GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Azilsartan Medoxomil and Chlorthalidone Tablets 40mg+12.5mg
2. Azilsartan Medoxomil and Chlorthalidone Tablets 80mg+12.5mg
3. Azilsartan Medoxomil and Chlorthalidone Tablets 40mg+6.25mg
4. Azilsartan Medoxomil and Chlorthalidone Tablets 80mg+6.25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Azilsartan Medoxomil and Chlorthalidone Tablets 40mg+12.5mg
Each film-coated bilayer tablet contains:
Azilsartan Kamedoxomil
Equivalent to Azilsartan Medoxomil…………40mg
Chlorthalidone IP………………………………………12.5mg
Excipients……………………………………………………q.s
Colour: Titanium Dioxide IP

2. Azilsartan Medoxomil and Chlorthalidone Tablets 80mg+12.5mg
Each film-coated bilayer tablet contains:
Azilsartan Kamedoxomil
Equivalent to Azilsartan Medoxomil……………80mg
Chlorthalidone IP…………………………………………12.5mg
Excipients…………………………………………………… q.s
Colour: Orange G

3. Azilsartan Medoxomil and Chlorthalidone Tablets 40mg+6.25mg
Each film-coated bilayer tablet contains:
Azilsartan Kamedoxomil
Equivalent to Azilsartan Medoxomil……………40mg
Chlorthalidone IP…………………………………………6.25mg
Excipients……………………………………………………q.s
Colour: Red Oxide of Iron

4. Azilsartan Medoxomil and Chlorthalidone Tablets 80mg+6.25mg
Each film-coated bilayer tablet contains:
Azilsartan Kamedoxomil
Equivalent to Azilsartan Medoxomi………………80mg
Chlorthalidone IP…………………………………………6.25mg
Excipients……………………………………………………q.s
Colour: Caramel

THERAPEUTIC INDICATIONS:

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

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
When pregnancy is detected Azilsartan should be discontinued as soon as possible. It can cause injury and even death to the developing fetus when used during second and third trimester of pregnancy.
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

STORAGE & DOSAGE:

Storage: Store below 25°C.
Protect from Light.
Dosage: As directed by the Physician.

Azilsartan Medoxomil and Chlorthalidone Tablets 80mg+12.5mg Technical Specification:

Product Name: Azilsartan Medoxomil and Chlorthalidone Tablets
Brand Name: Generic
Strength: (40mg+12.5mg), (80mg+12.5mg), (40mg+6.25mg), (80mg+6.25mg)
Dosage Form: Tablets(film-coated)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: Antihypertensive
Indication: Azilsartan and chlorthalidone combination is used to treat high blood pressure (hypertension).
Storage: Store below 25°C. Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Azilsartan Medoxomil and Chlorthalidone Tablets 40mg+12.5mg
2. Azilsartan Medoxomil and Chlorthalidone Tablets 80mg+12.5mg

3. Azilsartan Medoxomil and Chlorthalidone Tablets 40mg+6.25mg
4. Azilsartan Medoxomil and Chlorthalidone Tablets 80mg+6.25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Azilsartan Medoxomil and Chlorthalidone Tablets 40mg+12.5mg
Each film-coated bilayer tablet contains:
Azilsartan Kamedoxomil
Equivalent to Azilsartan Medoxomil……………40mg
Chlorthalidone IP…………………………………………12.5mg
Excipients…………………………………………………….q.s
Colour: Titanium Dioxide IP

2.Azilsartan Medoxomil and Chlorthalidone Tablets 80mg+12.5mg
Each film-coated bilayer tablet contains:
Azilsartan Kamedoxomil
Equivalent to Azilsartan Medoxomil………………80mg
Chlorthalidone IP …………………………………………12.5mg
Excipients……………………………………………………q.s
Colour:  Orange G

3.Azilsartan Medoxomil and Chlorthalidone Tablets 40mg+6.25mg
Each film-coated bilayer tablet contains:
Azilsartan Kamedoxomil
Equivalent to Azilsartan Medoxomil………………40mg
Chlorthalidone IP…………………………………………6.25mg
Excipients…………………………………………………….q.s

4. Azilsartan Medoxomil and Chlorthalidone Tablets 80mg+6.25mg
Each film-coated bilayer tablet contains:
Azilsartan Kamedoxomil
Equivalent to Azilsartan Medoxomil……………………80mg
Chlorthalidone IP………………………………………………6.25mg
Excipients……………………………………………………. q.s
Colour: Caramel

THERAPEUTIC INDICATIONS:

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

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

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

SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

STORAGE & DOSAGE:

Storage: Store below 25°C.
Protect from Light.

Dosage: As directed by the Physician