Lenalidomide glenmark

Package leaflet: Information for the patient

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

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

Contents of the leaflet

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

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

Lenalidomide Glenmark contains the active substance lenalidomide. This medicine belongs to a group of medicines that affect the function of the immune system.
Lenalidomide Glenmark is used in adults to treat:

• 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.
Generally, multiple myeloma cannot be cured. However, it is possible to achieve a significant temporary reduction or disappearance of signs and symptoms of the disease. This condition is called "remission".

Newly diagnosed multiple myeloma – in patients who have undergone bone marrow transplantation
Lenalidomide Glenmark is used as monotherapy for maintenance treatment in patients who have responded to prior therapy including bone marrow transplantation.

Newly diagnosed multiple myeloma – in patients who cannot undergo bone marrow transplantation
Lenalidomide Glenmark is taken together 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".

Patients take these medicines at the beginning of treatment, and then continue treatment with lenalidomide as monotherapy.
If you are 75 years of age or older, or have moderate to severe kidney problems, your doctor will perform careful assessments before starting treatment.

Multiple myeloma – in patients who have been previously treated
Lenalidomide Glenmark is used in combination with another anti-inflammatory medicine called "dexamethasone".
Lenalidomide Glenmark may stop the progression of signs and symptoms of multiple myeloma.
It has also been shown to delay the return of multiple myeloma after treatment.

Myelodysplastic syndromes (MDS)
Myelodysplastic syndromes (MDS) are a group of different blood and bone marrow disorders. Abnormal blood cells are present that do not function properly. Patients may experience various symptoms, including low numbers of red blood cells (anaemia), need for blood transfusions, and risk of infection.
Lenalidomide Glenmark, as monotherapy, is used to treat adult patients with MDS if all of the following conditions are met:

• the patient requires regular blood transfusions due to low numbers of red blood cells ("transfusion-dependent anaemia");
• the patient has an abnormality in 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 not sufficiently effective.

Taking Lenalidomide Glenmark 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 stop blood transfusions altogether.

Mantle cell lymphoma (MCL)
MCL is a cancer affecting 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, leading to their accumulation in lymphatic tissue, bone marrow or blood.
Lenalidomide Glenmark, as monotherapy, is used to treat adult patients who have been previously treated with other medicines.

Follicular lymphoma
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 follicular lymphoma, too many B-lymphocytes may accumulate in the blood, bone marrow, lymph nodes and spleen.
Lenalidomide Glenmark is used in combination with another medicine called "rituximab" to treat adult patients who have been previously treated for follicular lymphoma.

How Lenalidomide Glenmark works
Lenalidomide Glenmark works by affecting the function of the immune system and directly attacking cancer cells. The medicine works in several different ways:

• by inhibiting the growth of cancer cells,
• by inhibiting the formation of blood vessels in the tumour,
• by stimulating part of the immune system to attack cancer cells.

2. Important information before using Lenalidomide Glenmark

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

• If the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, because lenalidomide may be harmful to the unborn child (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men").
• If the patient is capable of becoming pregnant, unless she uses all necessary contraceptive measures (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men"). If the patient is capable of becoming pregnant, the doctor must always document at each prescription that all necessary precautions have been taken and confirm this with the patient.
• If the patient is allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). If the patient suspects an allergy, he or she should consult a doctor for advice.

If any of the above situations apply, do not use Lenalidomide
Glenmark. If in doubt, discuss this with your doctor.
Warnings and precautions
Before starting treatment with Lenalidomide Glenmark, discuss this with your doctor,
pharmacist or nurse, if:

• the patient has previously had blood clots – the risk of developing blood clots in veins and arteries is increased during treatment
• the patient has any signs of infection, such as cough or fever
• the patient currently has or has previously had a viral infection, particularly hepatitis B virus, shingles virus (herpes zoster), or HIV. If the patient is unsure, he or she should discuss this with the doctor. Treatment with Lenalidomide Glenmark may cause reactivation of viruses in patients previously infected. This may lead to recurrence of the disease. The doctor will check whether the patient has previously had hepatitis B.
• the patient has kidney problems – the doctor may adjust the dose of Lenalidomide Glenmark
• the patient has had a heart attack, previously experienced a blood clot, smokes, has high blood pressure or elevated cholesterol levels
• the patient experienced allergic reactions while taking thalidomide (another medicine used in the treatment of multiple myeloma), such as rash, itching, swelling, dizziness or difficulty breathing
• the patient has previously experienced any of the following symptoms together: widespread rash, skin redness, high fever, flu-like symptoms, increased liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes – these are symptoms 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 the above situations apply, discuss them with your doctor, pharmacist
or nurse before starting treatment.
If at any time during or after treatment the patient experiences:

