lenalidomide.
• The other components are:
• Capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capsule shell: titanium dioxide (E171) and gelatin.
• Printing ink: shellac, propylene glycol (E1520), black iron oxide (E172) and potassium hydroxide.

Description of the appearance of KLEDER and the contents of the pack
KLEDER 2.5 mg hard capsules have a dark blue opaque cap and a light orange opaque body, the capsule shell is size No. 4, 14–15 mm, with the imprint "LP" printed in black ink on the cap and "637" on the body.
KLEDER 5 mg hard capsules have a green opaque cap and a brownish opaque body, the capsule shell is size No. 2, 18–19 mm, with the imprint "LP" printed in black ink on the cap and "638" on the body.
KLEDER 7.5 mg hard capsules have a violet opaque cap and a pink opaque body, the capsule shell is size No. 1, 19–20 mm, with the imprint "LP" printed in black ink on the cap and "643" on the body.
KLEDER 10 mg hard capsules have a yellow opaque cap and a grey opaque body, the capsule shell is size No. 0, 21–22 mm, with the imprint "LP" printed in black ink on the cap and "639" on the body.
KLEDER 15 mg hard capsules have a brown opaque cap and a grey opaque body, the capsule shell is size No. 2, 18–19 mm, with the imprint "LP" printed in black ink on the cap and "640" on the body.
KLEDER 20 mg hard capsules have a dark red opaque cap and a light grey opaque body, the capsule shell is size No. 1, 19–20 mm, with the imprint "LP" printed in black ink on the cap and "641" on the body.
KLEDER 25 mg hard capsules have a white opaque cap and a white opaque body, the capsule shell is size No. 0, 21–22 mm, with the imprint "LP" printed in black ink on the cap and "642" on the body.
Carton pack containing PVC/PCTFE/aluminum blisters with 7 capsules each.
KLEDER 2.5 mg and 5 mg
Pack sizes of 7 or 21 capsules. Not all pack sizes may be marketed.
KLEDER 7.5 mg, 20 mg and 25 mg
Pack size of 21 capsules.
KLEDER 10 mg and 15 mg
Pack sizes of 7 or 21 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder
EG S.p.A., Via Pavia 6, 20136 Milan, Italy
Manufacturers
Pharmadox Healthcare Ltd, KW20A Kordin Industrial Park, Paola PLA 3000, Malta
Pharmacare Premium Ltd, HHF003 Hal Far Industrial Estate, Hal Far Birzebbugia BBG 3000, Malta
Alvogen Malta (Out-Licensing) Ltd, Malta Life Sciences Park Building 1, Level 4 Sir Temi Zammit Buildings San Gwann Industrial Estate, 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 in the European Economic Area (EEA) Member States under the following names:
IS Kleder 2.5 mg hart hylki
Kleder 5 mg hart hylki
Kleder 7.5 mg hart hylki
Kleder 10 mg hart hylki
Kleder 15 mg hart hylki
Kleder 20 mg hart hylki
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