Lenalidomide Mylan 5 mg capsules – patient leaflet, side effects, dosage

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

Lenalidomide Mylan contains the active substance ‘lenalidomide’. This medicine belongs to a group of medicines which afect how your immune system works. Lenalidomide Mylan is used in adults for Multiple myeloma and Follicular lymphoma

Multiple myeloma

Multiple myeloma is a type of cancer which afects a certain kind of white blood cell, called the plasma cell. These cells collect in the bone marrow and divide, becoming out of control. This can damage the bones and kidneys.

Multiple myeloma generally cannot be cured. However, the signs and symptoms can be greatly reduced or disappear for a period of time. This is called a ‘response’. Newly diagnosed multiple myeloma – in patients who have had a bone marrow transplant

Lenalidomide Mylan is used on its own as a maintenance therapy after patients have recovered enough following a bone marrow transplant.

Newly diagnosed multiple myeloma – in patients who cannot have a bone marrow transplant

Lenalidomide Mylan is taken with other medicines. These may include:

• a chemotherapy medicine called ‘bortezomib’

• an anti-inlammatory medicine called

  ‘dexamethasone’

• a chemotherapy medicine called ‘melphalan’ and an

  immunosuppressant medicine called ‘prednisone’. You will take these other medicines at the start of treatment and then continue to take Lenalidomide Mylan on its own.

If you are aged 75 years or older or have moderate to severe kidney problems - your doctor will check you carefully before starting treatment.

Multiple myeloma – in patients who have had treatment before

Lenalidomide Mylan is taken together with an anti-inlammatory medicine called ‘dexamethasone’. Lenalidomide Mylan can stop the signs and symptoms of multiple myeloma getting worse. It has also been shown to delay multiple myeloma from coming back following treatment

Follicular lymphoma (FL)

FL is a slow growing cancer that afects the B-lymphocytes. These are a type of white blood cells that help your body ight infection. When you have FL, too many of these B-lymphocytes may collect in your blood, bone marrow, lymph nodes and spleen. Lenalidomide Mylan is taken together with another medicine called ‘rituximab’ for the treatment of adult patients with previously treated follicular lymphoma. How Lenalidomide Mylan works

Lenalidomide Mylan works by afecting the body’s immune system and directly attacking the cancer. It works in a number of diferent ways:

• by stopping the cancer cells developing
• by stopping blood vessels growing in the cancer

• by stimulating part of the immune system to attack

  the cancer cells.

2. What you need to know before you take Lenalidomide Mylan

You must read the package lealet of all medicinal products to be taken in combination with Lenalidomide Mylan before starting treatment with

Lenalidomide Mylan.

Do not take Lenalidomide Mylan

• if you are pregnant, think you may be pregnant or

  are planning to become pregnant, as Lenalidomide Mylan is expected to be harmful to an unborn child (see section 2, ‘Pregnancy, breast-feeding and contraception – information for women and men’).

• if you are able to become pregnant, unless you

  follow all the necessary measures to prevent you from becoming pregnant (see section 2, ‘Pregnancy, breast-feeding and contraception – information for women and men’). If you are able to become pregnant, your doctor will record with each prescription that the necessary measures have been taken and provide you with this conirmation.

• if you are allergic to lenalidomide or any of the other

  ingredients of this medicine listed in section 6. If you think you may be allergic, ask your doctor for advice. If any of these apply to you, do not take Lenalidomide Mylan. Talk to your doctor if you are not sure. Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Lenalidomide Mylan if:

• you have had blood clots in the past - you have an

  increased risk of developing blood clots in the veins and arteries during treatment

• you have any signs of an infection, such as a cough

  or fever

• you have or have ever had previous viral infection,

  particularly: hepatitis B infection, varicella zoster, HIV. If you are in doubt, talk to your doctor. Treatment with Lenalidomide Mylan may cause the virus to become active again, in patients who carry the virus. This results in a recurrence of the infection. Your doctor should check whether you have ever had hepatitis B infection

• you have kidney problems - your doctor may adjust

  your dose of Lenalidomide Mylan

• you have had a heart attack, have ever had a blood

  clot, or if you smoke, have high blood pressure or high cholesterol levels

• you have had an allergic reaction whilst taking

  thalidomide (another medicine used to treat multiple myeloma) such as rash, itching, swelling, dizziness or trouble breathing

• you have experienced in the past a combination of

  any of the following symptoms: widespread rash, red skin, high body temperature, lu-like symptoms, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes – these are signs of a severe skin reaction called Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome. (see also section 4 “Possible side efects”).

