Telmisartan Tablets USP 20mg Technical Specification:

Product Name:Telmisartan Tablets USP 20mg
Brand Name:Telmisar
Strength:(20mg), (40mg), (80mg)
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 is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.
Storage:Store at 20° to 25°C (68° to 77°F). Store in dry place protected from light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Telmisartan Tablets USP 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Telmisartan Tablets USP 20mg
    Each uncoated tablet contains:
    Telmisartan USP………………20mg
    Excipients…………………………q.s
    Color: Sunset yellow FCF

THERAPEUTIC INDICATIONS:

Telmisartan is used alone or together with other medicines 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 TIGHT, LIGHT-RESISTANT CONTAINER AS DEFINED IN THE USP USING A CHILD-RESISTANT CLOSURE.
KEEP THE CONTAINER TIGHTLY CLOSED.

IMPORTANT: MOISTURE SENSITIVE TABLETS- DO NOT REMOVE FROM STRIP UNTIL IMMEDIATELY BEFORE USE.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
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)
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 Tablets USP 20mg
B. Telmisartan Tablets USP 40mg
C. Telmisartan Tablets USP 80mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Telmisartan Tablets USP 20mg
Each uncoated tablet contains:
Telmisartan USP………………20mg
Excipients…………………………q.s
Color: Sunset yellow FCF


B. Telmisartan Tablets USP 40mg
Each uncoated tablet contains:
Telmisartan USP…………………..40mg
Excipients…………………………….q.s
Color: Ponceau 2R

C. Telmisartan Tablets USP 80mg
Each uncoated tablet contains:
Telmisartan USP…………………80mg
Excipients……………………………..q.s
Color: Ponceau 4R

THERAPEUTIC INDICATIONS:

Telmisartan is used alone or together with other medicines 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 TIGHT, LIGHT-RESISTANT CONTAINER AS DEFINED IN THE USP USING A CHILD-RESISTANT CLOSURE.
KEEP THE CONTAINER TIGHTLY CLOSED.
IMPORTANT: MOISTURE SENSITIVE TABLETS- DO NOT REMOVE FROM STRIP UNTIL IMMEDIATELY BEFORE USE.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
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)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.