Lenalidomide medical valley

Package leaflet: Information for the patient

Lenalidomide Medical Valley, 2.5 mg, hard capsules
Lenalidomide Medical Valley, 5 mg, hard capsules
Lenalidomide Medical Valley, 7.5 mg, hard capsules
Lenalidomide Medical Valley, 10 mg, hard capsules
Lenalidomide Medical Valley, 15 mg, hard capsules
Lenalidomide Medical Valley, 20 mg, hard capsules
Lenalidomide Medical Valley, 25 mg, hard capsules
Lenalidomide
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

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

Contents of the leaflet

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

1. What Lenalidomide Medical Valley is and what it is used for

What Lenalidomide Medical Valley is
Lenalidomide Medical Valley contains the active substance "lenalidomide". This medicine belongs to a group of medicines that affect the function of the immune system.

What Lenalidomide Medical Valley is used for
Lenalidomide Medical Valley is used in adult patients for the treatment of:

• Multiple myeloma
• Myelodysplastic syndromes (MDS)
• Mantle cell lymphoma (MCL)
• Follicular lymphoma (FL)

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. However, it is possible to achieve a significant temporary reduction or disappearance of signs and symptoms of the disease. This is called "remission".

Newly diagnosed multiple myeloma – in patients who have undergone bone marrow transplantation
In this indication, Lenalidomide Medical Valley is used as a single agent for maintenance treatment after achieving an adequate response following transplantation.

Newly diagnosed multiple myeloma – in patients who are not eligible for bone marrow transplantation
Lenalidomide Medical Valley is taken in combination with other medicines, including:

• a chemotherapy medicine called "bortezomib"
• an anti-inflammatory medicine called "dexamethasone"
• a chemotherapy medicine called "melphalan" and
• an immunosuppressive medicine called "prednisone"

Treatment is initiated with additional medicines and then continued with Lenalidomide Medical Valley alone.

If you are 75 years of age or older, or have moderate to severe kidney problems, your doctor will perform careful assessments before starting treatment.

Multiple myeloma – in previously treated patients
Lenalidomide Medical Valley is taken in combination with an anti-inflammatory medicine called "dexamethasone".
Lenalidomide Medical Valley may stop the progression of signs and symptoms of multiple myeloma. It has also been shown to delay relapse 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 numbers of red blood cells (anaemia), need for blood transfusions, and risk of infection.

Lenalidomide Medical Valley, used as monotherapy, is indicated for the treatment of adult patients with MDS when 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 known as "isolated cytogenetic abnormality del(5q)". This means the patient's body does not produce enough healthy blood cells
• the patient has previously been treated with other therapies that were inappropriate or insufficiently effective.

Taking Lenalidomide Medical Valley may lead to an increased production of healthy blood cells by the body, by reducing the number of abnormal cells.

• This may result in a reduced need for blood transfusions. It may even become possible to discontinue transfusions altogether.

Mantle cell lymphoma (MCL)
MCL is a cancer affecting part of the immune system (lymphatic tissue). It attacks a type of white blood cells called B-lymphocytes or B-cells. Mantle cell lymphoma is characterized by uncontrolled growth of B-lymphocytes, leading to their accumulation in lymphatic tissue, bone marrow, or blood.
Lenalidomide Medical Valley, used as monotherapy, is indicated for the treatment of adult patients who have been previously treated with other medicines.

Follicular lymphoma (FL)
Follicular lymphoma is a slowly growing malignant cancer 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.
Lenalidomide Medical Valley is taken in combination with another medicine called "rituximab" for the treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide Medical Valley works
Lenalidomide Medical Valley works by affecting the immune system and directly attacking cancer cells. The medicine acts 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 using Lenalidomide Medical Valley

Before starting treatment with Lenalidomide Medical Valley, carefully read the package leaflets of all medicinal products used in combination with Lenalidomide Medical Valley.
When not to use Lenalidomide Medical Valley:

• if the patient is pregnant, suspects she is pregnant, or plans to become pregnant, because Lenalidomide Medical Valley may harm the unborn child (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men");
• if the patient could become pregnant, unless she uses all required contraceptive measures (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men"). If the patient could become pregnant, the doctor will always document at the time of prescription that necessary measures have been taken and will ensure the patient is aware of them;
• if the patient has hypersensitivity to lenalidomide or to any of the other ingredients of this medicine (listed in section 6). If the patient thinks they may be allergic, they should consult a doctor. If any of these points apply to the patient, Lenalidomide Medical Valley must not be used. In case of doubt, consult a doctor.