If any of the above apply to you, tell your doctor, pharmacist or nurse before starting treatment. At any time during or after your treatment, tell your doctor or nurse immediately if you:

• experience blurred, loss of or double vision, diiculty

  speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion. These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML). If you had these symptoms prior to treatment with lenalidomide, tell your doctor about any change in these symptoms.

• experience shortness of breath, tiredness, dizziness,

  pain in the chest, a faster 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 checks

Before and during the treatment with Lenalidomide Mylan you will have regular blood tests. This is because Lenalidomide Mylan may cause a fall in the blood cells that help ight infection (white blood cells) and help the blood to clot (platelets).

Your doctor will ask you to have a blood test:

• before treatment
• every week for the irst 8 weeks of treatment
• then at least every month after that.

You may be evaluated for signs of cardiopulmonary problems before and during the treatment with lenalidomide.

For patients with FL taking Lenalidomide Mylan Your doctor will ask you to have a blood test:

• before treatment
• every week for the irst 3 weeks (1 cycle) of treatment

• then every 2 weeks in cycles 2 to 4 (see Section 3

  ‘Treatment cycle’ for more information)

• After this it will happen at the start of each cycle and
• at least every month.

Your doctor may check if you have a high total amount of tumour throughout the body, including your bone marrow. This could lead to a condition where the tumours break down and cause unusual levels of chemicals in the blood which can lead to kidney failure (this condition is called ‘Tumour Lysis Syndrome’). Your doctor may check you for changes to your skin such as red spots or rashes.

Your doctor may adjust your dose of Lenalidomide Mylan or stop your treatment based on the results of your blood tests and on your general condition. If you are newly diagnosed, your doctor may also assess your treatment based on your age and other conditions you already have.

Blood donation

You should not donate blood during treatment and for at least 7 days after the end of treatment.

Children and adolescents

Lenalidomide Mylan is not recommended for use in children and adolescents under 18 years.

Elderly and people with kidney problems

If you are aged 75 years or older or have moderate to severe kidney problems - your doctor will check you carefully before starting treatment.

Other medicines and Lenalidomide Mylan

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because Lenalidomide Mylan can afect the way some other medicines work. Also, some other medicines can afect the way Lenalidomide Mylan works. In particular, tell your doctor or nurse if you are taking any of the following medicines:

• some medicines used to prevent pregnancy such as oral contraceptives, as they may stop working
• some medicines used for heart problems – such as digoxin
• some medicines used to thin the blood – such as warfarin.

Pregnancy, breast-feeding and contraception - information for women and men

Pregnancy

For women taking Lenalidomide Mylan

• You must not take Lenalidomide Mylan if you are pregnant, as it is expected to be harmful to an unborn baby.

• You must not become pregnant while taking

  Lenalidomide Mylan. Therefore you must use efective methods of contraception if you are a woman of childbearing potential (see ‘Contraception’).

• If you do become pregnant during your treatment with

  Lenalidomide Mylan, you must stop the treatment and inform your doctor immediately.

For men taking Lenalidomide Mylan

• If your partner becomes pregnant whilst you are taking Lenalidomide Mylan, you should inform your doctor immediately. It is recommended that your partner seeks medical advice.

• You must also use efective methods of contraception

  (see ‘Contraception’).

Breast-feeding

You must not breast-feed when taking Lenalidomide Mylan, as it is not known if Lenalidomide Mylan passes into breast milk.

Contraception

For women taking Lenalidomide Mylan

Before starting the treatment, ask your doctor if you are able to become pregnant, even if you think this is unlikely. If you are able to become pregnant

• you will have pregnancy tests under the supervision of your doctor (before every treatment, at least every 4 weeks during treatment, and at least 4 weeks after the treatment has inished) except where it has been conirmed that the fallopian tubes have been severed and sealed, to stop eggs from reaching the uterus (tubal sterilisation)

AND• you must use efective methods of contraception for at least 4 weeks before starting treatment, during treatment, and until at least 4 weeks after stopping treatment. Your doctor will advise you on appropriate methods of contraception.

