Lenalidomide Ranbaxi

Leaflet accompanying the packaging: patient information

Lenalidomide Ranbaxy, 2.5 mg, hard capsules

Lenalidomide Ranbaxy, 5 mg, hard capsules

Lenalidomide Ranbaxy, 7.5 mg, hard capsules

Lenalidomide Ranbaxy, 10 mg, hard capsules

Lenalidomide Ranbaxy, 15 mg, hard capsules

Lenalidomide Ranbaxy, 20 mg, hard capsules

Lenalidomide Ranbaxy, 25 mg, hard capsules

Lenalidomide

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lenalidomide Ranbaxy and what is it used for
• 2. Important information before taking Lenalidomide Ranbaxy
• 3. How to take Lenalidomide Ranbaxy
• 4. Possible side effects
• 5. How to store Lenalidomide Ranbaxy
• 6. Package contents and other information

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

What is Lenalidomide Ranbaxy

Lenalidomide Ranbaxy contains the active substance "lenalidomide". This medicine belongs to a group of medicines that affect the functioning of the immune system.

What is Lenalidomide Ranbaxy used for

Lenalidomide Ranbaxy is used in adult patients to treat:

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

Multiple myeloma

Multiple myeloma is a type of cancer that attacks a certain type of white blood cell called plasma cells. These cells accumulate in the bone marrow and undergo uncontrolled divisions. This can lead to bone and kidney damage. In principle, multiple myeloma is incurable. However, it is possible to temporarily significantly alleviate or eliminate the signs and symptoms of the disease. We call this "remission". Newly diagnosed multiple myeloma — in patients after bone marrow transplantation In this indication, Lenalidomide Ranbaxy is used without other medicines as maintenance treatment after achieving a suitable condition after transplantation. Newly diagnosed multiple myeloma – in patients who are not eligible for bone marrow transplantation treatment Lenalidomide Ranbaxy is taken with other medicines, including:

• a chemotherapy medicine called bortezomib;
• an anti-inflammatory medicine called dexamethasone;
• a chemotherapy medicine called melphalan and
• an immunosuppressant medicine called prednisone. The patient starts treatment with additional medicines and then continues with Lenalidomide Ranbaxy alone.

If the patient is 75 years old or older, or has moderate to severe kidney problems, the doctor will perform thorough tests before starting treatment. Multiple myeloma – in patients who have received previous treatment Lenalidomide Ranbaxy is taken in combination with an anti-inflammatory medicine called dexamethasone. Lenalidomide Ranbaxy may stop the progression of multiple myeloma symptoms and signs. 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 diseases. There are abnormal blood cells that do not function properly. Patients may experience various subjective and objective symptoms, including a low number of red blood cells (anemia), the need for blood transfusions, and the risk of infection. Lenalidomide Ranbaxy is used alone to treat adult patients who have been diagnosed with MDS, if all of the following conditions are met:

• the patient has a low number of red blood cells and needs regular blood transfusions ("transfusion-dependent anemia");
• the patient has an abnormality in bone marrow cells called "isolated cytogenetic deletion 5q". This means that the patient's body does not produce enough healthy blood cells;
• the patient has previously used other treatments that have proven to be ineffective or insufficient.

Taking Lenalidomide Ranbaxy 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 is possible that transfusions will no longer be needed.

Mantle cell lymphoma (MCL)

MCL is a cancer of part of the immune system (lymphoid tissue). It attacks a certain type of white blood cell called B lymphocytes or B cells. Mantle cell lymphoma is a disease characterized by uncontrolled growth of B lymphocytes, resulting in their accumulation in lymphoid tissue, bone marrow, or blood. Lenalidomide Ranbaxy is used alone to treat adult patients who have previously been treated with other medicines.

Follicular lymphoma (FL)

FL is a slow-growing malignant cancer that attacks B lymphocytes. It is a type of white blood cell that helps the body fight infections. In patients with FL, there may be an accumulation of too many B lymphocytes in the blood, bone marrow, lymph nodes, and spleen. Lenalidomide Ranbaxy is taken with another medicine called rituximab to treat adult patients with previously treated follicular lymphoma.

