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HSA Approval

PANTIN 40 PANTOPRAZOLE GASTRO-RESISTANT TABLETS 40 MG

SIN15041P

PANTIN 40 PANTOPRAZOLE GASTRO-RESISTANT TABLETS 40 MG

PANTIN 40 PANTOPRAZOLE GASTRO-RESISTANT TABLETS 40 MG

July 4, 2016

MEDICELL PHARMACEUTICAL (S) PTE. LTD.

MEDICELL PHARMACEUTICAL (S) PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantMEDICELL PHARMACEUTICAL (S) PTE. LTD.
Licence HolderMEDICELL PHARMACEUTICAL (S) PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

TABLET, ENTERIC COATED

**DOSAGE AND ADMINISTRATION** Mild reflux disease and associated Symptoms (e.g. heartburn,acid regurgitation, pain on swallowing) The recommended oral dosage is one gastro-resistant tablet Pantoprazole Gastro-Resistant Tablets 20 mg per day. Symptom relief is generally accomplished within 2–4 weeks, and a 4-week treatment period is usually required for healing of associated oesophagitis. If this is not sufficient, healing will normally be achieved within a further 4 weeks. Long‐term management and prevention of relapse in reflux oesophagitis For long-term management, a maintenance dose of one gastroresistant tablet Pantoprazole Gastro-Resistant Tablets 20 mg per day is recommended, increasing to 40 mg pantoprazole per day if a relapse occurs. Pantoprazole Gastro-Resistant Tablets 40 mg is available for this case. After healing of the relapse the dosage can be reduced again to 20 mg pantoprazole. Treatment of Moderate and severe reflux oesophagitis For the treatment of reflux esophagitis one tablet of Pantoprazole Gastro-Resistant Tablets 40mg per day. In individual cases the dose may be doubled (increase to 2 tablets Pantoprazole Gastro-Resistant Tablets 40mg daily) especially when there has been no response to other treatment. Special Populations Hepatic Impairment A daily dose of pantoprazole 20mg should not be exceeded in patients with severe liver impairment. In patients with severe liver impairment the dose has to be reduced to 1 tablet (40 mg pantoprazole) every other day. Furthermore, in these patients the liver enzymes should be monitored during Pantoprazole Gastro-Resistant Tablets 40 mg therapy. In the case of a rise of the liver enzymes, Pantoprazole Gastro-Resistant Tablets 40 mg should be discontinued. Renal Impairment No dose adjustment is necessary in elderly patients of in those with impaired renal function. Elderly The daily dose of 40 mg pantoprazole should not be exceeded in elderly patients or in patients with impaired kidney function. General instructions Pantoprazole Gastro-Resistant Tablets tablets should not be chewed or crushed, and should be swallowed whole with water 1 hour before a meal. A 4-week period is usually required for the treatment of reflux esophagitis. If this is not sufficient, healing will usually be achieved within a further 4 weeks.

ORAL

Medical Information

**INDICATION AND USAGE** Pantoprazole Gastro-Resistant Tablets 20mg: Mild reflux disease and associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing). Long-term management and prevention of relapse in reflux oesophagitis. Pantoprazole Gastro-Resistant Tablets 40mg: Moderate and severe reflux oesophagitis.

**CONTRAINDICATIONS** Pantoprazole gasro-resistent tablets must not be used in cases of known hypersensitivity to the active ingredient or/and any of the other constituents of Pantoprazole gasro-resistent tablets. Pantoprazole, like other PPIs, should not be co-administered with atazanavir (see Interaction with other medicinal products and other forms of interaction).

A02BC02

pantoprazole

Manufacturer Information

MEDICELL PHARMACEUTICAL (S) PTE. LTD.

Hetero Labs Limited

Active Ingredients

Pantoprazole Sodium Sesquihydrate 45.110 mg eqv Pantoprazole

40.0 mg

Pantoprazole

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PANTIN 40 PANTOPRAZOLE GASTRO-RESISTANT TABLETS 40 MG - HSA Approval | MedPath