For men taking Lenalidomide Mylan

Lenalidomide Mylan passes into human semen. If your female partner is pregnant or able to become pregnant, and she does not use efective methods of contraception, you must use condoms during treatment and for at least 7 days after the end of treatment, even if you have had a vasectomy.

Driving and using machines

Do not drive or operate machines if you feel dizzy, tired, sleepy, have vertigo or blurred vision after taking Lenalidomide Mylan.

Lenalidomide Mylan contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’

3. How to take Lenalidomide Mylan

Lenalidomide Mylan must be given to you by healthcare professionals with experience in treating multiple myeloma or FL.

• When Lenalidomide Mylan is used to treat multiple myeloma in patients who cannot have a bone marrow transplant or have had other treatments before, it is taken with other medicines (see section 1 ‘What Lenalidomide Mylan is used for’).
• When Lenalidomide Mylan is used to treat multiple myeloma in patients who have had a bone marrow transplant, it is taken alone
• When Lenalidomide Mylan is used to treat follicular lymphoma, it is taken with another medicine called ‘rituximab’.

Always take Lenalidomide Mylan exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

If you are taking Lenalidomide Mylan in combination with other medicines, you should refer to the package lealets for these medicines for further information on their use and efects.

Treatment cycle

Lenalidomide Mylan is taken on certain days over 3 weeks (21 days).

• Every 21 days 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 do not take any of the medicines.
• After completing every 21-day cycle, you should start a new ‘cycle’ over the next 21 days.

OR

Lenalidomide Mylan is taken on certain days over 4 weeks (28 days).

• Every 28 days 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 do not take any of the medicines.
• After completing every 28-day cycle, you should start a new ‘cycle’ over the next 28 days.

How much Lenalidomide Mylan to take

Before you start treatment, your doctor will tell you:

• how much Lenalidomide Mylan you should take
• how much of the other medicines you should take in combination with Lenalidomide Mylan, if any
• on what days of your treatment cycle to take each medicine.

How and when to take Lenalidomide Mylan

• swallow the capsules whole, preferably with water.
• do not break, open or chew the capsules. If powder from a broken Lenalidomide Mylan capsule makes contact with the skin, wash the skin immediately and thoroughly with soap and water.
• healthcare professionals, caregivers and family members should wear disposable gloves when handling the blister or capsule. Gloves should then be removed carefully to prevent skin exposure, placed in a sealable plastic polyethylene bag and disposed of in accordance with local requirements. Hands should then be washed thoroughly with soap and water. Women who are pregnant or suspect they may be pregnant should not handle the blister or capsule.

• the capsules can be taken either with or without food.

• you should take Lenalidomide Mylan at about the same time on the scheduled days.

Taking this medicine

To remove the capsule from the blister:

• press only one end of the capsule out to push it through the foil

  EU hard capsules

lenalidomide

Lenalidomide Mylan 2.5 mg Lenalidomide Mylan 5 mg Lenalidomide Mylan 7.5 mg Lenalidomide Mylan 10 mg

Lenalidomide Mylan 15 mg Lenalidomide Mylan 20 mg Lenalidomide Mylan 25 mg

Read all of this lealet carefully before you start taking this medicine because it contains important information for you.

• Keep this lealet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side efects, talk to your doctor, or pharmacist. This includes any possible side efects not listed in this lealet. See section 4.
• What Lenalidomide Mylan is and what it is used for

• What you need to know before you take

  Lenalidomide Mylan

• How to take Lenalidomide Mylan

  1. 4. Possible side efects
  2. 5. How to store Lenalidomide Mylan
  3. 6. Contents of the pack and other information What is in this lealet

Package lealet: Information for the patient

29 JAN 2021 12:10

do not put pressure on the centre of the capsule, as this can cause it to break.

Duration of the treatment with Lenalidomide Mylan

Lenalidomide Mylan is taken in treatment cycles, each cycle lasting 21 or 28 days (see above ‘Treatment cycle’). You should continue the cycles of treatment until your doctor tells you to stop.

If you take more Lenalidomide Mylan than you should

If you take more Lenalidomide Mylan than was prescribed, tell your doctor immediately.

If you forget to take Lenalidomide Mylan

If you forget to take Lenalidomide Mylan at your regular time and:

• less than 12 hours have passed - take your capsule

  immediately.

