LENALIDOMIDE 2.5 мг Капсулы твердые

Содержание инструкции

1. Lenalidomide TecniGen 5 mg hard capsules
2. Lenalidomide TecniGen 10 mg hard capsules, 15 mg hard capsules, 20 mg hard capsules
   1. What is Lenalidomide TecniGen and what is it used for
   2. What you need to know before taking Lenalidomide TecniGen
   3. How to take Lenalidomide TecniGen
   4. Possible side effects
   5. How to store Lenalidomide TecniGen
   6. Package contents and other information

Lenalidomide TecniGen 2.5 mg hard capsules

Lenalidomide TecniGen 5 mg hard capsules

Lenalidomide TecniGen 7.5 mg hard capsules

Lenalidomide TecniGen 10 mg hard capsules, 15 mg hard capsules, 20 mg hard capsules

Lenalidomide TecniGen 25 mg hard capsules
Generic medicine
lenalidomide

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Lenalidomide TecniGen is and what it is used for.
• 2. What you need to know before you take Lenalidomide TecniGen.
• 3. How to take Lenalidomide TecniGen.
• 4. Possible side effects.
• 5. How to store Lenalidomide TecniGen.
• 6. Contents of the pack and other information.

1. What is Lenalidomide TecniGen and what is it used for

Lenalidomide TecniGen contains the active substance “lenalidomide”. This medicine is part
of a group of medicines that affect the way the immune system works.
Lenalidomide TecniGen is used in adults for:

• multiple myeloma;
• myelodysplastic syndromes;
• mantle cell lymphoma;
• follicular lymphoma.

Multiple myeloma
Multiple myeloma is a type of cancer that affects a certain type of white blood cells, called
plasma cells. These cells collect in the bone marrow and divide uncontrollably.
This can damage the bones and kidneys.
Multiple myeloma is usually incurable. However, the signs and symptoms can be significantly
reduced or disappear for a certain period. This result is called “response”.
Newly diagnosed multiple myeloma: in patients undergoing bone marrow transplantation
Lenalidomide TecniGen is used alone as maintenance therapy in patients who
have recovered adequately after bone marrow transplantation.
Newly diagnosed multiple myeloma: in patients who cannot undergo transplantation
Lenalidomide TecniGen is taken with other medicines, which may include:

• a chemotherapy medicine called “bortezomib”;
• an anti-inflammatory medicine called “dexamethasone”;
• a chemotherapy medicine called “melphalan”;
• and an immunosuppressant medicine called “prednisone”.

You will take these other medicines at the beginning of treatment and then continue to take Lenalidomide
TecniGen alone.
If you are 75 years of age or older or have moderate to severe kidney problems, your doctor will
subject you to careful monitoring before starting treatment.
Multiple myeloma: in patients already treated
Lenalidomide TecniGen is taken together with an anti-inflammatory medicine called
“dexamethasone”.
Lenalidomide TecniGen can stop the worsening of the signs and symptoms of multiple
myeloma. It has also been shown to delay the recurrence of multiple myeloma after
treatment.

Myelodysplastic syndromes (MDS)
MDS are a group of many different blood and bone marrow diseases. Blood cells become abnormal and do not function properly. Patients may experience various
signs and symptoms, including a low number of red blood cells (anemia), the need for blood transfusions
and the risk of infection.
Alone, Lenalidomide TecniGen is used to treat adult patients who have been diagnosed with
MDS, in the presence of all of the following conditions:

• if you need regular blood transfusions to treat low levels of red blood cells ("transfusion-dependent anemia");
• if you have an abnormality of the bone marrow cells, called "an isolated deletion 5q cytogenetic abnormality". This means that your body does not produce enough healthy blood cells;
• if other treatments used previously are not suitable or are not effective enough.

Lenalidomide TecniGen can increase the number of healthy red blood cells produced by the body,
reducing the number of abnormal cells:

• this may reduce the number of blood transfusions needed. It may be possible to avoid transfusions altogether.

Mantle cell lymphoma (MCL)
MCL is a cancer of a part of the immune system (the lymphatic tissue). It affects a type of
white blood cells called B lymphocytes, or B cells. In MCL, B lymphocytes grow
uncontrollably and accumulate in the lymphatic tissue, bone marrow, or blood.
Lenalidomide TecniGen is used alone for the treatment of adult patients previously
treated with other medicines.

