GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Clofazimine Tablets 50mg
B. Clofazimine Tablets 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Clofazimine Tablets 50mg
Clofazimine I.P……………….50mg
Excipients ……………………..Q.s.
Colours: Red Oxide of Iron & Black Oxide of Iron.
B. Clofazimine Tablets 100mg
Clofazimine I.P……………….100mg
Excipients ……………………..Q.s.
Colours: Red Oxide of Iron & Black Oxide of Iron.

THERAPEUTIC INDICATIONS:

Clofazimine is a drug used to treat leprosy. It can slow down the growth and weakly kill Mycobacterium leprae, the bacterium that causes leprosy. It is used in combination with rifampicin and dapsone for the treatment of the many forms of leprosy. It is specifically used for multibacillary (MB) leprosy and erythema nodosum leprosum. Evidence is insufficient to support its use in other conditions. It is taken by mouth.

CAUTION & SCHEDULE:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at room temperature between 15°C to 30°C. Protect from Light & heat.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Dosage: For-Sensitive Lepromatous (multibacillary) Leprosy. Administer 100mg Clofazimine daily with meals in combination with two other anti-leprosy drugs for at least 2 years and if possible, until negative skin smears are obtained, followed by monotherapy with an appropriate anti leprosy drug.

Clofazimine Tablets 100mg Technical Specification:

Product Name:Clofazimine Tablets
Brand Name:Generic
Strength:50mg, 100mg
Dosage Form:Tablet
Route of Administration:Via Oral Route
Packing:10s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Anti tuberoculosis
Indication: Clofazimine is a drug used to treat leprosy. It can slow down the growth and weakly kill Mycobacterium leprae, the bacterium that causes leprosy.
Storage:Store at 20° to 25°C (68° to 77°F). Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Clofazimine Tablets 50mg
  • Clofazimine Tablets 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Clofazimine Tablets 50mg
    Clofazimine I.P……………….50mg
    Excipients ……………………..Q.s.
    Colours: Red Oxide of Iron & Black Oxide of Iron.
  • Clofazimine Tablets 100mg
    Clofazimine I.P……………….100mg
    Excipients ……………………..Q.s.
    Colours: Red Oxide of Iron & Black Oxide of Iron.

THERAPEUTIC INDICATIONS:

Clofazimine is a drug used to treat leprosy. It can slow down the growth and weakly kill Mycobacterium leprae, the bacterium that causes leprosy. It is used in combination with rifampicin and dapsone for the treatment of the many forms of leprosy.It is specifically used for multibacillary (MB) leprosy and erythema nodosum leprosum. Evidence is insufficient to support its use in other conditions.It is taken by mouth.

CAUTION & SCHEDULE:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE:  To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at room temperature between 15°C to 30°C. Protect from Light & heat.
Read enclosed leaflet before use.
Keep medicine out of reach of children.
Dosage:  For-Sensitive Lepromatous (multibacillary) Leprosy. Administer 100mg Clofazimine daily with meals in combination with two other anti-leprosy drugs for at least 2 years and if possible, until negative skin smears are obtained, followed by monotherapy with an appropriate anti leprosy drug.Note: *Not suitable for children under 5 years.