PANTOPRAZOLE 40mg Gastro-resistant tablets Ref.[7779] Active ingredients: Pantoprazole

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Takeda UK Limited, Building 3, Glory Park, Glory Park Avenue, Wooburn Green, Bucks, HP10 0DF, UK

Product name and form

Pantoprazole 40 mg gastro-resistant tablets.

Pharmaceutical Form
Gastro-resistant tablet (tablet). Yellow, oval, biconvex film-coated tablet imprinted with “P 40” in brown ink on one side.

Qualitative and quantitative composition

Each gastro-resistant tablet contains 40 mg of pantoprazole (as 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
Core: Sodium carbonate, anhydrous Mannitol (E421) Crospovidone Povidone K90 Calcium stearate Coating: Hypromellose Povidone K25 Titanium dioxide (E171) Yellow iron oxide (E172) Propylene glycol Methacrylic acid-ethyl acrylate copolymer (1:1) Polysorbate 80 Sodium laurilsulfate Triethyl citrate Printing ink: Shellac Red iron oxide (E172) Black iron oxide (E172) Yellow iron oxide (E172) Ammonia solution, concentrated

Pack sizes and marketing

HDPE bottles with LDPE screw cap closure.

7 gastro-resistant tablets
10 gastro-resistant tablets
14 gastro-resistant tablets
15 gastro-resistant tablets
24 gastro-resistant tablets
28 gastro-resistant tablets
30 gastro-resistant tablets
48 gastro-resistant tablets
49 gastro-resistant tablets
56 gastro-resistant tablets
60 gastro-resistant tablets
84 gastro-resistant tablets
90 gastro-resistant tablets
98 gastro-resistant tablets
98 (2x49) gastro-resistant tablets
100 gastro-resistant tablets

Hospital pack with:

50 gastro-resistant tablets
90 gastro-resistant tablets
100 gastro-resistant tablets
140 gastro-resistant tablets
140 (10x14) gastro-resistant tablets
150 (10x15) gastro-resistant tablets
700 (5x140) gastro-resistant tablets

Blister (ALU/ALU blister) without cardboard reinforcement.

Blister (ALU/ALU blister) with cardboard reinforcement (blister wallet).

Hospital pack with:

Not all pack sizes may be marketed.

Marketing authorization holder

Takeda UK Limited, Building 3, Glory Park, Glory Park Avenue, Wooburn Green, Bucks, HP10 0DF, UK

Marketing authorization dates and numbers

PL 16189/0035

Date of first authorisation: 25^th May 2009

Date of last renewal: 30^th July 2014

Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.