Lenalidomide Grindex

Package leaflet: Information for the user

Lenalidomide Grindeks 2.5 mg hard capsules, 5 mg hard capsules, 7.5 mg hard capsules, 10 mg hard capsules, 15 mg hard capsules, 20 mg hard capsules, 25 mg hard capsules

lenalidomide
equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What Lenalidomide Grindeks is
Lenalidomide Grindeks contains the active substance “lenalidomide”. This medicine belongs to a
group of medicines that affect the way the immune system works.
What Lenalidomide Grindeks is used for
Lenalidomide Grindeks is used in adults for:

• Multiple Myeloma
• Follicular Lymphoma

Multiple Myeloma
Multiple myeloma is a type of cancer that affects a certain type of white blood cells called
plasma cells. These cells accumulate in the bone marrow and divide uncontrollably.
This can damage the bones and kidneys.
Multiple myeloma is generally incurable. However, signs and symptoms can be greatly
reduced or disappear for a certain period of time. This outcome is called a “response”.
Newly diagnosed multiple myeloma: in patients undergoing bone marrow transplantation
Lenalidomide Grindeks is used alone as maintenance therapy in patients who have adequately recovered after bone marrow transplantation.
Newly diagnosed multiple myeloma: in patients who cannot undergo bone marrow transplantation
Lenalidomide Grindeks is taken with other medicines, which may include:

• a chemotherapy medicine called “bortezomib”.
• an anti-inflammatory medicine called “dexamethasone”.
• a chemotherapy medicine called “melphalan”, and
• an immunosuppressive medicine called “prednisone”. You will take these other medicines at the beginning of treatment and then continue taking Lenalidomide Grindeks alone.

If you are aged 75 years or older or have moderate to severe kidney problems, your doctor will carefully monitor you before starting treatment.
Multiple myeloma: in patients who have been previously treated
Lenalidomide Grindeks is taken together with an anti-inflammatory medicine called
“dexamethasone”.
Lenalidomide Grindeks can stop the worsening of signs and symptoms of multiple myeloma.
It has also been shown to delay the return of multiple myeloma after treatment.
Follicular Lymphoma (FL)
FL is a slow-growing form of cancer that affects B-lymphocytes. These are a type of white blood
cells that help the body fight infections. In FL, too many of these B-lymphocytes may accumulate
in the blood, bone marrow, lymph nodes, and spleen.
Lenalidomide Grindeks is taken together with another medicine called 'rituximab' for the treatment
of adult patients with previously treated follicular lymphoma.
How Lenalidomide Grindeks works
Lenalidomide Grindeks works on the body’s immune system and directly on the tumour in several ways:

• by stopping the development of cancer cells
• by stopping the growth of blood vessels that supply blood to tumour cells
• by stimulating part of the immune system so that it attacks cancer cells.

2. What you should know before taking Lenalidomide Grindeks

Before starting treatment with Lenalidomide Grindeks, you must read the package leaflet
of all the medicines you are required to take in combination with Lenalidomide Grindeks.
Do not take Lenalidomide Grindeks

• If you are pregnant, think you may be pregnant, or are planning a pregnancy, because Lenalidomide Grindeks is expected to be harmful to the unborn baby (see section 2, 'Pregnancy, breastfeeding and contraception – information for women and men').
• If there is any possibility that you may become pregnant unless you follow all necessary measures to avoid pregnancy (see section 2 'Pregnancy, breastfeeding and contraception – information for women and men'). If there is any possibility of becoming pregnant, your doctor will record and confirm at each prescription that the necessary measures to avoid pregnancy have been taken.
• If you are allergic to lenalidomide or to any of the other ingredients of this medicine (listed in section 6). If you think you are allergic, consult your doctor.

If any of these conditions apply to you, do not take Lenalidomide Grindeks. If you have any doubts, consult your doctor.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Lenalidomide Grindeks if:

• you have previously had episodes of blood clots, because your risk of developing blood clots in veins and arteries increases during treatment
• you have any signs of infection, such as cough or fever
• you have or have previously had a viral infection, particularly: hepatitis B infection, varicella-zoster, HIV. If you are in doubt, consult your doctor. Treatment with Lenalidomide Grindeks may cause reactivation of the virus in patients who carry the virus. This causes the infection to reappear. Your doctor must check whether you have previously had hepatitis B infection
• you have kidney problems – your doctor may adjust the dose of Lenalidomide Grindeks
• you have had a heart attack, have had a blood clot, or if you smoke, have high blood pressure or high cholesterol levels
• you have previously had an allergic reaction during treatment with thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness or difficulty breathing
• you have previously experienced any combination of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes; these are signs of a serious skin reaction called drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome (see also section 4 “Possible side effects”).

