InfoCons Consumer Protection informs you – Sirturo – Package Leaflet

Before anything else

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, pharmaci st 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 possi ble side effects not listed in this leaflet. See section 4.

ℹ️ 1. What SIRTURO is and what it is used for

SIRTURO contains the active substance bedaquiline.

SIRTURO is a type of antibiotic . Antibiotics are medicine sthat killbacteria that cause disease .

SIRTURO is used to treat tuberculosis that affects the lungs when the disease has become resistant to at least rifampicin and isoniazid, which are also antibiotics .

SIRTURO must always be taken together with o ther medicines for treating tuberculosis.

It is used in adults and children (2years and over, who weigh at least 7kg).SIRTURO 20 mg tablets should be used to achieve the appropriate dose in patients weighing less than 1 5kg.

⚠️ 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 t his medicine (listed in section 6).Do not take SIRTURO if this applies to you. If you are not sure, talk to your doctor or pharmacist before taking SIRTURO .

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking SIRTURO ,if:  you have had an abnormal heart reading on an electrocardiogram (ECG )or heart failure ;  you have a personal or family history of a heart problem called “congenital long QT syndrome” ;  you are taking any other medications, as some may increase the risk of side effects;  you have a decreased thyroid gland function. This can be seen in a blood test;  you have liver disease or you drink alcohol on a regular basis ;  you have a low level of potassium in the blood. This can be seen in a blood test;  you have human immunodeficiency virus (HIV) infection .

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

46Children and adolescents In adolescents weighing 30 to 40 kg, the levels of SIRTURO in the blood were predicted to be higher than in adults. This might be associated with an increased risk of abnormal heart reading on anECG (called QT prolongation) or increased liver enzymes (sho wn in blood test). Talk to your doctor, pharmacist or nurse before taking SIRTURO.

Do not give this medicine to children under 2years of age or weighing less than 7kgbecause it has not been studied in these patients .

Other medicines and SIRTURO

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 patients with pulmonary tuberculosis due to M. tuberculosis resistant to a t least rifampicin and isoniazid may take and thatmay potential lyinteract with SIRTURO:

Medicine (name of the active substance)Purpose of the medicine rifampicin, rifapentine, rifabutin to treat some infections like tuberculosis (antimycobacterial) efavirenz, etravirine to treat HIV infection ( antiretroviral non-nucleoside reverse transcriptase inhibitors carbamazepine, phenytoin to treat epileptic fits(anticonvulsants ) St. John’s wort ( Hypericum perforatum )an herbal product to relieve anxiety SIRTURO with alcohol You should not drink alcohol while taking SIRTURO.

Pregnancy and breast -feeding If you are pregnant or breast -feeding, 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 operate machinery.

SIRTURO contains lactose

SIRTURO contains “lactose” (a type of sugar). If you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.

💊 3. How to take SIRTURO

Always take this medicine exactly as your doctor or pha rmacist has told you. Check with your doctor or pharmacist if you are not sure.

SIRTURO must always be taken together with ot her medicines for treating tuberculosis . Your doctor will decide which other medicines you should take with SIRTURO .

Use in children (5 years and over and weighing between 15kg and 20kg) How much to take You take SIRTURO for a 24 -week course.

First 2weeks:  Take 160mg once a day.

47From Week3 to Week24:  Take 80mg once a day for 3 days of each week only.  There must be at least 48 hours in between each time you take SIRTURO. For example, you may take SIRTURO on Monday, Wednesday and Friday every week from Week3 onwards.

Use in children (5 years and over and weighing between 20 kg and 30 kg) How much to take You take SIRTURO for a 24 -week course.

First 2 weeks:  Take 200 mg once a day.

From Week3 to Week24:  Take 100 mg once a day for 3days of each week only.  There must be at least 48 hours in between each time you take SIRTURO. For example, you may take SIRTURO on Monday, Wednesday and Friday every week from Week3 onwards.

Use in adults and in children (5years and over and w eighing at least 30 kg) How much to take You take SIRTURO for a 24 -week course.

First 2 weeks:  Take 40 0mg once a day .

From Week3 to Week24:  Take 200mg once a day for 3days of each week only.  There must be at least 48hours in between each time you take SIRTURO . For example, you may take SIRTURO on Monday, Wednesday and Friday every week from Week3 onwards.

You may need to keep taking your other medi cines for tuberculosis for longer than 6months . Check with your doctor or pharmacist.

Taking this medicine  Always t ake SIRTURO with food. The food is important to get the right levels of medicine in your body.  Swallow the tablet swhole with water .

If you take more SIRTURO than you should

If you take more SIRTURO than you should, talk to a doctor straight away. Take the medicine pack with you.

