Sirturo
bedaquiline
bedaquiline
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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.
What SIRTURO is and what it is used for
What you need to know before you take SIRTURO
How to take SIRTURO
Possible side effects
How to store SIRTURO
Contents of the pack and other information
SIRTURO contains the active substance bedaquiline.
SIRTURO is a type of antibiotic. Antibiotics are medicines that kill bacteria that cause disease. SIRTURO is used to treat tuberculosis that affects the lungs when the disease has become resistant to other antibiotics. This is called multi-drug resistant pulmonary tuberculosis.
SIRTURO must always be taken together with other medicines for treating tuberculosis. It is used in adults and children (5 years and over, who weigh at least 15 kg).
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, talk to your doctor or pharmacist before taking SIRTURO.
Talk to your doctor, pharmacist or nurse before taking SIRTURO, if:
you have had an abnormal heart reading (ECG) or heart failure;
you have a personal or family history of a heart problem called “congenital long QT syndrome”;
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 human immunodeficiency virus (HIV) infection.
If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking SIRTURO.
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 reading on the
electrocardiogram (QT prolongation) or increased liver enzymes (shown in blood test). Talk to your
doctor, pharmacist or nurse before taking SIRTURO.
Do not give this medicine to children under 5 years of age or weighing less than 15 kg because it has not been studied in these patients.
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 multi-drug resistant tuberculosis may take and which may potentially interact with SIRTURO:
Medicine (name of the active substance) | Purpose of the medicine |
rifampicin, rifapentine, rifabutin | to treat some infections like tuberculosis (antimycobacterial) |
ketoconazole, fluconazole | to treat fungal infections (antifungals) |
efavirenz, etravirine, lopinavir/ritonavir | to treat HIV infection (antiretroviral non-nucleoside reverse transcriptase inhibitors, antiretroviral protease inhibitors) |
clofazimine | to treat some infections like leprosy (antimycobacterial) |
carbamazepine, phenytoin | to treat epileptic fits (anticonvulsants) |
St. John’s wort (Hypericum perforatum) | an herbal product to relieve anxiety |
ciprofloxacin, erythromycin, clarithromycin | to treat bacterial infections (antibacterials) |
You should not drink alcohol while taking SIRTURO.
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.
You may feel dizzy after taking SIRTURO. If this happens, do not drive or operate machinery.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
SIRTURO must always be taken together with other medicines for treating tuberculosis. Your doctor will decide which other medicines you should take with SIRTURO.
You take SIRTURO for a 24 week course.
Take 160 mg once a day. From week 3 to week 24:
Take 80 mg 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 week 3 onwards.
You take SIRTURO for a 24 week course.
Take 200 mg once a day. From week 3 to week 24:
Take 100 mg 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 week 3 onwards.
You may need to keep taking your other medicines for tuberculosis for longer than 6 months. Check with your doctor or pharmacist.
You take SIRTURO for a 24 week course.
Take 400 mg once a day. From week 3 to week 24:
Take 200 mg 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 week 3 onwards.
Always take SIRTURO with food. The food is important to get the right levels of medicine in your body.
Swallow the tablets with water – the tablets can be taken whole or split in half.
If you are unable to swallow SIRTURO tablets, you may:
Swallow the mixture straight away, or
To help with taking SIRTURO you may add at least one extra teaspoon of water
(or another drink) or soft food and mix.
You can use the following drinks for mixing: water, milk product, apple juice, orange juice, cranberry juice or carbonated drinks. You can use the following soft foods for mixing: yoghurt, apple sauce, mashed bananas or porridge.
Swallow the mixture straight away.
Repeat with more tablets until you have taken all the dose.
Make sure no bits of the tablet are left in container, rinse with more of your drink
or soft food and swallow the mixture straight away.
Ask your healthcare provider for specific instructions on how to properly take the tablets through a feeding tube.
If you take more SIRTURO than you should, talk to a doctor straight away. Take the medicine pack with you.
Skip the missed dose and take the next dose as usual
Do not take a double dose to make up for a forgotten dose.
Take the missed dose as soon as possible.
Resume the three times a week schedule.
Make sure that 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.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
headache
joint pain
feeling dizzy
feeling or being sick (nausea or vomiting).
diarrhoea
increased liver enzymes (shown in blood tests)
aching or tender muscles, not caused by exercise
abnormal reading on the electrocardiogram called “QT prolongation”. Tell your doctor right away if you faint.
increased liver enzymes (shown in blood tests)
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 thenationalreporting
systemlistedinAppendixV. By reporting side effects you can help provide more information on the
safety of this medicine.
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 in the original container and keep the container tightly closed in order to protect from light and moisture. Do not remove desiccant (pouch containing drying agent).
This medicine may pose a risk to the environment. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is bedaquiline. Each tablet contains bedaquiline fumarate equivalent to 20 mg of bedaquiline.
The other ingredients are: microcrystalline cellulose, crospovidone, colloidal anhydrous silica, hypromellose, polysorbate 20, sodium stearly fumarate.
Uncoated, white to almost white oblong tablet with score line on both sides, debossed with “2” and “0” on one side and plain on other side.
A plastic bottle containing 60 tablets
B-2340 Beerse Belgium
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:
UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 88
„Джонсън & Джонсън България” ЕООД Тел.: +359 2 489 94 00
Janssen-Cilag NV Tél/Tel: +32 14 64 94 11
Janssen-Cilag A/S Tlf: +45 4594 8282
AM MANGION LTD Tel: +356 2397 6000
Janssen-Cilag GmbH Tel: +49 2137 955 955
Janssen-Cilag B.V. Tel: +31 76 711 1111
UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7410
Janssen-Cilag AS Tlf: +47 24 12 65 00
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε. Tηλ: +30 210 80 90 000
Janssen-Cilag Pharma GmbH Tel: +43 1 610 300
Janssen-Cilag, S.A. Tel: +34 91 722 81 00
Janssen-Cilag Polska Sp. z o.o. Tel.: +48 22 237 60 00
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
Janssen-Cilag Farmacêutica, Lda. Tel: +351 214 368 600
Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 700
Johnson & Johnson România SRL Tel: +40 21 207 1800
Janssen Sciences Ireland UC Tel: +353 1 800 709 122
Johnson & Johnson d.o.o. Tel: +386 1 401 18 00
Janssen_safety_slo@its.jnj.com
Janssen-Cilag AB c/o Vistor hf.
Sími: +354 535 7000
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
Βαρνάβας Χατζηπαναγής Λτδ Τηλ: +357 22 207 700
Janssen-Cilag AB Tfn: +46 8 626 50 00
UAB "JOHNSON & JOHNSON" filiāle Latvijā Tel: +371 678 93561
Janssen Sciences Ireland UC Tel: +44 1 494 567 444
This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine. The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.