Follicular lymphoma (FL)
FL is a slow-growing form of cancer that affects B lymphocytes, a type of white blood cells that
help the body fight infections. In the presence of FL, an excessive number can accumulate
of these B lymphocytes in the blood, bone marrow, lymph nodes, and spleen.
Lenalidomide TecniGen is taken together with another medicine called “rituximab” for the
treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide TecniGen works
Lenalidomide TecniGen acts on the body's immune system and directly on the tumor,
in several ways:

• stopping the development of cancer cells;
• stopping the growth of blood vessels that bring blood to cancer cells;
• stimulating part of the immune system to attack cancer cells.

2. What you need to know before taking Lenalidomide TecniGen

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

• If you are pregnant, think you may be pregnant, or are planning a pregnancy, because Lenalidomide TecniGen is expected to harm the fetus(see section 2, ‘Pregnancy, breastfeeding and contraception – information for women and men’).
• If there is a possibility that you may become pregnant unless you follow all the necessary measures to avoid pregnancy (see section 2 ‘Pregnancy, breastfeeding and contraception – information for women and men’). If there is a possibility that you may become pregnant, at each prescription the doctor will note and confirm to you that the necessary measures to avoid pregnancy have been adopted.
• If you are allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor. If any of these applies to you, do not take Lenalidomide TecniGen. If you have doubts, consult your doctor.

Warnings and precautions
Consult your doctor, pharmacist or nurse before taking Lenalidomide TecniGen if:

• you have had episodes of blood clot formation in the past, as the risk of blood clots forming in veins and arteries increases during treatment;
• you have any signs of infection, such as cough or fever;
• you have or have had a viral infection in the past, in particular: hepatitis B infection, shingles, HIV. If you have doubts, consult your doctor. Treatment with Lenalidomide TecniGen may cause reactivation of the virus in patients carrying the virus. This causes the infection to recur. The doctor must check if you have had a hepatitis B infection in the past;
• you have kidney problems, the doctor may adjust the dose of Lenalidomide TecniGen;
• you have had a heart attack, have had a blood clot, or if you smoke, have high blood pressure or high cholesterol levels;
• you have had an allergic reaction during treatment with thalidomide (another medicine for the treatment of multiple myeloma), such as rash, itching, swelling, dizziness or difficulty breathing;
• you have had in the past 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 applies to you, tell your doctor, pharmacist or nurse before starting treatment. At any time during or after treatment, immediately inform your doctor or nurse if you experience:
• blurred vision, loss of vision or double vision, difficulty speaking, weakness in an arm or leg, changes in the way you walk or problems with balance, persistent numbness, decreased sensitivity 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 treatment with lenalidomide, inform your doctor of any changes in these symptoms.
• 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 Lenalidomide TecniGen you will undergo regular blood tests.
This is because Lenalidomide TecniGen can cause a decrease in the blood cells that defend you
from infections (white blood cells) and those that promote blood clotting (platelets). The doctor will
ask you to undergo blood tests:

• before treatment,
• every week for the first 8 weeks of treatment,
• then at least once a month afterwards.

You may be evaluated for signs of cardiopulmonary problems before and during treatment with
lenalidomide.
For patients with MDS taking Lenalidomide TecniGen
If you suffer from MDS, you are more likely to develop a more advanced disease called
acute myeloid leukemia (AML). Furthermore, the role of lenalidomide in the probability of
developing AML is not known. The doctor may ask you for some tests to check the signs that could
more accurately predict the probability that you will develop AML during treatment with
Lenalidomide TecniGen.
For patients with MCL taking Lenalidomide TecniGen
The doctor will ask you to undergo a blood test:

• before treatment,
• once a week for the first 8 weeks (2 cycles) of treatment,
• then every 2 weeks in cycles 3 and 4 (for more information see section 3 "Treatment cycle"),
• subsequently at the start of each cycle and
• at least once a month.

For patients with FL taking Lenalidomide TecniGen
The doctor will ask you to undergo a blood test:

• before treatment,
• once a week for the first 3 weeks (1 cycle) of treatment
• then every 2 weeks in cycles 2 to 4 (for more information see section 3 “Treatment cycle”)
• subsequently at the start of each cycle and
• at least once a month.

