GENERIC NAME OF THE MEDICINAL PRODUCT

A. Combi pack of Tamsulosin Hydrochloride Prolonged Release Capsule IP 0.4MG and Dutasteride Capsules IP 0.5MG

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Combi pack of Tamsulosin Hydrochloride Prolonged Release Capsule IP 0.4MG and Dutasteride Capsules IP 0.5MG Composition:
Each capsule contains:
a. Tamsulosin Hydrochloride IP……………………0.4mg
(As prolonged release pellets form)

b. Dutasteride Capsule IP 0.5MG
Each soft gelatin capsule contain:
Dutasteride IP………………………0.5MG
Colour: carmoisine & Erythrosine
Approved colour used in capsule shell.

THERAPEUTIC INDICATIONS:

This medication relieves the symptoms of benign prostatic hyperplasia. Tamsulosin is an alpha-blocker. It works by relaxing the muscle around the bladder exit and prostate gland so as to allow easy passage of urine. Dutasteride is a 5-alpha-reductase inhibitor which helps in shrinking the prostate gland by decreasing the level of the hormone which helps the prostate gland grow.

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Capsule to be swallowed as a whole, and not to be chewed or crushed.

SCHEDULE H PRESCRIPTION DRUG- CAUTION: Not to be sold by retail without the prescription of Registered medical practitioner.

STORAGE & DOSAGE:

Storage: Store at a temperature not exceeding 30℃.
Store in cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by the physician.

Combi pack of Tamsulosin Hydrochloride Prolonged Release Capsule IP 0.4MG and Dutasteride Capsules IP 0.5MG technical specification:

Product Name: Combi pack of Tamsulosin Hydrochloride Prolonged Release Capsule IP 0.4MG and Dutasteride Capsules IP 0.5MG
Brand Name: Generic
Strength: 0.4mg/0.5mg
Dosage Form: Capsule
Route of Administration: Via Oral Route
Packing: 10 Strips of 10 Capsules Each
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Regulatory Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: Alpha-blocker, 5-alpha reductase
Indication: This medication relieves the symptoms of benign prostatic hyperplasia.
Storage: Store at a temperature not exceeding 30℃. Store in cool, dry & dark place. Protect from Light & moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

Combi pack of Tamsulosin Hydrochloride Prolonged Release Capsule IP 0.4MG and Dutasteride Capsules IP 0.5MG


QUALITATIVE AND QUANTITATIVE COMPOSITION:

  1. Combi pack of Tamsulosin Hydrochloride Prolonged Release Capsule IP 0.4MG and Dutasteride Capsules IP 0.5MG Composition:
    Each capsule contains:
    Tamsulosin Hydrochloride IP……………………0.4mg
    (As prolonged release pellets form)
    b. Dutasteride Capsule IP 0.5MG
    Each soft gelatin capsule contain:
    Dutasteride IP………………………0.5MG
    Colour: carmoisine & Erythrosine
    Approved colour used in capsule shell.

THERAPEUTIC INDICATIONS:

  • This medication relieves the symptoms of benign prostatic hyperplasia. Tamsulosin is an alpha-blocker. It works by relaxing the muscle around the bladder exit and prostate gland so as to allow easy passage of urine. Dutasteride is a 5-alpha-reductase inhibitor which helps in shrinking the prostate gland by decreasing the level of the hormone which helps the prostate gland grow.

CAUTION & WARNING:

  • CAUTION: Read enclosed leaflet before use. Keep medicine out of reach of children.Capsule to be swallowed as a whole, and not to be chewed or crushed.
  • SCHEDULE H PRESCRIPTION DRUG- CAUTION: Not to be sold by retail without the prescription of Registered medical practitioner.

STORAGE & DOSAGE:

  • Storage:Store at a temperature not exceeding 30℃. Store in cool, dry & dark place. Protect from Light & moisture.
  • Dosage: As directed by the physician.