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 abnormality del(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 limiting 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 the patient is pregnant, suspects pregnancy, or plans 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 the patient can become pregnant, unless they use all required pregnancy prevention measures (see section 2 "Pregnancy, breastfeeding, and contraceptives - information for women and men"). If the patient can become pregnant, the doctor will always prescribe the medicine and ensure that the necessary measures are taken and inform the patient about it.
• If the patient is allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). In case of suspected allergy, you should consult a doctor.

If any of these points apply to the patient, they 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 the patient:

• has had blood clots in the past - this means an increased risk of developing blood clots in the veins and arteries during treatment;
• has any symptoms of infection, such as cough or fever;
• has a current or past viral infection, especially hepatitis B, chickenpox, and shingles. In case of doubts, you should consult a doctor. Treatment with Lenalidomide Ranbaxy may cause the reactivation of viruses in patients who have been infected in the past, leading to the recurrence of the infection. The doctor will check if the patient has had hepatitis B in the past;
• has kidney problems - the doctor may adjust the dose of Lenalidomide Ranbaxy;
• has had a heart attack, has had a blood clot, smokes, has high blood pressure, or high cholesterol levels;
• has had allergic symptoms when taking thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing;
• has 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 the patient, they should consult a doctor, pharmacist, or nurse. You should immediately tell your doctor or nurse if, at any time during or after treatment, the patient experiences:

• 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 the patient had such symptoms before treatment with Lenalidomide Ranbaxy, they should inform their doctor about any changes.
• shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or swelling of the legs 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, the patient will undergo regular blood tests, as Lenalidomide Ranbaxy may cause a decrease in the number of blood cells that fight infection (white blood cells) and help blood clotting (platelets). The doctor will call the patient 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, the patient may undergo an assessment for circulation and breathing problems.

Patient with MDS taking Lenalidomide Ranbaxy If the patient has 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, the doctor may perform tests to check for signs that can better predict the risk of acute myeloid leukemia during treatment with Lenalidomide Ranbaxy. Patients with MCL taking Lenalidomide Ranbaxy The doctor will ask for 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 The doctor will ask for 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.

The doctor may perform a test to check if the patient has a large amount of tumor tissue in the 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"). The doctor may perform a test to check if the patient has skin changes, such as red spots or rash. The doctor may change the dose of Lenalidomide Ranbaxy or stop treatment based on the results of the patient's blood tests and overall condition. If the disease is newly diagnosed, the doctor may also assess treatment based on 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 stopping treatment, the patient 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 the patient is 75 years old or older, or has moderate to severe kidney problems, the doctor will perform thorough tests before starting treatment.

Lenalidomide Ranbaxy and other medicines

The patient should tell their doctor or nurse about all medicines they 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, the patient should inform their doctor or nurse if they are taking:

• certain contraceptives, such as oral contraceptives, as 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 contraceptives - information for women and men

For women taking Lenalidomide Ranbaxy

• Lenalidomide Ranbaxy should not be taken if the patient is pregnant, as it is expected to be harmful to the unborn child.
• A woman should not become pregnant while taking Lenalidomide Ranbaxy. Therefore, women who can become pregnant must use effective contraception (see "Contraception").
• If the patient becomes pregnant while taking Lenalidomide Ranbaxy, they should stop treatment immediately and inform their doctor.

For men taking Lenalidomide Ranbaxy If the partner of a man taking Lenalidomide Ranbaxy becomes pregnant, she should immediately inform her doctor. The partner should consult a doctor. Men should also use effective contraception (see "Contraception").

Breastfeeding

Breastfeeding should not be done while taking Lenalidomide Ranbaxy, as it is not known whether the medicine passes into human milk.

Contraception

Women taking Lenalidomide Ranbaxy Before starting treatment, the patient should ask their doctor about the possibility of becoming pregnant, even if they 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 they have had their fallopian tubes cut and sealed to prevent the egg from reaching the womb (tubal sterilization) OR
• must use effective contraception methods for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after stopping treatment. The doctor will recommend the appropriate contraception methods to the patient.

Men taking Lenalidomide Ranbaxy Lenalidomide Ranbaxy passes into human sperm. If a woman is pregnant or may become pregnant and is not using effective contraception, her partner should use a condom during treatment and for at least 7 days after stopping treatment. This also applies to men who have had a vasectomy. During treatment and for at least 7 days after stopping treatment, the patient should not donate semen or sperm.

Driving and using machines

The patient should not drive or operate machines if they experience dizziness, fatigue, drowsiness, balance disturbances due to dizziness, or blurred vision after taking Lenalidomide Ranbaxy.

Lenalidomide Ranbaxy contains lactose

Lenalidomide Ranbaxy contains lactose. If the patient has been diagnosed with intolerance to some sugars, they should consult their 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.

