Lenalidomide ranbaxy

Package leaflet: Information for the patient

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
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 personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Lenalidomide Ranbaxy is and what it is 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. Contents of the pack and other information

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

What Lenalidomide Ranbaxy is
Lenalidomide Ranbaxy contains the active substance "lenalidomide". This medicine belongs to a group of medicines
that affect the function of the immune system.
What Lenalidomide Ranbaxy is 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 affects a certain kind of white blood cells called plasma cells. These cells accumulate in the bone marrow and divide uncontrollably. This may lead to damage of bones and kidneys.
Multiple myeloma is generally incurable. However, it is possible to achieve a significant temporary reduction or disappearance of signs and symptoms of the disease. This is called "remission".
Newly diagnosed multiple myeloma — in patients who have undergone stem cell transplantation
In this indication, Lenalidomide Ranbaxy is used alone as maintenance therapy after achieving an adequate response following transplantation.
Newly diagnosed multiple myeloma — in patients not eligible for stem cell transplantation
Lenalidomide Ranbaxy is taken in combination with other medicines, including:

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

If the patient is 75 years of age or older, or has moderate to severe kidney problems, the doctor will perform careful assessments before starting treatment.
Multiple myeloma — in previously treated patients
Lenalidomide Ranbaxy is taken in combination with an anti-inflammatory medicine called dexamethasone.
Lenalidomide Ranbaxy may stop the progression of signs and symptoms of multiple myeloma. It has also been shown to delay the recurrence of multiple myeloma after treatment.
Myelodysplastic syndromes (MDS)
Myelodysplastic syndromes (MDS) are a group of different blood and bone marrow disorders. Abnormal blood cells are present, which do not function properly. Patients may experience various subjective and objective symptoms, including low red blood cell count (anaemia), need for blood transfusions, and risk of infection.
Lenalidomide Ranbaxy, used as monotherapy, is indicated for the treatment of adult patients with MDS when all of the following conditions are met:

• the patient has anaemia requiring regular blood transfusions ("transfusion-dependent anaemia");
• the patient has an abnormality in bone marrow cells called "isolated cytogenetic abnormality del(5q)". This means the patient's body does not produce enough healthy blood cells;
• the patient has previously been treated with other therapies that were inappropriate or insufficiently effective.

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 may even become possible to discontinue transfusions altogether.

Mantle cell lymphoma (MCL)
MCL is a cancer of part of the immune system (lymphatic tissue). It affects a type of white blood cells called B-lymphocytes or B-cells. Mantle cell lymphoma is a disease characterized by uncontrolled growth of B-lymphocytes, leading to their accumulation in lymphatic tissue, bone marrow, or blood.
Lenalidomide Ranbaxy, used as monotherapy, is indicated for the treatment of adult patients who have been previously treated with other medicines.
Follicular lymphoma (FL)
FL is a slowly growing malignant tumour affecting B-lymphocytes. These are a type of white blood cells that help the body fight infections. In patients with FL, excessive numbers of B-lymphocytes may accumulate in the blood, bone marrow, lymph nodes, and spleen.
Lenalidomide Ranbaxy is taken in combination with another medicine called rituximab for the treatment of adult patients with previously treated follicular lymphoma.
How Lenalidomide Ranbaxy works
Lenalidomide Ranbaxy works by affecting the immune system and directly attacking cancer cells. The medicine acts in several different ways:

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

2. Important information before taking Lenalidomide Ranbaxy

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

• If the patient is pregnant, suspects she is pregnant, or plans to become pregnant, because Lenalidomide Ranbaxy is expected to be harmful to the unborn child (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men").
• If the patient could become pregnant, unless she uses all required contraceptive measures (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men"). If the patient could become pregnant, the doctor will always document that 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). In case of suspected allergy, consult a doctor for advice.

If any of these points apply, do not take Lenalidomide Ranbaxy.
If in doubt, consult your doctor.
Warnings and precautions
Before starting Lenalidomide Ranbaxy, discuss with your doctor, pharmacist, or nurse if the patient:

• Has previously had blood clots – this increases the risk of developing blood clots in veins and arteries during treatment;
• Has any signs of infection, such as cough or fever;
• Currently has or has had in the past a viral infection, particularly hepatitis B, varicella-zoster virus (chickenpox and shingles), or HIV. If in doubt, consult your doctor. Treatment with Lenalidomide Ranbaxy may reactivate viruses in patients previously infected, leading to recurrence of infection. The doctor will check whether the patient has previously had hepatitis B;
• Has kidney problems – the doctor may adjust the dose of Lenalidomide Ranbaxy;
• Has had a heart attack (myocardial infarction), blood clots, smokes, has high blood pressure, or high cholesterol levels;
• Experienced allergic reactions while taking thalidomide (another medicine used in the treatment of multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing;
• Had in the past any combination of the following symptoms: widespread rash, skin redness, high fever, flu-like symptoms, elevated liver enzymes, blood abnormalities (eosinophilia), or swollen lymph nodes – these are symptoms of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms (DRESS), also known as "drug hypersensitivity syndrome" (see also section 4 "Possible side effects").

If any of the above situations apply, consult your doctor, pharmacist, or nurse.
Immediately inform your doctor or nurse if at any time during or after treatment the patient experiences:

• Vision disturbances, loss of vision, double vision, difficulty speaking, weakness in the arm or leg, change in walking or balance problems, 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 treatment with Lenalidomide Ranbaxy, inform the doctor of any changes.
• Shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or swelling of the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Tests and examinations
Before and during treatment with Lenalidomide Ranbaxy, regular blood tests will be performed because Lenalidomide Ranbaxy may reduce the number of blood cells that help fight infection (white blood cells) and help blood to clot (platelets). The doctor will schedule blood tests:

• Before treatment,
• Weekly for the first 8 weeks of treatment,
• Then at least once a month. Before starting lenalidomide treatment and during treatment, the patient may be evaluated for circulatory and respiratory problems.

Patients with MDS taking Lenalidomide Ranbaxy
If the patient has myelodysplastic syndromes (MDS), there is an increased risk of developing a serious disease called acute myeloid leukemia. Furthermore, 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 help better predict the risk of acute myeloid leukemia during treatment with Lenalidomide Ranbaxy.
Patients with MCL taking Lenalidomide Ranbaxy
The doctor will request blood tests:

• Before treatment,
• Weekly for the first 8 weeks (2 cycles) of treatment,
• Then every 2 weeks during cycles 3 and 4 (more information in section 3 "Treatment cycle"),
• Then at the beginning of each cycle and
• At least once a month.

Patients with FL taking Lenalidomide Ranbaxy
The doctor will request blood tests:

• Before treatment,
• Weekly for the first 3 weeks (1 cycle) of treatment,
• Then every 2 weeks during cycles 2 to 4 (more information in section 3 "Treatment cycle"),
• Then at the beginning of each cycle and
• At least once a month.

The doctor may perform an examination to determine whether the patient has a large amount of tumor tissue in the body, including bone marrow. This may lead to a situation where tumor 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 called "tumor 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 Ranbaxy or discontinue treatment based on blood test results and the patient's overall condition. If the disease was recently diagnosed, the doctor may also consider treatment based on the patient's age and other conditions the patient may have had 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 Ranbaxy 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 evaluations before starting treatment.
Lenalidomide Ranbaxy and other medicines
Inform your doctor or nurse about all medicines currently or recently taken by the patient. This is necessary because Lenalidomide Ranbaxy may affect the action of other medicines. Likewise, other medicines may affect the action of Lenalidomide Ranbaxy.
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 problems – such as digoxin;
• Certain medicines used to thin the blood – such as warfarin.

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

• Do not take Lenalidomide Ranbaxy if the patient is pregnant, because it is expected to be harmful to the unborn child.
• A woman must not become pregnant while taking Lenalidomide Ranbaxy. Therefore, effective contraception is required for women who could become pregnant (see "Contraception").
• If the patient becomes pregnant during treatment with Lenalidomide Ranbaxy, treatment must be stopped immediately and the doctor informed.

For men taking Lenalidomide Ranbaxy
If the female partner of a man undergoing treatment with Lenalidomide Ranbaxy becomes pregnant, she should inform her doctor immediately. The partner should seek medical advice.
For men, effective contraception is also required (see "Contraception").
Breastfeeding
Do 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, ask your doctor about the possibility of becoming pregnant, even if the patient considers it unlikely.
Women who could become pregnant:

• Will have pregnancy tests performed under the supervision of a doctor (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends), except in cases where the fallopian tubes have been cut and blocked to prevent the egg from reaching the uterus (tubal sterilization) AND
• Must use effective methods 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 taking Lenalidomide Ranbaxy
Lenalidomide Ranbaxy passes into human semen. If a woman is pregnant or could become pregnant and is not using an effective contraceptive method, her partner should use a condom during treatment and for at least 7 days after treatment ends. This applies also to men who have had a vasectomy. During treatment and for at least 7 days after treatment ends, the patient must not donate semen or sperm.
Driving and using machines
Do not drive or operate machinery if the patient experiences dizziness, fatigue, drowsiness, balance problems due to vestibular dizziness, or blurred vision after taking Lenalidomide Ranbaxy.
Lenalidomide Ranbaxy contains lactose
Lenalidomide Ranbaxy contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking Lenalidomide Ranbaxy.