If any of these conditions apply to you, inform your doctor, pharmacist or nurse before starting treatment.
At any time during or after treatment, inform your doctor or nurse immediately if:

• you experience blurred vision, loss of vision or double vision, difficulty speaking, weakness in one arm or leg, changes in the way you walk or problems with balance, persistent numbness, reduced sensation or loss of sensation, memory loss or confusion. These may be symptoms of a serious brain condition that can be fatal, known as progressive multifocal leukoencephalopathy (PML). If you had these symptoms before treatment with lenalidomide, inform your doctor of any changes in these symptoms.
• you experience shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat or swelling in the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Tests and monitoring
Before and during treatment with Lenalidomide Grindeks, you will undergo regular blood tests. This is because Lenalidomide Grindeks may cause a reduction in blood cells that protect you from infections (white blood cells) and those that help blood to clot (platelets). Your doctor will ask you to have blood tests:

• before starting treatment
• every week for the first 8 weeks of treatment
• then at least once a month thereafter.

You may be evaluated for signs of cardiopulmonary problems before and during treatment with lenalidomide.
For patients with follicular lymphoma taking Lenalidomide Grindeks
Your doctor will ask you to have a blood test:

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

Your doctor may assess whether you have a high tumour burden throughout the body, including in the bone marrow. This could lead to a condition in which tumours break down and cause abnormal levels of chemicals in the blood, which may result in kidney failure (this condition is called “tumour lysis syndrome”).
Your doctor may check for skin changes, such as red spots or rashes.
Your doctor may decide to adjust the dose of Lenalidomide Grindeks or stop treatment depending on the results of blood tests and your overall condition. If you are a newly diagnosed patient, your doctor may also consider treatment based on your age and any other pre-existing conditions.
Blood donation
You must not donate blood during treatment with lenalidomide and for at least 7 days after stopping treatment.
Children and adolescents
The use of Lenalidomide Grindeks is not recommended in children and adolescents under 18 years of age.
Elderly and patients with kidney problems
In patients aged 75 years or older, or with moderate or severe kidney problems, your doctor will perform careful monitoring before starting treatment.
Other medicines and Lenalidomide Grindeks
Inform your doctor or nurse if you are taking, have recently taken or might take any other medicines. This is because Lenalidomide Grindeks may affect the action of other medicines and other medicines may affect the action of Lenalidomide Grindeks.
In particular, inform your doctor or nurse if you are taking any of the following medicines:

• certain medicines used to prevent pregnancy, such as oral contraceptives, because they may become less effective
• certain medicines used for heart problems, such as digoxin
• certain medicines used to thin the blood, such as warfarin.

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

• You must not take Lenalidomide Grindeks if you are pregnant, because this medicine is expected to be harmful to the unborn baby.
• During treatment with Lenalidomide Grindeks, you must not become pregnant. If there is any possibility of becoming pregnant, you must use effective contraceptive methods (see the section “Contraception”).
• If you become pregnant during treatment with Lenalidomide Grindeks, you must stop your treatment immediately and inform your doctor.

For men taking Lenalidomide Grindeks

• If your partner becomes pregnant while you are taking Lenalidomide Grindeks, inform your doctor immediately. It is also recommended that your partner contacts her doctor.
• In addition, you must use effective contraceptive methods (see the section “Contraception”).

