Patient leaflet - Imbruvica

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

IMBRUVICA 140 mg hard capsules ibrutinib

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 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 effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What IMBRUVICA is and what it is used for

What IMBRUVICA is

IMBRUVICA is an anticancer medicine that contains the active substance ibrutinib. It belongs to a class of medicines called protein kinase inhibitors.

What IMBRUVICA is used for

It is used to treat the following blood cancers in adults:

Mantle cell lymphoma (MCL), a type of cancer affecting the lymph nodes, when the disease has

come back or has not responded to treatment.

Chronic lymphocytic leukaemia (CLL) a type of cancer affecting white blood cells called

lymphocytes that also involves the lymph nodes. IMBRUVICA is used in patients who have not previously been treated for CLL or when the disease has come back or has not responded to treatment.

Waldenstrom’s macroglobulinaemia (WM), a type of cancer affecting white blood cells called lymphocytes. It is used in patients who have not previously been treated for WM or when the disease has come back or has not responded to treatment or in patients for whom chemotherapy given together with an antibody is not a suitable therapy.

How IMBRUVICA works

In MCL, CLL and WM, IMBRUVICA works by blocking Bruton's tyrosine kinase, a protein in the body that helps these cancer cells grow and survive. By blocking this protein, IMBRUVICA helps kill and reduce the number of cancer cells. It also slows down the worsening of the cancer.

2. What you need to know before you take IMBRUVICA

Do not take IMBRUVICA

if you are allergic to ibrutinib or any of the other ingredients of this medicine (listed in
section 6)

if you are taking a herbal medicine called St. John’s Wort, used for depression. If you are not

sure about this, talk to your doctor, pharmacist or nurse before taking this medicine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking IMBRUVICA:

if you have ever had unusual bruising or bleeding or are on any medicines or supplements that

increase your risk of bleeding (see section “Other medicines and IMBRUVICA” )

if you have irregular heart beat or have a history of irregular heart beat or severe heart failure, or

if you feel any of the following: shortness of breath, weakness, dizziness, light-headedness, fainting or near fainting, chest pain or swollen legs

if you have liver problems, including if you ever had or now have a hepatitis B infection (a liver

infection)

if you have high blood pressure
if you have recently had any surgery, especially if this might affect how you absorb food or

medicines from your stomach or gut

if you are planning to have any surgery- your doctor may ask you to stop taking IMBRUVICA

for a short time (3 to 7 days) before and after your surgery

if you have kidney problems.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before or while taking this medicine (see section

“Possible side effects”

When taking IMBRUVICA, tell your doctor immediately if you notice or someone notices in you: memory loss, trouble thinking, difficulty walking or sight loss – these may be due to a very rare but serious brain infection which can be fatal (Progressive Multifocal Leukoencephalopathy or PML).

Tell your doctor immediately if you notice or someone notices in you: sudden numbness or weakness in the limbs (especially on one side of the body), sudden confusion, trouble speaking or understanding speech, sight loss, difficulty walking, loss of balance or lack of coordination, sudden severe headache with no known cause. These may be signs and symptoms of stroke.

Tell your doctor immediately if you develop left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder (these may be symptoms of rupture of the spleen) after you stop taking IMBRUVICA.

Tell your doctor immediately if you notice breathlessness, difficulty breathing when lying down, swelling of the feet, ankles or legs and weakness/tiredness (these may be signs of heart failure) during treatment with IMBRUVICA.

You may experience viral, bacterial, or fungal infections during treatment with IMBRUVICA. Contact your doctor if you have fever, chills, weakness, confusion, body aches, cold or flu symptoms, feel tired or feel short of breath, yellowing of the skin or eyes (jaundice). These could be signs of an infection.

Haemophagocytic lymphohistiocytosis

There have been rare reports of excessive activation of white blood cells associated with inflammation (haemophagocytic lymphohistiocytosis), which can be fatal if not diagnosed and treated early. If you experience multiple symptoms such as fever, swollen glands, bruising, or skin rash, contact your doctor immediately.

Tests and check-ups before and during treatment

Tumour lysis syndrome (TLS): Unusual levels of chemicals in the blood caused by the fast breakdown of cancer cells have happened during treatment of cancer and sometimes even without treatment. This may lead to changes in kidney function, abnormal heartbeat, or seizures. Your doctor or another healthcare provider may do blood tests to check for TLS.

Lymphocytosis: Laboratory tests may show an increase in white blood cells (called “lymphocytes”) in your blood in the first few weeks of treatment. This is expected and may last for a few months. This does not necessarily mean that your blood cancer is getting worse. Your doctor will check your blood counts before or during the treatment and in rare cases they may need to give you another medicine. Talk to your doctor about what your test results mean.

Events related to the liver: Your doctor will do some blood tests to check whether your liver is working properly or that you do not have a liver infection, known as viral hepatitis, or whether hepatitis B has become active again, which could be fatal.

Children and adolescents

IMBRUVICA should not be used in children and adolescents. This is because it has not been studied in these age groups.

Other medicines and IMBRUVICA

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, herbal medicines and supplements. This is because IMBRUVICA may affect the way some other medicines work. Also some other medicines can affect the way IMBRUVICA works.

IMBRUVICA may make you bleed more easily. This means you should tell your doctor if you take other medicines that increase your risk of bleeding. This includes:

acetyl salicylic acid and non-steroidal anti-inflammatories (NSAIDs) such as ibuprofen or

naproxen

blood thinners such as warfarin, heparin or other medicines for blood clots
supplements that may increase your risk of bleeding such as fish oil, vitamin E or flaxseed.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking IMBRUVICA.