3. How to take Lenalidomide Ranbaxy

Lenalidomide Ranbaxy must be prescribed and supervised by healthcare professionals experienced in the treatment of multiple myeloma, MDS, MCL, or FL.
When Lenalidomide Ranbaxy is used to treat multiple myeloma in patients who are not eligible for bone marrow transplant or who have previously received other treatment, the medicine should be used in combination with other medicines (see section 1, "Why Lenalidomide Ranbaxy is used").
When Lenalidomide Ranbaxy is used to treat multiple myeloma in patients after bone marrow transplant, or in patients with MDS or MCL, the medicine should be used as monotherapy.
When Lenalidomide Ranbaxy is used to treat follicular lymphoma, it should be taken together with another medicine called rituximab.
Lenalidomide Ranbaxy should always be taken exactly as prescribed by the doctor. If in doubt, consult your doctor or pharmacist.
If you are taking Lenalidomide Ranbaxy together with other medicines, you should read the package leaflet provided with those medicines to obtain information about their use and effects.

Treatment cycle
Lenalidomide Ranbaxy is taken on specific days within a three-week period (21 days).

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

• Depending on the day of the cycle, you may 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 within a four-week period (28 days).

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

• Depending on the day of the cycle, you may 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 much of any other medicines you should take in combination with Lenalidomide Ranbaxy, if applicable;
• which medicines to take on which days of the cycle.

How and when to take Lenalidomide Ranbaxy

• Swallow the capsule whole, preferably with water.
• Do not crush, open, or chew the capsules. If the powder from a damaged Lenalidomide Ranbaxy capsule comes into contact with the skin, wash the skin thoroughly with soap and water immediately.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsules. Gloves should 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 capsules.
• Capsules may be taken with or without food.
• Lenalidomide Ranbaxy should be taken at approximately the same time each day on which the dose is scheduled.

How to take this medicine
To remove a 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 Ranbaxy
Lenalidomide Ranbaxy is administered in treatment cycles; each cycle lasts 21 or 28 days (see above, "Treatment cycle"). Treatment cycles should continue until your doctor decides to stop treatment.

If you take more Lenalidomide Ranbaxy than prescribed
If you take more Lenalidomide Ranbaxy than prescribed, contact your doctor immediately.

If you miss a dose of Lenalidomide Ranbaxy
If you miss a dose of Lenalidomide Ranbaxy 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 capsule. Take the next capsule at the scheduled time on the following day.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur, stop taking
Lenalidomide Ranbaxy immediately and contact your doctor straight away – immediate
treatment may be necessary:

• urticaria, rash, swelling of the eyes, 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, spreading over the entire body and associated with significant loss of the outer layer of skin (Stevens-Johnson syndrome and/or toxic epidermal necrolysis);
• widespread rash, high fever, 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
adverse reactions occur:

• fever, chills, sore throat, cough, mouth ulcers or any other signs of infection (including blood infections (sepsis));
• bleeding or bruising without injury;
• chest pain or leg pain;
• shortness of breath;
• bone pain, muscle weakness, confusion or fatigue which may result from high levels of calcium in the blood.

Lenalidomide Ranbaxy may reduce the number of white blood cells that fight infection, as well as
platelets, the blood cells that help blood to clot, which may lead to bleeding disorders such as
nosebleeds and bruising.
Lenalidomide Ranbaxy may also cause blood clots in the veins (venous thrombosis).
Other adverse reactions
Please note that in a small number of patients other types of cancer may develop, and this risk may possibly be increased by treatment with Lenalidomide Ranbaxy. Therefore, your doctor should carefully assess the benefits and risks before prescribing Lenalidomide Ranbaxy to you.
Very common adverse reactions (may affect more than 1 in 10 people):