The doctor may check if you have a high tumor burden throughout the body, including in the
bone marrow. This may cause a disease in which tumors break down and cause the
presence of unusual levels of chemicals in the blood, which can lead to kidney failure (this disease is
called “tumor lysis syndrome”).
The doctor may check for changes on the skin, such as red spots or rashes.
The doctor may decide to adjust the dose of Lenalidomide TecniGen or stop the
treatment depending on the results of the blood tests and your general condition. If you are a
newly diagnosed patient, the doctor may also assess the treatment based on your age and any other
pre-existing conditions.

Blood donation
You must not donate blood during therapy with lenalidomide and for at least 7 days after
stopping treatment.

Children and adolescents
The use of Lenalidomide TecniGen is not recommended in children and adolescents under
18 years of age.

Elderly and people with kidney problems
In patients aged 75 years or older, or with moderate or severe kidney problems, the doctor
will perform careful checks before starting treatment.

Other medicines and Lenalidomide TecniGen
Tell your doctor or nurse if you are taking, have recently taken or may take
any other medicines. This is because Lenalidomide TecniGen can affect the action of other
medicines and other medicines can affect the action of Lenalidomide TecniGen.
In particular, tell your doctor or nurse if you are taking any of the following medicines:

• some medicines used to prevent pregnancy, such as oral contraceptives, because they may no longer be effective,
• some medicines used for heart problems, such as digoxin,
• some medicines used to thin the blood, such as warfarin.

Pregnancy, breastfeeding and contraception – information for women and men
Pregnancy
For women taking Lenalidomide TecniGen

• You must not take Lenalidomide TecniGen if you are pregnant, as this medicine is expected to harm the fetus.
• During treatment with Lenalidomide TecniGen, you must not start a pregnancy. If there is a possibility of becoming pregnant, you must use effective contraceptive methods (see the “Contraception” section).
• If you become pregnant during treatment with Lenalidomide TecniGen, you must stop treatment immediately and inform your doctor. For men taking Lenalidomide TecniGen
• If your partner becomes pregnant while you are taking Lenalidomide TecniGen, immediately inform your doctor. It is also recommended that your partner contact the doctor.
• Furthermore, you must use effective contraceptive methods (see the “Contraception” section).

Breastfeeding
You must not breastfeed while taking Lenalidomide TecniGen, as it is not known whether this medicine
passes into breast milk.

Contraception
For women taking Lenalidomide TecniGen
Before starting treatment, ask your doctor if there is a possibility for you to become
pregnant, even if you think it is unlikely.
If there is a possibility of becoming pregnant:

• you will have to undergo pregnancy tests under the supervision of your doctor (before each treatment, at least every 4 weeks during treatment and at least 4 weeks after the end of treatment) except in cases where it has been confirmed that the fallopian tubes have been cut and closed to prevent eggs from reaching the uterus (sterilization by tubal ligation

of the tubes)
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 all the information on appropriate contraceptive methods.

For men taking Lenalidomide TecniGen
Lenalidomide TecniGen passes into human seminal fluid. If there is a possibility that your partner
is pregnant or becomes 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 undergone a vasectomy.

Driving and using machines
Do not drive or use machines if you experience dizziness, fatigue, drowsiness, vertigo or blurred vision
after taking Lenalidomide TecniGen.
Lenalidomide TecniGen contains lactose
Lenalidomide TecniGen contains lactose. If your doctor has told you that you have an intolerance to some
sugars, contact your doctor before taking this medicine.

Lenalidomide TecniGen contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule. This means that the
medicine is essentially “sodium-free”.

3. How to take Lenalidomide TecniGen

Lenalidomide TecniGen must be administered by healthcare professionals experienced in the treatment of
multiple myeloma, MDS, MCL or FL.

• When Lenalidomide TecniGen is used for the treatment of multiple myeloma in patients who are not eligible for bone marrow transplantation or who have received other treatments previously, it is taken with other medicines (see section 1 “What Lenalidomide TecniGen is and what it is used for”).
• When Lenalidomide TecniGen is used for the treatment of multiple myeloma in patients who have undergone bone marrow transplantation or to treat patients with MDS or MCL, it is taken alone.
• When Lenalidomide TecniGen is used to treat follicular lymphoma, it is taken with another medicine called “rituximab”.