Warnings and precautions
Before starting treatment with Lenalidomide Medical Valley, discuss with a doctor,
pharmacist, or nurse if the patient:

• has previously experienced blood clots – this means an increased risk of developing blood clots in veins and arteries during treatment;
• has any signs of infection, such as cough or fever;
• currently has or has previously had a viral infection, particularly hepatitis B virus, varicella-zoster virus, or HIV. In case of doubt, consult a doctor. Treatment with Lenalidomide Medical Valley may cause reactivation of viruses in patients previously infected, leading to recurrence of infection. The doctor will check whether the patient has previously had hepatitis B;
• has kidney problems – the doctor may adjust the dose of Lenalidomide Medical Valley;
• has had a heart attack (heart attack), blood clots at any time, smokes, has high blood pressure, or high cholesterol levels;
• experienced allergic reactions while taking thalidomide (another drug used in the treatment of multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing;
• previously experienced a combination of any of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, elevated liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes – these are symptoms of a severe skin reaction known as

drug rash with eosinophilia and systemic symptoms, also known as “DRESS”
(Drug Reaction with Eosinophilia and Systemic Symptoms) or “drug hypersensitivity syndrome” (see also section 4 “Possible side effects”).
If any of the above apply to the patient, consult a doctor, pharmacist,
or nurse before starting treatment.
Immediately inform the doctor or nurse if at any time during or after treatment the patient experiences:

• vision disturbances, loss of vision, double vision, difficulty speaking, weakness in the arm or leg, change in gait or balance disturbances, persistent numbness, reduced sensation or loss of sensation, memory loss or disorientation – immediately inform the doctor or nurse. These may be symptoms of a serious and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML). If the patient had such symptoms before treatment with Lenalidomide Medical Valley, inform the doctor of any changes.
• 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
Before and during treatment with Lenalidomide Medical Valley, the patient will undergo regular blood tests because Lenalidomide Medical Valley may reduce the number of blood cells that help fight infection (white blood cells) and help blood clot (platelets).
The doctor will schedule blood tests for the patient:

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

Before starting lenalidomide treatment and during treatment, the patient may be evaluated for circulatory and respiratory problems.
Patients with MDS taking Lenalidomide Medical Valley
If the patient has myelodysplastic syndromes (MDS), there is an increased chance of developing a serious disease called acute myeloid leukemia. Furthermore, it is not known how Lenalidomide Medical Valley affects the likelihood of developing acute myeloid leukemia. Therefore, the doctor may perform tests and check for signs that better predict the risk of acute myeloid leukemia during treatment with Lenalidomide Medical Valley.
Patients with MCL taking Lenalidomide Medical Valley
The 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 Lenalidomide Medical Valley
The 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

The doctor may perform a test to determine whether the patient has a large amount of tumour tissue in the body, including bone marrow. This may lead to a situation where tumour tissue begins to die, causing an abnormal increase in the concentration of various substances in the blood, which may lead to kidney failure (a condition known as tumour lysis syndrome).
The doctor may examine the patient to check for skin changes such as red spots or rash.
The doctor may adjust the dose of Lenalidomide Medical Valley or discontinue treatment based on the patient's blood test results and general condition. If the disease was recently diagnosed, the doctor may also assess treatment based on the patient's age and other conditions that may have occurred in the past.
Blood donation
During treatment and for at least 7 days after treatment ends, the patient must not donate blood.
Children and adolescents
Lenalidomide Medical Valley is not recommended for use in children and adolescents under 18 years of age.
Elderly patients with kidney problems
If the patient is 75 years of age or older, or has moderate to severe kidney problems, the doctor will perform thorough evaluations before starting treatment.
Lenalidomide Medical Valley and other medicines
Inform the doctor or nurse about all medicines currently used, recently used, or planned for use. This is necessary because Lenalidomide Medical Valley may affect the action of other medicines. Likewise, other medicines may affect the action of Lenalidomide Medical Valley.
In particular, inform the doctor or nurse if the patient is taking the following medicines:

• certain contraceptives, such as oral contraceptives, as they may stop working;
• certain medicines used for heart conditions – 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 using Lenalidomide Medical Valley

• Lenalidomide Medical Valley must not be used if the patient is pregnant, as it may harm the unborn child.
• Women must not become pregnant while taking Lenalidomide Medical Valley. Therefore, women who could become pregnant must use an effective method of contraception (see "Contraception").
• If the patient becomes pregnant during treatment with Lenalidomide Medical Valley, treatment must be stopped immediately and the doctor informed.