Breastfeeding
You must not breastfeed while taking Lenalidomide Grindeks, because it is not known whether this medicine passes into breast milk.
Contraception
For women taking Lenalidomide Grindeks
Before starting treatment, ask your doctor whether there is any possibility that you could become pregnant, even if you think it is unlikely.
If there is any possibility that you could become pregnant

• you will need to undergo pregnancy testing under the supervision of your doctor (before each treatment, at least every 4 weeks during treatment and at least 4 weeks after stopping treatment), except in cases where it has been confirmed that your fallopian tubes have been cut and sealed to prevent eggs from reaching the uterus (sterilisation by tubal ligation) AND
• you must use effective contraceptive methods for at least 4 weeks before starting treatment, during treatment and for at least 4 weeks after stopping treatment. Your doctor will provide you with all necessary information regarding appropriate contraceptive methods.

For men taking Lenalidomide Grindeks
Lenalidomide Grindeks passes into human semen. If there is any possibility that your partner is pregnant or could become pregnant and she is not using effective contraceptive methods, you must use condoms during treatment and for at least 7 days after stopping treatment, even if you have had a vasectomy.
Driving and using machines
Do not drive or operate machinery if you experience dizziness, fatigue, drowsiness, vertigo or blurred vision after taking Lenalidomide Grindeks.
Lenalidomide Grindeks contains lactose
Lenalidomide Grindeks contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Lenalidomide Grindeks contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.

3. How to take Lenalidomide Grindeks

Lenalidomide Grindeks must be prescribed by healthcare professionals experienced in the treatment of multiple myeloma or follicular lymphoma.

• When Lenalidomide Grindeks is used for the treatment of multiple myeloma in patients who cannot undergo bone marrow transplantation or who have previously received other treatments, it is taken in combination with other medicines (see section 1, “What Lenalidomide Grindeks is and what it is used for”).
• When Lenalidomide Grindeks is used for the treatment of multiple myeloma in patients who have undergone bone marrow transplantation, it is taken alone.
• When Lenalidomide Grindeks is used for the treatment of follicular lymphoma, it is taken in combination with another medicine called 'rituximab'.

Always take Lenalidomide Grindeks exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
If you are taking Lenalidomide Grindeks in combination with other medicines, please refer to the package leaflet of those medicines for further information on their use and side effects.

Treatment cycle
Lenalidomide Grindeks is taken on certain days within a 3-week period (21 days).

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

• Depending on the day of the cycle, you will take one or more of the medicines. However, on some days you will not take any medicine.

• After completing each 21-day cycle, you must start a new “cycle” within the following 21 days.
  OR
  Lenalidomide Grindeks is taken on certain days within a 4-week period (28 days).

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

• Depending on the day of the cycle, you will take one or more of the medicines. However, on some days you will not take any medicine.

• After completing each 28-day cycle, you must start a new “cycle” within the following 28 days.

Dose of Lenalidomide Grindeks to be taken
Before starting treatment, your doctor will inform you:

• of the dose of Lenalidomide Grindeks to take
• of the dose of any other medicines to be taken in combination with Lenalidomide Grindeks, if prescribed
• on which days of the treatment cycle to take each medicine.

How and when to take Lenalidomide Grindeks

• Swallow the capsules whole, preferably with water.
• Do not break, open, or chew the capsules. If the powder from a broken Lenalidomide Grindeks capsule comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
• Healthcare providers, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Gloves should then be carefully removed to avoid skin exposure, placed in sealable polyethylene plastic bags, and disposed of according to local regulations. Hands should then be thoroughly washed with soap and water. Pregnant women or women who suspect they may be pregnant must not handle the blister pack or capsule.
• The capsules may be taken with or without food.
• You must take Lenalidomide Grindeks on the scheduled days at approximately the same time each day.

Taking this medicine
To remove the capsule from the blister:

• Press on one side of the capsule only, pushing it through the aluminium foil.
• Do not press in the centre of the capsule, as this may break it.

Duration of treatment with Lenalidomide Grindeks
Lenalidomide Grindeks is taken in treatment cycles, each lasting 21 or 28 days (see above, “Treatment cycle”). You must continue the treatment cycles until your doctor tells you to stop.

If you take more Lenalidomide Grindeks than you should
If you have taken more Lenalidomide Grindeks than prescribed, inform your doctor immediately.