• blurred vision, loss of vision or double vision, difficulty speaking, muscle weakness in the arm or leg, changes in walking or balance disturbances, persistent numbness, reduced sensation or loss of sensation, memory loss or disorientation. These may be symptoms of a serious and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML). If the patient had such symptoms before starting Lenalidomide Glenmark, inform the doctor about any changes in 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 starting and during treatment with Lenalidomide Glenmark, the patient will undergo regular blood tests because Lenalidomide Glenmark may reduce the number of blood cells that help fight infection (white blood cells) and help blood clot (platelets). The doctor will request 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 myelodysplastic syndromes taking Lenalidomide Glenmark
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 Glenmark affects the likelihood of developing acute myeloid leukaemia. Therefore, the doctor may perform tests and check for signs that help better predict the risk of acute myeloid leukaemia during treatment with Lenalidomide Glenmark.
Patients with mantle cell lymphoma taking Lenalidomide Glenmark
The doctor will request blood tests:

• before treatment
• weekly for the first 8 weeks (2 cycles) of treatment
• thereafter every 2 weeks during cycles 3 and 4 (more information in section 3 "Treatment cycle")
• then at the beginning of each cycle and
• at least once a month.

Patients with follicular lymphoma taking Lenalidomide Glenmark
The doctor will request blood tests:

• before treatment
• weekly for the first 3 weeks (1 cycle) of treatment
• thereafter every 2 weeks during cycles 2 to 4 (more information in section 3 "Treatment cycle")
• then at the beginning of each cycle and
• at least once a month.

The doctor may perform an assessment to determine 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, causing an abnormal increase in the concentration of various substances in the blood, which may lead to kidney failure (a condition known as "tumour lysis syndrome").
The doctor may examine the patient to check for skin changes such as red spots or rash.
The doctor may change the dose of Lenalidomide Glenmark 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 assess treatment progress considering the patient's age and other diseases that may have occurred in the past.
Blood donation
During treatment and for at least 7 days after treatment ends, the patient must not donate blood.
Children and adolescents
Lenalidomide Glenmark 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 examinations before starting treatment.
Lenalidomide Glenmark and other medicines
Tell your doctor or nurse about all medicines the patient is currently taking or has recently taken. This is necessary because Lenalidomide Glenmark may affect the action of other medicines. Likewise, other medicines may affect the action of Lenalidomide Glenmark.
In particular, inform your 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
Women using Lenalidomide Glenmark

• Do not use Lenalidomide Glenmark if the patient is pregnant, as it may be harmful to the unborn child.
• Women must not become pregnant while taking Lenalidomide Glenmark. Therefore, women of reproductive age must use an effective method of contraception (see below "Contraception").
• If the patient becomes pregnant during treatment with Lenalidomide Glenmark, treatment must be stopped immediately and the doctor informed.

Men using Lenalidomide Glenmark

• If the partner of a man undergoing treatment with Lenalidomide Glenmark becomes pregnant, the doctor must be informed immediately. The partner should seek medical advice.
• The man must also use an effective method of contraception (see "Contraception").

Breastfeeding
Do not breastfeed while taking Lenalidomide Glenmark, as it is not known whether
Lenalidomide Glenmark passes into human milk.
Contraception
Women using Lenalidomide Glenmark
Before starting treatment, ask your doctor if the patient could become pregnant, even if she considers it unlikely.
Women of reproductive age:

• A pregnancy test will be performed under medical supervision (before each treatment, at least every 4 weeks during treatment and at least 4 weeks after treatment ends), except for women who have undergone tubal ligation (sterilisation of the fallopian tubes) OR
• The woman must use an effective method of contraception for at least 4 weeks before starting treatment, during treatment and for at least 4 weeks after treatment ends. The doctor will advise the patient on appropriate contraceptive methods.

Men using Lenalidomide Glenmark
Lenalidomide passes into human semen. If the man's partner is pregnant or could become pregnant and is not using an effective contraceptive method, the partner must use a condom during treatment and for at least 7 days after treatment ends, including men who have had a vasectomy. During treatment and for at least 7 days after treatment ends, 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 due to vestibular dizziness or blurred vision after taking Lenalidomide Glenmark.
Lenalidomide Glenmark contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should contact the doctor before taking this medicine.
Lenalidomide Glenmark contains sodium
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 Glenmark

Lenalidomide Glenmark must be administered by medical professionals experienced in the treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma, or follicular lymphoma.