Also tell your doctor if you take any of the following medicines – The effects of IMBRUVICA or other medicines may be influenced if you take IMBRUVICA together with any of the following medicines:

medicines called antibiotics to treat bacterial infections – clarithromycin, telithromycin,

ciprofloxacin, erythromycin or rifampicin

medicines for fungal infections – posaconazole, ketoconazole, itraconazole, fluconazole or

voriconazole

medicines for HIV infection – ritonavir, cobicistat, indinavir, nelfinavir, saquinavir, amprenavir,

atazanavir, or fosamprenavir

medicines to prevent nausea and vomiting associated with chemotherapy – aprepitant
medicines for depression – nefazodon
medicines called kinase inhibitors for treatment of other cancers – crizotinib or imatinib
medicines called calcium channel blockers for high blood pressure or chest pain – diltiazem or

verapamil

medicines called statins to treat high cholesterol – rosuvastatin
heart medicines/anti-arrhythmics – amiodarone or dronedarone
medicines to prevent seizures or to treat epilepsy, or medicines to treat a painful condition of the

face called trigeminal neuralgia – carbamazepine or phenytoin.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking IMBRUVICA.

If you are taking digoxin, a medicine used for heart problems, or methotrexate, a medicine used to treat other cancers and to reduce the activity of the immune system (e.g., for rheumatoid arthritis or psoriasis), it should be taken at least 6 hours before or after IMBRUVICA.

IMBRUVICA with food

Do not take IMBRUVICA with grapefruit or Seville oranges (bitter oranges) – this includes eating them, drinking the juice or taking a supplement that might contain them. This is because it can increase the amount of IMBRUVICA in your blood.

Pregnancy and breast-feeding

Do not get pregnant while you are taking this medicine. IMBRUVICA should not be used during pregnancy. There is no information about the safety of IMBRUVICA in pregnant women.

Women of childbearing age must use a highly effective method of birth control during and up to three months after receiving IMBRUVICA, to avoid becoming pregnant while being treated with IMBRUVICA.

Tell your doctor immediately if you become pregnant.
Do not breast-feed while you are taking this medicine.

Driving and using machines

You may feel tired or dizzy after taking IMBRUVICA, which may affect your ability to drive or use any tools or machines.

IMBRUVICA contains sodium

IMBRUVICA contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

3. How to take IMBRUVICA

Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to take

Mantle cell lymphoma (MCL)

The recommended dose of IMBRUVICA is four capsules (560 mg) once a day.

Chronic lymphocytic leukaemia (CLL)/Waldenstrom’s macroglobulinaemia (WM)

The recommended dose of IMBRUVICA is three capsules (420 mg) once a day.

Your doctor may adjust your dose.

Taking this medicine

Take the capsules orally (by mouth) with a glass of water.
Take the capsules about the same time each day.
Swallow the capsules whole. Do not open, break or chew them.

If you take more IMBRUVICA than you should

If you take more IMBRUVICA than you should, talk to a doctor or go to a hospital straight away.

Take the capsules and this leaflet with you.

If you forget to take IMBRUVICA

If you miss a dose, it can be taken as soon as possible on the same day with a return to the

normal schedule the following day.

Do not take a double dose to make up for a forgotten dose.
If you are not sure, talk to your doctor, pharmacist or nurse about when to take your next dose.

If you stop taking IMBRUVICA

Do not stop taking this medicine unless your doctor tells you.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may happen with this medicine:

Stop taking IMBRUVICA and tell a doctor straight away if you notice any of the following side effects:

itchy bumpy rash, difficulty breathing, swelling of your face, lips, tongue or throat – you may be having an allergic reaction to the medicine.

Tell a doctor straight away if you notice any of the following side effects:

Very common (may affect more than 1 in 10 people)

fever, chills, body aches, feeling tired, cold or flu symptoms, being short of breath – these could

be signs of an infection (viral, bacterial or fungal). These could include infections of the nose, sinus or throat (upper respiratory tract infection), or lung, or skin

bruising or increased tendency of bruising
mouth sores
feeling dizzy
headache
constipation
feeling or being sick (nausea or vomiting)
diarrhoea, your doctor may need to give you a fluid and salt replacement or another medicine
skin rash
painful arms or legs
back pain or joint pain
muscle cramps, aches or spasms
low number of cells that help blood clot (platelets), very low number of white blood cells –

shown in blood tests

an increase in the number or proportion of white blood cells shown in blood tests
high level of “uric acid” in the blood (shown in blood tests), which may cause gout
swollen hands, ankles or feet
high blood pressure
increased level of “creatinine” in the blood.

Common (may affect up to 1 in 10 people)

severe infections throughout the body (sepsis)
infections of the urinary tract
nose bleeds, small red or purple spots caused by bleeding under the skin
blood in your stomach, gut, stools or urine, heavier periods, or bleeding that you cannot stop

from an injury

heart failure
fast heart rate, missed heart beats, weak or uneven pulse, lightheadedness, shortness of breath,

chest discomfort (symptoms of heart rhythm problems)

low white blood cell counts with fever (febrile neutropenia)
non-melanoma skin cancer, most frequently squamous cell and basal cell skin cancer
blurred vision
redness of the skin
inflammation within the lungs that may lead to permanent damage
breaking of the nails
weakness, numbness, tingling or pain in your hands or feet or other parts of the body (peripheral

neuropathy).

