Leaflet MDT-COMBI 300mg+100mg+50mg+100mg capsules and tablets

Indicated for: leprosy

Route of administration: oral

Substance: rifampicin + clofazimine + dapsone (antimycobacterial agents)

ATC: J04BA51 (Antiinfectives for systemic use | Drugs for treatment of lepra)

Precautions:
Dose adjustment in renal impairment
Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Anaphylaxis
Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Colitis / severe diarrhea
Colitis / severe diarrhea

Seek medical advice if severe or persistent diarrhea occurs.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Rifampicin + clofazimine + dapsone is an antibiotic combination used to treat leprosy, or Hansen’s disease. Leprosy is caused by Mycobacterium leprae and affects the skin and peripheral nerves. Combination treatment kills the bacteria, reduces infectiousness and prevents resistance. When taken correctly, it can cure the disease and reduce disability.

The exact regimen depends on the type of leprosy and is set by the doctor or public health programme. Some doses may be supervised, others taken daily at home for months. It is essential not to miss doses and to finish the full course, even if skin patches or numbness improve. Treatment may not reverse established nerve damage.

Side effects may include nausea, abdominal pain, rash, itching, anaemia, tiredness or liver problems. Rifampicin can turn urine, tears and sweat orange-red, which can stain soft contact lenses. Clofazimine can darken the skin and body fluids, sometimes for months after treatment. Dapsone can rarely cause severe skin reactions, low haemoglobin or breathing problems, especially in G6PD deficiency.

Contact your doctor if you develop fever, yellow skin or eyes, very dark urine, marked paleness, shortness of breath, blistering rash, new nerve pain or loss of sensation. Tell your healthcare team about all other medicines, because rifampicin has many interactions and can reduce the effectiveness of hormonal contraceptives. Care of skin, eyes, hands and feet helps prevent complications.

General data about MDT-COMBI 300mg+100mg+50mg+100mg

  • Substance: rifampicin + clofazimine + dapsone
  • Date of latest medicines list: 01-02-2026
  • Product code: W71609001
  • Concentration: 300mg+100mg+50mg+100mg
  • Pharmaceutical form: capsules and tablets
  • Quantity: 1
  • Product type: Generic medicine
  • Prescription status: X

Marketing authorisation

  • Manufacturer: SANDOZ PRIVATE LIMITED - INDIA
  • Holder: CN UNIFARM S.A. - ROMANIA
  • Number: 1161/2025/01