GENERIC NAME OF THE MEDICINAL PRODUCT:

Candesartan Cilexetil and Hydrochlorothiazide Tablets 32mg/12.5mg
Candesartan Cilexetil and Hydrochlorothiazide Tablets 16mg/12.5mg.
Candesartan Cilexetil and Hydrochlorothiazide Tablets 32mg/25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) 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

b) 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.

c) Candesartan Cilexetil and Hydrochlorothiazide Tablets 32mg/25mg
Each film coated tablets contains:
Candesartan cilexetil USP…………………...32mg
Hydrochlorothiazide USP……………………25mg
Excipients……………………………………...q.s
Colours: Quinoline Yellow

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.
Attach dispensing label as per end county.

Candesartan and Hydrochlorothiazide Tablets USP Technical Specification:

Product Name:
 Candesartan and Hydrochlorothiazide Tablets USP
Brand Name: Candesartan HCT
Strength: 16mg/12.5mg, 32mg/12.5mg, 32mg/25mg.
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:

  • Candesartan Cilexetil and Hydrochlorothiazide Tablets 32mg/12.5mg
  • Candesartan Cilexetil and Hydrochlorothiazide Tablets 16mg/12.5mg
  • Candesartan Cilexetil and Hydrochlorothiazide Tablets 32mg/25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) 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

b) 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.

c) Candesartan Cilexetil and Hydrochlorothiazide Tablets 32mg/25mg
Each film coated tablets contains:
Candesartan cilexetil USP……………………32mg
Hydrochlorothiazide USP……………………25mg
Excipients………………………………………q.s
Colours: Quinoline Yellow

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.
Attach dispensing label as per end county.