Uncommon (may affect up to 1 in 100 people)

liver failure, including events with fatal outcome
severe fungal infections
confusion, headache with slurred speech or feeling faint – these could be signs of serious

internal bleeding in your brain

unusual levels of chemicals in the blood caused by the fast breakdown of cancer cells have

happened during treatment of cancer and sometimes even without treatment (tumour lysis syndrome)

allergic reaction, sometimes severe, that may include a swollen face, lip, mouth, tongue or

throat, difficulty swallowing or breathing, itchy rash (hives)

inflammation of the fatty tissue underneath the skin
temporary episode of decreased brain or nerve function caused by loss of blood flow, stroke
bleeding in the eye (in some cases associated with loss of vision)
painful skin ulceration (pyoderma gangrenosum) or red, raised painful patches on the skin, fever

and an increase in white blood cells (these may be signs of acute febrile neutrophilic dermatosis or Sweet’s syndrome).

Rare (may affect up to 1 in 1,000 people)

severely increased white blood cell count that may cause cells to clump together.

Not known (frequency cannot be estimated from available data)

severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals

(Stevens-Johnson syndrome).

Reporting of side effects

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

5. How to store IMBRUVICA

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 carton and bottle label after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 IMBRUVICA contains

The active substance is ibrutinib. Each hard capsule contains 140 mg of ibrutinib.
The other ingredients are:
– capsule content: croscarmellose sodium, magnesium stearate, microcrystalline cellulose

and sodium lauril sulfate (E487)

– capsule shell: gelatin and titanium dioxide (E171)
– printing ink: shellac, black iron oxide (E172), and propylene glycol (E1520).

What IMBRUVICA looks like and contents of the pack

IMBRUVICA are white opaque, hard capsules marked with “ibr 140 mg” in black ink on one side.

The capsules are provided in a plastic bottle with a child resistant polypropylene closure. Each bottle contains either 90 or 120 capsules. Each pack contains one bottle.

Marketing Authorisation Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Pharmaceutica NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Janssen-Cilag NV

Tel/Tél: +32 14 64 94 11

Lietuva

UAB „JOHNSON & JOHNSON“

Tel: +370 5 278 68 88

Efc^rapufl

„Æ'/KOHC'bH & ^-/KOHCbH Ebnrapua” EOOfl

Ten.: +359 2 489 94 00

Luxembourg/Luxemburg

Janssen-Cilag NV

Tél/Tel: +32 14 64 94 11

Česká republika

Janssen-Cilag s.r.o.

Tel: +420 227 012 227

Magyarország

Janssen-Cilag Kft.

Tel.: +36 1 884 2858

Danmark

Janssen-Cilag A/S Tlf: +45 4594 8282

Malta

AM MANGION LTD.

Tel: +356 2397 6000

Deutschland

Janssen-Cilag GmbH

Tel: +49 2137 955 955

Nederland

Janssen-Cilag B.V.

Tel: +31 76 711 1111

Eesti

UAB „JOHNSON & JOHNSON“ Eesti filiaal

Tel: +372 617 7410

Norge

Janssen-Cilag AS

Tlf: +47 24 12 65 00

EÀÀàôa

Janssen-Cilag OappaKsuTiK^ A.E.B.E.

Tql: +30 210 80 90 000

Österreich

Janssen-Cilag Pharma GmbH

Tel: +43 1 610 300

España

Janssen-Cilag, S.A.

Tel: +34 91 722 81 00

Polska

Janssen-Cilag Polska Sp. z o.o.

Tel.:+48 22 237 60 00

France

Janssen-Cilag

Tél: 0 800 25 50 75 / +33 1 55 00 40 03

Portugal

Janssen-Cilag Farmacêutica, Lda.

Tel: +351 214 368 600

Hrvatska

Johnson & Johnson S.E. d.o.o.

Tel: +385 1 6610 700

România

Johnson & Johnson România SRL

Tel: +40 21 207 1800

Ireland

Janssen Sciences Ireland UC

Tel: +353 1 800 709 122

Slovenija

Johnson & Johnson d.o.o.

Tel.: +386 1 401 18 00

Ísland

Janssen-Cilag AB c/o Vistor hf

Sími: +354 535 7000

Slovenská republika

Johnson & Johnson, s.r.o.

Tel: +421 232 408 400

Italia

Janssen-Cilag SpA

Tel: 800 688 777 / +39 02 2510 1

Suomi/Finland

Janssen-Cilag Oy

Puh/Tel: +358 207 531 300

Kùnpoç

Bapváßaç XaTZnnavaY^ç Ató

Tql: +357 22 207 700

Sverige

Janssen-Cilag AB

Tfn: +46 8 626 50 00

Latvija

UAB „JOHNSON & JOHNSON“ filiäle Latvijä

Tel: +371 678 93561

United Kingdom (Northern Ireland)

Janssen Sciences Ireland UC

Tel: +44 1 494 567 444

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

Package leaflet: Information for the patient

IMBRUVICA 140 mg film-coated tablets

IMBRUVICA 280 mg film-coated tablets

IMBRUVICA 420 mg film-coated tablets

IMBRUVICA 560 mg film-coated tablets ibrutinib

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 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 effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What IMBRUVICA is and what it is used for

What IMBRUVICA is

IMBRUVICA is an anticancer medicine that contains the active substance ibrutinib. It belongs to a class of medicines called protein kinase inhibitors.

What IMBRUVICA is used for

It is used to treat the following blood cancers in adults:

Mantle cell lymphoma (MCL), a type of cancer affecting the lymph nodes, when the disease has

come back or has not responded to treatment.

Chronic lymphocytic leukaemia (CLL) a type of cancer affecting white blood cells called

lymphocytes that also involves the lymph nodes. IMBRUVICA is used in patients who have not previously been treated for CLL or when the disease has come back or has not responded to treatment.

