GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Amlodipine Tablets 2.5mg
B. Amlodipine Tablets 5mg
C. Amlodipine Tablets 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Amlodipine Besylate Tablets USP 2.5mg
Each uncoated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine ………. 2.5mg
Excipients ……………………………... q.s
Color: Sunset yellow FCF

B. Amlodipine Besylate Tablets USP 5mg
Each uncoated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………...5mg
Excipients………………………………… q.s
Color: Ponceau 4R


C. Amlodipine Besylate Tablets USP 10mg
Each uncoated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine …………...10mg
Excipients …………………………………... q.s
Color: Ponceau 2R

THERAPEUTIC INDICATIONS:

Amlodipine Besylate tablet is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Read enclosed leaflet before use.
DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER AS DEFINED IN THE USP.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

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.

Amlodipine Tablets 5mg Technical Specification:

Product Name:Amlodipine Tablets 5mg
Brand Name:Generic
Strength:2.5mg, 5mg, 10mg
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: Amlodipine Besylate tablet is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
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:

  • Amlodipine Tablets 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Amlodipine Besylate Tablets USP 5mg
    Each uncoated tablet contains:
    Amlodipine Besylate USP
    Equivalent to Amlodipine ………. 5mg
    Excipients ……………………………… q.s
    Color: Ponceau 4R

THERAPEUTIC INDICATIONS:

Amlodipine Besylate tablet is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.

Read enclosed leaflet before use.

DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER AS DEFINED IN THE USP.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

Keep medicine out of reach of children.

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.