• reduction in red blood cells, which may lead to anaemia causing tiredness and weakness;
• skin 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;
• decreased appetite, altered taste sensation;
• worsening of pain, increase in size 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 infections;
• shortness of breath;
• blurred vision;
• cloudy vision (cataract);
• kidney problems, including abnormal kidney function or inability to maintain normal kidney function;
• abnormal liver function test results;
• increased values in liver function tests;
• changes in blood proteins leading to blood vessel swelling (vasculitis);
• increased blood sugar levels (diabetes);
• decreased blood sugar levels;
• headache;
• nosebleeds;
• dry skin;
• depression, mood changes, difficulty sleeping;
• cough;
• low blood pressure;
• vague feeling of physical discomfort, malaise;
• painful inflammation of the mouth, dry mouth;
• dehydration.

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

• breakdown of red blood cells (haemolytic anaemia);
• certain types of skin tumours;
• bleeding from gums, stomach or intestines;
• increased blood pressure, slow, fast or irregular heartbeat;
• increased levels of substances produced during normal and abnormal breakdown of red blood cells;
• increased levels of a protein indicating inflammation in the body;
• darkening of the skin; skin discolouration due to bleeding under the skin, usually caused by bruising; blood-filled skin swelling, bruises;
• increased levels of uric acid in the blood;
• skin eruptions, redness of the skin, cracking, peeling or flaking of the skin, urticaria;
• itching, increased sweating, night sweats;
• difficulty swallowing, sore throat, voice quality problems or voice changes;
• rhinitis (runny nose);
• 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, 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 blockage of bile flow from the liver;
• low levels of phosphate or magnesium in the blood;
• difficulty speaking;
• liver damage;
• loss of balance, difficulty moving;
• deafness, tinnitus (ringing in the ears);
• nerve pain, unpleasant abnormal sensations, especially in response to touch;
• excess iron in the body;
• thirst;
• confusion;
• toothache;
• falls which may lead to injury.

Uncommon adverse reactions (may affect up to 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 typhlitis); kidney tubular cell damage (known as tubular necrosis);
• change in skin colour, sensitivity to sunlight;
• tumour lysis syndrome – metabolic complications which may occur during cancer treatment, and sometimes even without treatment. These complications are caused by the 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 the blood vessels leading to the lungs (pulmonary hypertension).

Adverse reactions of unknown frequency (frequency cannot be estimated 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 pulse – 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 which occurred when Lenalidomide Ranbaxy 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);
• perforation 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 the stool or changes in bowel function;
• viral infections, including shingles (a viral disease causing a painful skin rash with blisters) and reactivation of hepatitis B virus (which may cause yellowing of the skin and eyes, dark-coloured urine, pain in the right upper abdomen, fever, nausea and vomiting);
• solid organ transplant rejection (e.g. kidney, heart).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Lenalidomide Ranbaxy

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the specified month.
• Store below 25°C.
• Do not use this medicine if you notice any damage to the packaging or signs of tampering.
• 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 Ranbaxy contains
Lenalidomide Ranbaxy 2.5 mg, 10 mg, 20 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 2.5 mg, 10 mg, or 20 mg of lenalidomide, respectively.
• 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);
• printing ink: shellac, black iron oxide (E 172), and potassium hydroxide.

Lenalidomide Ranbaxy 5 mg and 25 mg, hard capsules:

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

Lenalidomide Ranbaxy 7.5 mg, hard capsules:

• The active substance 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);
• printing ink: shellac, black iron oxide (E 172), and potassium hydroxide.

Lenalidomide Ranbaxy 15 mg, hard capsules:

• The active substance 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), indigo carmine (E 132), gelatin;
• printing ink: shellac, black iron oxide (E 172), and potassium hydroxide.

What Lenalidomide Ranbaxy looks like and contents of the pack
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, marked with “RL” on the cap and “78” on the body, containing white to off-white granular powder.
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, marked with “RL” on the cap and “79” on the body, containing white to off-white granular powder.
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, marked with “RL” on the cap and “86” on the body, containing white to off-white granular powder.
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, marked with “RL” on the cap and “80” on the body, containing white to off-white granular powder.
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, marked with “RL” on the cap and “81” on the body, containing white to off-white granular powder.
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, marked with “RL” on the cap and “82” on the body, containing white to off-white granular powder.
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, marked with “RL” on the cap and “83” on the body, containing white to off-white granular powder.
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 also 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
The Netherlands
Terapia S.A.
Str. Fabriciei no. 124
400632 Cluj-Napoca
Romania