Waldenstrom’s macroglobulinaemia (WM), a type of cancer affecting white blood cells called lymphocytes. It is used in patients who have not previously been treated for WM or when the disease has come back or has not responded to treatment or in patients for whom chemotherapy given together with an antibody is not a suitable therapy.

How IMBRUVICA works

2. What you need to know before you take IMBRUVICA

Do not take IMBRUVICA

if you are allergic to ibrutinib or any of the other ingredients of this medicine (listed in

section 6)

if you are taking a herbal medicine called St. John’s Wort, used for depression. If you are not

sure about this, talk to your doctor, pharmacist or nurse before taking this medicine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking IMBRUVICA:

if you have ever had unusual bruising or bleeding or are on any medicines or supplements that

increase your risk of bleeding (see section “Other medicines and IMBRUVICA” )

if you have irregular heart beat or have a history of irregular heart beat or severe heart failure, or

if you feel any of the following: shortness of breath, weakness, dizziness, light-headedness, fainting or near fainting, chest pain or swollen legs

if you have liver problems, including if you ever had or now have a hepatitis B infection (a liver

infection)

if you have high blood pressure
if you have recently had any surgery, especially if this might affect how you absorb food or

medicines from your stomach or gut

if you are planning to have any surgery- your doctor may ask you to stop taking IMBRUVICA

for a short time (3 to 7 days) before and after your surgery

if you have kidney problems.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before or while taking this medicine (see section

“Possible side effects”

Haemophagocytic lymphohistiocytosis

Tests and check-ups before and during treatment

Children and adolescents

IMBRUVICA should not be used in children and adolescents. This is because it has not been studied in these age groups.

Other medicines and IMBRUVICA

IMBRUVICA may make you bleed more easily. This means you should tell your doctor if you take other medicines that increase your risk of bleeding. This includes:

acetyl salicylic acid and non-steroidal anti-inflammatories (NSAIDs) such as ibuprofen or

naproxen

blood thinners such as warfarin, heparin or other medicines for blood clots
supplements that may increase your risk of bleeding such as fish oil, vitamin E or flaxseed.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking IMBRUVICA.

medicines called antibiotics to treat bacterial infections – clarithromycin, telithromycin,

ciprofloxacin, erythromycin or rifampicin

medicines for fungal infections – posaconazole, ketoconazole, itraconazole, fluconazole or

voriconazole

medicines for HIV infection – ritonavir, cobicistat, indinavir, nelfinavir, saquinavir, amprenavir,

atazanavir, or fosamprenavir

medicines to prevent nausea and vomiting associated with chemotherapy – aprepitant
medicines for depression – nefazodon
medicines called kinase inhibitors for treatment of other cancers – crizotinib or imatinib
medicines called calcium channel blockers for high blood pressure or chest pain – diltiazem or

verapamil

medicines called statins to treat high cholesterol – rosuvastatin
heart medicines/anti-arrhythmics – amiodarone or dronedarone
medicines to prevent seizures or to treat epilepsy, or medicines to treat a painful condition of the

face called trigeminal neuralgia – carbamazepine or phenytoin.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking IMBRUVICA.

IMBRUVICA with food

Pregnancy and breast-feeding

Do not get pregnant while you are taking this medicine. IMBRUVICA should not be used during pregnancy. There is no information about the safety of IMBRUVICA in pregnant women.

Women of childbearing age must use a highly effective method of birth control during and up to three months after receiving IMBRUVICA, to avoid becoming pregnant while being treated with IMBRUVICA.

Tell your doctor immediately if you become pregnant.
Do not breast-feed while you are taking this medicine.

Driving and using machines

You may feel tired or dizzy after taking IMBRUVICA, which may affect your ability to drive or use any tools or machines.

IMBRUVICA contains lactose

IMBRUVICA contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

IMBRUVICA contains sodium

IMBRUVICA contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

3. How to take IMBRUVICA

Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to take

Mantle cell lymphoma (MCL)

The recommended dose of IMBRUVICA is 560 mg once a day.

Chronic lymphocytic leukaemia (CLL)/Waldenström’s macroglobulinaemia (WM)

The recommended dose of IMBRUVICA is 420 mg once a day.

Your doctor may adjust your dose.

Taking this medicine

Take the tablets orally (by mouth) with a glass of water.
Take the tablets about the same time each day.
Swallow the tablets whole. Do not break or chew them.

If you take more IMBRUVICA than you should

If you take more IMBRUVICA than you should, talk to a doctor or go to a hospital straight away.

Take the tablets and this leaflet with you.

If you forget to take IMBRUVICA

If you miss a dose, it can be taken as soon as possible on the same day with a return to the

normal schedule the following day.

Do not take a double dose to make up for a forgotten dose.
If you are not sure, talk to your doctor, pharmacist or nurse about when to take your next dose.

If you stop taking IMBRUVICA

Do not stop taking this medicine unless your doctor tells you.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may happen with this medicine:

Stop taking IMBRUVICA and tell a doctor straight away if you notice any of the following side effects:

itchy bumpy rash, difficulty breathing, swelling of your face, lips, tongue or throat – you may be having an allergic reaction to the medicine.

Tell a doctor straight away if you notice any of the following side effects:

Very common (may affect more than 1 in 10 people)

fever, chills, body aches, feeling tired, cold or flu symptoms, being short of breath – these could

be signs of an infection (viral, bacterial or fungal). These could include infections of the nose, sinus or throat (upper respiratory tract infection), or lung, or skin

bruising or increased tendency of bruising
mouth sores
feeling dizzy
headache
constipation
feeling or being sick (nausea or vomiting)
diarrhoea, your doctor may need to give you a fluid and salt replacement or another medicine
skin rash
painful arms or legs
back pain or joint pain
muscle cramps, aches or spasms
low number of cells that help blood clot (platelets), very low number of white blood cells –

shown in blood tests

an increase in the number or proportion of white blood cells shown in blood tests
high level of “uric acid” in the blood (shown in blood tests), which may cause gout
swollen hands, ankles or feet
high blood pressure
increased level of “creatinine” in the blood.

