Prospect: information for the patient

SIRTURO 100 mg tablets

Bedaquilina

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You may contribute by reporting any adverse effects you experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, because

it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this prospect. See section 4.

SIRTURO contains the active ingredient bedaquiline.

SIRTURO is a type of antibiotic. Antibiotics are medications that destroy bacteria

causing diseases.

SIRTURO is used to treat tuberculosis that affects the lungs when the disease has become resistant to other antibiotics. This is known as multi-drug resistant pulmonary tuberculosis.

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

It is used in adults 18 years of age or older.

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 unsure, consult your doctor or pharmacist before taking SIRTURO.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take SIRTURO, if:

• you have any abnormality in your electrocardiogram (ECG) or heart failure;

• you have a personal or family history of a heart condition called “congenital long QT syndrome”;

• you have a decreased function of the thyroid gland. This can be observed 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 situations apply to you (or if you are unsure), speak with your doctor, pharmacist, or nurse before taking SIRTURO.

Children and adolescents

Do not administer 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. Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

The following are examples of medicines that patients with multi-drug resistant tuberculosis may take and that may potentially interact with SIRTURO:

Taking SIRTURO with alcohol

You should not consume alcohol while taking SIRTURO.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, or if you intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

You may feel dizzy after taking SIRTURO. If this happens, do not drive or operate machinery.

SIRTURO contains lactose monohydrate

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

SIRTURO must be used always in combination with other medications for the treatment of tuberculosis. Your doctor will decide which other medications 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 for 3 days a week only.
• A minimum interval of 48 hours must pass between doses whenever you take SIRTURO. For example, you can take SIRTURO on Mondays, Wednesdays, and Fridays every week from week 3.

You may have to continue taking your other medications for tuberculosis for a period longer than 6 months. Consult your doctor or pharmacist.

How to take this medication

• Take SIRTURO with food. Food is important to achieve the appropriate medication levels 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, inform your doctor immediately. Bring the medication packaging with you.

If you forget to take SIRTURO

During the first 2 weeks

• Omit the missed dose and take the next dose at your usual time.
• Do not take a double dose to compensate for the missed doses.

From week 3 onwards

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

If you forget to take a dose and are unsure of what to do, speak with your doctor or pharmacist.

If you interrupt treatment with SIRTURO

Do not stop taking SIRTURO without first speaking with your doctor.

Missing doses or not completing the full treatment cycle may:

• make the treatment ineffective and worsen your tuberculosis, and;
• increase the likelihood that the bacteria will become resistant to the medication. This may make your disease not respond to treatment with SIRTURO or other medications in the future.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Very Frequent(may affect more than 1 in 10 people):

• Headache
• Joint pain
• Sensation of dizziness
• Feeling or being sick (nausea or vomiting)

Frequent(may affect up to 1 in 10 people):

• Diarrhea
• Elevation of liver enzymes (appears in blood tests)
• Muscle pain or hypersensitivity, not caused by exercise
• Anomaly detected in the electrocardiogram called “prolongation of the QT interval”. Inform your doctor immediately if you experience a fainting spell.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendixV. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD.

The expiration date is the last day of the month indicated.

Store SIRTURO in the original packaging to protect it from light.

This medication may pose a risk to the environment. Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of SIRTURO

• The active ingredient is bedaquiline. Each tablet contains fumarate of bedaquiline equivalent to 100 mg of bedaquiline.
• The other components are: anhydrous colloidal silica, sodium croscarmellose, hypromellose, lactose monohydrate, magnesium stearate, cornstarch, microcrystalline cellulose, and polisorbate 20.

Appearance of the product and contents of the pack

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

Plastic bottle containing 188 tablets.

Pack containing 4 blisters (each containing 6 tablets).

Only some pack sizes may be marketed.

Marketing Authorization Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Responsible for manufacturing

Janssen Pharmaceutica NV

Turnhoutseweg 30

B-2340 Beerse

36

Belgium

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics

This medicinal product has been granted a conditional marketing authorisation.

This type of authorisation means that further information will be obtained from this medicinal product. The European Medicines Agency will review the new information on this medicinal product at least once a year and this summary of product characteristics will be updated as necessary.

Further information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.