Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - sirturo

Document Subject

Generated Narrative: MedicinalProductDefinition mpa0f24920a40b1c73ed1d880ba04e208e

identifier: http://ema.europa.eu/identifier/EU/1/13/901/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: SIRTURO 20 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-a0f24920a40b1c73ed1d880ba04e208e

identifier: http://ema.europa.eu/identifier/EU/1/13/901/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - sirturo

Attesters

What is in this leaflet

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

SIRTURO contains the active substance bedaquiline. SIRTURO is a type of antibiotic. Antibiotics are medicines that kill bacteria that cause disease. SIRTURO is used to treat tuberculosis that affects the lungs when the disease has become resistant to other antibiotics. This is called multi-drug resistant pulmonary tuberculosis. SIRTURO must always be taken together with other medicines for treating tuberculosis. It is used in adults and children (5 years and over, who weigh at least 15 kg).

Do not take SIRTURO

if you are allergic to bedaquiline or any of the other ingredients of this medicine (listed in section 6). Do not take SIRTURO if this applies to you. If you are not sure, talk to your doctor or pharmacist before taking SIRTURO. Warnings and precautions Talk to your doctor, pharmacist or nurse before taking SIRTURO, if:

you have had an abnormal heart reading (ECG) or heart failure;

you have a personal or family history of a heart problem called congenital long QT syndrome ;

you have a decreased thyroid gland function. This can be seen in a blood test;

you have liver disease or you drink alcohol on a regular basis;

you have human immunodeficiency virus (HIV) infection. If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking SIRTURO. Children and adolescents In adolescents weighing 30 to 40 kg, the levels of SIRTURO in the blood were predicted to be higher than in adults. This might be associated with an increased risk of abnormal reading on the electrocardiogram (QT prolongation) or increased liver enzymes (shown in blood test). Talk to your doctor, pharmacist or nurse before taking SIRTURO. Do not give this medicine to children under 5 years of age or weighing less than 15 kg because it has not been studied in these patients. Other medicines and SIRTURO Other medicines may affect SIRTURO. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The following are examples of medicines patients with multi-drug resistant tuberculosis may take and which may potentially interact with SIRTURO: Medicine (name of the active substance) Purpose of the medicine rifampicin, rifapentine, rifabutin to treat some infections like tuberculosis (antimycobacterial) ketoconazole, fluconazole to treat fungal infections (antifungals) efavirenz, etravirine, lopinavir/ritonavir to treat HIV infection (antiretroviral non-nucleoside reverse transcriptase inhibitors, antiretroviral protease inhibitors) clofazimine to treat some infections like leprosy (antimycobacterial) carbamazepine, phenytoin to treat epileptic fits (anticonvulsants) St. John s wort (Hypericum perforatum) an herbal product to relieve anxiety ciprofloxacin, erythromycin, clarithromycin to treat bacterial infections (antibacterials) SIRTURO with alcohol You should not drink alcohol while taking SIRTURO. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines You may feel dizzy after taking SIRTURO. If this happens, do not drive or operate machinery.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. SIRTURO must always be taken together with other medicines for treating tuberculosis. Your doctor will decide which other medicines you should take with SIRTURO. Use in children (5 years and over and weighing between 15 kg and 20 kg) How much to take You take SIRTURO for a 24 week course. First 2 weeks:

Take 160 mg once a day. From week 3 to week 24:

Take 80 mg once a day for 3 days of each week only.

There must be at least 48 hours in between each time you take SIRTURO. For example, you may take SIRTURO on Monday, Wednesday and Friday every week from week 3 onwards. Use in children (5 years and over and weighing between 20 kg and 30 kg) How much to take You take SIRTURO for a 24 week course. First 2 weeks:

Take 200 mg once a day. From week 3 to week 24:

Take 100 mg once a day for 3 days of each week only.

There must be at least 48 hours in between each time you take SIRTURO. For example, you may take SIRTURO on Monday, Wednesday and Friday every week from week 3 onwards. You may need to keep taking your other medicines for tuberculosis for longer than 6 months. Check with your doctor or pharmacist. Use in adults and in children (5 years and over and weighing at least 30 kg) How much to take You take SIRTURO for a 24 week course. First 2 weeks:

Take 400 mg once a day. From week 3 to week 24:

Take 200 mg once a day for 3 days of each week only.

