Esomeprazole EC & Domperidone SR Capsule 40mg/30mg Technical Specification:

Product Name: Esomeprazole EC & Domperidone SR Capsule 40mg/30mg
Brand Name:Esotaj-DSR
Strength:40mg/30mg, 20mg/30mg
Dosage Form:Capsule (Hard-Gelatine)
Route of Administration:Via oral Route
Packing:10s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Antiulcer
Indication: Esomeprazole + Domperidone is a combination of two medicines: Domperidone and Pantoprazole. This combination is used to treat acidity, heartburn or Gastroesophageal Reflux Disease (GERD); a condition where the acid in the stomach flows back up into the food pipe (esophagus).
Storage:Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Esomeprazole EC & Domperidone SR Capsule 40mg/30mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Esomeprazole EC & Domperidone SR Capsule 40mg/30mg
    Each Hard-gelatin capsules contains:
    Esomeprazole Magnesium Trihydrate
    Eq. to Esomeprazole Magnesium I.P. ………40mg
    (As enteric coated pellets)
    Domperidone I.P. ……………………………….30mg
    (As sustain release pellets)
    Excipients ………………………………………… q.s.
    Approved colours used in the empty capsule shell.

THERAPEUTIC INDICATIONS:

Esomeprazole + Domperidone is a combination of two medicines: Domperidone and Pantoprazole. This combination is used to treat acidity, heartburn or Gastroesophageal Reflux Disease (GERD); a condition where the acid in the stomach flows back up into the food pipe (esophagus).

CAUTION & schedule:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH

They should be swallowed whole with water.

Read enclosed leaflet before use.

schedule: schedule H PRESCRIPTION DRUG-CAUTION:  To be sold by retail on the prescription of a Registered Medical Practitioner only.

Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage:  Store below 25°C in a dry place.  Do not freeze.  Keep the container tightly closed in order to protect from moisture.

Dosage:  As directed by the physician.

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Esomeprazole EC & Domperidone SR Capsule 40mg/30mg
B. Esomeprazole EC & Domperidone SR Capsule 20mg/30mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Esomeprazole EC & Domperidone SR Capsule 40mg/30mg
Each Hard-gelatin capsules contains:
Esomeprazole Magnesium Trihydrate
Eq. to Esomeprazole Magnesium I.P. ………40mg
(As enteric coated pellets)
Domperidone I.P. ……………………………….30mg
(As sustain release pellets)
Excipients ………………………………………… q.s.
Approved colours used in the empty capsule shell.


B. Esomeprazole EC & Domperidone SR Capsule 20mg/30mg
Each Hard-gelatin capsules contains:
Esomeprazole Magnesium Trihydrate
Eq. to Esomeprazole Magnesium I.P. ………20mg
(As enteric coated pellets)
Domperidone I.P. ……………………………….30mg
(As sustain release pellets)
Excipients ………………………………………… q.s.
Approved colours used in the empty capsule shell.

THERAPEUTIC INDICATIONS:

Esomeprazole + Domperidone is a combination of two medicines: Domperidone and Pantoprazole. This combination is used to treat acidity, heartburn or Gastroesophageal Reflux Disease (GERD); a condition where the acid in the stomach flows back up into the food pipe (esophagus).

CAUTION & SCHEDULE:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
They should be swallowed whole with water.
Read enclosed leaflet before use.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG-CAUTION: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Store below 25°C in a dry place.
Do not freeze.
Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the physician.
Attach dispensing label as per end country.