• more than 12 hours have passed - do not take your

  capsule. Take your next capsule at the usual time the next day.

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

4. Possible side efects

Like all medicines, Lenalidomide Mylan can cause side efects, although not everybody gets them. Stop taking Lenalidomide Mylan and see a doctor straight away if you notice any of the following serious side efects – you may need urgent medical treatment:

• Hives, rashes, swelling of eyes, mouth or face,

  diiculty breathing, or itching, which may be symptoms of serious types of allergic reactions called angioedema and anaphylactic reaction.

• A serious allergic reaction that may begin as a rash in

  one area but spread with extensive loss of skin over the whole body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).

• Widespread rash, high body temperature, liver

  enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome). See also section 2.

Tell your doctor straight away if you notice any of the following serious side efects:

• Fever, chills, sore throat, cough, mouth ulcers or

  any other symptoms of infection including within the bloodstream (sepsis)

• Bleeding or bruising in the absence of injury
• Chest pain or leg pain
• Shortness of breath

• Bone pain, muscle weakness, confusion or tiredness

  that might be due to high level of calcium in the blood. Lenalidomide Mylan may reduce the number of white blood cells that ight infection and also the blood cells which help the blood to clot (platelets) which may lead to bleeding disorders such as nosebleeds and bruising. Lenalidomide Mylan may also cause blood clots in the veins (thrombosis).

Other side efects

It is important to note that a small number of patients may develop additional types of cancer, and it is possible that this risk may be increased with Lenalidomide Mylan treatment. Therefore, your doctor should carefully evaluate the beneit and risk when you are prescribed Lenalidomide Mylan.

Very common (may afect more than 1 in 10 people):

• A fall in the number of red blood cells which may

  cause anaemia leading to tiredness and weakness

• Rashes, itching

• Muscle cramps, muscle weakness, muscle pain,

  muscle aches, bone pain, joint pain, back pain, pain in the extremities

• Generalised swelling including swelling of your arms

  and legs

• Weakness, tiredness

• Fever and lu like symptoms including fever, muscle

  ache, headache, earache, cough and chills

• Numbness, tingling or burning sensation to the skin,

  pains in hands or feet, dizziness, tremor

• Decreased appetite, changes in the way things taste

• Increase in pain, tumour size or redness around the

  tumour

• Weight loss

• Constipation, diarrhoea, nausea, vomiting, stomach

  pain, heartburn

• Low levels of potassium or calcium and/or sodium in

  the blood

• Thyroid functioning less than it should be

• Leg pain (which could be a symptom of thrombosis),

  chest pain or shortness of breath (which may be a symptom of blood clots in the lungs, called pulmonary embolism)

• Infections of all types, including infection of the

  sinuses that surround the nose, infection of the lung and the upper respiratory tract.

• Shortness of breath
• Blurred vision
• Clouding of your eye (cataract)

• Kidney problems which include kidneys not working

  properly or not being able to maintain normal function

• Abnormal liver test results
• Increase in liver test results

• Changes to a protein in the blood that can cause

  swelling of the arteries (vasculitis)

• Increases in your blood sugar level (diabetes)
• Decreases in your blood sugar levels
• Headache
• Nosebleed
• Dry skin
• Depression, mood change, diiculty sleeping
• Cough
• A fall in blood pressure
• A vague feeling of bodily discomfort, feeling bad
• Sore inlamed mouth, dry mouth
• Dehydration

Common (may afect up to 1 in 10 people):

• Destruction of red blood cells (haemolytic anaemia)
• Certain types of skin tumour
• Bleeding from the gums, stomach, or bowels

• Increased blood pressure, slow, fast or irregular heart

  beat

• Increase in the amount of a substance which

  results from normal and abnormal breakdown of red blood cells

• Increase in a type of protein that indicates

  inlammation in body

• Darkening of your skin, discolouration of your skin

  resulting from bleeding underneath, typically caused by bruising, swelling of the skin illed with blood, bruise

• Increase in uric acid in the blood

• Skin eruptions, redness of skin, cracking, laking or

  peeling skin, hives

• Increased sweating, night sweats

• Diiculty swallowing, sore throat, diiculty with voice

  quality or voice changes

• Runny nose

• Production of much more or much less urine than

  usual or the inability to control when to urinate

• Passing blood in the urine

• Shortness of breath especially when lying down

  (which may be a symptom of heart failure)