How Lenalidomide Ranbaxy works

Lenalidomide Ranbaxy works by affecting the functioning 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 growth of blood vessels in the tumor;
• by stimulating part of the immune system to attack cancer cells.

2. Important information before taking Lenalidomide Ranbaxy

Before starting treatment with Lenalidomide Ranbaxy, you should carefully read the leaflets of all medicinal products taken in combination with Lenalidomide Ranbaxy.

When not to take Lenalidomide Ranbaxy:

• If you are pregnant, suspect you are pregnant, or plan to become pregnant, as it is expected that Lenalidomide Ranbaxy is harmful to the unborn child(see section 2 "Pregnancy, breastfeeding, and contraceptives - information for women and men").
• If you can become pregnant, unless you use all required pregnancy prevention measures (see section 2 "Pregnancy, breastfeeding, and contraceptives - information for women and men"). If you can become pregnant, your doctor will always prescribe the medicine and ensure that you are aware of the necessary measures.
• If you are allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). If you suspect an allergy, you should ask your doctor for advice.

If any of these points apply to you, you should not take Lenalidomide Ranbaxy. In case of doubts, you should consult a doctor.

Warnings and precautions

Before starting treatment with Lenalidomide Ranbaxy, you should discuss it with your doctor, pharmacist, or nurse if you:

• have had blood clots in the past - this means an increased risk of forming blood clots in veins and arteries during treatment;
• have any symptoms of infection, such as cough or fever;
• have a current or past viral infection, especially hepatitis B, chickenpox, and shingles. If in doubt, you should consult a doctor. Treatment with Lenalidomide Ranbaxy may cause reactivation of viruses in previously infected patients, leading to recurrence of the infection. Your doctor will check if you have had hepatitis B in the past;
• have kidney problems - your doctor may adjust the dose of Lenalidomide Ranbaxy;
• have had a heart attack, have had a blood clot, if you smoke, have high blood pressure, or high cholesterol levels;
• have had allergic reactions when taking thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing;
• have had a combination of any of the following symptoms in the past: widespread rash, skin redness, high body temperature, flu-like symptoms, elevated liver enzyme levels, blood abnormalities (eosinophilia), swollen 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 situations apply to you, you should consult a doctor, pharmacist, or nurse. You should immediately tell your doctor or nurse if you experience any of the following at any time during or after treatment:

• vision disturbances, loss of vision, or double vision, difficulty speaking, weakness in the arm or leg, change in gait, or balance disturbances, persistent numbness, decreased sensation, or loss of sensation, memory loss, or disorientation. These may be symptoms of a severe and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If you have had such symptoms before treatment with Lenalidomide Ranbaxy, you should inform your doctor of any changes.
• shortness of breath, fatigue, dizziness, chest pain, rapid heart rate, or swelling of the feet or ankles. These may be symptoms of a severe condition called pulmonary hypertension (see section 4).

Tests and examinations

Before and during treatment with Lenalidomide Ranbaxy, you will have regular blood tests, as Lenalidomide Ranbaxy may cause a decrease in the number of blood cells that fight infection (white blood cells) and cells that help blood clot (platelets). Your doctor will call you for blood tests:

• before treatment,
• every week for the first 8 weeks of treatment,
• then at least once a month. Before starting treatment with lenalidomide and during treatment, you may be evaluated for circulation and breathing problems.

Patient with MDS taking Lenalidomide Ranbaxy If you have myelodysplastic syndromes, there is an increased chance of developing a severe disease called acute myeloid leukemia. Additionally, it is not known how Lenalidomide Ranbaxy affects the likelihood of developing acute myeloid leukemia. Therefore, your doctor may perform tests to better predict the risk of acute myeloid leukemia during treatment with Lenalidomide Ranbaxy. Patients with MCL taking Lenalidomide Ranbaxy Your doctor will ask you to have a blood test:

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

Patient with FL taking Lenalidomide Ranbaxy Your doctor will ask you to have a blood test:

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

Your doctor may perform a test to check if you have a large amount of tumor tissue in your body, including bone marrow. This may lead to a situation where the tumor tissue starts to die and causes abnormal growth of various substances in the blood, which can lead to kidney failure (a condition called "tumor lysis syndrome"). Your doctor may perform a test to check if you have any skin changes, such as red spots or rash. Your doctor may change the dose of Lenalidomide Ranbaxy or stop treatment based on the results of your blood tests and your overall condition. If the disease is newly diagnosed, your doctor may also assess treatment based on your age and other conditions that may have occurred in the past.

