| Product Name: | Telmisartan and Amlodipine Tablets USP |
| Brand Name: | Generics |
| Strength: | 40mg+5mg, 40mg+10mg, 80mg+5mg, 80mg+10mg |
| Dosage Form: | Tablets |
| Route of Administration: | Via oral route |
| Packing: | 30s,100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-hypertensive,diuretics. |
| Indication: | Telmisartan and Amlodipine combination is used to treat high blood pressure (hypertension). |
| Storage: | Store at 20° to 25°C (68° to 77°F) |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Telmisartan and Amlodipine Tablets USP 40mg+5mg.
- Telmisartan and Amlodipine Tablets USP 40mg+10mg.
- Telmisartan and Amlodipine Tablets USP 80mg+5mg.
- Telmisartan and Amlodipine Tablets USP 80mg+10mg.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Telmisartan and Amlodipine Tablets USP 40mg+5mg.
Each film coated tablet contains:
Telmisartan USP…………………….……40mg
Amlodipine USP……………….5mg
Excipients…………………………………. q.s.
colors: Quinoline Yellow - Telmisartan and Amlodipine Tablets USP 40mg+10mg.
Each film coated tablet contains:
Telmisartan USP……………………40mg
Amlodipine USP…………….10mg
Excipients……………………………………q.s.
colours: Titanium dioxide. - Telmisartan and Amlodipine Tablets USP 80mg+5mg.
Each film coated tablet contains:
Telmisartan USP…………………….……80mg
Amlodipine USP……………….5mg
Excipients…………………………………. q.s.
colors: Quinoline Yellow - Telmisartan and Amlodipine Tablets USP 80mg+10mg.
Each film coated tablet contains:
Telmisartan USP…………………….……80mg
Amlodipine USP……………….10mg
Excipients…………………………………. q.s.
colors: Quinoline Yellow
THERAPEUTIC INDICATIONS:
Treatment of essential hypertension.
Telmisartan/Amlodipine fixed dose combination is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
You should not use this medicine if you are allergic to Amlodipine or telmisartan, if you are unable to urinate.
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). Protect from light.
Dosage: As directed by the Physician.