Clofazimine (kloe-FAZ-i-meen)

Treats lepromatous leprosy.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine is taken together with other medicines (including other antileprosy medicines, steroids). Follow your doctor's orders on the right times to take these medicines.
• It is best to take this medicine with food or milk.
• Take all of the medicine in your prescription to clear up your infection, even if you feel better after the first few doses. You may need to use this medicine for at least 2 to 3 years.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how clofazimine works. Tell your doctor if you are using bedaquiline.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Your doctor will give you a pregnancy test before starting treatment with this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment with this medicine and for at least 4 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 4 months after the last dose.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, stomach or bowel problems, heart rhythm problems, or mental health problems.
• This medicine may cause the following problems:
  • Stomach or bowel blockage or bleeding, spleen problems (including splenic infarction)
  • Heart rhythm problems (including QT prolongation)
• This medicine may turn your skin orange-pink to brownish-black. It may also cause your sweat, tears, spit, urine, bowel movements, and the whites of your eyes to turn red to brownish-black in color. These may take up to several months or years to change back to its normal color, even after stopping treatment with this medicine.
• Skin discoloration may cause psychological effects, which can lead to depression or suicidal thoughts and behaviors. Tell your doctor if you have concerns about this.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Bloody or black stools
• Changes in mood or behavior, thoughts of hurting yourself
• Dizziness, lightheadedness, or fainting
• Fast, pounding, or uneven heartbeat
• Severe nausea, vomiting, or diarrhea
• Severe stomach pain, cramps, or burning, pain spreading to left your shoulder

If you notice these less serious side effects, talk with your doctor:

• Changes in the color of your skin, eyes, urine, sweat, spit, stools, or tears
• Dry, scaly, or itching skin

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088