Griseofulvin Tablets BP 250mg Technical Specification:

Product Name:Griseofulvin Tablets BP 250mg
(Griseofulvin of Fine Particle)
Brand Name:Generic
Strength:125mg, 250mg, 375mg, 500mg
Dosage Form:Tablets (Uncoated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antifungal
Indication: Griseofulvin is used to treat skin infections such as jock itch, athlete’s foot, and ringworm; and fungal infections of the scalp, fingernails, and toenails. This medicine works by stopping the growth of fungi. It does not treat infections due to bacteria or yeast.
Storage:Store at 15° to 30°C. Keep away from heat & light. Do not store in the bathroom.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Griseofulvin Tablets BP 250mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Griseofulvin Tablets BP 250mg
    Each uncoated tablet contains:
    Griseofulvin BP ……………….250mg
    Excipients ………………………. q. s

THERAPEUTIC INDICATIONS:

Griseofulvin is an antifungal medication used to treat a number of types of dermatophytosis. Griseofulvin is used to treat skin infections such as jock itch, athlete’s foot, and ringworm; and fungal infections of the scalp, fingernails, and toenails. This medicine works by stopping the growth of fungi. It does not treat infections due to bacteria or yeast.

CAUTION & WARNING:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH

*Not suitable for children under 5 years.

Read enclosed leaflet before use.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage: Store at 15° to 30°C. Keep away from heat & light. Do not store in the bathroom.

Dosage: The recommended dose is 375mg daily or 250mg three times daily of the ultramicrosize formulation depending on the type of infection. The dosing recommendation for the microsize formulation is 500mg once or twice daily, or 1000mg as a single dose depending on the type of fungal infection.

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Griseofulvin Tablets BP 125mg
B. Griseofulvin Tablets BP 250mg
C. Griseofulvin Tablets BP 375mg
D. Griseofulvin Tablets BP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Griseofulvin Tablets BP 125mg
Each uncoated tablet contains:
Griseofulvin BP ……………….125mg
Excipients ………………………. q. s

B. Griseofulvin Tablets BP 250mg
Each uncoated tablet contains:
Griseofulvin BP ……………….250mg
Excipients ………………………. q. s


C. Griseofulvin Tablets BP 375mg
Each uncoated tablet contains:
Griseofulvin BP ……………….375mg
Excipients ………………………. q. s

D. Griseofulvin Tablets BP 500mg
Each uncoated tablet contains:
Griseofulvin BP ……………….500mg
Excipients ………………………. q. s

THERAPEUTIC INDICATIONS:

Griseofulvin is an antifungal medication used to treat a number of types of dermatophytosis. Griseofulvin is used to treat skin infections such as jock itch, athlete's foot, and ringworm; and fungal infections of the scalp, fingernails, and toenails. This medicine works by stopping the growth of fungi. It does not treat infections due to bacteria or yeast.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
*Not suitable for children under 5 years.
Read enclosed leaflet before use.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Store at 15° to 30°C.
Keep away from heat & light.
Do not store in the bathroom.
Dosage: The recommended dose is 375mg daily or 250mg three times daily of the ultramicrosize formulation depending on the type of infection.
The dosing recommendation for the microsize formulation is 500mg once or twice daily, or 1000mg as a single dose depending on the type of fungal infection.
Attach dispensing label as per end country.