PANTOLOC CONTROL Gastro-resistant tablet Ref.[27530] Active ingredients: Pantoprazole

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Takeda GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Germany Telephone: 0800 825332 4 Telefax: 0800 825332 9

Product name and form

PANTOLOC Control 20 mg gastro-resistant tablets.

Pharmaceutical Form

Gastro-resistant tablet.

Yellow, oval, biconvex film-coated tablets imprinted with “P20” in brown ink on one side.

Qualitative and quantitative composition

Each gastro-resistant tablet contains 20 mg 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)
Sodium laurilsulfate
Polysorbate 80
Triethyl citrate

Printing ink:

Shellac
Red iron oxide (E172)
Black iron oxide (E172)
Yellow iron oxide (E172)
Ammonia solution, concentrated

Pack sizes and marketing

Alu/Alu blisters with or without cardboard reinforcement containing 7 or 14 gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Takeda GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Germany
Telephone: 0800 825332 4
Telefax: 0800 825332 9

Marketing authorization dates and numbers

EU/1/09/519/001-004

Date of first authorisation: 12 June 2009
Date of latest renewal: 21 February 2014

Drugs

Drug Countries
PANTOLOC Austria, Canada, Estonia, Hong Kong, Lithuania, Poland, United Kingdom, South Africa
 
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