If you forget to take Lenalidomide Grindeks
If you forget to take Lenalidomide Grindeks at your usual time and:

• less than 12 hours have passed: take your capsule immediately
• more than 12 hours have passed: do not take the missed capsule; instead, take the next capsule at the usual time the following day.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Lenalidomide Grindeks and consult a doctor immediately if you experience any of the following serious side effects – you may need urgent medical treatment:

• Hives, rash, swelling of the eyes, mouth or face, difficulty breathing, or itching, which may be symptoms of serious allergic reactions called angioedema and anaphylactic reaction.
• A severe allergic reaction may start as a localized rash but can spread with extensive skin loss throughout the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.

Contact your doctor immediately if you notice any of the following serious side effects:

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection, including blood infection (sepsis)
• Bleeding or bruising without injury
• Chest or leg pain
• Shortness of breath
• Bone pain, muscle weakness, confusion, or fatigue, which may be due to high levels of calcium in the blood.

Lenalidomide Grindeks may reduce the number of white blood cells that fight infections and also reduce blood cells that help blood clot (platelets), which may lead to bleeding disorders such as nosebleeds and bruising. Lenalidomide Grindeks may also cause blood clots in veins (thrombosis).
Other side effects
It is important to note that a small number of patients may develop other types of cancer, and this risk may possibly increase with treatment with Lenalidomide Grindeks.
Therefore, your doctor must carefully evaluate the benefits and risks when prescribing Lenalidomide Grindeks to you.
Very common side effects (may affect more than 1 in 10 people):

• Decrease in red blood cell count, which may cause anaemia leading to fatigue and weakness
• Rash, itching
• Muscle cramps, muscle weakness, muscle pain, bone pain, joint pain, back pain, limb pain
• Generalised swelling, including swelling of arms and legs
• Weakness, fatigue
• Fever and flu-like symptoms including fever, muscle pain, headache, earache, cough, and chills
• Numbness, tingling or burning sensation on the skin, pain in hands or feet, dizziness, tremor
• Loss of appetite, altered taste
• Increase in pain, size of tumour, or redness around the tumour
• Weight loss
• Constipation, diarrhoea, nausea, vomiting, stomach pain, heartburn
• Low levels of potassium, calcium, and/or sodium in the blood
• Underactive thyroid gland
• 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)
• Any type of infection including sinus infections (around the nose), lung infection, and upper respiratory tract infection
• Shortness of breath
• Blurred vision
• Clouding of the lens (cataract)
• Kidney problems including impaired kidney function or inability to maintain normal function
• Abnormal liver function test results
• Increase in liver function test values
• Changes in a protein in the blood that may cause swelling of arteries (vasculitis)
• Increased blood sugar levels (diabetes)
• Decreased blood sugar levels
• Headache
• Nosebleeds
• Dry skin
• Depression, mood changes, difficulty sleeping
• Cough
• Decreased blood pressure
• Vague feeling of physical discomfort, malaise
• Inflammation of the mouth, dry mouth
• Dehydration

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

• Destruction of red blood cells (haemolytic anaemia)
• Certain types of skin tumours
• Bleeding from gums, stomach, or intestine
• Increased blood pressure, slow, fast, or irregular heartbeat
• Increase in a substance resulting from normal and abnormal breakdown of red blood cells
• Increase in a type of protein indicating inflammation in the body
• Darkening of the skin, skin discolouration due to underlying bleeding, typically caused by bruising, blood-filled skin swelling, bruising
• Increased uric acid in the blood
• Skin rashes, redness, cracking, peeling, or flaking of the skin, hives
• Increased sweating, night sweats
• Difficulty swallowing, sore throat, voice difficulties or voice changes
• Runny nose
• Urine output much greater or less than usual, or inability to control when you urinate
• Presence of blood in the urine
• Shortness of breath, especially when lying down (which may be a symptom of heart failure)
• Difficulty achieving an erection
• Stroke, fainting, dizziness (inner ear problems causing a sensation of spinning), temporary loss of consciousness
• Chest pain spreading to arms, neck, jaw, back, or stomach, sweating, shortness of breath, feeling unwell or vomiting, which may be symptoms of a heart attack (myocardial infarction)
• Muscle weakness, lack of energy
• Neck pain, chest pain
• Chills
• Joint swelling
• Slowed or blocked flow of bile from the liver
• Low levels of phosphate or magnesium in the blood
• Difficulty speaking
• Liver damage
• Balance problems, difficulty moving
• Deafness
• Ringing in the ears (tinnitus)
• Nerve pain, altered sensation, especially touch
• Excess iron in the blood
• Thirst
• Confusion
• Toothache
• Falls that may lead to injury

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

• Bleeding inside the skull

• Circulatory problems

• Loss of vision

• Loss of sexual desire (libido)

• Excessive urine flow with pain and bone weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)

• Yellowish discoloration of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itchy skin, rash, stomach pain or swelling. These may be symptoms of liver damage (liver failure).