Take Lenalidomide TecniGen following your doctor’s instructions exactly. If you have any doubts
consult your doctor or pharmacist.
If you are taking Lenalidomide TecniGen in combination with other medicines, consult the leaflet
of those medicines for further information on their use and their effects.

Treatment cycle
Lenalidomide TecniGen is taken on some days over a 3-week (21-day) period.

• 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, on some days you will not take any medicine.
• Once each 21-day cycle is completed, you will need to start a new “cycle” within the next 21 days.

OR
Lenalidomide TecniGen is taken on some days over a 4-week (28-day) period.

• 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, on some days you will not take any medicine.
• Once each 28-day cycle is completed, you will need to start a new “cycle” within the next 28 days.

Dose of Lenalidomide TecniGen to be taken
Before starting treatment, your doctor will tell you:

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

How and when to take Lenalidomide TecniGen

• The capsules should be swallowed whole, preferably with water.
• Do not break, open or chew the capsules. If the powder from a broken Lenalidomide TecniGen capsule comes into contact with the skin, wash the skin immediately and thoroughly with water and soap.
• Healthcare professionals, those providing care to the patient and family members must wear disposable gloves when handling the blister or the capsule. The gloves should then be removed carefully to avoid skin exposure, placed in a sealable polyethylene bag and disposed of in accordance with local regulations. Then wash your hands thoroughly with water and soap. Pregnant or suspected pregnant women should not handle the blister or the capsule.
• The capsules can be taken with or without food.
• You should take Lenalidomide TecniGen on the established days at more or less the same time.

Taking this medicine
To remove the capsule from the blister:

• press on only one side of the capsule, pushing it through the aluminum foil;
• do not press on the center of the capsule, otherwise there is a risk of breaking it.

Duration of treatment with Lenalidomide TecniGen
Lenalidomide TecniGen is taken in treatment cycles, each lasting 21 or 28 days
(see above “Treatment cycle”). You should continue the treatment cycles until your doctor
tells you to stop the treatment.

If you take more Lenalidomide TecniGen than you should
If you have taken more Lenalidomide TecniGen than you have been prescribed, inform
your doctor immediately.

If you forget to take Lenalidomide TecniGen
If you forget to take Lenalidomide TecniGen at the usual time and:

• less than 12 hours have passed: take your capsule immediately
• more than 12 hours have passed: do not take the forgotten capsule, but take the next capsule the following day at the usual time.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Lenalidomide TecniGen and consult your doctor immediately if you experience any of the following serious side effects – urgent medical treatment may be necessary:

• Hives, skin rashes, 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 throughout the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• Widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also paragraph 2.

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

• Fever, chills, sore throat, cough, ulcers in the mouth or any other symptom of infection, even 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 a high level of calcium in the blood.

Lenalidomide TecniGen can reduce the number of white blood cells that fight infections and also of blood cells that help blood to clot (platelets), which can cause bleeding disorders such as nosebleeds and bruising. Lenalidomide TecniGen can also cause blood clots in the veins (thrombosis).

Other side effects
It is important to note that a small number of patients may develop other types of cancer and it is possible that this risk may increase with treatment with Lenalidomide TecniGen. Therefore, the doctor must carefully assess the benefit and risk when prescribing Lenalidomide TecniGen.

Very common(may affect more than 1 in 10 people):

• Decrease in the number of red blood cells (anemia), which can cause fatigue and weakness.
• Skin rash, itching.
• Muscle cramps, muscle weakness, acute muscle pain, muscle aches, bone pain, joint pain, back pain, pain in the extremities.
• Generalized swelling, including swelling of the arms and legs.
• Weakness, fatigue.
• Fever and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough and chills.
• Numbness, tingling or burning sensation on the skin, pain in the hands or feet, dizziness, tremor.
• Decreased appetite, changes in taste.
• Increased pain, size of the tumor or redness around the tumor.
• Weight loss.
• Constipation, diarrhea, nausea, vomiting, stomach pain, heartburn.
• Low levels of potassium or calcium and/or sodium in the blood.
• Insufficient thyroid function.
• 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, called pulmonary embolism).
• Infections of any kind, including infections of the sinuses surrounding the nose, lungs and upper respiratory tract.
• Shortness of breath.
• Blurred vision.
• Clouding of the vision (cataract).
• Kidney problems, including improper functioning of the kidneys or the inability of the kidneys to maintain normal function.
• Abnormal values in liver function tests.
• Increased values in liver function tests.
• Changes in a protein in the blood that can cause inflammation of the arteries (vasculitis).
• Increases in blood sugar levels (diabetes).
• Decreases in blood sugar levels.
• Headache.
• Nosebleeds.
• Dry skin.
• Depression, mood changes, difficulty sleeping.
• Cough.
• Decreased blood pressure.
• Vague sensation of physical discomfort, malaise.
• Inflammation of the oral cavity, dry mouth.
• Dehydration.

