Prescribing Information

CLINICAL ADVANTAGES OF ESOMEPRAZOLE MUPS TABLET
• Once daily dosing • Minimizes fluctuation in plasma concentration of drug • Ensures reduction of esophageal residence time • Ensures lesser possibility of dose dumping • Ensures uniform drug release • Ensures greater bioavailability • Ensures lesser chance of localized irritation • Ensures better and more uniform drug absorption

PHARMACODYNAMIC ADVANTAGES
• Since the number of pellets per unit tablet is much more than a conventional pellet-filled capsule, there is reduced inter- and intra-subject variability in drug absorption and clinical response is facilitated. In addition, the risk of dose dumping and incomplete drug release is minimized.

DESCRIPTION
Esoral® MUPS (both Esoral MUPS 20 mg & 40 mg) is a pink color caplet shaped tablet composed of multiple unit enteric coated pellets of Esomeprazole. Esomeprazole (S-isomer of Omeprazole) is acid labile and therefore is administered orally as enteric coated pellets compressed into tablet. Esomeprazole magnesium (a substituted Benzimidazole), reduces gastric acid secretion through a highly targeted mechanism of action. It is a specific inhibitor of the gastric enzyme H+,K+- ATPase (the proton pump) which is responsible for acid secretion by the parietal cells of the stomach.

INDICATIONS
Adults aged 18 & above
• Erosive esophagitis • Maintenance treatment of patients with reflux esophagitis • Nonerosive Reflux Disease (NERD) (i.e. heartburn and regurgitation) • Healing of NSAID associated gastric ulcers • Reduction of risk of NSAID-associated gastric ulcers • H. pylori eradication (triple therapy)

Adolescents aged 12 & above
• Gastroesophageal Reflux Disease (GERD) • H. Pylori eradication

CONTRAINDICATIONS
• Hypersensitivity to Esomeprazole, substituted Benzimidazole or any of the compounds of this medication • When used for
eradication of Helicobacter pylori, the contraindications for Amoxicillin and Clarithromycin should be followed

SIDE EFFECTS
• Nausea • Headache • Flatulence • Diarrhea • Constipation • Dizziness • Abdominal pain • Vomiting

PRECAUTION & WARNING
General
This medicine should not be taken in presence of severe liver problems and severe kidney problems. Esomeprazole may hide the symptoms of other diseases. If the following happens to you, before taking Esomeprazole or during its consumption, you should report to the doctor straight away: loss of weight or difficulty in swallowing, stomach pain or indigestion, vomiting food or blood, passing black stools.

Drug Interaction
Possible interaction with Clopidogrel, Atazanavir, Ketoconazole, Itraconazole, Voriconazole, Erlotinib, Citalopram, Imipramine, Clomipramine, Diazepam, Phenytoin, Warfarin and Cilostazol.

USE IN PREGNANCY & LACTATION
The safety of Esomeprazole in pregnancy has not been established. Esomeprazole should not be administered to pregnant women unless the expected benefits outweigh the potential risks. It has not been investigated whether or not Esomeprazole is excreted in human breast milk. No studies in lactating women have been performed. Therefore, Esomeprazole should not be given to nursing mothers unless its use is considered essential.

PHARMACEUTICAL PRECAUTION
Store below 25 ˚C temperature, away from light and wet place. Keep out of reach of children.

PACKAGING
Esoral® MUPS 20 Tablet: Box containing 5 strips of 10 tablets each. Each tablet contains Esomeprazole 20 mg.
Esoral® MUPS 40 Tablet: Box containing 5 strips of 6 tablets each. Each tablet contains Esomeprazole 40 mg.