For men using Lenalidomide Medical Valley

• If the male patient's partner becomes pregnant during his treatment with Lenalidomide Medical Valley, she should immediately inform the doctor. The partner should seek medical advice.
• Men must also use an effective method of contraception (see "Contraception").

Breastfeeding
Breastfeeding must not be used while taking Lenalidomide Medical Valley, as it is not known whether Lenalidomide Medical Valley passes into human milk.
Contraception
Women using Lenalidomide Medical Valley
Before starting treatment, ask the doctor about the possibility of becoming pregnant, even if the patient considers it unlikely.
Women who could become pregnant

• will have pregnancy tests performed under the supervision of a doctor (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. The doctor will advise the patient on appropriate contraceptive methods. Men using Lenalidomide Medical Valley Lenalidomide Medical Valley passes into human semen. If a woman is pregnant or could become pregnant and is not using an effective contraceptive method, her partner should use a condom during treatment and for at least 7 days after treatment ends. This applies also to men who have had a vasectomy. The patient must not be a donor of semen or sperm during treatment and for at least 7 days after treatment ends.

Driving and operating machinery
Do not drive or operate machinery if the patient experiences dizziness, fatigue, drowsiness, balance disturbances due to vertigo, or blurred vision after taking Lenalidomide Medical Valley.
Lenalidomide Medical Valley contains lactose
Lenalidomide Medical Valley contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the 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 use Lenalidomide Medical Valley

Lenalidomide Medical Valley must be administered by medical professionals experienced in the treatment of multiple myeloma, MDS, MCL, or FL.

• When Lenalidomide Medical Valley 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 should be used in combination with other drugs (see section 1, "Why Lenalidomide Medical Valley is used").
• When Lenalidomide Medical Valley is used to treat multiple myeloma in patients after bone marrow transplantation, or in patients with MDS or MCL, the medicine should be used as monotherapy.
• When Lenalidomide Medical Valley is used to treat follicular lymphoma, it should be taken together with another medicine called "rituximab".

Always take Lenalidomide Medical Valley exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
If you are taking Lenalidomide Medical Valley together with other medicines, you should read the package leaflet included with those medicines to obtain information about their use and effects.

Treatment cycle
Lenalidomide Medical Valley is taken on specific days over a period of three weeks (21 days).

• Every 21 days is referred to as a treatment cycle.
• Depending on the day of the cycle, you may take one or more medicines. However, on certain days you will not take any medicines.
• After completing each 21-day cycle, you should start a new 21-day cycle.

OR
Lenalidomide Medical Valley is taken on specific days over a period of four weeks (28 days).

• Every 28 days is referred to as a treatment cycle.
• Depending on the day of the cycle, you may take one or more medicines. However, on certain days you will not take any medicines.
• After completing each 28-day cycle, you should start a new 28-day cycle.

Recommended dose of Lenalidomide Medical Valley
Before starting treatment, your doctor will inform you:

• what dose of Lenalidomide Medical Valley you should take;
• what dose of other medicines you should take in combination with Lenalidomide Medical Valley, if other medicines are required;
• which medicines to take on which days of the cycle.

How and when to take Lenalidomide Medical Valley

• Swallow the capsule whole, preferably with water;
• Do not crush, open, or chew the capsules. If powder from a damaged Lenalidomide Medical Valley capsule comes into contact with the skin, wash the skin immediately and thoroughly with soap and water;
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsules. Gloves should 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;
• Lenalidomide Medical Valley should be taken at approximately the same time each day on which dosing is scheduled.

Taking this medicine
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 Lenalidomide Medical Valley
Lenalidomide Medical Valley is administered in treatment cycles; each cycle lasts 21 or 28 days (see above, "Treatment cycle"). Treatment cycles should continue until your doctor decides to discontinue the medicine.

