A. Teneligliptin and Metformin Hydrochloride Extended Release Tablets (20mg+500mg)
B. Teneligliptin and Metformin Hydrochloride Extended Release Tablets (20mg+1000mg)
GENERIC NAME OF THE MEDICINAL PRODUCT:
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)
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.
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.
Store in cool, dry & dark place Protect from Light & moisture.
Dosage: As directed by the Physician.
Teneligliptin and Metformin Hydrochloride Extended Release Tablets (20mg+1000mg) Technical Specification:
| Product Name: | Teneligliptin and Metformin Hydrochloride Extended Release Tablets (20mg+1000mg) |
| 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+1000mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Teneligliptin and Metformin Hydrochloride Extended Release Tablets (20mg+1000mg)
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(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.
