GENERIC NAME OF THE MEDICINAL PRODUCT

A. Tamsulosin Hydrochloride Prolonged Release Capsules IP 0.4mg
B. Tamsulosin Hydrochloride Prolonged Release Capsules IP 0.2mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Tamsulosin Hydrochloride Prolonged Release Capsules IP 0.4mg
Each hard gelatin capsule contains:
Tamsulosin Hydrochloride IP……………………0.4mg
(As prolonged release pellets form)
Excipients………………………………………….…....q.s
Colour: carmoisine & Erythrosine

B) Tamsulosin Hydrochloride Prolonged Release Capsules IP 0.2mg
Each hard gelatin capsule contains:
Tamsulosin Hydrochloride IP……………………0.2mg
(As prolonged release pellets form)
Excipients………………………………………….…....q.s
Colour: Red oxide of iron

THERAPEUTIC INDICATIONS:

This drug is used to improve urination in men with enlarged prostate (benign prostatic hyperplasia). it works by relaxing the muscles around the bladder exit and prostate gland so urine is passed more easily. this helps empty the bladder completely and reduces the need to pass urine frequently or urgently in BPH.

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.

Tamsulosin Hydrochloride Prolonged Release Capsules IP 0.4mg Technical specification:

Product Name: Tamsulosin Hydrochloride Prolonged Release Capsules IP
Brand Name: Generic
Strength: 0.4mg, 0.2mg
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
Indication: This drug is used to improve urination in men with enlarged prostate (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:

Tamsulosin Hydrochloride Prolonged Release Capsules IP 0.4mg
Tamsulosin Hydrochloride Prolonged Release Capsules IP 0.2mg


QUALITATIVE AND QUANTITATIVE COMPOSITION:

  1. Tamsulosin Hydrochloride Prolonged Release Capsules IP 0.4mg
    Each hard gelatin capsule contains:
    Tamsulosin Hydrochloride IP……………………0.4mg
    (As prolonged release pellets form)
    Excipients………………………………………….…….q.s
    Colour: carmoisine & Erythrosine
  2. Tamsulosin Hydrochloride Prolonged Release Capsules IP 0.2mg
    Each hard gelatin capsule contains:
    Tamsulosin Hydrochloride IP……………………0.2mg
    (As prolonged release pellets form)
    Excipients………………………………………….…….q.s
    Colour: Red oxide of iron

THERAPEUTIC INDICATIONS:

  • This drug is used to improve urination in men with enlarged prostate (benign prostatic hyperplasia). it works by relaxing the muscles around the bladder exit and prostate gland so urine is passed more easily. this helps empty the bladder completely and reduces the need to pass urine frequently or urgently in BPH.

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.