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
Lenalidomidum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, inform 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 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 temporary significant reduction or disappearance of signs and symptoms of the disease. This is called "remission".
Newly diagnosed multiple myeloma – in patients undergoing bone marrow transplantation
In this indication, Lenalidomide Medical Valley is used as a single agent for maintenance therapy after achieving an adequate response following transplantation.
Newly diagnosed multiple myeloma – in patients 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"
  The patient starts treatment with additional medicines and then continues with Lenalidomide Medical Valley alone.

If the patient is 75 years of age or older, or has moderate to severe kidney problems, the 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 the recurrence of multiple myeloma after treatment.

Myelodysplastic syndromes (MDS)
Myelodysplastic syndromes (MDS) are a group of different blood and bone marrow disorders. Abnormal blood cells are present and do not function properly. Patients may experience various 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, if all 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 the bone marrow cells called "isolated cytogenetic abnormality with deletion 5q". This means the patient's body does not produce enough healthy blood cells
• the patient has previously received other treatments that were inappropriate or insufficiently effective.

Taking Lenalidomide Medical Valley 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 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 a disease 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 together 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 being 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 be harmful to the unborn child (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men");
• if the patient could become pregnant, unless all required contraceptive measures are being used (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men"). If the patient could become pregnant, the doctor will always document that necessary precautions have been taken and will confirm this with the patient;
• if the patient has an allergy to lenalidomide or any of the other ingredients of this medicine (listed in section 6). If the patient thinks they may be allergic, they should consult their doctor. If any of these points apply, 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 had 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 (chickenpox and shingles), or HIV. If in 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), has ever had a blood clot, smokes, has high blood pressure, or high cholesterol levels;
• experienced allergic reactions while taking thalidomide (another medicine used to treat 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 fever, flu-like symptoms, elevated liver enzymes, blood abnormalities (eosinophilia), or 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, 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, changes in gait or balance problems, persistent numbness, reduced sensation, or loss of sensation, memory loss or disorientation – inform the doctor or nurse immediately. 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 in these symptoms.
• shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or swelling of the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Tests and examinations
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 to clot (platelets).
The doctor will schedule blood tests:

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

Before starting lenalidomide treatment and during treatment, 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 help 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
• then 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

• then 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 tumor tissue in the body, including in the bone marrow. This may lead to a situation where tumor tissue begins to die, causing abnormal increases in various substances in the blood, which may lead to kidney failure (a condition known as tumor 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 blood test results and the patient's general condition. If the disease has been recently diagnosed, the doctor may also consider the patient's age and any previous medical conditions when evaluating treatment.
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 and 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
Tell the doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. 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, because they may become ineffective;
• 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 taking Lenalidomide Medical Valley

• Lenalidomide Medical Valley must not be used if the patient is pregnant, as it may be harmful to the unborn child.
• Women must not become pregnant while taking Lenalidomide Medical Valley. For this reason, effective contraception must be used by women who could become pregnant (see "Contraception").
• If the patient becomes pregnant during treatment with Lenalidomide Medical Valley, treatment must be stopped immediately and the doctor must be informed.

For men taking Lenalidomide Medical Valley

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

Breastfeeding
Breastfeeding must not be used during treatment with Lenalidomide Medical Valley, as it is not known whether Lenalidomide Medical Valley passes into human milk.
Contraception
Women taking 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 medical supervision (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends), except in cases where the fallopian tubes have been cut and sealed 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 taking Lenalidomide Medical Valley
  Lenalidomide Medical Valley passes into human semen. If a woman is pregnant or could become pregnant and is not using effective contraception, her partner must use a condom during treatment and for at least 7 days after treatment ends. This applies also to men who have 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 using machines
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, they should contact their 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 healthcare 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 been previously treated, the medicine is given in combination with other medicines (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 is taken together with another medicine called "rituximab".

Lenalidomide Medical Valley should always be taken exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist.
If the patient is taking Lenalidomide Medical Valley together with other medicines, they 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 during a three-week period (21 days).

• Each 21-day period is called a treatment cycle.
• Depending on the day of the cycle, the patient will take one or more medicines. However, on some days the patient will not take any medicines.
• After completing each 21-day cycle, the patient should start a new 21-day cycle.

OR
Lenalidomide Medical Valley is taken on specific days during a four-week period (28 days).

• Each 28-day period is called a treatment cycle.
• Depending on the day of the cycle, the patient will take one or more medicines. However, on some days the patient will not take any medicines.
• After completing each 28-day cycle, the patient should start a new 28-day cycle.

Recommended dose of Lenalidomide Medical Valley
Before starting treatment, the doctor will inform the patient:

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

How and when to take Lenalidomide Medical Valley

• Swallow the capsule whole, preferably with water;
• Do not crush, open, or chew the capsules. If the 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 must 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 the doctor decides to discontinue the medicine.

If you take more Lenalidomide Medical Valley than prescribed
If more than the prescribed dose of Lenalidomide Medical Valley has been taken, contact the doctor immediately.

