Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - imbruvica

Document Subject

Generated Narrative: MedicinalProductDefinition mpedd8370352554e19efb5ccd7f477212d

identifier: http://ema.europa.eu/identifier/EU/1/14/945/001 (90 hard capsules)

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: IMBRUVICA 140 mg hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-edd8370352554e19efb5ccd7f477212d

identifier: http://ema.europa.eu/identifier/EU/1/14/945/001 (90 hard capsules)

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - imbruvica

Attesters

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

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.

Waldenstr m 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.

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. Effects on the heart Treatment with IMBRUVICA may affect the heart, especially if you already have heart diseases such as rhythm problems, heart failure, high blood pressure, have diabetes or are of advanced age. The effects may be severe and could cause death, including sometimes sudden death. Your heart function will be checked before and during treatment with IMBRUVICA. Tell your doctor immediately if you feel breathless, have difficulty breathing when lying down, swelling of the feet, ankles or legs and weakness/tiredness during treatment with IMBRUVICA these may be signs of heart failure. 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. 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 - nefazodone

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 .

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)/Waldenstr m 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.

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)

indigestion

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

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

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

high level of uric acid in the blood (shown in blood tests), which may cause gout

breaking of the nails

sudden kidney damage

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)

cardiac arrest (heart stops beating)

abnormally fast heart beat

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)

small, red bump on the skin that may bleed easily (pyogenic granuloma). Rare (may affect up to 1 in 1 000 people)

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

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.

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.

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 B-2340 Beerse Belgium Manufacturer Janssen Pharmaceutica NV Turnhoutseweg B-2340 Beerse Belgium 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: Belgi /Belgique/Belgien Janssen-Cilag NV Tel/T l: +32 14 64 94 janssen@jacbe.jnj.com Lietuva UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 lt@its.jnj.com

&
.: +359 2 489 94 jjsafety@its.jnj.com Luxembourg/Luxemburg Janssen-Cilag NV T l/Tel: +32 14 64 94 janssen@jacbe.jnj.com esk republika Janssen-Cilag s.r.o. Tel: +420 227 012 Magyarorsz g Janssen-Cilag Kft. Tel.: +36 1 884 2janssenhu@its.jnj.com Danmark Janssen-Cilag A/S Tlf: +45 4594 8jacdk@its.jnj.com Malta AM MANGION LTD. Tel: +356 2397 6Deutschland Janssen-Cilag GmbH Tel: +49 2137 955 jancil@its.jnj.com Nederland Janssen-Cilag B.V. Tel: +31 76 711 1janssen@jacnl.jnj.com Eesti UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7ee@its.jnj.com Norge Janssen-Cilag AS Tlf: +47 24 12 65 jacno@its.jnj.com

Janssen-Cilag . . . . T : +30 210 80 90 sterreich Janssen-Cilag Pharma GmbH Tel: +43 1 610 Espa a Janssen-Cilag, S.A. Tel: +34 91 722 81 contacto@its.jnj.com Polska Janssen-Cilag Polska Sp. z o.o. Tel.:+48 22 237 60 France Janssen-Cilag T l: 0 800 25 50 75 / +33 1 55 00 40 medisource@its.jnj.com Portugal Janssen-Cilag Farmac utica, Lda. Tel: +351 214 368 Hrvatska Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 jjsafety@JNJCR.JNJ.com Rom nia Johnson & Johnson Rom nia SRL Tel: +40 21 207 1Ireland Janssen Sciences Ireland UC Tel: 1 800 709 medinfo@its.jnj.com Slovenija Johnson & Johnson d.o.o. Tel.: +386 1 401 18 Janssen_safety_slo@its.jnj.com sland Janssen-Cilag AB c/o Vistor hf S mi: +354 535 7janssen@vistor.is Slovensk republika Johnson & Johnson, s.r.o. Tel: +421 232 408 Italia Janssen-Cilag SpA Tel: 800 688 777 / +39 02 2510 1 janssenita@its.jnj.com Suomi/Finland Janssen-Cilag Oy Puh/Tel: +358 207 531 jacfi@its.jnj.com

: +357 22 207 Sverige Janssen-Cilag AB Tfn: +46 8 626 50 jacse@its.jnj.com Latvija UAB "JOHNSON & JOHNSON" fili le Latvij Tel: +371 678 93lv@its.jnj.com United Kingdom (Northern Ireland) Janssen Sciences Ireland UC Tel: +44 1 494 567 medinfo@its.jnj.com This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: