ZOTON FASTAB Oro-dispersible tablet Ref.[27747] Active ingredients: Lansoprazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CN13 9NJ, United Kingdom

Product name and form

Zoton FasTab* 15 mg oro-dispersible tablets.

Pharmaceutical Form

White to yellowish white, circular flat beveled-edge oro-dispersible tablet with “15” debossed on one side. Each oro-dispersible tablet contains orange to dark brown microgranules.

Qualitative and quantitative composition

Each oro-dispersible tablet contains 15 mg of lansoprazole.

Excipient(s) with known effect:

Each Zoton 15 mg oro-dispersible tablet contains 15 mg lactose and 4.5 mg aspartame.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Lansoprazole

Lansoprazole is a gastric proton pump inhibitor. It inhibits the final stage of gastric acid formation by inhibiting the activity of H+/K+ ATPase of the parietal cells in the stomach. The inhibition is dose-dependent and reversible, and the effect applies to both basal and stimulated secretion of gastric acid.

List of Excipients

Gastro-resistant microgranules: Lactose monohydrate, microcrystalline cellulose, heavy magnesium carbonate, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, hypromellose, titanium dioxide, talc, mannitol, methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30 percent, polyacrylate dispersion 30 percent, macrogol 8000, citric acid anhydrous, glyceryl monostearate, polysorbate 80, triethyl citrate, iron oxide yellow (E172) and iron oxide red (E172).

Other excipients: Mannitol, microcrystalline cellulose, low-substituted hydroxypropylcellulose, citric acid anhydrous, crospovidone, magnesium stearate, strawberry flavour and aspartame (E951).

Pack sizes and marketing

Aluminium blister packs of 28 or 56 Tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CN13 9NJ, United Kingdom

Marketing authorization dates and numbers

PL 00057/1296

17 June 2011

Drugs

Drug Countries
ZOTON Australia, Estonia, Ireland, Italy, United Kingdom

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.