Sirturo 100 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

SIRTURO 100 mg tablets

Bedaquiline

This medicine is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are possible side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What SIRTURO is and what it is used for

SIRTURO contains the active substance bedaquiline.

SIRTURO is a type of antibiotic. Antibiotics are medicines that destroy bacteria causing disease.

SIRTURO is used to treat tuberculosis affecting the lungs when the disease has become resistant to other antibiotics. This is known as 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 and older.

2. What you need to know before starting SIRTURO

Do not take SIRTURO:

• if you are allergic to bedaquiline or to 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

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

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

• you or a family member has a history of a heart condition called "congenital long QT syndrome";

• you have reduced function of the thyroid gland. This can be detected through a blood test;

• you have liver disease or regularly drink alcohol;

• you have an infection with the human immunodeficiency virus (HIV).

If any of the above situations apply to you (or if you have any doubts), speak with 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. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Examples of medicines that patients with multidrug-resistant tuberculosis may take and that could potentially interact with SIRTURO are listed below:

Taking SIRTURO with alcohol

You must not consume alcohol while taking SIRTURO.

Pregnancy and breastfeeding

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

Driving and using machines

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

SIRTURO contains lactose monohydrate

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

3. How to take SIRTURO

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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 together with SIRTURO.

What dose to take

Take SIRTURO for a period of 24 weeks.

First 2 weeks:

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

From week 3 to week 24:

• Take 200 mg (2 tablets of 100 mg) once daily, on only 3 days per week.
• There must be a minimum interval of 48 hours between doses whenever you take SIRTURO. For example, you may take SIRTURO on Mondays, Wednesdays, and Fridays every week starting from week 3.

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

How to take this medicine

• Take SIRTURO with food. Food is important to achieve adequate 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, inform your doctor immediately. Bring the medicine package with you.

If you forget to take SIRTURO

During the first 2 weeks:

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

From week 3 onwards:

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

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

If you stop taking SIRTURO

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

Missing doses or not completing the full course of treatment may:

• make the treatment ineffective and cause your tuberculosis to worsen; and
• increase the likelihood that the bacteria become resistant to the medicine. This could mean that your illness will no longer respond to treatment with SIRTURO or other medicines in the future.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

• headache
• joint pain
• dizziness
• feeling unwell or being unwell (nausea or vomiting)

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

• diarrhoea
• increased liver enzymes (detected in blood tests)
• muscle pain or tenderness not caused by exercise
• abnormality detected on electrocardiogram called "prolongation of the QT interval". Inform your doctor immediately if you experience fainting.

Reporting of 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 leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the carton after EXP.

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

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

This medicine may pose a risk to the environment. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of SIRTURO

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

Nature of the product and pack size

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

Plastic bottle containing 188 tablets.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Pharmaceutica NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

More information about this medicinal product can be obtained by contacting the local representative of the Marketing Authorization Holder:

Date of the latest review of this patient information leaflet

This medicinal product has been authorised under a "conditional approval".

This type of approval means that further information on the medicinal product is expected. The European Medicines Agency will review the new information on this medicinal product at least once a year, and this patient information leaflet will be updated as necessary.

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