If you miss a dose of Lenalidomide Medical Valley
If a dose of Lenalidomide Medical Valley was missed at the scheduled time and

• less than 12 hours have passed: take the capsule immediately;
• more than 12 hours have passed: do not take the missed capsule. Take the next capsule at the scheduled time on the following day. If there are any further doubts about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur, stop taking
Lenalidomide Medical Valley immediately and contact your doctor without delay – immediate
treatment may be required:

• Urticaria, rash, swelling of the eyes, lips or face, breathing difficulties or itching, which may be symptoms of severe allergic reactions known as angioedema and anaphylactic reaction.
• Severe allergic reaction possibly starting as a rash in one area, spreading over the entire body and associated with significant skin peeling (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• Widespread rash, high fever, 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 calcium levels 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 clot (platelets), which may lead to bleeding disorders such as nosebleeds and bruising. Lenalidomide Medical Valley may also cause blood clots in veins (venous thrombosis).

Other adverse reactions
It should be noted that in a small number of patients, development of other types of cancer may occur, and this risk may possibly 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):

• Decreased number of red blood cells, which may lead to anaemia causing fatigue and weakness
• Rash, itching
• Muscle cramps, muscle weakness, muscle pain, muscle tenderness, bone pain, joint pain, back pain, limb pain
• Generalised swelling, including swelling of hands and feet
• Weakness, fatigue
• Influenza and influenza-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
• Loss of appetite, altered taste sensation
• Worsening of pain, enlargement or redness around a tumour
• Weight loss
• Constipation, diarrhoea, nausea, vomiting, abdominal pain, heartburn
• Low levels of potassium or calcium and/or sodium in the blood
• Abnormally low thyroid function
• Leg pain (which may be a sign of thrombosis), chest pain or shortness of breath (which may be symptoms of blood clots in the lungs, 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 function tests
• Increased liver function test values
• Changes in blood proteins, leading to blood vessel inflammation (vasculitis)
• Increased blood sugar levels (diabetes)
• Decreased blood sugar levels
• Headache
• Nosebleeds
• Dry skin
• Depression, mood changes, sleep disturbances
• Cough
• Low blood pressure
• Vague feeling of physical discomfort, malaise
• Painful inflammation of the mouth, dry mouth
• Dehydration

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

• Breakdown of red blood cells (haemolytic anaemia)
• Certain types of skin tumours
• Bleeding from gums, stomach or intestines
• Increased blood pressure, slow, fast or irregular heartbeat
• Increased levels of substances produced during normal and abnormal breakdown of red blood cells
• Increased levels of a protein indicating presence of inflammation in the body
• Skin darkening; skin discolouration due to bleeding under the skin, usually caused by bruising; blood-filled skin swelling, bruises
• Increased levels of uric acid 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
• Nasal inflammation (rhinitis)
• 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 symptom 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
• Balance disorders, difficulty moving
• Hearing loss, 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 – these may be symptoms of liver damage (liver failure)
• Abdominal pain, bloating or diarrhoea, which may be symptoms of inflammation of the large intestine (colitis or caecitis)
• Kidney tubular cell damage (known as tubular necrosis)
• Skin colour changes, sensitivity to sunlight
• Tumour lysis syndrome – metabolic complications that may occur during cancer treatment, and sometimes even without treatment. These complications are caused by products released from dying tumour cells and may include: changes in blood chemistry; high levels of potassium, 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 with unknown frequency (frequency cannot be estimated from available data):

• Sudden or gradually 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 indicate pancreatitis;
• Wheezing, shortness of breath or dry cough, which may be caused by lung tissue inflammation;
• 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 (leucocytoclastic 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 stools or changes in bowel function;
• Viral infections, including herpes zoster (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);
• Solid organ transplant rejection (e.g. kidney, heart).

Reporting of adverse reactions
If you experience any adverse reactions, including any 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, 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 marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Lenalidomide Medical Valley

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

6. Contents of the pack 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 components 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 components 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 components 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 components 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 components 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 components 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 components 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, size 4 capsule shell, 14–15 mm in length, printed in black ink with "LP" on the cap and "637" on the body.
Lenalidomide Medical Valley 5 mg: hard capsules with an opaque green cap and an opaque light brown body, size 2 capsule shell, 18–19 mm in length, printed in black ink with "LP" on the cap and "638" on the body.
Lenalidomide Medical Valley 7.5 mg: hard capsules with an opaque violet cap and an opaque pink body, size 1 capsule shell, 19–20 mm in length, printed in black ink with "LP" on the cap and "643" on the body.
Lenalidomide Medical Valley 10 mg: hard capsules with an opaque yellow cap and an opaque grey body, size 0 capsule shell, 21–22 mm in length, printed in black ink with "LP" on the cap and "639" on the body.
Lenalidomide Medical Valley 15 mg: hard capsules with an opaque brown cap and an opaque grey body, size 2 capsule shell, 18–19 mm in length, printed in black ink with "LP" on the cap and "640" on the body.
Lenalidomide Medical Valley 20 mg: hard capsules with an opaque dark red cap and an opaque light grey body, size 1 capsule shell, 19–20 mm in length, printed in black ink with "LP" on the cap and "641" on the body.
Lenalidomide Medical Valley 25 mg: hard capsules with an opaque white cap and an opaque white body, size 0 capsule shell, 21–22 mm in length, printed in black ink with "LP" on the cap and "642" on the body.

Carton box containing blisters made of Polyvinyl Chloride (PVC)/Aclar/Aluminium, 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 member states 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