• Diiculty getting an erection

• Stroke, fainting, vertigo (problem with your inner ear

  which leads to a feeling that everything is spinning), temporary loss of consciousness

• Chest pain spreading to the arms, neck, jaw, back

  or stomach, feeling sweaty and breathless, feeling sick or vomiting, which may be symptoms of a heart attack (myocardial infarction)

• Muscle weakness, lack of energy
• Neck pain, chest pain
• Chills
• Joint swelling
• Bile low from the liver slowed or blocked
• Low levels of phosphate or magnesium in the blood
• Diiculty speaking
• Liver injury
• Impaired balance, diiculty moving
• Deafness, ringing in the ears (tinnitus)

• Nerve pain, unpleasant abnormal sensation especially

  to touch

• An excess of iron in the body
• Thirst
• Confusion
• Toothache
• Fall which may result in injury

Uncommon (may afect up to 1 in 100 people):

• Bleeding within the skull
• Circulatory problems

• Increase in blood pressure within blood vessels that

  supply the lungs (pulmonary hypertension).

• Loss of vision
• Loss of sex drive (libido)

• Passing large amount of urine with bone pain and

  weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)

• Yellow pigmentation to the skin, mucus membrane or

  eyes (jaundice), pale coloured stools, dark coloured urine, skin itch, rash, pain or swelling of the stomach – these may be symptoms of injury to the liver (hepatic failure)

• Stomach pain, bloating, or diarrhoea, which may be

  symptoms of inlammation in the large intestine (called colitis or caecitis)

• Damage to the cells of the kidney(called renal tubular

  necrosis)

• Changes to the colour of your skin, sensitivity to

  sunlight

• Tumour lysis syndrome - metabolic complications that

  can occur during treatment of cancer and sometimes even without treatment. These complications are caused by the break-down products of dying cancer cells and may include the following: changes to blood chemistry; high potassium, phosphorus,

  uric acid, and low calcium consequently leading to changes in kidney function, heart beat, seizures, and sometimes death.

  Not known (frequency cannot be estimated from the available data):

  • Sudden, or mild but worsening pain in the upper stomach and/or back, which remains for a few days, possibly accompanied by nausea, vomiting, fever and a rapid pulse – these symptoms may be due to inlammation of the pancreas.
  • Wheezing, shortness of breath or a dry cough, which may be symptoms caused by inlammation of the tissue in the lungs.
  • Rare cases of muscle breakdown (muscle pain, weakness or swelling) which can lead to kidney problems (rhabdomyolysis) have been observed, some of them when Lenalinomide Mylan is administered with a statin (a type of cholesterol lowering medicines).
  • A condition afecting the skin caused by inlammation of small blood vessels, along with pain in the joints and fever (leukocytoclastic vasculitis).
  • Breakdown of the wall of the stomach or gut. This may lead to very serious infection. Tell your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in your stool, or changes in bowel habits.
  • Viral infections, including herpes zoster (also known as ‘shingles’, a viral disease that causes a painful skin rash with blisters) and recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown-colored urine, right-sided stomach pain, fever and feeling nauseous or being sick).
  • Rejection of solid organ transplant (such as kidney, heart).

Reporting of side efects

If you get any side efects, talk to your doctor, pharmacist or nurse. This includes any possible side efects not listed in this lealet. You can also report side efects directly via the national reporting system listed in Appendix V. By reporting side efects you can help provide more information on the safety of this medicine.

5. How to store Lenalidomide Mylan

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date, which is stated on the blister and on the carton after ‘EXP’. The expiry date refers to the last day of that month.
• Do not store above 30°C.
• Do not use this medicine if you notice any damage or signs of tampering to the pack
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Lenalidomide Mylan contains

Lenalidomide Mylan 2.5 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.

• The other ingredients are:

  • capsule contents: pregelatinized starch, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, sodium stearyl fumarate
  • capsule shell: gelatine, titanium dioxide [E171], yellow iron oxide [E172] and indigo carmine [E132]
  • printing ink: shellac, propylene glycol [E1520], potassium hydroxide and black iron oxide [E172]. Lenalidomide Mylan 5 mg hard capsules:
• The active substance is lenalidomide. Each capsule contains 5 mg of lenalidomide.