Common (may affect up to 1 in 10 people)

severe infections throughout the body (sepsis)
infections of the urinary tract
nose bleeds, small red or purple spots caused by bleeding under the skin
blood in your stomach, gut, stools or urine, heavier periods, or bleeding that you cannot stop

from an injury

heart failure
fast heart rate, missed heart beats, weak or uneven pulse, lightheadedness, shortness of breath,

chest discomfort (symptoms of heart rhythm problems)

low white blood cell counts with fever (febrile neutropenia)
non-melanoma skin cancer, most frequently squamous cell and basal cell skin cancer
blurred vision
redness of the skin
inflammation within the lungs that may lead to permanent damage
breaking of the nails
weakness, numbness, tingling or pain in your hands or feet or other parts of the body (peripheral

neuropathy).

Uncommon (may affect up to 1 in 100 people)

liver failure, including events with fatal outcome
severe fungal infections
confusion, headache with slurred speech or feeling faint – these could be signs of serious

internal bleeding in your brain

unusual levels of chemicals in the blood caused by the fast breakdown of cancer cells have

happened during treatment of cancer and sometimes even without treatment (tumour lysis syndrome)

allergic reaction, sometimes severe, that may include a swollen face, lip, mouth, tongue or

throat, difficulty swallowing or breathing, itchy rash (hives)

inflammation of the fatty tissue underneath the skin
temporary episode of decreased brain or nerve function caused by loss of blood flow, stroke
bleeding in the eye (in some cases associated with loss of vision)
painful skin ulceration (pyoderma gangrenosum) or red, raised painful patches on the skin, fever

and an increase in white blood cells (these may be signs of acute febrile neutrophilic dermatosis or Sweet’s syndrome).

Rare (may affect up to 1 in 1,000 people)

severely increased white blood cell count that may cause cells to clump together.

Not known (frequency cannot be estimated from available data)

severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals

(Stevens-Johnson syndrome).

Reporting of side effects

5. How to store IMBRUVICA

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 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 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 IMBRUVICA contains

The active substance is ibrutinib.
– IMBRUVICA 140 mg film-coated tablets: Each tablet contains 140 mg of ibrutinib.
– IMBRUVICA 280 mg film-coated tablets: Each tablet contains 280 mg of ibrutinib.
– IMBRUVICA 420 mg film-coated tablets: Each tablet contains 420 mg of ibrutinib.
– IMBRUVICA 560 mg film-coated tablets: Each tablet contains 560 mg of ibrutinib.

The other ingredients are:
Tablet core: colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate (see

section 2 “IMBRUVICA contains lactose” ), magnesium stearate, microcrystalline cellulose, povidone, sodium lauril sulfate (E487).

Tablet film-coat: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171);

IMBRUVICA 140 mg and IMBRUVICA 420 mg film-coated tablets also contain black iron oxide (E172) and yellow iron oxide (E172);

IMBRUVICA 280 mg film-coated tablets also contain black iron oxide (E172) and red iron oxide (E172);

IMBRUVICA 560 mg film-coated tablets also contain red iron oxide (E172) and yellow iron oxide (E172).

What IMBRUVICA looks like and contents of the pack

IMBRUVICA are white opaque, hard capsules marked with “ibr 140 mg” in black ink on one side.

The capsules are provided in a plastic bottle with a child resistant polypropylene closure. Each bottle contains either 90 or 120 capsules. Each pack contains one bottle.

Marketing Authorisation Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Pharmaceutica NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Janssen-Cilag NV

Tel/Tél: +32 14 64 94 11

Lietuva

UAB „JOHNSON & JOHNSON“

Tel: +370 5 278 68 88

Efc^rapufl

„Æ'/KOHC'bH & ^-/KOHCbH Ebnrapua” EOOfl

Ten.: +359 2 489 94 00

Luxembourg/Luxemburg

Janssen-Cilag NV

Tél/Tel: +32 14 64 94 11

Česká republika

Janssen-Cilag s.r.o.

Tel: +420 227 012 227

Magyarország

Janssen-Cilag Kft.

Tel.: +36 1 884 2858

Danmark

Janssen-Cilag A/S Tlf: +45 4594 8282

Malta

AM MANGION LTD.

Tel: +356 2397 6000

Deutschland

Janssen-Cilag GmbH

Tel: +49 2137 955 955

Nederland

Janssen-Cilag B.V.

Tel: +31 76 711 1111

Eesti

UAB „JOHNSON & JOHNSON“ Eesti filiaal

Tel: +372 617 7410

Norge

Janssen-Cilag AS

Tlf: +47 24 12 65 00

EÀÀàôa

Janssen-Cilag OappaKsuTiK^ A.E.B.E.

Tql: +30 210 80 90 000

Österreich

Janssen-Cilag Pharma GmbH

Tel: +43 1 610 300

España

Janssen-Cilag, S.A.

Tel: +34 91 722 81 00

Polska

Janssen-Cilag Polska Sp. z o.o.

Tel.:+48 22 237 60 00

France

Janssen-Cilag

Tél: 0 800 25 50 75 / +33 1 55 00 40 03

Portugal

Janssen-Cilag Farmacêutica, Lda.