If you take more Lenalidomide Medical Valley than you should
If you take more Lenalidomide Medical Valley than prescribed, contact your doctor immediately.

If you miss a dose of Lenalidomide Medical Valley
If you miss a dose of Lenalidomide Medical Valley 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 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 any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur, stop taking
Lenalidomide Medical Valley immediately and contact your doctor straight away – immediate
treatment may be necessary:

• Urticaria, rash, swelling of the eyes, lips or face, difficulty breathing or itching, which may be symptoms of severe allergic reactions known as angioedema and anaphylactic reaction.
• Severe allergic reaction which may start 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 reaction 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 levels of calcium in the blood. Lenalidomide Medical Valley may reduce the number of white blood cells that fight infection, as well as blood cells that help blood to clot (platelets), which may lead to bleeding disorders such as nosebleeds and bruising. Lenalidomide Medical Valley 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 cancer may develop, and this risk may potentially be increased by treatment with Lenalidomide Medical Valley. Therefore, your treating physician should carefully evaluate the benefits and risks before prescribing Lenalidomide Medical Valley to you.
Very common adverse reactions (may occur in more than 1 in 10 people):

• Decrease in red blood cells, which may cause anemia leading to tiredness and weakness
• Rash, itching
• Muscle cramps, muscle weakness, muscle pain, bone pain, joint pain, back pain, limb pain
• Generalized swelling, including swelling of hands and feet
• Weakness, fatigue
• Flu 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 sensation
• Worsening of pain, increase in size or redness around a tumor
• Weight loss
• Constipation, diarrhea, 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, known as 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
• Blood protein changes leading to blood vessel swelling (vasculitis)
• Increased blood sugar levels (diabetes)
• Decreased blood sugar levels
• Headache
• Nosebleeds
• Dry skin
• Depression, mood changes, sleep disturbances
• Cough
• Low blood pressure
• Vague 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 (hemolytic anemia)
• Certain types of skin tumors
• Bleeding from gums, stomach or intestines
• Increased blood pressure, slow, fast or irregular heartbeat
• Increased levels of a substance produced during normal and abnormal breakdown of red blood cells
• Increased levels of a protein indicating inflammation in the body
• Skin darkening; skin discoloration due to bleeding under the skin, usually caused by bruising; blood-filled skin swelling, bruising
• Increased uric acid levels in the blood
• Skin eruptions, skin redness, skin cracking, peeling or flaking, urticaria
• Itching, excessive sweating, night sweats
• Difficulty swallowing, sore throat, voice quality problems or voice changes
• Rhinitis (runny nose)
• 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)
• Erectile difficulties
• 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, 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 blockage of bile flow from the liver
• Low levels of phosphates or magnesium in the blood
• Speech difficulties
• Liver damage
• Loss of balance, 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 sex drive (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 stools, dark urine, itchy skin, rash, abdominal pain or swelling – may be symptoms of liver damage (liver failure)
• Abdominal pain, bloating or diarrhea, which may be symptoms of inflammation of the large intestine (colitis or typhlitis)
• Kidney tubular cell damage (known as tubular necrosis)
• Skin color changes, sensitivity to sunlight
• Tumor lysis syndrome – metabolic complications that may occur during cancer treatment, and sometimes even without treatment. These complications are caused by the breakdown products of dying tumor cells and may include: changes in blood chemistry; high levels of potassium, phosphate, uric acid and low calcium levels, leading to kidney dysfunction, heart rhythm disturbances, seizures, and sometimes death
• Increased blood pressure in blood vessels leading to the lungs (pulmonary hypertension)

Adverse reactions of unknown frequency (frequency cannot be estimated 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 pulse – these symptoms may indicate pancreatitis;
• Wheezing, shortness of breath or dry cough, possibly due to inflammation of lung tissue;
• Rare cases of muscle breakdown (muscle pain, weakness or swelling) leading to kidney problems (rhabdomyolysis) have been observed, some occurring when Lenalidomide Medical Valley 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 (leukocytoclastic vasculitis);
• Perforation of the stomach or intestinal wall, which may lead to severe infection. Inform your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in stool or changes in bowel function;
• Viral infections, including varicella-zoster virus (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, right-sided abdominal pain, 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 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Lenalidomide Medical Valley

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following:
"EXP" or "Expiry date (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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures will help protect
the environment.

