GENERIC NAME OF THE MEDICINAL PRODUCT:

Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 10mg/6.25mg
Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 5mg/6.25mg
Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 2.5mg/6.25mg
Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 5mg/12.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 10mg/6.25mg
Each film-coated tablet contains:
Bisoprolol fumarate USP 10mg
Hydrochlorothiazide USP 6.25mg
Excipients: q.s.
Colours: Red Oxide Iron

B) Bisoprolol fumarate and hydrochlorothiazide tablets usp 5 mg /6.25 mg
Each film-coated tablet contains:
Bisoprolol fumarate USP 5mg
Hydrochlorothiazide USP 6.25mg
Excipients: q.s.
Colours: Titanium Dioxide USP

C) Bisoprolol fumarate and hydrochlorothiazide tablets usp 2.5 mg /6.25 mg
Each film-coated tablet contains:
Bisoprolol fumarate USP 2.5mg
Hydrochlorothiazide USP 6.25mg
Excipients: q.s.
Colours: Yellow Oxide of Iron

D) Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 5mg/12.5mg
Each film-coated tablet contains:
Bisoprolol fumarate USP 5 mg
Hydrochlorothiazide USP 12.5 mg
Excipients: q.s.
Colours: SunSet Yellow FCF.

THERAPEUTIC INDICATIONS:

Treatment of essential hypertension.
The fixed dose combinations are indicated in patients whose blood pressure is not adequately controlled on bisoprolol fumarate or hydrochlorothiazide alone.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Never suddenly stop taking treatment, in particular if you suffer from certain heart disorders.

WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: protect from moisture. Store in the original package Do not store above 30 °C.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.

Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP Technical Specification:

Product Name: Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP
Brand Name: Generics
Strength: 2.5mg/6.25mg, 5mg/6.25mg, 10mg/6.25mg, 5mg/12.5mg,
Dosage Form: Tablets (Film-coated)
Route of Administration: Via Oral Route
Packing: 30s,50s,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: Anti-hypertensive, Cardiovascular System.
Indication: It is used to treat high blood pressure. The medication keeps the high blood pressure in the control level range and prevents heart attacks.
Storage: protect from moisture. Store in the original package. Do not store above 30 °C.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 2.5mg/6.25mg
  • Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 5mg/6.25mg
  • Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 10mg/6.25mg
  • Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 5mg/12.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) BISOPROLOL Fumarate and Hydrochlorothiazide Tablets USP 2.5mg/6.25mg
Each film-coated tablet contains:
Bisoprolol fumarate USP……………………….2.5mg
Hydrochlorothiazide USP………………………6.25mg
Excipients:………………………………………….q.s.
Colours: Yellow Oxide of Iron

B) Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 5mg/6.25mg
Each film-coated tablet contains:
Bisoprolol fumarate USP……………………………5mg
Hydrochlorothiazide USP………………………….6.25mg
Excipients:……………………………………………..q.s.
Colours: Titanium Dioxide USP

C)Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 10mg/6.25mg
Each film-coated tablet contains:
Bisoprolol fumarate USP…………………………….10mg
Hydrochlorothiazide USP……………………………6.25mg
Excipients:……………………………………………….q.s.
Colours: Red Oxide Iron

D) Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 5mg/12.5mg
Each film-coated tablet contains:
Bisoprolol fumarate USP…………………………….5 mg
Hydrochlorothiazide USP…………………………..12.5 mg
Excipients:………………………………………………..q.s.
Colours: SunSet Yellow FCF

THERAPEUTIC INDICATIONS:

  • Treatment of essential hypertension. The fixed dose combinations are indicated in patients whose blood pressure is not adequately controlled on bisoprolol fumarate or hydrochlorothiazide alone.

CAUTION & WARNING:

  • CAUTION:
    Read enclosed leaflet before use.
    Keep medicine out of reach of children.
    Never suddenly stop taking treatment, in particular if you suffer from certain heart disorders.
  • Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

  • Storage: protect from moisture.
    Store in the original package
    Do not store above 30 °C.
  • Dosage: As directed by the Physician.
Attach dispensing label as per end county.