Lenalidomide g.l.

Package leaflet: Information for the patient

Lenalidomide G.L., 5 mg, hard capsules
Lenalidomide G.L., 10 mg, hard capsules
Lenalidomide G.L., 15 mg, hard capsules
Lenalidomide G.L., 25 mg, hard capsules
Lenalidomidum
Please read 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, please 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, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Lenalidomide G.L. is and what it is used for

What Lenalidomide G.L. is
Lenalidomide G.L. contains the active substance "lenalidomide". This medicine belongs to a group of medicines that affect the function of the immune system.
What Lenalidomide G.L. is used for
Lenalidomide G.L. is used in adult patients for the treatment of:

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

Multiple myeloma
Multiple myeloma is a type of cancer that affects a certain kind 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 temporary significant reduction or disappearance of signs and symptoms of the disease. This is called "remission".
Newly diagnosed multiple myeloma — in patients after bone marrow transplantation
In this indication, Lenalidomide G.L. is used as monotherapy for maintenance treatment following achievement of an adequate response after transplantation.
Newly diagnosed multiple myeloma – in patients who are not eligible for bone marrow transplantation
Lenalidomide G.L. 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 G.L. alone.

If the patient is 75 years of age or older, or has moderate to severe kidney problems, the doctor will perform thorough examinations before starting treatment.
Multiple myeloma – in previously treated patients
Lenalidomide G.L. is taken in combination with an anti-inflammatory medicine called "dexamethasone".
Lenalidomide 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 which do not function properly. Patients may experience various subjective and objective symptoms, including low number of red blood cells (anaemia), need for blood transfusions and risk of infection.
Lenalidomide G.L. as monotherapy is used in the treatment of adult patients diagnosed with MDS, if all the following conditions are met:

• the patient requires regular blood transfusions due to low number of red blood cells ("transfusion-dependent anaemia");
• the patient has an abnormality in the bone marrow cells called "isolated cytogenetic abnormality of deletion 5q". This means that the patient's body does not produce enough healthy blood cells;
• the patient has previously been treated with other treatment options which have proven inappropriate or insufficiently effective.

Taking Lenalidomide G.L. may increase the number of healthy red blood cells produced by the body by reducing the number of abnormal cells:

• this may lead to a reduction in the number of required blood transfusions. It may even become possible that transfusions are no longer needed.
  Mantle cell lymphoma (MCL)
  MCL is a cancer of part of the immune system (lymphatic tissue). It attacks a certain type of white blood cells called B-lymphocytes or B-cells. Mantle cell lymphoma is a disease characterised by uncontrolled growth of B-lymphocytes, resulting in their accumulation in lymphatic tissue, bone marrow or blood.

Lenalidomide G.L. as monotherapy is used in the treatment of adult patients who have been previously treated with other medicines.
Follicular lymphoma (FL)
FL is a slowly growing malignant tumour affecting B-lymphocytes. These are a type of white blood cells that help the body fight infections. In patients with FL, an excessive number of B-lymphocytes may accumulate in the blood, bone marrow, lymph nodes and spleen.
Lenalidomide G.L. is taken together with another medicine called "rituximab" in the treatment of adult patients with previously treated follicular lymphoma.
How Lenalidomide G.L. works
Lenalidomide G.L. works by affecting the function of the immune system and directly attacking tumour cells. The medicine works in several different ways:

• by inhibiting the development of tumour cells;
• by inhibiting the development of blood vessels in the tumour;
• by stimulating part of the immune system to attack tumour cells.

2. Important information before taking Lenalidomide G.L.
Before starting treatment with Lenalidomide G.L., please read carefully the leaflets of all medicinal products taken in combination with Lenalidomide G.L.
When not to take Lenalidomide G.L.:

• If the patient is pregnant, suspects she may be pregnant, or plans to have a child, because Lenalidomide G.L. is expected to be harmful to the unborn child (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men").
• If the patient is able to become pregnant, unless she uses all required contraceptive measures (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men"). If the patient is able to become pregnant, the doctor will always document during prescription that necessary measures have been taken and will ensure the patient is informed.
• If the patient is allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). If allergy is suspected, please consult your doctor for advice.

If any of these points apply to the patient, Lenalidomide G.L. must not be used.
If in doubt, please consult your doctor.
Warnings and precautions
Before starting to take Lenalidomide G.L., please discuss with your doctor, pharmacist or nurse if the patient:

• has previously had blood clots – this means an increased risk of blood clots forming 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 chickenpox and shingles, hepatitis B, or HIV. If in doubt, please consult your doctor. Treatment with Lenalidomide G.L. 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 disorders – the doctor may adjust the dose of Lenalidomide G.L.;
• has had a heart attack (heart attack), has ever had a blood clot, if the patient smokes, has high blood pressure or high cholesterol levels;
• has had allergic symptoms while taking thalidomide (another medicine used in the treatment of multiple myeloma), such as rash, itching, swelling, dizziness or difficulty breathing;
• has previously experienced a combination of any of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes – these are symptoms of a severe skin reaction called drug rash with eosinophilia and systemic symptoms, also known as "DRESS" or "drug hypersensitivity syndrome" (see also section 4 "Possible side effects").

