| Product Name: | Amlodipine Besylate + Hydrochlorothiazide tablet |
| Brand Name: | Generic |
| Strength: | 2.5mg+12.5mg, 5mg+12.5mg |
| Dosage Form: | uncoated Oral Tablets |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 15s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-hypertensive |
| Indication: | Amlodipine/hydrochlorothiazide 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 in in cool, dry and dark place. Keep out of reach of children. |
GENERIC NAME OF THE MEDICINAL PRODUCT
- Amlodipine Besylate + Hydrochlorothiazide tablet 2.5mg+12.5mg
- Amlodipine Besylate + Hydrochlorothiazide tablet 5mg+12.5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Amlodipine Besylate + Hydrochlorothiazide tablet 2.5mg+12.5mg
Each uncoated tablet contains:
S (-) Amlodipine Besylate IP
equivalent to 5 (-) Amlodipine 2.5 mg
Hydrochlorothiazide IP……….12.5 mg
Excipients………q. s
Colour: Lake of Sunset Yellow - Amlodipine Besylate + Hydrochlorothiazide tablet 5mg+12.5mg
Each uncoated tablet contains:
S (-) Amlodipine Besylate IP
equivalent to 5 (-) Amlodipine 5 mg
Hydrochlorothiazide IP……….12.5 mg
Excipients………q. s
Colour: Lake of Sunset Yellow
THERAPEUTIC INDICATIONS:
Amlodipine/hydrochlorothiazide 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 & SCHEDULE:
SCHEDULE H: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
SCHEDULE G: it is dangerous to take this combination except under the supervision of medical supervisor.
STORAGE & DOSAGE:
storage: Store in in cool, dry and dark place.
Keep out of reach of children
Dosage: As directed by the Physician.