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SIRTURO 100 MG TABLETS

SIRTURO 100 MG TABLETS

Ask a doctor about a prescription for SIRTURO 100 MG TABLETS

5.0(38)
Doctor

Nuno Tavares Lopes

Family medicine17 years of experience

Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC. He offers online consultations in Portuguese, English, and Spanish — combining global expertise with a patient-centred, evidence-based approach.

  • Emergency care: infections, fever, chest/abdominal pain, minor injuries, paediatric emergencies
  • Family medicine: hypertension, diabetes, cholesterol, chronic disease management
  • Travel medicine: pre-travel advice, vaccinations, fit-to-fly certificates, travel-related illnesses
  • Sexual and reproductive health: PrEP, STD prevention, counselling, treatment
  • Weight management and wellness: personalised weight loss programmes, lifestyle guidance
  • Skin and ENT issues: acne, eczema, allergies, rashes, sore throat, sinusitis
  • Pain management: acute and chronic pain, post-surgical care
  • Public health: prevention, health screenings, long-term monitoring
  • Sick leave (Baixa médica) connected to Segurança Social in Portugal
  • IMT medical certificates for driving licence exchange
Dr. Lopes also provides interpretation of medical tests, follow-up care for complex patients, and multilingual support. Whether for urgent concerns or long-term care, he helps patients act with clarity and confidence.
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This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use SIRTURO 100 MG TABLETS

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 this leaflet includes information on 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 18 years of age or older.

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 of age), 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.

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 stated.

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

Tablet (not coated), 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.

Pack containing 4 blister strips (each strip contains 6 tablets).

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 get more information on this medicine by contacting the local 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

????????

„??????? & ??????? ????????” ????

?.?. ??????? 4

?????? ???? ?????, ?????? 4

????? 1766

???.: +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

Ελλ?da

Janssen-Cilag Faρµaκeυtικ? Α.Ε.Β.Ε.

Λeωf?ρος Ειρ?νης 56

GR-151 21 Πe?κη, Αθ?νa

Tηλ: +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

Κ?pρος

Βaρν?ßaς Χatζηpaνaγ?ς Λtd,

Λeωf?ρος Gι?ννου Κrανιdι?tη 226

Λatsι?

CY-2234 Λeυκωs?a

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 dosage, side effects, interactions, contraindications, and prescription renewal for SIRTURO 100 MG TABLETS – subject to medical assessment and local rules.

5.0(38)
Doctor

Nuno Tavares Lopes

Family medicine17 years of experience

Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC. He offers online consultations in Portuguese, English, and Spanish — combining global expertise with a patient-centred, evidence-based approach.

  • Emergency care: infections, fever, chest/abdominal pain, minor injuries, paediatric emergencies
  • Family medicine: hypertension, diabetes, cholesterol, chronic disease management
  • Travel medicine: pre-travel advice, vaccinations, fit-to-fly certificates, travel-related illnesses
  • Sexual and reproductive health: PrEP, STD prevention, counselling, treatment
  • Weight management and wellness: personalised weight loss programmes, lifestyle guidance
  • Skin and ENT issues: acne, eczema, allergies, rashes, sore throat, sinusitis
  • Pain management: acute and chronic pain, post-surgical care
  • Public health: prevention, health screenings, long-term monitoring
  • Sick leave (Baixa médica) connected to Segurança Social in Portugal
  • IMT medical certificates for driving licence exchange
Dr. Lopes also provides interpretation of medical tests, follow-up care for complex patients, and multilingual support. Whether for urgent concerns or long-term care, he helps patients act with clarity and confidence.
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Dr. Agami provides medical support for patients using GLP-1 medications (such as Ozempic or Mounjaro) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Portugal and Israel.

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She offers care for people undergoing GLP-1 therapy (Ozempic, Mounjaro, and others) for weight management. Her support follows Spanish clinical guidelines, from treatment planning and side effect counselling to regular follow-ups and coordination with private or public healthcare providers.

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Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

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  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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