• Stomach pain, bloating, or diarrhoea, which may be symptoms of inflammation of the large intestine (called colitis or typhlitis)

• Damage to kidney cells (called renal tubular necrosis)

• Changes in skin colour, sensitivity to sunlight

• Tumour lysis syndrome – metabolic complications occurring during cancer treatment and sometimes even without treatment. These complications are caused by the breakdown products of dying tumour cells and may include the following:
  changes in blood chemistry tests, increased potassium, phosphate, uric acid, and
  decreased calcium, leading to impaired kidney function, irregular heartbeat, seizures, and sometimes death.

• Increased blood pressure in the blood vessels leading to the lungs (pulmonary hypertension).

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

• Sudden or mild but worsening pain in the upper abdomen and/or back, persisting for several days, possibly accompanied by nausea, vomiting, fever, and rapid pulse; these symptoms may be due to inflammation of the pancreas.
• Wheezing, shortness of breath, or dry cough, which may be symptoms caused by inflammation of lung tissue.
• Rare cases of muscle breakdown (muscle pain, weakness, or swelling), which may lead to kidney problems (rhabdomyolysis), some of which occurred when Lenalidomide Grindeks was administered with a statin (a type of cholesterol-lowering medicine).
• A disease affecting the skin caused by inflammation of small blood vessels, with joint pain and fever (leukocytoclastic vasculitis).
• Deterioration of the stomach or intestinal wall, which may lead to severe infections. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in stools, or changes in bowel habits.
• Viral infections, including herpes zoster (also known as "shingles", a viral disease causing painful rash with blisters) and reactivation of hepatitis B infection (which may cause yellowing of the skin and eyes, dark brown urine, stomach pain on the right side, fever, and nausea or vomiting).
• Rejection of solid organ transplant (such as kidney, heart)

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at the website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lenalidomide Grindeks

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister pack and carton after "Exp.". The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not use this medicine if you notice damaged packaging or signs of tampering.
• Do not dispose of medicines via wastewater or household waste. Return unused medicines to your pharmacist. This will help protect the environment.

6. Package contents and other information

What Lenalidomide Grindeks contains
Lenalidomide Grindeks 2.5 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 2.5 mg of lenalidomide.
• The other components are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
  • capsule shell: gelatin, titanium dioxide (E171), Brilliant Blue FCF - Blue FD&C 1 (E133) and yellow iron oxide (E172)
  • printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) and concentrated ammonia solution (E527).

Lenalidomide Grindeks 5 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 5 mg of lenalidomide.
• The other components are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
  • capsule shell: gelatin and titanium dioxide (E171)
  • printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) and concentrated ammonia solution (E527).

Lenalidomide Grindeks 7.5 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 7.5 mg of lenalidomide.
• The other components are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
  • capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172)
  • printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) and concentrated ammonia solution (E527).

Lenalidomide Grindeks 10 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 10 mg of lenalidomide.
• The other components are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
  • capsule shell: gelatin, titanium dioxide (E171), Brilliant Blue FCF - Blue FD&C 1 (E133) and yellow iron oxide (E172)
  • printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) and concentrated ammonia solution (E527).

Lenalidomide Grindeks 15 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 15 mg of lenalidomide.
• The other components are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
  • capsule shell: gelatin, titanium dioxide (E171) and Brilliant Blue FCF - Blue FD&C 1 (E133)
  • printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) and concentrated ammonia solution (E527).

Lenalidomide Grindeks 20 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 20 mg of lenalidomide.
• The other components are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
  • capsule shell: gelatin, titanium dioxide (E171), Brilliant Blue FCF - Blue FD&C 1 (E133) and yellow iron oxide (E172)
  • printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) and concentrated ammonia solution (E527).