Blood donation

During treatment and for at least 7 days after stopping treatment, you should not donate blood.

Children and adolescents

Lenalidomide Ranbaxy is not recommended for use in children and adolescents under 18 years of age.

Elderly and patients with kidney problems

If you are 75 years old or older, or have moderate to severe kidney problems, your doctor will perform thorough tests before starting treatment.

Lenalidomide Ranbaxy and other medicines

You should tell your doctor or nurse about all medicines you are currently taking or have recently taken. This is necessary because Lenalidomide Ranbaxy may affect the action of other medicines. Other medicines may also affect the action of Lenalidomide Ranbaxy. In particular, you should inform your doctor or nurse if you are taking:

• certain contraceptives, such as oral contraceptives, as they may stop working;
• certain heart medicines, such as digoxin;
• certain blood-thinning medicines, such as warfarin.

Pregnancy, breastfeeding, and contraceptives – information for women and men

For women taking Lenalidomide Ranbaxy

• You should not take Lenalidomide Ranbaxy if you are pregnant, as it is expected to be harmful to the unborn child.
• You should not become pregnant while taking Lenalidomide Ranbaxy. Therefore, women who can become pregnant must use effective contraception (see "Contraception").
• If you become pregnant while taking Lenalidomide Ranbaxy, you should stop treatment immediately and inform your doctor.

For men taking Lenalidomide Ranbaxy If your partner becomes pregnant while you are taking Lenalidomide Ranbaxy, she should immediately inform her doctor. Your partner should consult a doctor. Men should also use effective contraception (see "Contraception").

Breastfeeding

You should not breastfeed while taking Lenalidomide Ranbaxy, as it is not known whether the medicine passes into human milk.

Contraception

Women taking Lenalidomide Ranbaxy Before starting treatment, you should ask your doctor about the possibility of becoming pregnant, even if you think it is unlikely. Women who can 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 stopping treatment), unless you have had your fallopian tubes cut and sealed to prevent eggs from reaching the uterus (tubal sterilization) AND
• must use effective contraception methods for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after stopping treatment. Your doctor will recommend the appropriate contraception methods.

Men taking Lenalidomide Ranbaxy Lenalidomide Ranbaxy passes into human semen. If your partner is pregnant or may become pregnant and is not using effective contraception, she should immediately inform her doctor. Your partner should consult a doctor. During treatment and for at least 7 days after stopping treatment, you should not donate sperm or semen.

Driving and using machines

You should not drive or operate machines if you experience dizziness, fatigue, drowsiness, or blurred vision after taking Lenalidomide Ranbaxy.

Lenalidomide Ranbaxy contains lactose

Lenalidomide Ranbaxy contains lactose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking Lenalidomide Ranbaxy.

3. How to take Lenalidomide Ranbaxy

Lenalidomide Ranbaxy must be administered by medical personnel who have experience in treating multiple myeloma, MDS, MCL, or FL.

When using Lenalidomide Ranbaxy to treat multiple myeloma in patients who are not eligible for bone marrow transplantation or who have received previous treatment, the medicine is used with other medicines (see section 1 "What is Lenalidomide Ranbaxy used for"). When using Lenalidomide Ranbaxy to treat multiple myeloma in patients after bone marrow transplantation or to treat patients with MDS or MCL, the medicine is used alone. When Lenalidomide Ranbaxy is used to treat follicular lymphoma, it is taken with another medicine called rituximab. You should always take Lenalidomide Ranbaxy as directed by your doctor. If you have any doubts, you should consult a doctor or pharmacist. If you are taking Lenalidomide Ranbaxy with other medicines, you should read the leaflet that comes with their packaging to get information about their use and effects.