6. Contents of the packaging and other information

What Lenalidomide Medical Valley contains
Lenalidomide Medical Valley, 2.5 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 2.5 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), erythrosine (E 127), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), and gelatin;
  • printing ink: shellac, propylene glycol, iron oxide black (E 172), and potassium hydroxide.

Lenalidomide Medical Valley, 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, propylene glycol, iron oxide black (E 172), and potassium hydroxide.

Lenalidomide Medical Valley, 7.5 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 7.5 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), erythrosine (E 127), iron oxide red (E 172), titanium dioxide (E 171), and gelatin;
  • printing ink: shellac, propylene glycol, iron oxide black (E 172), and potassium hydroxide.

Lenalidomide Medical Valley, 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, propylene glycol, iron oxide black (E 172), and potassium hydroxide.

Lenalidomide Medical Valley, 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, propylene glycol, iron oxide black (E 172), and potassium hydroxide.

Lenalidomide Medical Valley, 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, propylene glycol, iron oxide black (E 172), and potassium hydroxide.

Lenalidomide Medical Valley, 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, propylene glycol, iron oxide black (E 172), and potassium hydroxide.

What Lenalidomide Medical Valley looks like and contents of the pack
Lenalidomide Medical Valley 2.5 mg: hard capsules with an opaque dark blue cap and an opaque light orange body, with a capsule shell size No. 4, 14–15 mm in length, marked with "LP" on the cap and "637" on the body in black ink.
Lenalidomide Medical Valley 5 mg: hard capsules with an opaque green cap and an opaque light brown body, with a capsule shell size No. 2, 18–19 mm in length, marked with "LP" on the cap and "638" on the body in black ink.
Lenalidomide Medical Valley 7.5 mg: hard capsules with an opaque violet cap and an opaque pink body, with a capsule shell size No. 1, 19–20 mm in length, marked with "LP" on the cap and "643" on the body in black ink.
Lenalidomide Medical Valley 10 mg: hard capsules with an opaque yellow cap and an opaque grey body, with a capsule shell size No. 0, 21–22 mm in length, marked with "LP" on the cap and "639" on the body in black ink.
Lenalidomide Medical Valley 15 mg: hard capsules with an opaque brown cap and an opaque grey body, with a capsule shell size No. 2, 18–19 mm in length, marked with "LP" on the cap and "640" on the body in black ink.
Lenalidomide Medical Valley 20 mg: hard capsules with an opaque dark red cap and an opaque light grey body, with a capsule shell size No. 1, 19–20 mm in length, marked with "LP" on the cap and "641" on the body in black ink.
Lenalidomide Medical Valley 25 mg: hard capsules with an opaque white cap and an opaque white body, with a capsule shell size No. 0, 21–22 mm in length, marked with "LP" on the cap and "642" on the body in black ink.

Carton box containing blisters made of polyvinyl chloride (PVC)/Aclar/aluminium foil, with 7 capsules in each blister.
Pack sizes: 21 hard capsules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden

Manufacturer/Importer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
PLA 3000 Paola
Malta
Adalvo Limited
Malta Life Sciences Park
Building 1, Level 4, Sir Temi Zammit Buildings,
SGN 3000 San Gwann
Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: Lenalidomid Medical Valley
Iceland: Lenalidomid Medical Valley 2.5 mg hörð hylki
Lenalidomid Medical Valley 5 mg hörð hylki
Lenalidomid Medical Valley 7.5 mg hörð hylki
Lenalidomid Medical Valley 10 mg hörð hylki
Lenalidomid Medical Valley 15 mg hörð hylki
Lenalidomid Medical Valley 20 mg hörð hylki
Lenalidomid Medical Valley 25 mg hörð hylki
Germany: Lenalidomid Axiromed
Norway: Lenalidomid Medical Valley
Poland: Lenalidomide Medical Valley
Sweden: Lenalidomid Medical Valley 2.5 mg hårda kapslar
Lenalidomid Medical Valley 5 mg hårda kapslar
Lenalidomid Medical Valley 7.5 mg hårda kapslar
Lenalidomid Medical Valley 10 mg hårda kapslar
Lenalidomid Medical Valley 15 mg hårda kapslar
Lenalidomid Medical Valley 20 mg hårda kapslar
Lenalidomid Medical Valley 25 mg hårda kapslar