Tel: +351 214 368 600

Hrvatska

Johnson & Johnson S.E. d.o.o.

Tel: +385 1 6610 700

România

Johnson & Johnson România SRL

Tel: +40 21 207 1800

Ireland

Janssen Sciences Ireland UC

Tel: +353 1 800 709 122

Slovenija

Johnson & Johnson d.o.o.

Tel.: +386 1 401 18 00

Ísland

Janssen-Cilag AB c/o Vistor hf

Sími: +354 535 7000

Slovenská republika

Johnson & Johnson, s.r.o.

Tel: +421 232 408 400

Italia

Janssen-Cilag SpA

Tel: 800 688 777 / +39 02 2510 1

Suomi/Finland

Janssen-Cilag Oy

Puh/Tel: +358 207 531 300

Kùnpoç

Bapváßaç XaTZnnavaY^ç Ató

Tql: +357 22 207 700

Sverige

Janssen-Cilag AB

Tfn: +46 8 626 50 00

Latvija

UAB „JOHNSON & JOHNSON“ filiäle Latvijä

Tel: +371 678 93561

United Kingdom (Northern Ireland)

Janssen Sciences Ireland UC

Tel: +44 1 494 567 444

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

Package leaflet: Information for the patient

IMBRUVICA 140 mg film-coated tablets

IMBRUVICA 280 mg film-coated tablets

IMBRUVICA 420 mg film-coated tablets

IMBRUVICA 560 mg film-coated tablets ibrutinib

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 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 effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What IMBRUVICA is and what it is used for

What IMBRUVICA is

IMBRUVICA is an anticancer medicine that contains the active substance ibrutinib. It belongs to a class of medicines called protein kinase inhibitors.

What IMBRUVICA is used for

It is used to treat the following blood cancers in adults:

Mantle cell lymphoma (MCL), a type of cancer affecting the lymph nodes, when the disease has

come back or has not responded to treatment.

Chronic lymphocytic leukaemia (CLL) a type of cancer affecting white blood cells called

lymphocytes that also involves the lymph nodes. IMBRUVICA is used in patients who have not previously been treated for CLL or when the disease has come back or has not responded to treatment.

Waldenstrom’s macroglobulinaemia (WM), a type of cancer affecting white blood cells called lymphocytes. It is used in patients who have not previously been treated for WM or when the disease has come back or has not responded to treatment or in patients for whom chemotherapy given together with an antibody is not a suitable therapy.

How IMBRUVICA works

2. What you need to know before you take IMBRUVICA

Do not take IMBRUVICA

if you are allergic to ibrutinib or any of the other ingredients of this medicine (listed in

section 6)

if you are taking a herbal medicine called St. John’s Wort, used for depression. If you are not

sure about this, talk to your doctor, pharmacist or nurse before taking this medicine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking IMBRUVICA:

if you have ever had unusual bruising or bleeding or are on any medicines or supplements that

increase your risk of bleeding (see section “Other medicines and IMBRUVICA” )

if you have irregular heart beat or have a history of irregular heart beat or severe heart failure, or

if you feel any of the following: shortness of breath, weakness, dizziness, light-headedness, fainting or near fainting, chest pain or swollen legs

if you have liver problems, including if you ever had or now have a hepatitis B infection (a liver

infection)

if you have high blood pressure
if you have recently had any surgery, especially if this might affect how you absorb food or

medicines from your stomach or gut

if you are planning to have any surgery- your doctor may ask you to stop taking IMBRUVICA

for a short time (3 to 7 days) before and after your surgery

if you have kidney problems.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before or while taking this medicine (see section

“Possible side effects”

Haemophagocytic lymphohistiocytosis

Tests and check-ups before and during treatment

Children and adolescents

IMBRUVICA should not be used in children and adolescents. This is because it has not been studied in these age groups.

Other medicines and IMBRUVICA

IMBRUVICA may make you bleed more easily. This means you should tell your doctor if you take other medicines that increase your risk of bleeding. This includes:

acetyl salicylic acid and non-steroidal anti-inflammatories (NSAIDs) such as ibuprofen or

naproxen

blood thinners such as warfarin, heparin or other medicines for blood clots
supplements that may increase your risk of bleeding such as fish oil, vitamin E or flaxseed.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking IMBRUVICA.

medicines called antibiotics to treat bacterial infections – clarithromycin, telithromycin,

ciprofloxacin, erythromycin or rifampicin

medicines for fungal infections – posaconazole, ketoconazole, itraconazole, fluconazole or

voriconazole

medicines for HIV infection – ritonavir, cobicistat, indinavir, nelfinavir, saquinavir, amprenavir,

atazanavir, or fosamprenavir

medicines to prevent nausea and vomiting associated with chemotherapy – aprepitant
medicines for depression – nefazodon
medicines called kinase inhibitors for treatment of other cancers – crizotinib or imatinib
medicines called calcium channel blockers for high blood pressure or chest pain – diltiazem or

verapamil

medicines called statins to treat high cholesterol – rosuvastatin
heart medicines/anti-arrhythmics – amiodarone or dronedarone
medicines to prevent seizures or to treat epilepsy, or medicines to treat a painful condition of the

face called trigeminal neuralgia – carbamazepine or phenytoin.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking IMBRUVICA.

IMBRUVICA with food

Pregnancy and breast-feeding

Do not get pregnant while you are taking this medicine. IMBRUVICA should not be used during pregnancy. There is no information about the safety of IMBRUVICA in pregnant women.

Women of childbearing age must use a highly effective method of birth control during and up to three months after receiving IMBRUVICA, to avoid becoming pregnant while being treated with IMBRUVICA.