Treatment cycle

Lenalidomide Ranbaxy is taken on specific days during a period of three weeks (21 days).

• Each 21-day period is called a treatment cycle.
• Depending on the day of the cycle, you will take one or more medicines. However, on some days, you will not take any medicines.

After completing each 21-day cycle, you should start a new 21-day cycle. OR Lenalidomide Ranbaxy is taken on specific days during a period of four weeks (28 days).

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

Recommended dose of Lenalidomide Ranbaxy

Before starting treatment, your doctor will inform you:

• how much Lenalidomide Ranbaxy you should take;
• how many other medicines you should take in combination with Lenalidomide Ranbaxy, if other medicines are necessary;
• on which days of the cycle you should take which medicines.

How and when to take Lenalidomide Ranbaxy

• The capsule should be swallowed whole, preferably with water.
• Do not break, open, or chew the capsules. If the powder from a damaged Lenalidomide Ranbaxy capsule comes into contact with your skin, wash the skin immediately with soap and water.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister or capsule. The gloves should then be carefully removed to avoid skin exposure, placed in a sealed plastic bag, and disposed of in accordance with local regulations. Then, wash your hands with soap and water. Pregnant or potentially pregnant women should not touch the blister or capsule.
• The capsules can be taken with or without food.
• Lenalidomide Ranbaxy should be taken at approximately the same time every day when the product is scheduled to be administered.

Taking this medicine

To remove a capsule from the blister:

• press the capsule only on one side and push it through the foil;
• do not press the center of the capsule, as this may damage it.

Duration of treatment with Lenalidomide Ranbaxy

Lenalidomide Ranbaxy is used in treatment cycles; each cycle lasts 21 or 28 days (see above "Treatment cycle"). Treatment cycles should be continued until the doctor stops the treatment.

Taking a higher dose of Lenalidomide Ranbaxy than recommended

If you take a higher dose of Lenalidomide Ranbaxy than prescribed, you should immediately inform your doctor.

Missing a dose of Lenalidomide Ranbaxy

If you miss a dose of Lenalidomide Ranbaxy at the scheduled time and

• it has been less than 12 hours since then: you should take the capsule immediately;
• it has been more than 12 hours since then: do not take the capsule. You should take the next capsule at the scheduled time the next day.

If you have any further doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Lenalidomide Ranbaxy can cause side effects, although not everybody gets them.

If you experience any of the following severe side effects, you should stop taking Lenalidomide Ranbaxy and immediately consult a doctor – you may need urgent treatment:

• hives, rash, swelling of the eyes, lips, or face, difficulty breathing, or itching, which may be symptoms of severe allergic reactions called angioedema and anaphylaxis;
• a severe allergic reaction that starts as a rash in one area and spreads to the whole body, accompanied by a high body temperature, and skin peeling (Stevens-Johnson syndrome and (or) toxic epidermal necrolysis);
• widespread rash, high body temperature, elevated liver enzyme levels, blood abnormalities (eosinophilia), swollen 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 should immediately inform your doctor about any of the following severe side effects:

• 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 that may be due to high calcium levels in the blood.

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

Other side effects

Note that a small number of patients may develop other types of cancer, and it is possible that the risk may increase with Lenalidomide Ranbaxy treatment. Therefore, your doctor should carefully weigh the benefits and risks of prescribing Lenalidomide Ranbaxy to you. Very commonside effects (may affect more than 1 in 10 people):

• decrease in the number of red blood cells, which may cause anemia leading to fatigue and weakness;
• rash, itching;
• muscle spasms, muscle weakness, muscle pain, muscle tenderness, bone pain, joint pain, back pain, limb pain;
• generalized swelling, including swelling of the hands and feet;
• weakness, fatigue;
• flu and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough, and chills;
• decreased appetite, altered taste;
• increased pain, tumor growth, or redness around the tumor;
• weight loss;
• constipation, diarrhea, nausea, vomiting, abdominal pain, heartburn;
• low levels of potassium or calcium and (or) sodium in the blood;
• abnormal thyroid function;
• leg pain (which may be a sign of thrombosis), chest pain, or shortness of breath (which may be a sign of blood clots in the lungs, called pulmonary embolism);
• all types of infections, including sinusitis, pneumonia, 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 enzyme levels;
• changes in blood proteins, leading to blood vessel inflammation (vasculitis)
• increased blood sugar levels (diabetes);
• decreased blood sugar levels;
• headache;
• nosebleeds;
• dry skin;
• depression, mood changes, sleep disturbances;
• cough;
• low blood pressure;
• general feeling of physical discomfort, malaise;
• painful mouth ulcers, dry mouth;
• dehydration.