If you forget to take SIRTURO

During the first 2 weeks  Skip the missed dose and take the next dose as usual .  Do not take a double dose to make up for a forgotten dose.

From Week3onwards  Take the missed dose as soon as possible.  Resume the three times a week schedule.  Make sure there is at least 24 hours between taking the missed dose and the next scheduled dose.  Do not take more than the prescribed weekly dose in a 7 -day period.

If you have missed a dose and you are not sure what to do, talk to your doctor or pharmacist.

48If you stop taking SIRTURO Do not stop taking SIRTURO without first talking to your doctor.

Skipping doses or not completing the full course of therapy may:  make your treatment ineffective and your tuberculosis could get worse ,and;  increase the chance that the bacteria will become resistant to the medicine. This means your disease may not be treatable by 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 1 0people)

 abnormal reading on an ECG called “QT prolongation”. Tell your doctor right away if you faint  increased liver enzymes (shown in blood tests)  headache  joint pain  feeling dizzy  feeling of or being sick ( nausea or vomiting) .

Common (may affect up to 1 in 1 0people)

 diarrhoea  aching ortender muscles, not caused by exercise .

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 e ffects you can help provide more information on the safety of this medicine .

🌡️ 5. How to store 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 that month.

Store SIRTURO in the orig inal container or package in order to protect it from light.

This medicine may pose a risk tothe environment. Do not throw away any medicines via wastewater or household wast e. Ask your pharmacist how to throw away medicines you no longer use. These measures 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 100mg of bedaquiline.  The other ingredient s are: colloidal anhydrous silica, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polysorbate 20.

49What SIRTURO looks like and contents of the pack Uncoated , white to almost white round biconvex tablet, 11mm in diameter, with debossing of “T” over “207” on one side and “100” on the other side.

A plastic bottle containing 188tablets.

A carton containing 4 push -through blister strips (containing 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 Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Janssen -Cilag NV Tel/Tél: +32 14 64 94 11 [email protected] UAB “JOHNSON & JOHNSON” Tel: +370 5 278 68 88 [email protected] България „Джонсън & Джонсън България” ЕООД Тел.: +359 2 489 94 00 [email protected]/Luxemburg Janssen -Cilag NV Tél/Tel: +32 14 64 94 11 [email protected] Česká republika Janssen -Cilag s.r.o.

Tel: +420 227 012 227Magyarország Janssen -Cilag Kft.

Tel.: +36 1 884 2858 [email protected] Danmark Janssen -Cilag A/S Tlf.: +45 4594 8282 [email protected] AM MANGION LTD Tel: +356 2397 6000 Deutschland Janssen -Cilag GmbH Tel: 0800 086 9247 / +49 2137 955 6955 [email protected] Janssen -Cilag B.V.

Tel: +31 76 711 1111 [email protected] Eesti UAB “JOHNSON & JOHNSON” Eesti filiaal Tel: +372 617 7410 [email protected] Janssen -Cilag AS Tlf: +47 24 12 65 00 [email protected] 50Ελλάδα Janssen -Cilag Φαρμακευτική Μονοπρόσωπη Α.Ε.Β.Ε.

Tηλ: +30 210 80 90 000Österreich Janssen -Cilag Pharma GmbH Tel: +43 1 610 300 España Janssen -Cilag, S.A.

Tel: +34 91 722 81 00 [email protected] Janssen -Cilag Polska Sp. z o.o.

Tel.: +48 22 237 60 00 France Janssen -Cilag Tél: 0 800 25 50 75 / +33 1 55 00 40 03 [email protected] Janssen -Cilag Farmacêutica, Lda.

Tel: +351 214 368 600 Hrvatska Johnson & Johnson S.E. d.o.o.

Tel: +385 1 6610 700 [email protected]ânia Johnson & Johnson Rom ânia SRL Tel: +40 21 207 1800 Ireland Janssen Sciences Ireland UC Tel: 1 800 709 122 [email protected] Johnson & Johnson d.o.o.

Tel: +386 1 401 18 00 [email protected] Ísland Janssen -Cilag AB c/o Vistor ehf.

Sími: +354 535 7000 [email protected]á republika Johnson & Johnson, s.r.o.

Tel: +421 232 408 400 Italia Janssen -Cilag SpA Tel: 800.688.777 / +39 02 2510 1 [email protected]/Finland Janssen -Cilag Oy Puh/Tel: +358 207 531 300 [email protected] Κύπρος Βαρνάβας Χατζηπαναγής Λτδ Τηλ: +357 22 207 700Sverige Janssen -Cilag AB Tfn: +46 8 626 50 00 [email protected] Latvija UAB “JOHNSON & JOHNSON” filiāle Latvijā Tel: +371 678 93561 [email protected]

This leaflet was last revised i n

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

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Sirturo (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/13/901).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.