| Product Name: | Candesartan and Hydrochlorothiazide Tablets USP |
| Brand Name: | Candesartan HCT |
| Strength: | 16mg/12.5mg, 32mg/12.5mg |
| Packing: | 7s, 14s, 28s, 30s, 56s, 70s, 90s, 98s, 100s |
| Dosage Form: | Tablet (Film-Coated) |
| Route Of Administration: | Via Oral Route |
| 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, Cardiovascular System. |
| Indication: | Candesartan and hydrochlorothiazide combination is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. |
| Storage: | Store to 20˚C-25˚C.Protected from Light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Candesartan Cilexetil and Hydrochlorothiazide Tablets 16mg/12.5mg
b) Candesartan Cilexetil and Hydrochlorothiazide Tablets 32mg/12.5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Candesartan Cilexetil and Hydrochlorothiazide Tablets 16mg/12.5mg
Each film coated tablets contains:
Candesartan cilexetil USP……………………16mg
Hydrochlorothiazide USP……………………12.5mg
Excipients………………………………………q.s
Colours: Sunset Yellow FCF.
b) Candesartan Cilexetil and Hydrochlorothiazide Tablets 32mg/12.5mg
Each film coated tablets contains:
Candesartan cilexetil USP…………………32mg
Hydrochlorothiazide USP…………………12.5mg
Excipients…………………………………q.s
Colours: Lake ponceau 4R and Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
Candesartan Hydrochlorothiazide is indicated for the:
Treatment of essential hypertension in adult patients whose blood pressure is not optimally controlled with candesartan cilexetil or hydrochlorothiazide monotherapy.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store to 20˚C-25˚C.Protected from Light.
Dosage: As directed by the Physician.