Patient leaflet - Sirturo 100 mg tablets
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 kill bacteria 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 other medicines for treating tuberculosis.
It is used in adults and children (2 years and over, who weigh at least 7 kg). SIRTURO 20 mg tablets should be used to achieve the appropriate dose in patients weighing less than 15 kg.
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, 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 applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking SIRTURO.
Children 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 an ECG (called 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 2 years of age or weighing less than 7 kg because 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 at least rifampicin and isoniazid may take and that 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) |
| 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 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.
Use in children (5 years and over and weighing between 15 kg and 20 kg)
How much to take
You take SIRTURO for a 24-week course.
First 2 weeks:
- 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.
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 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.
Use in adults and in children (5 years and over and weighing at least 30 kg)
How much to take
You take SIRTURO for a 24-week course.
First 2 weeks:
- 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.
You may need to keep taking your other medicines for tuberculosis for longer than 6 months. Check with your doctor or pharmacist.
Taking this medicine
- Always take SIRTURO with food. The food is important to get the right levels of 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, 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 Week 3 onwards
- 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.
If 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 10 people):
- 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 10 people):
- diarrhoea
- aching or tender muscles, not caused by exercise.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects 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. This medicine does not require any special temperature storage conditions. Store SIRTURO in the original container or package in order to protect it from light.
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.
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, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polysorbate 20.
What SIRTURO looks like and contents of the pack
Uncoated, white to almost white round biconvex tablet, 11 mm in diameter, with debossing of "T" over "207" on one side and "100" on the other side. A plastic bottle containing 188 tablets.
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 Limited
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK
Manufacturer
Janssen Pharmaceutica
NV Turnhoutseweg 30
B-2340
Beerse
Belgium