NEXAZOLE Hard gastro-resistant capsule Ref.[49867] Active ingredients: Esomeprazole

Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Pinewood Laboratories Ltd, Ballymacarbry, Clonmel, Co. Tipperary, Ireland

Product name and form

Nexazole 20 mg hard gastro-resistant capsules.

Pharmaceutical Form
Hard gastro-resistant capsule. The body and the cap of the capsule are slightly pink. The content of capsules are white to almost white pellets.

Qualitative and quantitative composition

Each hard gastro-resistant capsule contains 20 mg esomeprazole (as magnesium dihydrate).

Excipient (s) with known effect:

	20 mg gastro-resistant capsules
sucrose	28,464 – 32,556 mg

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Esomeprazole	Esomeprazole is the S-isomer of omeprazole and reduces gastric acid secretion through a specific targeted mechanism of action. Esomeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the secretory canaliculi of the parietal cell, where it inhibits the enzyme H+ K+ -ATPase – the acid pump and inhibits both basal and stimulated acid secretion.

List of Excipients
Capsule core (pellets): Sucrose Maize starch Povidone K30 Sodium laurilsulfate Poly(vinyl alcohol) Titanium dioxide (E171) Macrogol 3000 Macrogol 6000 Talc Heavy magnesium carbonate Methacrylic acid – ethyl acrylate copolymer (1:1), dispersion 30% Polysorbate 80 Capsule shell: Gelatin Titanium dioxide (E171) Red iron oxide (E172)

Pack sizes and marketing

Blister pack (OPA/Alu/PE + DES film/Alu + PE foil): 7, 14, 15, 28, 30, 50, 56, 60, 90, 98 and 100 hard gastro-resistant capsules, in a box.

Blister pack (OPA/Alu/PVC/Alu foil): 7, 14, 15, 28, 30, 50, 56, 60, 90, 98 and 100 hard gastro-resistant capsules, in a box.

HDPE tablet container with PP closure with desiccant: 98 hard gastro-resistant capsules, and a desiccant capsule, in a box. Do not eat the desiccant capsule provided in the container.

Not all pack sizes may be marketed.

Marketing authorization holder

Pinewood Laboratories Ltd, Ballymacarbry, Clonmel, Co. Tipperary, Ireland

Marketing authorization dates and numbers

PA0281/146/001

Date of first authorisation: 12^th February 2010
Date of last renewal: 15^th January 2015

Drugs

Drug	Countries
NEXAZOLE	Australia, Ireland

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