Tell your doctor immediately if you become pregnant.
Do not breast-feed while you are taking this medicine.

Driving and using machines

You may feel tired or dizzy after taking IMBRUVICA, which may affect your ability to drive or use any tools or machines.

IMBRUVICA contains lactose

IMBRUVICA contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

IMBRUVICA contains sodium

IMBRUVICA contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

3. How to take IMBRUVICA

Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to take

Mantle cell lymphoma (MCL)

The recommended dose of IMBRUVICA is 560 mg once a day.

Chronic lymphocytic leukaemia (CLL)/Waldenström’s macroglobulinaemia (WM)

The recommended dose of IMBRUVICA is 420 mg once a day.

Your doctor may adjust your dose.

Taking this medicine

Take the tablets orally (by mouth) with a glass of water.
Take the tablets about the same time each day.
Swallow the tablets whole. Do not break or chew them.

If you take more IMBRUVICA than you should

If you take more IMBRUVICA than you should, talk to a doctor or go to a hospital straight away.

Take the tablets and this leaflet with you.

If you forget to take IMBRUVICA

If you miss a dose, it can be taken as soon as possible on the same day with a return to the

normal schedule the following day.

Do not take a double dose to make up for a forgotten dose.
If you are not sure, talk to your doctor, pharmacist or nurse about when to take your next dose.

If you stop taking IMBRUVICA

Do not stop taking this medicine unless your doctor tells you.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may happen with this medicine:

Stop taking IMBRUVICA and tell a doctor straight away if you notice any of the following side effects:

itchy bumpy rash, difficulty breathing, swelling of your face, lips, tongue or throat – you may be having an allergic reaction to the medicine.

Tell a doctor straight away if you notice any of the following side effects:

Very common (may affect more than 1 in 10 people)

fever, chills, body aches, feeling tired, cold or flu symptoms, being short of breath – these could

be signs of an infection (viral, bacterial or fungal). These could include infections of the nose, sinus or throat (upper respiratory tract infection), or lung, or skin

bruising or increased tendency of bruising
mouth sores
feeling dizzy
headache
constipation
feeling or being sick (nausea or vomiting)
diarrhoea, your doctor may need to give you a fluid and salt replacement or another medicine
skin rash
painful arms or legs
back pain or joint pain
muscle cramps, aches or spasms
low number of cells that help blood clot (platelets), very low number of white blood cells –

shown in blood tests

an increase in the number or proportion of white blood cells shown in blood tests
high level of “uric acid” in the blood (shown in blood tests), which may cause gout
swollen hands, ankles or feet
high blood pressure
increased level of “creatinine” in the blood.

Common (may affect up to 1 in 10 people)

severe infections throughout the body (sepsis)
infections of the urinary tract
nose bleeds, small red or purple spots caused by bleeding under the skin
blood in your stomach, gut, stools or urine, heavier periods, or bleeding that you cannot stop

from an injury

heart failure
fast heart rate, missed heart beats, weak or uneven pulse, lightheadedness, shortness of breath,

chest discomfort (symptoms of heart rhythm problems)

low white blood cell counts with fever (febrile neutropenia)
non-melanoma skin cancer, most frequently squamous cell and basal cell skin cancer
blurred vision
redness of the skin
inflammation within the lungs that may lead to permanent damage
breaking of the nails
weakness, numbness, tingling or pain in your hands or feet or other parts of the body (peripheral

neuropathy).

Uncommon (may affect up to 1 in 100 people)

liver failure, including events with fatal outcome
severe fungal infections
confusion, headache with slurred speech or feeling faint – these could be signs of serious

internal bleeding in your brain

unusual levels of chemicals in the blood caused by the fast breakdown of cancer cells have

happened during treatment of cancer and sometimes even without treatment (tumour lysis syndrome)

allergic reaction, sometimes severe, that may include a swollen face, lip, mouth, tongue or

throat, difficulty swallowing or breathing, itchy rash (hives)

inflammation of the fatty tissue underneath the skin
temporary episode of decreased brain or nerve function caused by loss of blood flow, stroke
bleeding in the eye (in some cases associated with loss of vision)
painful skin ulceration (pyoderma gangrenosum) or red, raised painful patches on the skin, fever

and an increase in white blood cells (these may be signs of acute febrile neutrophilic dermatosis or Sweet’s syndrome).

Rare (may affect up to 1 in 1,000 people)

severely increased white blood cell count that may cause cells to clump together.

Not known (frequency cannot be estimated from available data)

severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals

(Stevens-Johnson syndrome).

Reporting of side effects

5. How to store IMBRUVICA

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 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 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 IMBRUVICA contains

The active substance is ibrutinib.
– IMBRUVICA 140 mg film-coated tablets: Each tablet contains 140 mg of ibrutinib.
– IMBRUVICA 280 mg film-coated tablets: Each tablet contains 280 mg of ibrutinib.
– IMBRUVICA 420 mg film-coated tablets: Each tablet contains 420 mg of ibrutinib.
– IMBRUVICA 560 mg film-coated tablets: Each tablet contains 560 mg of ibrutinib.

The other ingredients are:
Tablet core: colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate (see

section 2 “IMBRUVICA contains lactose” ), magnesium stearate, microcrystalline cellulose, povidone, sodium lauril sulfate (E487).

Tablet film-coat: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171);

IMBRUVICA 140 mg and IMBRUVICA 420 mg film-coated tablets also contain black iron oxide (E172) and yellow iron oxide (E172);

IMBRUVICA 280 mg film-coated tablets also contain black iron oxide (E172) and red iron oxide (E172);

IMBRUVICA 560 mg film-coated tablets also contain red iron oxide (E172) and yellow iron oxide (E172).

