| Product Name: | Olmesartan Medoxomil and Amlodipine Besilate Tablets |
| Brand Name: | Generic |
| Strength: | 20mg+5mg , 40mg+5mg, 40mg+10mg |
| 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: | Olmesartan, amlodipine, and hydrochlorothiazide is a combination of medicines that may be used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. |
| 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:
- Olmesartan Medoxomil and Amlodipine Besilate Tablets (20mg+ 5mg)
- Olmesartan Medoxomil and Amlodipine Besilate Tablets (40mg+ 5mg)
- Olmesartan Medoxomil and Amlodipine Besilate Tablets (40mg+10mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Olmesartan Medoxomil and Amlodipine Besilate Tablets (20mg+ 5mg)
Each film-coated tablet contains:
Olmesartan Medoxomil USP ……..20mg
Amlodipine Besilate USP …………..6.94mg
Equivalent to Amlodipine ………… 5mg
Excipients …………………………….q.s
Color: Sunset yellow FCF - Olmesartan Medoxomil and Amlodipine Besilate Tablets (40mg+5mg)
Each film-coated tablet contains:
Olmesartan Medoxomil USP ……..40mg
Amlodipine Besilate USP …………..6.94mg
Equivalent to Amlodipine ………… 5mg
Excipients …………………………….q.s
Color: Sunset yellow FCF - Olmesartan Medoxomil and Amlodipine Besilate Tablets (40mg+10mg)
Each film-coated tablet contains:
Olmesartan Medoxomil USP ……..40mg
Amlodipine Besilate USP …………..6.94mg
Equivalent to Amlodipine ………… 5mg
Excipients …………………………….q.s
Color: Sunset yellow FCF
THERAPEUTIC INDICATIONS:
Olmesartan, amlodipine, and hydrochlorothiazide is a combination of medicines that may be used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly.
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.
When pregnancy is detected, Olmesartan should be discontinued as soon as possible, as it can cause injury and even death to the developing foetus, when used during yhe second and third trimester of pregnancy.
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