Telmisartan and Hydrochlorothiazide Tablets USP 80mg+12.5mg Technical Specification:

Product Name:Telmisartan and Hydrochlorothiazide Tablets USP 80mg+12.5mg
Brand Name:Generic
Strength:(40mg+12.5mg), (80mg+12.5mg), (80mg+25mg)
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:Antihypertensive
Indication: Telmisartan and hydrochlorothiazide combination is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.
Storage:Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store in dry place protected from light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Telmisartan and Hydrochlorothiazide Tablets USP 80mg+12.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Telmisartan and Hydrochlorothiazide Tablets USP 80mg+12.5mg
    Each uncoated bilayered tablet contains:
    Telmisartan USP………………………….80mg
    Hydrochlorothiazide USP…………….12.5mg
    Excipients……………………………..…… q.s
    Colour: Resorcin brown

THERAPEUTIC INDICATIONS:

Telmisartan and hydrochlorothiazide combination is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHTLY CLOSED CONTAINER.

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

It is dangerous to take this preparation except under medical supervision.

 When pregnancy is detected, Telmisartan should be discontinued as soon as possible, as it can cause injury and even death to the developing fetus, when used during the second and third trimester of pregnancy.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) ); excursions permitted to 15°C to 30°C (59°F to 86°F)
Store in dry place protected from light and moisture.

Dosage: As directed by the Physician

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Telmisartan and Hydrochlorothiazide Tablets USP 40mg+12.5mg
B. Telmisartan and Hydrochlorothiazide Tablets USP 80mg+12.5mg
C. Telmisartan and Hydrochlorothiazide Tablets USP 80mg+25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Telmisartan and Hydrochlorothiazide Tablets USP 40mg+12.5mg
Each uncoated bilayered tablet contains:
Telmisartan USP………………………….40mg
Hydrochlorothiazide USP…………….12.5mg
Excipients……………………………..…… q.s
Colour: Red oxide of iron

B. Telmisartan and Hydrochlorothiazide Tablets USP 80mg+12.5mg
Each uncoated bilayered tablet contains:
Telmisartan USP………………………….80mg
Hydrochlorothiazide USP…………….12.5mg
Excipients……………………………..…… q.s
Colour: Resorcin brown


C. Telmisartan and Hydrochlorothiazide Tablets USP 80mg+25mg
Each uncoated bilayered tablet contains:
Telmisartan USP………………………….80mg
Hydrochlorothiazide USP…………….25mg
Excipients……………………………..…… q.s
Colour: Tartrazine

THERAPEUTIC INDICATIONS:

Telmisartan and hydrochlorothiazide combination is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHTLY CLOSED CONTAINER.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
It is dangerous to take this preparation except under medical supervision.
When pregnancy is detected, Telmisartan should be discontinued as soon as possible, as it can cause injury and even death to the developing fetus, when used during the second and third trimester of pregnancy.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) ); excursions permitted to 15°C to 30°C (59°F to 86°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.