If any of the above apply to the patient, please consult your doctor, pharmacist or nurse.
If at any time during or after completion of treatment the patient experiences:

• vision disturbances, loss of vision or double vision, difficulty speaking, weakness of the arm or leg, change in gait or balance disturbances, persistent tingling, reduced sensation or loss of sensation, memory loss or disorientation, please inform your doctor or nurse immediately. These may be symptoms of a severe and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML). If the patient had such symptoms before treatment with Lenalidomide G.L., please 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 G.L., the patient will undergo regular blood tests because Lenalidomide G.L. may cause a reduction in the number of blood cells that help fight infection (white blood cells) and help blood to clot (platelets).
The doctor will call the patient for blood tests:

• before treatment,
• weekly for the first 8 weeks of treatment,
• then 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 G.L.
If the patient has myelodysplastic syndromes, there is an increased chance of developing a serious disease called acute myeloid leukaemia. Furthermore, it is not known how Lenalidomide G.L. affects the likelihood of developing acute myeloid leukaemia. Therefore, the doctor may perform tests and check for signs that may better predict the risk of acute myeloid leukaemia during treatment with Lenalidomide G.L.
Patients with MCL taking Lenalidomide G.L.
The doctor will request a blood test:

• 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 G.L.
The doctor will request a blood test:

• 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 check whether the patient has a large amount of tumour tissue in the body, including in the bone marrow. This may lead to a situation where tumour tissue begins to die and causes abnormal increases in the concentration of various substances in the blood, which may lead to kidney failure (a condition called 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 G.L. or interrupt treatment based on the results of the patient's blood tests and general condition. If the disease has been 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 completion of treatment, the patient must not donate blood.
Children and adolescents
Lenalidomide G.L. is not recommended for use in children and adolescents under 18 years of age.
Elderly patients and patients with kidney disorders
If the patient is 75 years of age or older, or has moderate to severe kidney disorders, the doctor will perform thorough examinations before starting treatment.
Lenalidomide G.L. and other medicines
Please inform your doctor or nurse about all medicines currently taken or recently taken by the patient. This is necessary because Lenalidomide G.L. may affect the action of other medicines. Other medicines may also affect the action of Lenalidomide G.L.
In particular, please inform your doctor or nurse if the patient is taking the following medicines:

• certain contraceptives, such as oral contraceptives, because they may stop working;
• certain medicines used for heart problems – such as digoxin;
• certain medicines used to thin the blood – such as warfarin.

Pregnancy, breastfeeding and contraception – information for women and men
Pregnancy
For women taking Lenalidomide G.L.

• Lenalidomide G.L. must not be used if the patient is pregnant, because it is expected to be harmful to the unborn child.
• A woman must not become pregnant while taking Lenalidomide G.L. Therefore, women who may become pregnant must use an effective method of contraception (see "Contraception").
• If the patient becomes pregnant while being treated with Lenalidomide G.L., treatment must be stopped immediately and the doctor must be informed.

For men taking Lenalidomide G.L.

• If the partner of a man undergoing treatment with Lenalidomide G.L. becomes pregnant, 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 performed while taking Lenalidomide G.L., because it is not known whether lenalidomide passes into human milk.
Contraception
Women taking Lenalidomide G.L.
Before starting treatment, please ask your doctor about the possibility of becoming pregnant, even if the patient considers it unlikely.
Women who may 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 completion of treatment), unless the fallopian tubes have been cut and ligated to prevent the egg from reaching the uterus (tubal sterilisation) AND
• must use effective methods of contraception for at least 4 weeks before starting treatment, during treatment and for at least 4 weeks after completion of treatment. The doctor will recommend appropriate contraceptive methods to the patient.

Men taking Lenalidomide G.L.
Lenalidomide G.L. passes into human semen. If a woman is pregnant or may become pregnant and does not use an effective contraceptive method, her partner should use a condom during treatment and for at least 7 days after completion of treatment. This also applies to men after vasectomy. During treatment and for at least 7 days after completion of treatment, the patient must not donate semen.
Driving and using machines
Do not drive or operate machinery if the patient experiences dizziness, fatigue, drowsiness, balance disturbances caused by vertigo or blurred vision after taking Lenalidomide G.L.
Lenalidomide G.L. contains lactose.
Lenalidomide G.L. contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking Lenalidomide G.L.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, i.e. the medicine is considered "sodium-free".