Commonside effects (may affect up to 1 in 10 people):

• breakdown of red blood cells (hemolytic anemia);
• certain types of skin tumors;
• bleeding from the gums, stomach, or intestines;
• high blood pressure, slow, fast, or irregular heart rhythm;
• increased levels of a substance produced by the breakdown of red and abnormal red blood cells;
• increased levels of a protein that indicates inflammation in the body;
• skin darkening; skin discoloration due to bleeding under the skin, usually caused by bruising; skin swelling filled with blood, bruising;
• increased levels of uric acid in the blood;
• skin rashes, skin redness, peeling, cracking, or shedding of the skin, hives;
• itching, increased sweating, night sweats;
• difficulty swallowing, sore throat, voice problems, or voice changes;
• runny nose (rhinitis);
• passing much more or much less urine than normal or inability to control the time 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 disturbances that cause a feeling of spinning), transient loss of consciousness;
• chest pain radiating to the arms, neck, jaw, back, or abdomen, feeling of sweating and shortness of breath, nausea, or vomiting, which may be symptoms of a heart attack (myocardial infarction);
• muscle weakness, lack of energy;
• neck pain, chest pain;
• chills;
• joint swelling;
• slowing or blocking the flow of bile from the liver;
• low levels of phosphates or magnesium in the blood;
• difficulty speaking;
• liver damage;
• balance disturbances, difficulty walking;
• hearing loss, ringing in the ears (tinnitus);
• nerve pain, unpleasant abnormal sensations, especially in response to touch;
• excessive iron in the body;
• thirst;
• confusion;
• toothache;
• fall that may lead to injury.

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

• bleeding in the brain;
• circulation problems;
• vision loss;
• loss of sex drive (libido);
• passing large amounts of urine, with accompanying bone pain and weakness, which may be a sign of kidney disease (Fanconi syndrome);
• yellowing of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching, rash, abdominal pain, or swelling - these may be symptoms of liver damage (liver failure);
• abdominal pain, bloating, or diarrhea, which may be symptoms of colon inflammation (colitis or proctitis); kidney cell damage (renal tubular necrosis);
• skin color changes, sensitivity to sunlight;
• breakdown of the stomach or intestine wall, which can lead to a severe infection. You should tell your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel movements;
• viral infections, including shingles (a viral disease that causes a painful rash with blisters) and reactivation of hepatitis B virus (which may cause yellowing of the skin and eyes, dark urine, abdominal pain on the right side, fever, nausea, and vomiting);
• rejection of a transplanted organ (e.g., kidney, heart).

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

• sudden or gradual, but worsening, pain in the upper abdomen and (or) back, lasting for several days, usually accompanied by nausea, vomiting, fever, and rapid heart rate - these symptoms may occur in connection with pancreatitis;
• wheezing, shortness of breath, or dry cough, which may be caused by lung inflammation;
• rare cases of muscle breakdown (pain, weakness, or swelling of the muscles) that can lead to kidney problems (rhabdomyolysis), some of which occurred when Lenalidomide Ranbaxy was taken with a statin (a type of cholesterol-lowering medicine);
• a skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis);
• breakdown of the stomach or intestine wall, which can lead to a severe infection. You should tell your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel movements;
• viral infections, including shingles (a viral disease that causes a painful rash with blisters) and reactivation of hepatitis B virus (which may cause yellowing of the skin and eyes, dark urine, abdominal pain on the right side, fever, nausea, and vomiting);
• rejection of a transplanted organ (e.g., kidney, heart).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309 Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lenalidomide Ranbaxy

• The medicine should be stored out of 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 month stated.
• Store at a temperature below 25°C.
• Do not use this medicine if you notice any damage or signs of opening of the packaging.
• 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. Package contents and other information

What Lenalidomide Ranbaxy contains

Lenalidomide Ranbaxy 2.5 mg, 10 mg, 20 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains 2.5 mg, 10 mg, or 20 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose monohydrate (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
• capsule shell: titanium dioxide (E 171), indigo carmine (E 132), gelatin, and yellow iron oxide (E 172);
• the printing ink: shellac, black iron oxide (E 172), and potassium hydroxide.

Lenalidomide Ranbaxy 5 mg and 25 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains 5 mg or 25 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose monohydrate (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: titanium dioxide (E 171), gelatin
• the printing ink: shellac, black iron oxide (E 172), and potassium hydroxide.

Lenalidomide Ranbaxy 7.5 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose monohydrate (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: titanium dioxide (E 171), gelatin, and yellow iron oxide (E 172);
• the printing ink: shellac, black iron oxide (E 172), and potassium hydroxide.

Lenalidomide Ranbaxy 15 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose monohydrate (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: titanium dioxide (E 171) and indigo carmine (E 132), gelatin;
• the printing ink: shellac, black iron oxide (E 172), potassium hydroxide.

How the medicine Lenalidomide Ranbaxy looks like and what the pack contains

Lenalidomide Ranbaxy, 2.5 mg, hard capsules are hard gelatin capsules approximately 14 mm in length with a blue-green, opaque cap and a white, opaque body with the inscription ”RL” on the cap and ”78” on the body, containing powder in the form of white to off-white granules.
Lenalidomide Ranbaxy, 5 mg, hard capsules are hard gelatin capsules approximately 18 mm in length with a white, opaque cap and a white, opaque body with the inscription ”RL” on the cap and ”79” on the body, containing powder in the form of white to off-white granules.
Lenalidomide Ranbaxy, 7.5 mg, hard capsules are hard gelatin capsules approximately 18 mm in length, with a light yellow, opaque cap and a white, opaque body with the inscription ”RL” on the cap and ”86” on the body, containing powder in the form of white to off-white granules.
Lenalidomide Ranbaxy, 10 mg, hard capsules are hard gelatin capsules approximately 21 mm in length, with a blue-green, opaque cap and a light yellow, opaque body with the inscription ”RL” on the cap and ”80” on the body, containing powder in the form of white to off-white granules.
Lenalidomide Ranbaxy, 15 mg, hard capsules are hard gelatin capsules approximately 21 mm in length, with a pale blue, opaque cap and a white, opaque body with the inscription ”RL” on the cap and ”81” on the body, containing powder in the form of white to off-white granules.
Lenalidomide Ranbaxy, 20 mg, hard capsules are hard gelatin capsules approximately 21 mm in length, with a blue-green, opaque cap and a pale blue, opaque body with the inscription ”RL” on the cap and ”82” on the body, containing powder in the form of white to off-white granules.
Lenalidomide Ranbaxy, 25 mg, hard capsules are hard gelatin capsules approximately 21 mm in length, with a white, opaque cap and a white, opaque body with the inscription ”RL” on the cap and ”83” on the body, containing powder in the form of white to off-white granules.
Lenalidomide Ranbaxy 2.5 mg/5 mg/ 7.5 mg/10 mg/ 15 mg/20 mg/25 mg is available in packs containing 7, 14, 21, 28 or 42 capsules in a cardboard box.
Lenalidomide Ranbaxy 2.5 mg/ 5 mg/ 7.5 mg/ 10 mg/ 15 mg/ 20 mg/ 25 mg is available in packs containing 7 x 1, 14 x 1, 21 x 1, 28 x 1 or 42 x 1 capsules in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warszawa
Poland

Manufacturer/Importer

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
Terapia S.A.
Str. Fabricii nr. 124
400632 Cluj-Napoca
Romania
Date of last revision of the leaflet: 18.01.2024