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:

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:

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.