Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - zytiga

Document Subject

Generated Narrative: MedicinalProductDefinition mp18a94f164fb1fa919f787ce6c80174e7

identifier: http://ema.europa.eu/identifier/EU/1/11/714/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: ZYTIGA 250 mg tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-18a94f164fb1fa919f787ce6c80174e7

identifier: http://ema.europa.eu/identifier/EU/1/11/714/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - zytiga

Attesters

What is in this leaflet:

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

ZYTIGA contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men that has spread to other parts of the body. ZYTIGA stops your body from making testosterone; this can slow the growth of prostate cancer. When ZYTIGA is prescribed for the early stage of disease where it is still responding to hormone therapy, it is used with a treatment that lowers testosterone (androgen deprivation therapy). When you take this medicine your doctor will also prescribe another medicine called prednisone or prednisolone. This is to lower your chances of getting high blood pressure, having too much water in your body (fluid retention), or having reduced levels of a chemical known as potassium in your blood.

Do not take ZYTIGA

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

if you are a woman, especially if pregnant. ZYTIGA is for use in male patients only.

if you have severe liver damage.

in combination with Ra-223 (which is used to treat prostate cancer). Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine. Warnings and precautions Talk to your doctor or pharmacist before taking this medicine:

if you have liver problems

if you have been told you have high blood pressure or heart failure or low blood potassium (low blood potassium may increase the risk of heart rhythm problems)

if you have had other heart or blood vessel problems

if you have an irregular or rapid heart rate

if you have shortness of breath

if you have gained weight rapidly

if you have swelling in the feet, ankles, or legs

if you have taken a medicine known as ketoconazole in the past for prostate cancer

about the need to take this medicine with prednisone or prednisolone

about possible effects on your bones

if you have high blood sugar. Tell your doctor if you have been told you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions. Tell your doctor if you have yellowing of the skin or eyes, darkening of the urine, or severe nausea or vomiting, as these could be signs or symptoms of liver problems. Rarely, failure of the liver to function (called acute liver failure) may occur, which can lead to death. Decrease in red blood cells, reduced sex drive (libido), muscle weakness and/or muscle pain may occur. ZYTIGA must not be given in combination with Ra-223 due to a possible increase in the risk of bone fracture or death. If you plan to take Ra-223 following treatment with ZYTIGA and prednisone/prednisolone, you must wait 5 days before starting treatment with Ra-223. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine. Blood monitoring ZYTIGA may affect your liver, and you may not have any symptoms. When you are taking this medicine, your doctor will check your blood periodically to look for any effects on your liver. Children and adolescents This medicine is not for use in children and adolescents. If ZYTIGA is accidentally ingested by a child or adolescent, go to the hospital immediately and take the package leaflet with you to show to the emergency doctor. Other medicines and ZYTIGA Ask your doctor or pharmacist for advice before taking any medicine. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is important because ZYTIGA may increase the effects of a number of medicines including heart medicines, tranquilisers, some medicines for diabetes, herbal medicines (e.g., St John s wort) and others. Your doctor may want to change the dose of these medicines. Also, some medicines may increase or decrease the effects of ZYTIGA. This may lead to side effects or to ZYTIGA not working as well as it should. Androgen deprivation treatment may increase the risk of heart rhythm problems. Tell your doctor if you are receiving medicine

used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol);

known to increase the risk of heart rhythm problems [e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses)]. Tell your doctor if you are taking any of the medicines listed above. ZYTIGA with food

This medicine must not be taken with food (see section 3, Taking this medicine ).

Taking ZYTIGA with food may cause side effects. Pregnancy and breast-feeding ZYTIGA is not for use in women.

This medicine may cause harm to the unborn child if it is taken by women who are pregnant.

Women who are pregnant or who may be pregnant should wear gloves if they need to touch or handle ZYTIGA.

If you are having sex with a woman who can become pregnant, use a condom and another effective birth control method.