In the case of 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 taken with other medicines (see section 1 "What is Lenalidomide Ranbaxy used for").

In the case of using Lenalidomide Ranbaxy to treat multiple myeloma in patients after bone marrow transplantation or in 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.

Lenalidomide Ranbaxy should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

If the patient is taking Lenalidomide Ranbaxy with other medicines, they should read the leaflet of those medicines 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, the patient will take one or more medicines. However, on some days, the patient will not take any medicines.

After completing each 21-day cycle, the patient should start a new 21-day cycle. OR Lenalidomide 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, the patient will take one or more medicines. However, on some days, the patient will not take any medicines.
• After completing each 28-day cycle, the patient should start a new 28-day cycle.

Recommended dose of Lenalidomide Ranbaxy

Before starting treatment, the doctor will inform the patient:

• how much Lenalidomide Ranbaxy to take;
• how many other medicines to take in combination with Lenalidomide Ranbaxy, if other medicines are necessary;
• which days of the cycle to 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 the skin, it should be washed 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, the hands should be washed thoroughly 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 the 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 a higher dose of Lenalidomide Ranbaxy than prescribed is taken, the doctor should be informed immediately.

Missing a dose of Lenalidomide Ranbaxy

If a dose of Lenalidomide Ranbaxy is missed at the scheduled time and

• less than 12 hours have passed since then: the capsule should be taken immediately;
• more than 12 hours have passed since then: the capsule should not be taken. The next capsule should be taken at the scheduled time the next day.

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

If any of the following severe side effects occur, the patient should stop taking Lenalidomide Ranbaxy and immediately consult their doctor - immediate treatment may be necessary:

• hives, rash, swelling of the eyes, lips, or face, difficulty breathing, or itching, which may be symptoms of severe allergic reactions called angioedema and anaphylactic reaction;
• a severe allergic reaction that starts as a rash in one area and spreads to the whole body, accompanied by a 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");
• 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.

The patient should immediately inform their doctor about any of the following severe side effects:

• fever, chills, sore throat, cough, mouth sores, or any other symptoms of infection (including blood infections);
• 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 the number of blood cells that help blood clotting (platelets), which can lead to bleeding disorders, such as nosebleeds and bruising. Lenalidomide Ranbaxy may also cause the formation of blood clots in the veins (thrombosis).

Other side effects

Note that in a small number of patients, Lenalidomide Ranbaxy may cause the development of other types of cancer, and it is possible that this risk may increase with treatment with Lenalidomide Ranbaxy. Therefore, the treating doctor should carefully assess the benefits and risks of prescribing Lenalidomide Ranbaxy to the patient. Very commonside effects (may occur in 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, pain in muscles, 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;
• abnormally low thyroid function;
• leg pain (which may be a symptom of thrombosis), chest pain, or shortness of breath (which may be symptoms of blood clots in the lungs, called pulmonary embolism);
• all types of infections, including sinusitis, pneumonia, and upper respiratory tract infections;
• shortness of breath;
• blurred vision;
• blurred vision (cataract);
• kidney problems, including abnormal kidney function or inability to maintain normal kidney function;
• abnormal liver test results;
• elevated liver enzyme levels;
• changes in blood proteins, leading to blood vessel inflammation (vasculitis)
• elevated blood sugar levels (diabetes);
• low blood sugar levels;
• headache;
• nosebleeds;
• dry skin;
• depression, mood changes, sleep disturbances;
• cough;
• low blood pressure;
• general feeling of physical discomfort, malaise;
• painful mouth sores, dry mouth;
• dehydration.

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

• red blood cell breakdown (hemolytic anemia);
• certain types of skin tumors;
• bleeding from the gums, stomach, or intestines;
• high blood pressure, slow, fast, or irregular heartbeat;
• increased levels of a substance produced by the breakdown of 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;
• high 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 timing of urination;
• passing blood in the urine;
• shortness of breath, especially when lying down (which may be a symptom 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 occur in 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 symptoms of kidney disease (Fanconi syndrome);
• yellowing of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching, rash, pain, or swelling of the abdomen - 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 (tubular necrosis);
• skin color changes, sensitivity to sunlight;
• breakdown of the stomach or intestine wall, which can lead to a severe infection. The patient should tell their doctor if they 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 hepatitis B virus reactivation (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 heartbeat - 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);
• 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. The patient should tell their doctor if they 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 hepatitis B virus reactivation (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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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, more information can be collected 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 in 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 the 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 iron oxide yellow (E 172);
• print ink: shellac, iron oxide black (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
• print ink: shellac, iron oxide black (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 iron oxide yellow (E 172);
• print ink: shellac, iron oxide black (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;
• print ink: shellac, iron oxide black (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.

Marketing Authorisation Holder

Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw
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 update of the leaflet: 18.01.2024