GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Azilsartan Medoxomil and Chlorthalidone Tablets 40mg+12.5mg
2. Azilsartan Medoxomil and Chlorthalidone Tablets 40mg+25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Azilsartan Medoxomil and Chlorthalidone Tablets 40mg+12.5mg
Each tablet contains:
Azilsartan Kamedoxomil 42.68mg
Equivalent to Azilsartan Medoxomil……..40mg
Chlorthalidone…………………………………………12.5mg
Excipients……………………………………………......q.s
Color: Sunset yellow FCF


2. Azilsartan Medoxomil and Chlorthalidone Tablets 40mg+25mg
Each tablet contains:
Azilsartan Kamedoxomil 42.68mg
Equivalent to Azilsartan Medoxomil……………40mg
Chlorthalidone………………………………………………25mg
Excipients………………………………………………………q.s
Color: Lake tartrazine

THERAPEUTIC INDICATIONS:

Azilsartan and chlorthalidone combination is used to treat high blood pressure (hypertension).

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Do not accept if tamper-evidence ring is broken or missing.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Keep container tightly closed.
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)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.

Azilsartan Medoxomil and Chlorthalidone Tablets 40mg+12.5mg Technical Specification:

Product Name: Azilsartan Medoxomil and Chlorthalidone Tablets
Brand Name: Generic
Strength: (40mg+12.5mg), (40mg+25mg)
Dosage Form: Tablets
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: Azilsartan and chlorthalidone combination is used to treat high blood pressure (hypertension).
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:

1. Azilsartan Medoxomil and Chlorthalidone Tablets 40mg+12.5mg
2. Azilsartan Medoxomil and Chlorthalidone Tablets 40mg+25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Azilsartan Medoxomil and Chlorthalidone Tablets 40mg+12.5mg
Each tablet contains:
Azilsartan Kamedoxomil 42.68mg
Equivalent to Azilsartan Medoxomil……..40mg
Chlorthalidone…………………………………………12.5mg
Excipients…………………………………………………q.s
Color: Sunset yellow FCF

2. Azilsartan Medoxomil and Chlorthalidone Tablets 40mg+25mg
Each tablet contains:
Azilsartan Kamedoxomil 42.68mg
Equivalent to Azilsartan Medoxomil……………40mg
Chlorthalidone………………………………………………25mg
Excipients………………………………………………………q.s
Color: Lake tartrazine

THERAPEUTIC INDICATIONS:

Azilsartan and chlorthalidone combination is used to treat high blood pressure (hypertension).

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Do not accept if tamper-evidence ring is broken or missing.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Keep container tightly closed.

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)
Store in dry place protected from light and moisture.

Dosage: As directed by the Physician

Attach dispensing label as per end country.