GENERIC NAME OF THE MEDICINAL PRODUCT

A. Budesonide Controlled Release Capsules 3mg
B. Budesonide Controlled Release Capsules 9mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Budesonide Controlled Release Capsules 3mg
Each capsule contains:
Budesonide IP…………………….3mg
(As controlled release pellets)
Excipients…………………………....q.s
Colour: Yellow oxide of iron
Approved colours used in capsule shell.

B) Budesonide Controlled Release Capsules 9mg
Each capsule contains:
Budesonide IP…………………….9mg
(As controlled release pellets)
Excipients…………………………....q.s
Colour: Red oxide of iron
Approved colours used in capsule shell.

THERAPEUTIC INDICATIONS:

Budesonide is used to treat mild to moderate active Crohn's disease, an inflammatory bowel disease. This medicine works inside the intestines (bowels) to reduce inflammation and symptoms of the disease. It also helps keep the symptoms of Crohn's disease from coming back.

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.

Budesonide Controlled Release Capsules 9mg Technical specification:

Product Name: Budesonide Controlled Release Capsules
Brand Name: Generic
Strength: 3mg, 9mg
Dosage Form: Capsule
Route of Administration: Via Oral Route
Packing: 1 Strip of 10 Capsules
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Regulatory Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: Corticosteroids
Indication: Budesonide is used to treat mild to moderate active Crohn’s disease, an inflammatory bowel disease. This medicine works inside the intestines (bowels) to reduce inflammation and symptoms of the disease. It also helps keep the symptoms of Crohn’s disease from coming back.
Storage: Store at a temperature not exceeding 30℃. Store in cool, dry & dark place. Protect from Light & moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Budesonide Controlled Release Capsules 3mg
  • Budesonide Controlled Release Capsules 9mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  1. Budesonide Controlled Release Capsules 3mg
    Each capsule contains:
    Budesonide IP…………………….3mg
    (As controlled release pellets)
    Excipients…………………………….q.s
    Colour: Yellow oxide of iron
    Approved colours used in capsule shell.
  2. Budesonide Controlled Release Capsules 9mg
    Each capsule contains:
    Budesonide IP…………………….9mg
    (As controlled release pellets)
    Excipients…………………………….q.s
    Colour: Red oxide of iron
    Approved colours used in capsule shell.

THERAPEUTIC INDICATIONS:

  • Budesonide is used to treat mild to moderate active Crohn’s disease, an inflammatory bowel disease. This medicine works inside the intestines (bowels) to reduce inflammation and symptoms of the disease. It also helps keep the symptoms of Crohn’s disease from coming back.

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.