Bedaquiline Oral Tablet (BEDAQUILINE - ORAL)

Instructions

Take the medicine with food.

Swallow with a full glass (8 oz) of water unless your doctor gives you different instructions.

This medicine is usually combined with another medicine to treat your condition.

Ask your doctor if any of your medicines need to be taken at the same time.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

This medicine is used to treat serious infections that may be resistant to other antibiotic medicines.

Drink plenty of water while on this medicine.

Tell your doctor if you have severe or persistent sweating, diarrhea or vomiting. These can increase your risk of a serious side effect.

If you forget to take your dose on time during the first 2 weeks of treatment, just wait and take the next dose as usual. If you miss a dose after the first 2 weeks of treatment, take the missed dose as soon as possible, then continue your 3 times a week schedule. Do not take 2 doses on the same day.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Talk to your doctor before taking other medicines, including aspirins and ibuprofen containing products. Speak to your doctor about which medicines are safe to use while you are on this medicine.

Keep using this medicine for the full number of days that it is prescribed. Do not stop the medicine even if you start to feel better.

Keep all appointments for medical exams and tests while on this medicine.

Do not take the medicine more than once during 24 hours.

Cautions

This medicine is not recommended for use in children younger than 12.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

This medicine is associated with a rare but very serious medical condition. Please speak with your doctor about symptoms you should look out for while on this medicine. Notify your doctor immediately if you develop those symptoms.

This medicine has been associated with a rare but serious skin rash. If you notice any red, peeling or blistered skin, contact your doctor immediately.

Do not use the medication any more than instructed.

Do not drink beverages with alcohol while on this medicine.

Speak with your health care provider before receiving any vaccinations.

This medicine passes into breast milk. Ask your doctor before breastfeeding.

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• headaches
• pain in the joints
• nausea

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• abdominal cramps
• decreased appetite
• chest pain
• cough up blood
• fainting
• fast or irregular heart beats
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• stomach pain
• severe or persistent vomiting

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.