There must be at least 48 hours in between each time you take SIRTURO. For example, you may take SIRTURO on Monday, Wednesday and Friday every week from week 3 onwards. Taking this medicine

Always take SIRTURO with food. The food is important to get the right levels of medicine in your body. If you can swallow tablets

Swallow the tablets with water the tablets can be taken whole or split in half. If you cannot swallow tablets

If you are unable to swallow SIRTURO tablets, you may:

Mix with water: Mix up to 5 tablets per one teaspoon of water until fully mixed. * Swallow the mixture straight away, or* To help with taking SIRTURO you may add at least one extra teaspoon of water (or another drink) or soft food and mix. * You can use the following drinks for mixing: water, milk product, apple juice, orange juice, cranberry juice or carbonated drinks. You can use the following soft foods for mixing: yoghurt, apple sauce, mashed bananas or porridge.* Swallow the mixture straight away. * Repeat with more tablets until you have taken all the dose. * Make sure no bits of the tablet are left in container, rinse with more of your drink or soft food and swallow the mixture straight away.

Crush tablets and mix with soft food: You can use soft food such as yoghurt, apple sauce, mashed bananas or porridge. Swallow the mixture straight away. Make sure no bits of the tablet are left in container - add more soft food and swallow the mixture straight away.

Feeding tube: SIRTURO 20 mg tablets may also be given through certain feeding tubes. Ask your healthcare provider for specific instructions on how to properly take the tablets through a feeding tube. If you take more SIRTURO than you should If you take more SIRTURO than you should, talk to a doctor straight away. Take the medicine pack with you. If you forget to take SIRTURO During the first 2 weeks

Skip the missed dose and take the next dose as usual

Do not take a double dose to make up for a forgotten dose. From week 3 onwards

Take the missed dose as soon as possible.

Resume the three times a week schedule.

Make sure that there is at least 24 hours between taking the missed dose and the next scheduled dose.

Do not take more than the prescribed weekly dose in a 7-day period. If you have missed a dose and you are not sure what to do, talk to your doctor or pharmacist. If you stop taking SIRTURO Do not stop taking SIRTURO without first talking to your doctor. Skipping doses or not completing the full course of therapy may:

make your treatment ineffective and your tuberculosis could get worse, and;

increase the chance that the bacteria will become resistant to the medicine. This means your disease may not be treatable by SIRTURO or other medicines in the future. 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. Very common (may affect more than 1 in 10 people):

headache

joint pain

feeling dizzy

feeling or being sick (nausea or vomiting). Common (may affect up to 1 in 10 people):

diarrhoea

increased liver enzymes (shown in blood tests)

aching or tender muscles, not caused by exercise

abnormal reading on the electrocardiogram called QT prolongation . Tell your doctor right away if you faint. Additional side effects in children Very common (may affect more than 1 in 10 people):

increased liver enzymes (shown in blood tests) 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 after EXP . The expiry date refers to the last day of that month. Store in the original container and keep the container tightly closed in order to protect from light and moisture. Do not remove desiccant (pouch containing drying agent). This medicine may pose a risk to the environment. 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 SIRTURO contains

The active substance is bedaquiline. Each tablet contains bedaquiline fumarate equivalent to 20 mg of bedaquiline.

The other ingredients are: microcrystalline cellulose, crospovidone, colloidal anhydrous silica, hypromellose, polysorbate 20, sodium stearly fumarate. What SIRTURO looks like and contents of the pack Uncoated, white to almost white oblong tablet with score line on both sides, debossed with 2 and 0 on one side and plain on other side. A plastic bottle containing 60 tablets Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg B-2340 Beerse Belgium Manufacturer Janssen Pharmaceutica NV Turnhoutseweg B-2340 Beerse Belgium 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 This medicine has been given conditional approval . This means that there is more evidence to come about this medicine. The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary. Detailed information on this medicine is available on the European Medicines Agency web site: