NOLPAZA Gastro-resistant tablet Ref.[49853] Active ingredients: Pantoprazole

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Product name and form

Nolpaza 20 mg Gastro-Resistant Tablets.

Pharmaceutical Form

Gastro-resistant tablet.

A light brownish yellow, oval, slightly biconvex tablet.

Qualitative and quantitative composition

Each gastro-resistant tablet contains 20 mg pantoprazole (as pantoprazole sodium sesquihydrate).

Excipient with known effect: sorbitol 18 mg/tablet.

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
Crospovidone (type A, type B)
Sodium carbonate
Sorbitol (E420)
Calcium stearate

Film coating:

Hypromellose
Povidone (K25)
Titanium dioxide (E171)
Iron oxide, yellow (E172)
Propylene glycol
Methacrylic acid – ethyl acrylate copolymer
Sodium laurilsulfate
Polysorbate 80
Macrogol 6000
Talc

Pack sizes and marketing

Blister pack (OPA/Aluminium/PVC film and aluminium foil) in a carton box. Pack-sizes of 7, 14, 15, 28, 30, 56, 60, 84, 100, 100 × 1, 112 or 140 gastro-resistant tablets.

HDPE containers with a silica gel desiccant in a tamper evident PP screw-cap. Pack-size of 250 gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Marketing authorization dates and numbers

PA1347/006/001

Date of first authorisation: 13th March 2009
Date of last renewal: 15th August 2016

Drugs

Drug Countries
NOLPAZA Austria, Estonia, Spain, Croatia, Ireland, Italy, Lithuania, Poland, Romania
 
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