What IMBRUVICA looks like and contents of the pack

IMBRUVICA 140 mg film-coated tablets

Yellow-green to green round (9 mm) tablets, written with “ibr” on one side and “140” on the other side. Each 28 day carton contains 28 film-coated tablets in 2 cardboard wallets of 14 film-coated tablets each. Each 30 day carton contains 30 film-coated tablets in 3 cardboard wallets of 10 film-coated tablets each.

IMBRUVICA 280 mg film-coated tablets

Purple oblong (15 mm in length and 7 mm in width), written with “ibr” on one side and “280” on the other side. Each 28 day carton contains 28 film-coated tablets in 2 cardboard wallets of 14 film-coated tablets each. Each 30 day carton contains 30 film-coated tablets in 3 cardboard wallets of 10 film-coated tablets each.

IMBRUVICA 420 mg film-coated tablets

Yellow-green to green oblong tablets (17.5 mm in length and 7.4 mm in width), written with “ibr” on one side and “420” on the other side. Each 28 day carton contains 28 film-coated tablets in 2 cardboard wallets of 14 film-coated tablets each. Each 30 day carton contains 30 film-coated tablets in 3 cardboard wallets of 10 film-coated tablets each.

IMBRUVICA 560 mg film-coated tablets

Yellow to orange oblong tablets (19 mm in length and 8.1 mm in width), written with “ibr” on one side and “560” on the other side. Each 28 day carton contains 28 film-coated tablets in 2 cardboard wallets of 14 film-coated tablets each. Each 30 day carton contains 30 film-coated tablets in 3 cardboard wallets of 10 film-coated tablets each.

Marketing Authorisation Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen-Cilag SpA

Via C. Janssen,

Loc. Borgo S. Michele,

04100 Latina,

Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien	Lietuva
Janssen-Cilag NV	UAB „JOHNSON & JOHNSON“
Tel/Tél: +32 14 64 94 11	Tel: +370 5 278 68 88

Efc^rapufl

„Æ'/KOHC'bH & 'OýKOHCbH Ebnrapua” EOOfl

Ten.: +359 2 489 94 00

Luxembourg/Luxemburg

Janssen-Cilag NV

Tél/Tel: +32 14 64 94 11

Česká republika

Janssen-Cilag s.r.o.

Tel: +420 227 012 227

Magyarország

Janssen-Cilag Kft.

Tel.: +36 1 884 2858

Danmark

Janssen-Cilag A/S Tlf: +45 4594 8282

Malta

AM MANGION LTD.

Tel: +356 2397 6000

Deutschland

Janssen-Cilag GmbH

Tel: +49 2137 955 955

Nederland

Janssen-Cilag B.V.

Tel: +31 76 711 1111

Eesti

UAB „JOHNSON & JOHNSON“ Eesti filiaal

Tel: +372 617 7410

Norge

Janssen-Cilag AS

Tlf: +47 24 12 65 00

EÀÀàôa

Janssen-Cilag OappaKauTiK^ A.E.B.E.

Tql: +30 210 80 90 000

Österreich

Janssen-Cilag Pharma GmbH

Tel: +43 1 610 300

España

Janssen-Cilag, S.A.

Tel: +34 91 722 81 00

Polska

Janssen-Cilag Polska Sp. z o.o.

Tel.:+48 22 237 60 00

France

Janssen-Cilag

Tél: 0 800 25 50 75 / +33 1 55 00 40 03

Portugal

Janssen-Cilag Farmacêutica, Lda.

Tel: +351 214 368 600

Hrvatska

Johnson & Johnson S.E. d.o.o.

Tel: +385 1 6610 700

România

Johnson & Johnson România SRL

Tel: +40 21 207 1800

Ireland

Janssen Sciences Ireland UC

Tel: +353 1 800 709 122

Slovenija

Johnson & Johnson d.o.o.

Tel.: +386 1 401 18 00

Ísland

Janssen-Cilag AB c/o Vistor hf

Sími: +354 535 7000

Slovenská republika

Johnson & Johnson, s.r.o.

Tel: +421 232 408 400

Italia

Janssen-Cilag SpA

Tel: 800 688 777 / +39 02 2510 1

Suomi/Finland

Janssen-Cilag Oy

Puh/Tel: +358 207 531 300

Kùnpoç

Bapváßaç XaTZnnavaY^ç Ató

Tql: +357 22 207 700

Sverige

Janssen-Cilag AB

Tfn: +46 8 626 50 00

Latvija

UAB „JOHNSON & JOHNSON“ filiäle Latvijä

Tel: +371 678 93561

United Kingdom (Northern Ireland)

Janssen Sciences Ireland UC

Tel: +44 1 494 567 444

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

121

Imbruvica - patient leaflet, side effects, dosage

Table of contents

Patient leaflet - Imbruvica

1. What IMBRUVICA is and what it is used for

2. What you need to know before you take IMBRUVICA

3. How to take IMBRUVICA

4. Possible side effects

5. How to store IMBRUVICA

6. Contents of the pack and other information

1. What IMBRUVICA is and what it is used for

2. What you need to know before you take IMBRUVICA

3. How to take IMBRUVICA

4. Possible side effects

5. How to store IMBRUVICA

6. Contents of the pack and other information

1. What IMBRUVICA is and what it is used for

What IMBRUVICA is used for

2. What you need to know before you take IMBRUVICA

“Possible side effects”

3. How to take IMBRUVICA

4. Possible side effects

5. How to store IMBRUVICA

6. Contents of the pack and other information

What IMBRUVICA looks like and contents of the pack