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SIRTURO 100 MG TABLETS

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About the medicine

How to use SIRTURO 100 MG TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the Patient

SIRTURO 100 mg tablets

Bedaquiline

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

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.

Contents of the pack

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

1. What is SIRTURO and what is it used for

SIRTURO contains the active substance bedaquiline.

SIRTURO is a type of antibiotic. Antibiotics are medicines that kill bacteria that cause diseases.

SIRTURO is used to treat tuberculosis that affects the lungs when the disease has become resistant to other antibiotics. This is called multidrug-resistant pulmonary tuberculosis.

SIRTURO must always be used in combination with other medicines for the treatment of tuberculosis.

It is used in adults aged 18 years and older.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you take SIRTURO

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, consult your doctor or pharmacist before taking SIRTURO.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start taking SIRTURO, if:

  • you have any abnormality in your electrocardiogram (ECG) or heart failure;
  • you have a personal or family history of a heart problem called "congenital long QT syndrome";
  • you have a decrease in thyroid function. This can be seen in a blood test;
  • you have liver disease or if you drink alcohol regularly;
  • you have a human immunodeficiency virus (HIV) infection.

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

Children and adolescents

Do not give this medicine to children and adolescents (under 18 years), as it has not been studied in this age group.

Taking SIRTURO with other medicines

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 that patients with multidrug-resistant tuberculosis may take and that may potentially interact with SIRTURO:

Table with names of medicines and their uses, including rifampicin, ketoconazole, efavirenz, clofazimine, and ciprofloxacin

Taking SIRTURO with alcohol

Do not drink alcohol while you are taking SIRTURO.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 use machines.

SIRTURO contains lactose monohydrate

SIRTURO contains "lactose" (a type of sugar). If you have intolerance to some sugars or cannot digest them, talk to your doctor before taking this medicine.

3. How to take SIRTURO

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

SIRTURO must always be used in combination with other medicines for the treatment of tuberculosis. Your doctor will decide which other medicines you should take with SIRTURO.

How much to take

Take SIRTURO for a period of 24 weeks.

First 2 weeks:

  • Take 400 mg (4 tablets of 100 mg) once a day.

From week 3 to week 24:

  • Take 200 mg (2 tablets of 100 mg) once a day, three times a week only.
  • There must be a minimum interval of 48 hours between doses when you take SIRTURO. For example, you can take SIRTURO on Mondays, Wednesdays, and Fridays every week from week 3 onwards.

You may need to continue taking your other tuberculosis medicines for more than 6 months. Ask your doctor or pharmacist.

How to take this medicine

  • Take SIRTURO with food. Food is important to achieve the right levels of the medicine in your body.
  • Swallow the tablets whole with water.

If you take more SIRTURO than you should

If you take more SIRTURO than you should, tell your doctor immediately. Take the medicine pack with you.

If you forget to take SIRTURO

During the first 2 weeks

  • Miss the missed dose and take the next dose at the usual time.
  • Do not take a double dose to make up for a missed dose.

From week 3 onwards

  • Take the missed dose of 200 mg as soon as possible.
  • Resume the three-times-a-week schedule

If you are not sure what to do, talk to your doctor or pharmacist.

If you stop taking SIRTURO

Do not stop taking SIRTURO without talking to your doctor first.

Missing doses or not completing the full treatment course may:

  • make the treatment ineffective and your tuberculosis worse; and
  • increase the likelihood that the bacteria will become resistant to the medicine. This can make your disease not respond to treatment with 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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

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):

  • diarrhea
  • increase in liver enzymes (seen in blood tests)
  • muscle pain or tenderness not caused by exercise
  • abnormality detected in the electrocardiogram called "prolongation of the QT interval". Tell your doctor immediately if you faint.

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. Storage of SIRTURO

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 the month shown.

Store SIRTURO in the original package or container to protect it from light.

This medicine may be harmful to the environment. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What SIRTURO contains

  • The active substance is bedaquiline. Each tablet contains bedaquiline fumarate equivalent to 100 mg of bedaquiline.
  • The other ingredients are: colloidal anhydrous silica, sodium croscarmellose, hypromellose, lactose monohydrate, magnesium stearate, corn starch, microcrystalline cellulose, polysorbate 20.

Appearance and packaging

Uncoated tablet, white to off-white, round, biconvex, 11 mm in diameter, with "T" over "207" engraved on one side and "100" on the other.

Plastic bottle with 188 tablets.

Blister pack containing 4 strips of 6 tablets per strip.

Not all pack sizes may be marketed.

Marketing authorisation holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Pharmaceutica NV

Turnhoutseweg 30

B-2340 Beerse

36

Belgium

You can ask for more information about this medicine from the representative of the marketing authorisation holder:

België/Belgique/Belgien

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Tel/Tél: +32 14 64 94 11

Lietuva

UAB "JOHNSON & JOHNSON"

Konstitucijos pr. 21C

LT-08130 Vilnius

Tel: +370 5 278 68 88

България

„Джонсън & Джонсън“ ЕАД

ул. „Тодор Александров“ 4

София 1303

Тел.: +359 2 489 94 00

Luxembourg/Luxemburg

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgique/Belgien

Tél/Tel: +32 14 64 94 11

Ceská republika

Janssen-Cilag s.r.o.

Walterovo námestí 329/1

CZ-158 00 Praha 5 – Jinonice

Tel: +420 227 012 227

Magyarország

Janssen-Cilag Kft.

