Teneligliptin and Metformin Hydrochloride Extended Release Tablets (20mg+500mg) (Tenitaj-M Forte)

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Teneligliptin and Metformin Hydrochloride Extended Release Tablets (20mg+500mg)
B. Teneligliptin and Metformin Hydrochloride Extended Release Tablets (20mg+1000mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Teneligliptin and Metformin Hydrochloride Extended Release Tablets (20mg+500mg)
Each uncoated bilayered tablet contains:
Teneligliptin Hydrochloride Hydrate
Equivalent to Teneligliptin……………….20mg
Metformin Hydrochloride IP…………….500mg
(As Extended Release)
Excipients………………………………………q.s
Colours: Ferric oxide Yellow USP-NF(Yellow Oxide of iron)
(In Teneligliptin layer)

B) Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 1000mg Tablets
Each uncoated bilayered tablet contains:
Teneligliptin Hydrochloride Hydrate
Equivalent to Teneligliptin……………….20mg
Metformin Hydrochloride IP…………….1000mg
(As Extended Release)
Excipients………………………………………q.s
Colours: Ferric oxide Red USP-NF(Red Oxide of iron)
(In Teneligliptin layer)

THERAPEUTIC INDICATIONS:

METFORMIN+TENELIGLIPTIN belongs to the group of medications called 'antidiabetic agents' used to treat Type 2 diabetes mellitus. This medication improves glycaemic control in diabetic patients in those patients who do not react well to Metformin alone.

CAUTION & SCHEDULE:

CAUTION: Tablet to be swallowed as a whole, and not to be chewed or crushed.
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 below 25℃.
Store in cool, dry & dark place Protect from Light & moisture.
Dosage: As directed by the Physician.

Teneligliptin and Metformin Hydrochloride Extended Release Tablets (20mg+500mg) Technical Specification:

Product Name:Teneligliptin and Metformin Hydrochloride Extended Release Tablets (20mg+500mg)
Brand Name:Tenitaj-M Forte
Strength:(20mg+500mg), (20mg+1000mg)
Dosage Form:Tablets (film-coated)
Route of Administration:Via Oral Route
Packing:10 strips of 10 tablets each
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Antidiabetic
Indication: METFORMIN+TENELIGLIPTIN belongs to the group of medications called ‘antidiabetic agents’ used to treat Type 2 diabetes mellitus. This medication improves glycaemic control in diabetic patients in those patients who do not react well to Metformin alone.
Storage:Store below 25℃.  Store in cool, dry & dark place Protect from Light & moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Teneligliptin and Metformin Hydrochloride Extended Release Tablets (20mg+500mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Teneligliptin and Metformin Hydrochloride Extended Release Tablets (20mg+500mg)
    Each uncoated bilayered tablet contains:
    Teneligliptin Hydrochloride Hydrate
    Equivalent to Teneligliptin……………….20mg
    Metformin Hydrochloride IP…………….500mg
    (As Extended Release)
    Excipients………………………………………q.s
    Colours: Ferric oxide Yellow USP-NF(Yellow
    Oxide of iron)
    (In Teneligliptin layer)

THERAPEUTIC INDICATIONS:

METFORMIN+TENELIGLIPTIN belongs to the group of medications called ‘antidiabetic agents’ used to treat Type 2 diabetes mellitus. This medication improves glycaemic control in diabetic patients in those patients who do not react well to Metformin alone.

CAUTION & SCHEDULE:

CAUTION:  Tablet to be swallowed as a whole, and not to be chewed or crushed.

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 below 25℃. Store in cool, dry & dark place Protect from Light & moisture.

Dosage:  As directed by the Physician.