If you are having sex with a pregnant woman, use a condom to protect the unborn child. Driving and using machines This medicine is not likely to affect your being able to drive and use any tools or machines. ZYTIGA contains lactose and sodium

ZYTIGA contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains 27.2 mg sodium (main component of cooking/table salt) in a four tablet daily dose. This is equivalent to 1.36% of the recommended maximum daily dietary intake of sodium for an adult.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. How much to take The recommended dose is 1 000 mg (four tablets) once a day. Taking this medicine

Take this medicine by mouth.

Do not take ZYTIGA with food. Taking ZYTIGA with food may cause more of the medicine to be absorbed by the body than is needed and this may cause side effects.

Take ZYTIGA tablets as a single dose once daily on an empty stomach. ZYTIGA must be taken at least two hours after eating and food must not be eaten for at least one hour after taking ZYTIGA. (see section 2, ZYTIGA with food ).

Swallow the tablets whole with water.

Do not break the tablets.

ZYTIGA is taken with a medicine called prednisone or prednisolone. Take the prednisone or prednisolone exactly as your doctor has told you.

You need to take prednisone or prednisolone every day while you are taking ZYTIGA.

The amount of prednisone or prednisolone you take may need to change if you have a medical emergency. Your doctor will tell you if you need to change the amount of prednisone or prednisolone you take. Do not stop taking prednisone or prednisolone unless your doctor tells you to. Your doctor may also prescribe other medicines while you are taking ZYTIGA and prednisone or prednisolone. If you take more ZYTIGA than you should If you take more than you should, talk to your doctor or go to a hospital immediately. If you forget to take ZYTIGA

If you forget to take ZYTIGA or prednisone or prednisolone, take your usual dose the following day.

If you forget to take ZYTIGA or prednisone or prednisolone for more than one day, talk to your doctor without delay. If you stop taking ZYTIGA Do not stop taking ZYTIGA or prednisone or prednisolone unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking ZYTIGA and see a doctor immediately if you notice any of the following:

Muscle weakness, muscle twitches or a pounding heart beat (palpitations). These may be signs that the level of potassium in your blood is low. Other side effects include: Very common (may affect more than 1 in 10 people): Fluid in your legs or feet, low blood potassium, liver function test increases, high blood pressure, urinary tract infection, diarrhoea. Common (may affect up to 1 in 10 people): High fat levels in your blood, chest pain, irregular heart beat (atrial fibrillation), heart failure, rapid heart rate, severe infections called sepsis, bone fractures, indigestion, blood in urine, rash. Uncommon (may affect up to 1 in 100 people): Adrenal gland problems (related to salt and water problems), abnormal heart rhythm (arrhythmia), muscle weakness and/or muscle pain. Rare (may affect up to 1 in 1 000 people): Lung irritation (also called allergic alveolitis). Failure of the liver to function (also called acute liver failure). Not known (frequency cannot be estimated from the available data): Heart attack, changes in ECG - electrocardiogram (QT prolongation), and serious allergic reactions with difficulty swallowing or breathing, swollen face, lips, tongue or throat, or an itchy rash. Bone loss may occur in men treated for prostate cancer. ZYTIGA in combination with prednisone or prednisolone may increase bone loss. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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 the bottle label. The expiry date refers to the last day of that month.

This medicinal product 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 to protect the environment.

What ZYTIGA contains

The active substance is abiraterone acetate. Each tablet contains 250 mg abiraterone acetate.

The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone (K29/K32), colloidal anhydrous silica, and sodium laurilsulfate (see section 2, ZYTIGA contains lactose and sodium ). What ZYTIGA looks like and contents of the pack

ZYTIGA tablets are white to off-white, oval shaped (15.9 mm long x 9.5 mm wide), with AA250 written on one side.

The tablets are provided in a plastic bottle with a child-resistant closure. Each bottle contains 120 tablets. Each carton contains one bottle. Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg B-2340 Beerse Belgium Manufacturer Janssen-Cilag SpA Via C. Janssen Borgo San Michele I-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 Tel/T l: +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 45 94 82 jacdk@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: +353 1 800 709 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 This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. Package leaflet: Information for the user ZYTIGA 500 mg film-coated tablets abiraterone acetate 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 or pharmacist.

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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.