• The other ingredients are:

  • capsule contents: pregelatinized starch, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, sodium stearyl fumarate
  • capsule shell: titanium dioxide [E171], gelatin
  • printing ink: shellac, propylene glycol [E1520], potassium hydroxide and black iron oxide [E172]. Lenalidomide Mylan 7.5 mg hard capsules:
• The active substance is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.

• The other ingredients are:

  • capsule contents: pregelatinized starch, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, sodium stearyl fumarate
  • capsule shell: yellow iron oxide [E172], titanium dioxide [E171], gelatin,
  • printing ink: shellac propylene glycol [E1520], black iron oxide [E172] and potassium hydroxide Lenalidomide Mylan 10 mg hard capsules:
• The active substance is lenalidomide. Each capsule contains 10 mg of lenalidomide.

• The other ingredients are:

  • capsule contents: pregelatinized starch, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, sodium stearyl fumarate
  • capsule shell: gelatine, titanium dioxide [E171], black iron oxide and yellow iron oxide [E172], indigo carmine[E132]
  • printing ink: shellac, propylene glycol [E1520], black iron oxide [E172]and potassium hydroxide Lenalidomide Mylan 15 mg hard capsules:
• The active substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.

• The other ingredients are:

  • capsule contents: pregelatinized starch, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, sodium stearyl fumarate
  • capsule shell: titanium dioxide [E171], gelatin
  • printing ink: shellac, propylene glycol [E1520], red iron oxide [E172] and simeticone

Lenalidomide Mylan 20 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 20 mg of lenalidomide.

• The other ingredients are:

  • capsule contents: pregelatinized starch, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, sodium stearyl fumarate
  • capsule shell: yellow iron oxide [E172], titanium dioxide, indigo carmine [E132], gelatin
  • printing ink: shellac, propylene glycol [E1520], red iron oxide [E172] and simeticone

Lenalidomide Mylan 25 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 25 mg of lenalidomide.

• The other ingredients are:

  • capsule contents: pregelatinized starch, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, sodium stearyl fumarate
  • capsule shell: titanium dioxide [E171], gelatin
  • printing ink: shellac, propylene glycol [E1520], potassium hydroxide, and black iron oxide [E172]. What Lenalidomide Mylan looks like and contents of the pack

Lenalidomide Mylan 2.5 mg hard capsules are green and white capsules, size 4, 14 mm, marked “MYLAN/LL 2.5”

Lenalidomide Mylan 5 mg hard capsules are white capsules, size 2, 18 mm, marked “MYLAN/LL 5” Lenalidomide Mylan 7.5 mg hard capsules are light grey and white capsules, size 2, 18 mm, marked “MYLAN/LL7.5”

Lenalidomide Mylan 10 mg hard capsules are green and light grey capsules, size 0, 22 mm, marked “MYLAN/LL 10”

Lenalidomide Mylan 15 mg hard capsules are white capsules, size 0, 22 mm, marked “MYLAN/LL15” Lenalidomide Mylan 20 mg hard capsules are green and white capsules, size 0, 22 mm, marked “MYLAN/LL 20”

Lenalidomide Mylan 25 mg hard capsules are white capsules, size 0, 22 mm, marked “MYLAN/LL 25” Lenalidomide Mylan 2.5 mg, 7.5 mg, 20 mg and 25 mg hard capsules are provided in blister packs containing 7 hard capsules.

Lenalidomide Mylan 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg and 25 mg hard capsules are provided in blister packs containing 21 hard capsules and in perforated blister packs containing 21 x 1 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan Ireland Limited

Unit 35/36 Grange Parade,

Baldoyle Industrial Estate

Dublin 13,

Ireland.

Manufacturer

McDermott Laboratories Ltd trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Mylan Hungary Kft, Mylan utca 1, 2900 Komárom, Hungary

Mylan UK Healthcare Limited, Building 20, Station Close, Potters Bar, EN6 1TL, United Kingdom For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom

Generics [UK] Ltd

Tel: +44 1707 853000

Ireland

Mylan Ireland Limited Tel: +353 (0) 87 1694982

This lealet was last revised in <{MM/YYYY}>. Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:

http://www.ema.europa.eu/.

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