GENERIC NAME OF THE MEDICINAL PRODUCT:

Telmisartan and Hydrochlorothiazide Tablets USP 40mg/12.5mg.
Telmisartan and Hydrochlorothiazide Tablets USP 80mg/12.5mg.
Telmisartan and Hydrochlorothiazide Tablets USP 80mg/25mg.

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Telmisartan and Hydrochlorothiazide Tablets USP 40mg/12.5mg.
Each film coated tablet contains:
Telmisartan USP…………………….40mg
Hydrochlorothiazide USP……………12.5mg
Excipients…………………………………. q.s.
colors: yellow oxide of iron

b) Telmisartan and Hydrochlorothiazide Tablets USP 80mg/12.5mg.
Each film coated tablet contains:
Telmisartan USP……………………80mg
Hydrochlorothiazide USP…………….12.5mg
Excipients…………………………………...q.s.
colours: Titanium dioxide.

c) Telmisartan and Hydrochlorothiazide Tablets USP 80mg/25mg.
Each film coated tablet contains:
Telmisartan USP…………………….…...80mg
Hydrochlorothiazide USP……………….25mg
Excipients…………………………………. q.s.
colors: Quinoline Yellow

THERAPEUTIC INDICATIONS:

Treatment of essential hypertension.
Telmisartan/Hydrochlorothiazide fixed dose combination is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
YOU SHOULD NOT USE THIS MEDICINE IF YOU ARE ALLERGIC TO HYDROCHLOROTHIAZIDE OR TELMISARTAN, IF YOU ARE UNABLE TO URINATE.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F). Protect from light.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.

Telmisartan and Hydrochlorothiazide Tablets USP Technical
specification:

Product Name: Telmisartan and Hydrochlorothiazide Tablets USP
Brand Name: Generics
Strength: 40mg/12.5mg, 80mg/12.5mg, 80mg/25mg.
Dosage Form: Tablets
Route of Administration: Via oral route
Packing: 30s,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: Anti-hypertensive, diuretics.
Indication: Telmisartan and hydrochlorothiazide combination is used to treat high blood pressure (hypertension).
Storage: Store at 20° to 25°C (68° to 77°F)

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Telmisartan and Hydrochlorothiazide Tablets USP 40mg/12.5mg.
  • Telmisartan and Hydrochlorothiazide Tablets USP 80mg/12.5mg.
  • Telmisartan and Hydrochlorothiazide Tablets USP 80mg/25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Telmisartan and Hydrochlorothiazide Tablets USP 40mg/12.5mg.
Each film coated tablet contains:
Telmisartan USP…………………….40mg
Hydrochlorothiazide USP……………12.5mg
Excipients…………………………………. q.s.
Colors: yellow oxide of iron

b) Telmisartan and Hydrochlorothiazide Tablets USP 80mg/12.5mg.
Each film coated tablet contains:
Telmisartan USP……………………80mg
Hydrochlorothiazide USP…………….12.5mg
Excipients……………………………………q.s.
Colours: Titanium dioxide.

c) Telmisartan and Hydrochlorothiazide Tablets USP 80mg/25mg.
Each film coated tablet contains:
Telmisartan USP…………………….……80mg
Hydrochlorothiazide USP……………….25mg
Excipients…………………………………. q.s.
Colors: Quinoline Yellow

THERAPEUTIC INDICATIONS:

  • Treatment of essential hypertension.Telmisartan/Hydrochlorothiazide fixed dose combination is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.

CAUTION & WARNING:

  • CAUTION:
    Read enclosed leaflet before use.
    Keep medicine out of reach of children.
    You should not use this medicine if you are allergic to hydrochlorothiazide or telmisartan, if you are unable to urinate.
  • Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

  • Storage: Store at 20° to 25°C (68° to 77°F). Protect from light.
  • Dosage: As directed by the Physician.
Attach dispensing label as per end county.