GENERIC NAME OF THE MEDICINAL PRODUCT:

Empagliflozin Tablets 25mg
Empagliflozin Tablets 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Empagliflozin Tablets 25mg
Each Film coated tablet contains:
Empagliflozin……………………25gm
Excipients…………………………Q. s
Colurs: Quinoline yellow

b) Empagliflozin Tablets 10mg
Each Film coated tablet contains:
Empagliflozin……………………10gm
Excipients…………………………Q. s
Colurs: Red oxide of iron

THERAPEUTIC INDICATIONS:

Empagliflozin Tablet is used alone or in combination with other medicines to treat type 2 diabetes mellitus. It helps control the high blood sugar levels seen in diabetes. This reduces the chances of serious complications of diabetes and also helps prevent heart disease.

CAUTION & WARNING:

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

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.

Empagliflozin Tablets 25mg Technical Specification:

Product Name:
 Empagliflozin Tablets
Brand Name: Generics
Strength: (10mg), (25mg)
Dosage Form: Tablets (Film coated)
Route of Administration: Via oral Route
Packing: 30s, 90s, 100s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Antidiabetic, Diabetology, sodium-glucose co-transporter 2 (SGLT2) inhibitors
Indication: Empagliflozin is a medicine used to treat type 2 diabetes. Type 2 diabetes is a condition where the body does not make enough insulin, or the insulin that it makes does not work properly. This can cause high blood sugar levels (hyperglycaemia).
Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Empagliflozin Tablets 25mg
  • Empagliflozin Tablets 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • a) Empagliflozin Tablets 25mg
    Each Film coated tablet contains:
    Empagliflozin……………………25gm
    Excipients…………………………Q. s
    Colurs: Quinoline yellow
  •  b) Empagliflozin Tablets 10mg
    Each Film coated tablet contains:
    Empagliflozin……………………10gm
    Excipients…………………………Q. s
    Colurs: Red oxide of iron

THERAPEUTIC INDICATIONS:

  • Empagliflozin Tablet is used alone or in combination with other medicines to treat type 2 diabetes mellitus. It helps control the high blood sugar levels seen in diabetes. This reduces the chances of serious complications of diabetes and also helps prevent heart disease.

CAUTION & WARNING:

  • CAUTION:
    Read enclosed leaflet before use.
    Keep medicine out of reach of children.
    SWALLOW WHOLE DO NOT CHEW OR CRUSH
  • Warning:To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

  • Storage: Protect form moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.
  • Dosage:  As directed by the Physician.
Attach dispensing label as per end county.