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

• Destruction of red blood cells in the blood (hemolytic anemia).
• Some types of skin cancer.
• Bleeding from the gums, stomach or intestines.
• Increased blood pressure, slow, fast or irregular heartbeat.
• Increased amount of a substance that comes from the normal and abnormal breakdown of red blood cells.
• Increase in a type of protein that indicates inflammation in the body.
• Darkening of the skin; change in skin color due to bleeding under the skin, typically caused by bruising; swelling of the skin due to the presence of blood; bruising.
• Increased uric acid in the blood.
• Skin rashes, redness of the skin, cracking of the skin, scaling or peeling, hives.
• Increased sweating, night sweats.
• Difficulty swallowing, sore throat, problems with voice quality or changes in voice
• Runny nose.
• Production of urine much more or less than usual or inability to control the urge to urinate.
• Blood in the urine.
• Shortness of breath, especially when lying down (which may be a symptom of heart failure).
• Difficulty having an erection.
• Stroke, fainting, dizziness (a problem with your inner ear that causes a sensation that everything is spinning), temporary loss of consciousness.
• Chest pain that radiates to the arms, neck, jaw, back or stomach, feeling of sweating and shortness of breath, feeling unwell or vomiting, which may be symptoms of a heart attack (myocardial infarction).
• Muscle weakness, lack of energy.
• Neck pain, chest pain.
• Chills.
• Swelling of the 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 sensitivity especially to touch.
• Excess iron in the blood.
• Thirst.
• Confusion.
• Toothache.
• Falls, which can cause injury.

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

• Bleeding inside the skull.
• Circulatory problems.
• Loss of vision.
• Loss of sexual drive (libido).
• Abundant urine flow with pain and weakness in the bones, which may be symptoms of a kidney disorder (Fanconi syndrome).
• Yellowing of the skin, mucous membranes or eyes (jaundice), pale stools, dark urine, itching, skin rash, pain or swelling of the stomach. These may be symptoms of liver damage (liver failure).
• Stomach pain, bloating or diarrhea, which may be symptoms of inflammation of the large intestine (called colitis or typhlitis).
• Damage to the cells of the kidneys (called tubular necrosis).
• Changes in skin color, sensitivity to sunlight.
• Tumor lysis syndrome: metabolic complications that can occur during cancer treatment and sometimes even in the absence of treatment. These complications are caused by the breakdown products of cancer cells that are dying, and can include changes in hematological parameters with high levels of potassium, phosphorus and uric acid, as well as low levels of calcium, which lead to changes in kidney function and heartbeat, seizures and sometimes death.
• Increased blood pressure in the vessels that carry blood to the lungs (pulmonary hypertension). Not known(frequency cannot be estimated based on available data):
• Sudden, or mild but worsening, pain in the upper abdomen and/or back, lasting for several days, with possible 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 (pain, weakness or swelling of the muscles), which can cause kidney problems (rhabdomyolysis), some of which when Lenalidomide is administered with a statin (a type of drug that lowers cholesterol).
• A disease affecting the skin that is caused by inflammation of small blood vessels, with joint pain and fever (leucocytoclastic vasculitis).
• Deterioration of the wall of the stomach or intestine, which can cause very serious infections. Tell your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in your stool or changes in your bowel habits.
• Viral infections, including herpes zoster (also known as “shingles”, a disease

viral that causes painful blistering rash) and recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown urine, stomach pain on the right side, fever and nausea or vomiting).