3. How to take Lenalidomide G.L.

Lenalidomide G.L. must be prescribed and administered by medical professionals experienced in the treatment of multiple myeloma, MDS, MCL, or FL.

• When Lenalidomide G.L. is used to treat multiple myeloma in patients who are not eligible for bone marrow transplantation or who have previously received other treatments, the medicine should be used in combination with other drugs (see section 1, "Why is Lenalidomide G.L. used?").
• When Lenalidomide G.L. 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 G.L. is used to treat follicular lymphoma, it is taken together with another medicine called "rituximab".

Lenalidomide G.L. should always be taken exactly as prescribed by the doctor. If in doubt, consult your doctor or pharmacist.
If the patient is taking Lenalidomide G.L. 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 G.L. is taken on specific days within a 3-week period (21 days).

• Each 21-day period is called a treatment cycle.

• Depending on the day of the cycle, the patient may take one or more medicines. However, on certain 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 G.L. is taken on specific days within a 4-week period (28 days).

• Each 28-day period is called a treatment cycle.

• Depending on the day of the cycle, the patient may take one or more medicines. However, on certain 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 G.L.
Before starting treatment, the doctor will inform the patient:

• how much Lenalidomide G.L. they should take;
• how many other medicines they should take in combination with Lenalidomide G.L., if additional medicines are required;
• on which days of the cycle to take each medicine.

How and when to take Lenalidomide G.L.

• Swallow the capsule whole, preferably with water.
• Do not crush, open, or chew the capsules. If the powder from a damaged Lenalidomide G.L. 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 capsule. Gloves should then be carefully removed to avoid skin exposure, placed in a sealed polyethylene plastic bag, and disposed of according to local regulations. Afterwards, hands should be washed thoroughly with soap and water. Pregnant women or women who suspect they may be pregnant should not handle the blister pack or capsule.
• Capsules may be taken with or without food.
• Lenalidomide G.L. should be taken at approximately the same time each day on which dosing is scheduled.

How to take this medicine
To remove a capsule from the blister pack:

• press on the capsule from one side only 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 G.L.
Lenalidomide G.L. 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 therapy.

Taking more than the recommended dose of Lenalidomide G.L.
If more Lenalidomide G.L. than prescribed has been taken, contact the doctor immediately.

Missed dose of Lenalidomide G.L.
If a dose of Lenalidomide G.L. has been missed:

• if less than 12 hours have passed since the scheduled time: take the capsule immediately;
• if 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 you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If any of the following serious side effects occur, you must stop taking Lenalidomide G.L. and contact your doctor immediately – immediate treatment may be required:

• hives, rash, swelling of the eyes, lips or face, difficulty breathing or wheezing, which may be symptoms of serious allergic reactions known as angioedema and anaphylactic reaction;
• severe allergic reaction which may start as a rash in one area, spreading over the whole body and associated with significant skin peeling (Stevens-Johnson syndrome and/or toxic epidermal necrolysis);
• widespread rash, high fever, increased liver enzyme activity, blood test abnormalities (eosinophilia), enlarged lymph nodes and involvement of other organs (drug rash with eosinophilia and systemic symptoms, also known as "DRESS" or "drug hypersensitivity syndrome"). See also section 2.

You must immediately inform your doctor if any of the following serious side effects 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 G.L. may reduce the number of white blood cells that fight infection, as well as
the number of blood cells involved in blood clotting (platelets), which may lead to bleeding disorders, such as nosebleeds and bruising. Lenalidomide G.L. may also cause blood clots in the veins (thrombosis).
Other side effects
Please note that in a small number of patients, other types of cancer may develop, and it is possible that this risk may be increased by treatment with Lenalidomide G.L.
Therefore, your doctor should carefully assess the benefits and risks before prescribing Lenalidomide G.L. to you.
Very common side effects (may affect more than 1 in 10 people):

• reduction in red blood cells, which may cause anaemia leading to tiredness and weakness;
• skin rashes, itching;
• muscle cramps, muscle weakness, muscle pain, muscle tenderness, bone pain, joint pain, back pain, limb pain;
• generalised swelling, including swelling of hands and feet;
• weakness, fatigue;
• flu and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough and chills;
• tingling, numbness or burning sensation of the skin, pain in hands or feet, dizziness, tremor;
• loss of appetite, altered taste sensation;
• increased pain, swelling 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;
• underactive thyroid gland;
• 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 sinusitis, lung infections 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;
• changes in blood proteins leading to blood vessel swelling (vasculitis);
• increased blood sugar levels (diabetes);
• decreased blood sugar levels;
• headache;
• nosebleeds;
• dry skin;
• depression, mood changes, difficulty sleeping;
• cough;
• low blood pressure;
• vague feeling of physical discomfort, malaise;
• painful inflammation of the mouth, dry mouth;
• dehydration.

