PANTOFLUX Gastro-resistant tablet Ref.[49767] Active ingredients: Pantoprazole

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Accord Healthcare Ireland Ltd., Euro House, Euro Business Park, Little Island, Cork T45 K857, Ireland

Product name and form

Pantoflux 40 mg gastro-resistant tablets.

Pharmaceutical Form

Gastro-resistant tablet.

Elliptical, biconvex, dark yellow gastro-resistant tablet.

Qualitative and quantitative composition

Each gastro-resistant tablet contains 40 mg of pantoprazole (as 45.16 mg pantoprazole sodium sesquihydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Pantoprazole

Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific blockade of the proton pumps of the parietal cells.

List of Excipients

Tablet core:

Mannitol
Sodium carbonate, anhydrous
Sodium starch glycolate (type A)
Basic butylated methacrylate copolymer (Eudragit E PO)
Calcium stearate

Sub coating:

Opadry white OY-D-7233; consisting of:
Hypromellose
Titanium dioxide E171
Talc
Macrogol 400
Sodium laurilsulphate

Enteric coating:

Kollicoat MAE 30 DP, yellow; consisting of:
Methacrylic acid-ethyl acrylate copolymer dispersion
Propylene glycol
Yellow iron oxide (E172)
Titanium dioxide (E171)
Talc

Pack sizes and marketing

Aluminium/aluminium blister pack.

Tablet container (HDPE) closed with PP cap with integrated desiccant.

Pack sizes:

Blister: 7, 14, 15, 20, 28, 30, 56, 60, 98, 100 tablets and 10 × 14 tablets (hospital pack)

Tablet container: 30, 100, 250 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Ireland Ltd., Euro House, Euro Business Park, Little Island, Cork T45 K857, Ireland

Marketing authorization dates and numbers

PA2315/187/002

Date of First Authorisation: 9th June 2008
Date of last renewal: 3rd May 2013

Drugs

Drug Countries
PANTOFLUX Cyprus, Ireland

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