• Rejection of solid organ transplant (such as kidney, heart).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through 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 Lenalidomide TecniGen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging or on the blister after
“Exp.”. The expiry date refers to the last day of that month.
Lenalidomide TecniGen hard capsules 2.5 mg, 5 mg, 7.5 mg: do not store at a temperature above 25°C.
Lenalidomide TecniGen hard capsules 10 mg, 15 mg, 20 mg, 25 mg: this medicine does not require any
special storage conditions.
Do not use this medicine if you notice damaged packaging or if it shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lenalidomide TecniGen contains
The active ingredient is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
The other ingredients are:

• capsule content: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate;
• capsule shell: gelatin, yellow iron oxide (E172), titanium dioxide (E171), black iron oxide (E172) and brilliant blue FCF (E133).

The active ingredient is lenalidomide. Each capsule contains 5 mg of lenalidomide.
The other ingredients are:

• capsule content: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate;
• capsule shell: gelatin, titanium dioxide (E171) and brilliant blue FCF (E133).

The active ingredient is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
The other ingredients are:

• capsule content: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate;
• capsule shell: gelatin, titanium dioxide (E171), black iron oxide (E172), yellow iron oxide (E172) and brilliant blue FCF (E133).

The active ingredient is lenalidomide. Each capsule contains 10 mg of lenalidomide.
The other ingredients are:

• capsule content: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate;
• capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172) and brilliant blue FCF (E133).

The active ingredient is lenalidomide. Each capsule contains 15 mg of lenalidomide.
The other ingredients are:

• capsule content: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• capsule shell: gelatin, titanium dioxide (E171) and brilliant blue FCF (E133).

The active ingredient is lenalidomide. Each capsule contains 20 mg of lenalidomide.
The other ingredients are:

• capsule content: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate;
• capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), brilliant blue FCF (E133) and black iron oxide (E172).

The active ingredient is lenalidomide. Each capsule contains 25 mg of lenalidomide.
The other ingredients are:

• capsule content: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate;
• capsule shell: gelatin and titanium dioxide (E171).

Description of the appearance of Lenalidomide TecniGen and package contents
Lenalidomide Tecnigen 2.5 mg hard capsules are size 4 capsules with a green capsule body
and a green capsule cap, with 14.3 mm ± 0.3 mm x 5.32 mm.
The capsules are supplied in packs containing 7 or 21 capsules.
Lenalidomide Tecnigen 5 mg hard capsules are size 4 capsules with a blue capsule body
and a blue capsule cap, with 14.3 mm ± 0.3 mm x 5.32 mm.
The capsules are supplied in packs containing 7 or 21 capsules.
Lenalidomide Tecnigen 7.5 mg hard capsules are size 2 capsules with a grey capsule body
and a green capsule cap, with 18.0 mm ± 0.3 mm x 6.35 mm.
The capsules are supplied in packs containing 21 capsules.
Lenalidomide Tecnigen 10 mg hard capsules are size 2 capsules with a white capsule body
and a green capsule cap, with 18.0 mm ± 0.3 mm x 6.35 mm.
The capsules are supplied in packs containing 7 or 21 capsules.
Lenalidomide Tecnigen 15 mg hard capsules are size 0 capsules with a white capsule body
and a blue capsule cap, with 21.7 mm ± 0.3 mm x 7.64 mm.
The capsules are supplied in packs containing 7 or 21 capsules.
Lenalidomide Tecnigen 20 mg hard capsules are size 0 capsules with a blue capsule body
and a green capsule cap, with 21.7 mm ± 0.3 mm x 7.64 mm.
The capsules are supplied in packs containing 21 capsules.
Lenalidomide Tecnigen 25 mg hard capsules are size 0 capsules with a white capsule body
and a white capsule cap, 24.2 mm ± 0.3 mm x 7.66 mm.
The capsules are supplied in packs containing 21 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Farmoz - Sociedade Técnico Medicinal, S.A.
Rua da Tapada Grande nº2
Abrunheira
2710-089 Sintra
Portugal
Manufacturer
Tecnimede – Sociedade Técnico-Medicinal S.A.
Quinta da Cerca, Caixaria
2565-187 Dois Portos
Portugal.

This medicinal product is authorised in the Member States of the EEA with the following denominations: