GENERIC NAME OF THE MEDICINAL PRODUCT:
2. Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+ 5mg+12.5mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains:
Olmesartan Medoxomil IP…………20mg
Amlodipine Besilate IP
Equivalent to Amlodipine……………5mg
Hydrochlorothiazide……………………12.5mg
Excipients………………………………………q.s
Colour: Titanium Dioxide IP
2. Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+ 5mg+12.5mg)
Each film-coated tablet contains:
Olmesartan Medoxomil IP………….40mg
Amlodipine Besilate IP
Equivalent to Amlodipine……………5mg
Hydrochlorothiazide……………………12.5mg
Excipient………………………………………q.s
Colour: Ferric oxide red
THERAPEUTIC INDICATIONS:
CAUTION & SCHEDULE:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: When pregnancy is detected, Olmesartan should be discontinued as soon as possible, as it can cause injury and even death to the developing fetus, when used during the second and third trimester of pregnancy.
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
SCHEDULE: SCHEDULE G: PRESCRIPTION DRUG-CAUTION It is dangerous to take this preparation except under Medical supervision.
STORAGE & DOSAGE:
Protect from Light and moisture.
Dosage: As directed by the Physician
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (20mg+ 5mg+12.5mg) Technical Specification:
| Product Name: | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets |
| Brand Name: | Generic |
| Strength: | (20mg+ 5mg+12.5mg), (40mg+10mg+12.5mg) |
| Dosage Form: | Tablets(film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| 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 below 25°C. Protect from Light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
1. Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (20mg+ 5mg+12.5mg)
2. Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+ 5mg+12.5mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (20mg+ 5mg+12.5mg)
Each film-coated tablet contains:
Olmesartan Medoxomil IP………..20mg
Amlodipine Besilate IP
Equivalent to Amlodipine………….5mg
Hydrochlorothiazide………………….12.5mg
Excipients…………………………………q.s
Colour: Titanium Dioxide IP
2. Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+ 5mg+12.5mg)
Each film-coated tablet contains:
Olmesartan Medoxomil IP…………….40mg
Amlodipine Besilate IP
Equivalent to Amlodipine………………5mg
Hydrochlorothiazide……………………..12.5mg
Excipients……………………………………q.s
Colour: Ferric oxide red
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 & SCHEDULE:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: When pregnancy is detected, Olmesartan should be discontinued as soon as possible, as it can cause injury and even death to the developing fetus, when used during the second and third trimester of pregnancy.
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
SCHEDULE: SCHEDULE G: PRESCRIPTION DRUG-CAUTION it is dangerous to take this preparation except under Medical supervision.
STORAGE & DOSAGE:
Storage: Store below 25°C.
Protect from Light and moisture.
Dosage: As directed by the Physician
