Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+12.5mg)

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+12.5mg)
2. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+25mg)
3. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+12.5mg)
4. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg)
5. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+320mg+25mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+12.5mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine……………..5mg
Valsartan USP………………………...160mg
Hydrochlorothiazide USP……………12.5mg
Excipients………………………………q.s
Color: Sunset yellow FCF

2. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+25mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine..................5mg
Valsartan USP...................................160mg
Hydrochlorothiazide USP................25mg
Excipients..........................................q.s
Color: Quinoline Yellow FCF

3. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+12.5mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine………………10mg
Valsartan USP………………………….160mg
Hydrochlorothiazide USP………………12.5mg
Excipients………………………………...q.s
Color: Orange G

4. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………10mg
Valsartan USP……………………………160mg
Hydrochlorothiazide USP…………………25mg
Excipients……………………………………q.s
Color: Ponceau 4 R

5. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP ((10mg+320mg+25mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine……………10mg
Valsartan USP ……………………….320mg
Hydrochlorothiazide USP……………25mg
Excipients………………………………q.s
Color: Ponceau 2 R

THERAPEUTIC INDICATIONS:

Amlodipine, valsartan, and hydrochlorothiazide is a combination of medicines that 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 tight container with a child-resistant closure.
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) ; excursions permitted between 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.

Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+12.5mg) Technical Specification:

Product Name: Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP
Brand Name: Noforge HCT
Strength: (5mg+160mg+12.5mg), (5mg+160mg+25mg),  (10mg+160mg+12.5mg), (10mg+160mg+25mg), (10mg+320mg+25mg)
Dosage Form: Tablets (film-coated)
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: Amlodipine, valsartan, and hydrochlorothiazide is a combination of medicines that is used 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); excursions permitted between 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:

1. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+12.5mg)
2. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+25mg)
3. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+12.5mg)
4. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg)
5. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+320mg+25mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1.  Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+12.5mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine……………..5mg
Valsartan USP…………………………160mg
Hydrochlorothiazide USP……………12.5mg
Excipients………………………………q.s
Color: Sunset yellow FCF

2. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+25mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine………………5mg
Valsartan USP……………………………..160mg
Hydrochlorothiazide USP…………….25mg
Excipients……………………………………q.s
Color: Quinoline Yellow FCF

3. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+12.5mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine………………10mg
Valsartan USP………………………….160mg
Hydrochlorothiazide USP………………12.5mg
Excipients…………………………………q.s
Color: Orange G

4. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………10mg
Valsartan USP……………………………160mg
Hydrochlorothiazide USP…………………25mg
Excipients……………………………………q.s
Color: Ponceau 4 R

5. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP ((10mg+320mg+25mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine……………10mg
Valsartan USP ……………………….320mg
Hydrochlorothiazide USP……………25mg
Excipients………………………………q.s
Color: Ponceau 2 R

THERAPEUTIC INDICATIONS:

Amlodipine, valsartan, and hydrochlorothiazide is a combination of medicines that 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 tight container with a child-resistant closure.

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) ; excursions permitted between 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.