Common side effects (may affect 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 inflammation in the body;
• darkening of the skin; skin discolouration due to bleeding under the skin, usually caused by bruising; blood-filled skin swelling, bruising;
• increased levels of uric acid in the blood;
• skin eruptions, skin redness, blistering, peeling or flaking of the skin, hives;
• itching, excessive sweating, night sweats;
• difficulty swallowing, sore throat, voice quality problems or voice changes;
• runny nose (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 sign of heart failure);
• erectile difficulties;
• stroke, fainting, dizziness (inner ear disorders causing a sensation that everything is spinning), transient loss of consciousness;
• chest pain spreading to arms, neck, jaw, back or abdomen, sweating, breathlessness, 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;
• 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 which may lead to injury.

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

• bleeding inside the skull;
• circulatory problems;
• loss of vision;
• loss of sexual desire (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 diarrhoea, which may be symptoms of inflammation of the large intestine (colitis or diverticulitis);
• kidney tubular cell damage (known as tubular necrosis);
• skin colour changes, sensitivity to sunlight;
• tumour lysis syndrome – metabolic complications which may occur during cancer treatment, and sometimes even without treatment. These complications are caused by the breakdown products of dying cancer cells and may include: changes in blood chemistry; high levels of potassium, phosphate, uric acid and low calcium levels, leading to kidney dysfunction, irregular heartbeat, seizures, and sometimes death.
• increased blood pressure in the blood vessels leading to the lungs (pulmonary hypertension).

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

• sudden or gradually worsening pain in the upper abdomen and/or back, lasting for several days, often accompanied by nausea, vomiting, fever and sudden increase in heart rate – these symptoms may occur in connection with 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 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);
• rupture of the wall of the stomach or intestine, which may lead to severe infection. You should inform your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in the stool or changes in bowel function;
• viral infections, including varicella-zoster virus (a viral disease causing painful skin rash with blisters) and reactivation of hepatitis B virus infection (which may cause yellowing of the skin and eyes, dark urine, pain in the right lower abdomen, fever, nausea and vomiting);
• rejection of transplanted organ (e.g. kidney, heart).

Reporting of side effects
If you experience any adverse effects, including any not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Side effects 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 181C,
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Lenalidomide G.L.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after:
"EXP". The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Do not use this medicine if you notice any damage to or signs of tampering with the packaging.
Medicines must not be disposed of via wastewater or household waste. Unused medicines should be returned to a pharmacy. This will help protect the environment.

6. Contents of the pack and other information

What Lenalidomide G.L. contains
Lenalidomide G.L., 5 mg, hard capsules

• The active substance is lenalidomide. Each capsule contains 5 mg of lenalidomide.
• The other ingredients are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
  • capsule shell: brilliant blue FCF (E 133), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), gelatin
  • printing ink: shellac, propylene glycol, iron oxide black (E 172), potassium hydroxide

Lenalidomide G.L., 10 mg, hard capsules

• The active substance is lenalidomide. Each capsule contains 10 mg of lenalidomide.
• The other ingredients are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
  • capsule shell: iron oxide black (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), gelatin
  • printing ink: shellac, propylene glycol, iron oxide black (E 172), potassium hydroxide

Lenalidomide G.L., 15 mg, hard capsules

• The active substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• The other ingredients are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
  • capsule shell: iron oxide black (E 172), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), gelatin
  • printing ink: shellac, propylene glycol, iron oxide black (E 172), potassium hydroxide

Lenalidomide G.L., 25 mg, hard capsules

• The active substance is lenalidomide. Each capsule contains 25 mg of lenalidomide.
• The other ingredients are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
  • capsule shell: titanium dioxide (E 171), gelatin
  • printing ink: shellac, propylene glycol, iron oxide black (E 172), potassium hydroxide

What Lenalidomide G.L. looks like and contents of the pack
Lenalidomide G.L., 5 mg, hard capsules
Dark green, opaque cap and flesh-coloured, opaque body, capsule size 2,
18-19 mm, with black print "LP" on the cap and "638" on the body.
Lenalidomide G.L., 10 mg, hard capsules
Intense yellow, opaque cap and grey, opaque body, capsule size 0,
21-22 mm, with black print "LP" on the cap and "639" on the body.
Lenalidomide G.L., 15 mg, hard capsules
Light bronze, opaque cap and light grey, opaque body, capsule size 2,
18-19 mm, with black print "LP" on the cap and "640" on the body.
Lenalidomide G.L., 25 mg, hard capsules
White, opaque cap and white, opaque body, capsule size 0, 21-22 mm,
with black print "LP" on the cap and "642" on the body.
Cardboard box containing PVC/ACLAR/Aluminium blisters with 7 capsules each.
Pack sizes: 7 or 21 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

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

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]