PANTOPRAZOLE 20mg Gastro-resistant tablets Ref.[7032] Active ingredients: Pantoprazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Product name and form

Pantoprazole 20 mg gastro-resistant tablets.

Pharmaceutical Form

Gastro-resistant tablet.

Light Yellow colored, enteric coated oval biconvex tablets plain on both the sides.

Qualitative and quantitative composition

Each gastro-resistant tablet contains 20 mg pantoprazole (as 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:

Sodium carbonate (Anhydrous)
Mannitol
Crospovidone (Type B)
Hydroxypropyl cellulose
Calcium stearate

Coating:

Hypromellose
Yellow iron oxide (E172)
Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%
Sodium laurilsulfate
Polysorbate 80
Triethyl citrate

Pack sizes and marketing

Blisters of Polyamide/Aluminium/PVC-Aluminium in a blister carton, and white opaque round HDPE container with white opaque polypropylene closure.

Pack sizes:

Blister: 7, 14, 15, 28, 30, 56, 60, 98, 100 and 500 gastro-resistant tablets.

HDPE: 14, 28, 56, 60, 98, 100 and 500 gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Marketing authorization dates and numbers

PL 16363/0403

Date of first authorisation: 24/07/2014

Date of last renewal: 07/11/2018

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