NIZATIDINE Capsule, hard Ref.[9149] Active ingredients: Nizatidine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts, EN6 1TL

Product name and form

Nizatidine 150 mg Capsules, hard.

Pharmaceutical Form

Capsule, hard.

Hard gelatin capsules containing white to off-white powder with a light yellow body and dark yellow cap. The body has “NZ 150” and the cap has “G”, both printed in black.

Qualitative and quantitative composition

Each capsule contains 150 mg of nizatidine.

Excipient with known effect: Each capsule contains Allura red.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Nizatidine

Nizatidine is a potent, selective, competitive and fully reversible histamine H2-receptor antagonist. Nizatidine significantly decreased basal and stimulated gastric acid and pepsin concentration, in addition to the volume of gastric secretion.

List of Excipients

Capsule Contents:

Croscarmellose sodium
Starch pregelatinised
Talc
Magnesium stearate

Capsule Composition:

Titanium dioxide (E171)
Gelatin
Quinoline yellow (E104)
Allura red (E129)
Yellow iron oxide (E172)

Ink Composition:

Shellac
Macrogol
Potassium hydroxide
Black iron oxide (E172)

Pack sizes and marketing

High density polyethylene bottles with polypropylene snap-on caps containing 28 or 30 capsules or PVC/Aluminium blister packs containing 28 or 30 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts, EN6 1TL

Marketing authorization dates and numbers

PL 04569/0471

Date of first authorisation: 17/07/2002
Date of latest renewal: 12/03/2009

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