Lenalidomide Grindeks 25 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains lenalidomide ammonium chloride equivalent to 25 mg of lenalidomide.
• The other components are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
  • capsule shell: gelatin and titanium dioxide (E171)
  • printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) and concentrated ammonia solution (E527).

Description of the appearance of Lenalidomide Grindeks and package contents

Lenalidomide Grindeks 2.5 mg hard capsules are light green/white in colour, size 4, marked with ‘L2.5’.
Lenalidomide Grindeks 5 mg hard capsules are white in colour, size 4, marked with ‘L5’.
Lenalidomide Grindeks 7.5 mg hard capsules are light yellow/white in colour, size 3, marked with ‘L7.5’.
Lenalidomide Grindeks 10 mg hard capsules are light green/light yellow in colour, size 2, marked with ‘L10’.
Lenalidomide Grindeks 15 mg hard capsules are blue/white in colour, size 1, marked with ‘L15’.
Lenalidomide Grindeks 20 mg hard capsules are light green/blue in colour, size 0, marked with ‘L20’.
Lenalidomide Grindeks 25 mg hard capsules are white in colour, size 0, marked with ‘L25’.
The capsules are supplied in packs of 7 capsules or 21 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53
Rīga LV-1057
Latvia

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Netherlands: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg, harde capsules
Austria: Lenalidomid Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Hartkapseln
Belgium: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg gélules
Bulgaria: Леналидомид Гриндекс 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg твърди капсули
Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hard capsules
Czech Republic: Lenalidomide Grindeks
Croatia: Lenalidomid Grindeks 2.5 mg tvrde kapsule
Lenalidomid Grindeks 5 mg tvrde kapsule
Lenalidomid Grindeks 7.5 mg tvrde kapsule
Lenalidomid Grindeks 10 mg tvrde kapsule
Lenalidomid Grindeks 15 mg tvrde kapsule
Lenalidomid Grindeks 20 mg tvrde kapsule
Lenalidomid Grindeks 25 mg tvrde kapsule
Cyprus: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hard capsules
Denmark: Lenalidomide Grindeks
Estonia: Lenalidomide Grindeks
Finland: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg kapselit, kovat
France: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg, Gélule
Germany: Lenalidomid Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Hartkapseln
Greece: Lenalidomide Grindeks 2.5 mg καψάκια σκληρά
Lenalidomide Grindeks 5 mg καψάκια σκληρά
Lenalidomide Grindeks 7.5 mg καψάκια σκληρά
Lenalidomide Grindeks 10 mg καψάκια σκληρά
Lenalidomide Grindeks 15 mg καψάκια σκληρά
Lenalidomide Grindeks 20 mg καψάκια σκληρά
Lenalidomide Grindeks 25 mg καψάκια σκληρά
Hungary: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg kemény kapszula
Iceland: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Capsules, hard
Ireland: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Capsules, hard
Italy: Lenalidomide Grindeks
Latvia: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg cietās kapsulas
Lithuania: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg kietosios kapsulės
Malta: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Hard Capsules
Norway: Lenalidomide Grindeks
Poland: Lenalidomide Grindeks
Portugal: Lenalidomida Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg cápsulas duras
Romania: Lenalidomidă Grindeks 2.5 mg capsule
Lenalidomidă Grindeks 5 mg capsule
Lenalidomidă Grindeks 7.5 mg capsule
Lenalidomidă Grindeks 10 mg capsule
Lenalidomidă Grindeks 15 mg capsule
Lenalidomidă Grindeks 20 mg capsule
Lenalidomidă Grindeks 25 mg capsule
Slovakia: Lenalidomid Grindeks 2.5 mg tvrdé kapsuly
Lenalidomid Grindeks 5 mg tvrdé kapsuly
Lenalidomid Grindeks 7.5 mg tvrdé kapsuly
Lenalidomid Grindeks 10 mg tvrdé kapsuly
Lenalidomid Grindeks 15 mg tvrdé kapsuly
Lenalidomid Grindeks 20 mg tvrdé kapsuly
Lenalidomid Grindeks 25 mg tvrdé kapsuly
Slovenia: Lenalidomid Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg trde kapsule
Spain: Lenalidomida Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg cápsula dura
Sweden: Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hårda kapslar
United Kingdom (Northern Ireland): Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Capsules, hard