Nagyenyed u. 8-14

H-Budapest, 1123

Tel.: +36 1 884 2858

Danmark

Janssen-Cilag A/S

Bregnerødvej 133

DK-3460 Birkerød

Tlf: +45 45 94 82 82

Malta

AM MANGION LTD.

Mangion Building, Triq Gdida fi Triq Valletta

MT-Hal-Luqa LQA 6000

Tel: +356 2397 6000

Deutschland

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

D-41470 Neuss

Tel: +49 2137 955-955

Nederland

Janssen-Cilag B.V.

Graaf Engelbertlaan 75

NL-4837 DS Breda

Tel: +31 76 711 1111

Eesti

UAB "JOHNSON & JOHNSON" Eesti filiaal

Lõõtsa 2

EE-11415 Tallinn

Tel: +372 617 7410

Norge

Janssen-Cilag AS

Postboks 144

NO-1325-Lysaker

Tlf: +47 24 12 65 00

Ελλάδα

Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε.

Λεωφόρος Ειρήνης 56

ΓΡ-151 21 Πεύκη, Αθήνα

Τηλ: +30 210 80 90 000

Österreich

Janssen-Cilag Pharma GmbH

Vorgartenstraße 206B

A-1020 Wien

Tel: +43 1 610 300

España

Janssen-Cilag, S.A.

Paseo de las Doce Estrellas, 5-7

E-28042 Madrid

Tel: +34 91 722 81 00

Polska

Janssen-Cilag Polska Sp. z o.o.

ul. Ilzecka 24

PL-02-135 Warszawa

Tel.: +48 22 237 60 00

France

Janssen-Cilag

1, rue Camille Desmoulins, TSA 91003

F-92787 Issy Les Moulineaux, Cedex 9

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

Portugal

Janssen-Cilag Farmacêutica, Lda.

Lagoas Park, Edifício 9

2740-262 PORTO SALVO

PORTUGAL

Tel: +351 214 368 600

Hrvatska

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

Oreškoviceva 6h

10010 Zagreb

Tel: +385 1 6610 700

România

Johnson & Johnson România SRL

Str. Tipografilor nr. 11-15

Cladirea S-Park, Corp B3-B4, Etaj 3

013714 Bucuresti, ROMÂNIA

Tel: +40 21 207 1800

Ireland

Janssen Sciences Ireland UC

Barnahely

Ringaskiddy

IRL – Co. Cork P43 FA46

Tel: +353 1 800 709 122

Slovenija

Johnson & Johnson d.o.o.

Šmartinska cesta 53

SI-1000 Ljubljana

Tel: +386 1 401 18 00

Ísland

Janssen-Cilag AB

c/o Vistor hf.

Hörgatúni 2

IS-210 Garðabær

Sími: +354 535 7000

Slovenská republika

Johnson & Johnson s.r.o.

CBC III, Karadžicova 12

SK-821 08 Bratislava

Tel: +421 232 408 400

Italia

Janssen-Cilag SpA

Via M.Buonarroti, 23

I-20093 Cologno Monzese MI

Tel: +39 02 2510 1

Suomi/Finland

Janssen-Cilag Oy

Vaisalantie/Vaisalavägen 2

FI-02130 Espoo/Esbo

Puh/Tel: +358 207 531 300

Κύπρος

Βαρνάβας Χατζηπαναγής Λτδ

Λεωφόρος Γιώργου Καλλιγά 226

Λεμεσός

Κύπρος

Τηλ: +357 22 207 700

Sverige

Janssen-Cilag AB

Box 4042

SE-16904 Solna

Tel: +46 8 626 50 00

Latvija

UAB "JOHNSON & JOHNSON" filiale Latvija

Mukusalas iela 101

Riga, LV-1004

Tel: +371 678 93561

United Kingdom

Janssen-Cilag Ltd.

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire HP12 4EG - UK

Tel: +44 1 494 567 444

Date of last revision of this leaflet

This medicine has been authorised with a "conditional approval".

This type of approval means that more information on this medicine is expected. The European Medicines Agency will review any new information on this medicine at least once a year and this leaflet will be updated as necessary.

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Online doctors for SIRTURO 100 MG TABLETS

Discuss questions about SIRTURO 100 MG TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (29)
Doctor

Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

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  • Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
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  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
  • Cardiovascular health: hypertension, cholesterol control, risk assessment for heart disease.
  • Preventive medicine: regular check-ups, health screenings, long-term management of chronic conditions.

Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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Doctor

Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

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Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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Doctor

Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

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Frequently Asked Questions

Is a prescription required for SIRTURO 100 MG TABLETS?
SIRTURO 100 MG TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in SIRTURO 100 MG TABLETS?
The active ingredient in SIRTURO 100 MG TABLETS is bedaquiline. This information helps identify medicines with the same composition but different brand names.
Who manufactures SIRTURO 100 MG TABLETS?
SIRTURO 100 MG TABLETS is manufactured by Janssen-Cilag International N.V. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of SIRTURO 100 MG TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether SIRTURO 100 MG TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to SIRTURO 100 MG TABLETS?
Other medicines with the same active substance (bedaquiline) include SIRTURO 100 MG TABLETS, DELTYBA 50 mg FILM-COATED TABLETS, Myambutol 400 mg film-coated tablets. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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