• If Lenalidomide Glenmark is used for the treatment of 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 Glenmark used?").
• If Lenalidomide Glenmark is used for the treatment of multiple myeloma in patients after bone marrow transplantation, or for the treatment of myelodysplastic syndromes or mantle cell lymphoma, the medicine should be used as monotherapy.
• If Lenalidomide Glenmark is used for the treatment of follicular lymphoma, it is taken together with another medicine called "rituximab".

This medicine must always be used exactly as prescribed by the doctor. In case of doubt, consult the doctor or pharmacist.
If the patient is taking Lenalidomide Glenmark together with other medicines, they should read the package leaflet included in the packaging of those medicines to obtain information about their use and effects.

Treatment cycle
Lenalidomide Glenmark 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 will 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 Glenmark 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 will 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 Glenmark
Before starting treatment, the doctor will inform the patient:

• what dose of Lenalidomide Glenmark should be taken
• what dose of other medicines should be taken together with Lenalidomide Glenmark, if other medicines are required
• on which days of the cycle each medicine should be taken.

How and when to take Lenalidomide Glenmark

• Swallow the capsule whole, preferably with water.
• Do not crush, open, or chew the capsules. If the powder from a damaged Lenalidomide Glenmark 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. Hands should then be washed thoroughly with soap and water. Pregnant women or women who suspect they may be pregnant should not handle the blister pack or capsule.
• Capsules may be taken with or without food.
• Lenalidomide Glenmark should be taken at approximately the same time each day on which the medicine is scheduled to be taken.

Taking this medicine
To remove the capsule from the blister pack:

• Press only on one side of the capsule to push it through the foil
• Do not press on the center of the capsule, as this may damage it.

Duration of treatment with Lenalidomide Glenmark
Lenalidomide Glenmark is used in treatment cycles, each lasting 21 or 28 days (see above "Treatment cycle"). Treatment cycles should continue until the doctor advises stopping the medicine.

Overdose of Lenalidomide Glenmark
If more than the prescribed dose of Lenalidomide Glenmark is taken, contact the doctor immediately.

Missed dose of Lenalidomide Glenmark
If the patient forgets to take Lenalidomide Glenmark 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 dose. 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following serious side effects occur, stop taking Lenalidomide Glenmark and seek
immediate medical advice – immediate treatment may be necessary:

• urticaria, rash, swelling of the eyelids, lips or face, difficulty breathing or itching, which may be symptoms of severe allergic reactions known as angioedema and anaphylactic reaction,
• severe allergic reaction which may start as a rash in one area and spread over the entire body and may be associated with significant skin peeling (Stevens-Johnson syndrome and/or toxic epidermal necrolysis),
• widespread rash, high body temperature, increased liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms also known as DRESS or drug hypersensitivity syndrome). See also section 2.

Immediately inform your doctor if any of the following serious side effects occur:

• fever, chills, sore throat, cough, mouth ulcers or any other signs of infection, including blood infection (sepsis)
• bleeding or bruising despite no injury
• chest pain or leg pain
• shortness of breath
• bone pain, muscle weakness, confusion or fatigue which may be due to high calcium levels in the blood.

Lenalidomide Glenmark may reduce the number of white blood cells that fight infection, as well as blood cells that help blood to clot (platelets), which may lead to bleeding disorders such as nosebleeds and bruising. Lenalidomide Glenmark may also cause blood clots in the veins (thrombosis).
Other side effects
It should be noted that a small number of patients may develop other types of cancer, and this risk may possibly be higher during treatment with Lenalidomide Glenmark. Therefore, your treating physician should carefully evaluate the benefits and risks before prescribing Lenalidomide Glenmark to the patient.
Very common side effects (may affect more than 1 in 10 people):

• reduction in red blood cells, which may lead to anaemia causing fatigue and weakness
• rash, itching
• muscle cramps, muscle weakness, muscle pain, 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, earache, cough and chills
• numbness, tingling or burning sensation of the skin, pain in hands and feet, dizziness, tremor, decreased 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
• 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 sinus infection, lung infection and upper respiratory tract infection
• shortness of breath
• blurred vision
• cloudy vision (cataract)
• kidney problems, including impaired 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, sleep disturbances
• cough
• low blood pressure
• vague feeling of physical discomfort, malaise
• painful inflammation of the mouth, dry mouth
• dehydration.

Common side effects (may affect less than 1 in 10 people)

• breakdown of red blood cells (haemolytic anaemia)
• certain types of skin tumours
• bleeding from gums, stomach or intestines
• high 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 surface, usually caused by bruising; blood-filled skin swelling, bruising
• 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
• rhinitis (nasal congestion)
• passing significantly more or significantly less urine than normal or inability to control the timing of urination
• passing blood in the urine
• shortness of breath, especially when lying down (which may be a sign of heart failure)
• erectile dysfunction
• 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 and breathlessness, nausea or vomiting, which may be symptoms of a heart attack (myocardial infarction)
• muscle weakness, lack of energy
• neck pain, chest pain
• chills
• joint swelling
• slowing or blockage of bile flow from the liver
• low levels of phosphates or magnesium in the blood
• difficulty speaking
• 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 that may lead to injury.

Uncommon side effects (may affect less than 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-coloured stools, dark-coloured 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 cell damage (called tubular necrosis)
• change in skin colour, sensitivity to sunlight
• tumour lysis syndrome – metabolic complications that may occur during cancer treatment, and sometimes even without treatment. These complications are caused by products 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.
• high blood pressure in blood vessels leading to the lungs (pulmonary hypertension).

Side effects of unknown frequency (frequency cannot be determined from available data)

• sudden or mild but 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 occur in association with pancreatitis
• wheezing, shortness of breath or dry cough, which may be caused by inflammation of lung tissue
• rare cases of muscle breakdown (muscle pain, weakness or swelling) leading to kidney problems (rhabdomyolysis) have been observed, some of them when Lenalidomide Glenmark was taken 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)
• rupture of the stomach or intestinal wall, which may lead to severe infection. Inform your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in stool or changes in bowel function
• viral infections, including 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-coloured urine, right-sided abdominal pain, fever, nausea and vomiting)
• solid organ transplant rejection (e.g. kidney, heart).

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects 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 181C, 02-222 Warsaw
tel.: +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 Glenmark

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton or blister after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions required.
Do not use this medicine if there are visible signs of damage or if the packaging seals appear to be broken.
Medicines should 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 Glenmark contains
Lenalidomide Glenmark 2.5 mg, hard capsules

• The active substance is lenalidomide. One capsule contains 2.5 mg of lenalidomide.
• The other ingredients are:
• Capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E 171), indigo carmine (E 132), yellow iron oxide (E 172).
• Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E 172).

Lenalidomide Glenmark 5 mg, hard capsules

• The active substance is lenalidomide. One capsule contains 5 mg of lenalidomide.
• The other ingredients are:
• Capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E 171).
• Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E 172).

Lenalidomide Glenmark 10 mg, hard capsules

• The active substance is lenalidomide. One capsule contains 10 mg of lenalidomide.
• The other ingredients are:
• Capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E 171), indigo carmine (E 132), yellow iron oxide (E 172).
• Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E 172).

Lenalidomide Glenmark 15 mg, hard capsules

• The active substance is lenalidomide. One capsule contains 15 mg of lenalidomide.
• The other ingredients are:
• Capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E 171), indigo carmine (E 132).
• Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E 172).

Lenalidomide Glenmark 25 mg, hard capsules

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

What Lenalidomide Glenmark looks like and contents of the pack
Lenalidomide Glenmark 2.5 mg, hard capsules have a matt white body and a matt green to light green cap, approximately 14.3 mm in length, marked with "L9NL" and "2.5".
Lenalidomide Glenmark 5 mg, hard capsules have a matt white body and a matt white cap, approximately 18.0 mm in length, marked with "L9NL" and "5".
Lenalidomide Glenmark 10 mg, hard capsules have a matt yellow body and a matt green to light green cap, approximately 21.7 mm in length, marked with "L9NL" and "10".
Lenalidomide Glenmark 15 mg, hard capsules have a matt white body and a matt blue to light blue cap, approximately 21.7 mm in length, marked with "L9NL" and "15".
Lenalidomide Glenmark 25 mg, hard capsules have a matt white body and a matt white cap, approximately 21.7 mm in length, marked with "L9NL" and "25".
Pack sizes available:
Lenalidomide Glenmark 2.5 mg, 5 mg, 10 mg, 15 mg, 25 mg is available in OPA/Aluminium/PVC/Aluminium blisters containing 21 capsules in a cardboard carton.

Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer/Importer
Synthon Hispania S.L.
Calle De Castelló 1
Sant Boi de Llobregat
08830 Barcelona
Spain
Synthon B.V.
Microweg 22
6545 CM, Nijmegen
The Netherlands

For any further information, please contact the local representative of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
ul. Osmańska 14
02-823 Warsaw