Zoton

Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeated dose toxicity, toxicity to reproduction or genotoxicity.

In two rat carcinogenicity studies, lansoprazole produced dose-related gastric ECL cell hyperplasia and ECL cell carcinoids associated with hypergastrinaemia due to inhibition of acid secretion. Intestinal metaplasia was also observed, as were Leydig cell hyperplasia and benign Leydig cell tumours. After 18 months of treatment retinal atrophy was observed. This was not seen in monkeys, dogs or mice.

In mouse carcinogenicity studies dose-related gastric ECL cell hyperplasia developed as well as liver tumours and adenoma of rete testis.

The clinical relevance of these findings is unknown.

Gastro-resistant microgranules: Lactose monohydrate, microcrystalline cellulose, heavy magnesium carbonate, low-substituted hydroxypropylcellulose, hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, mannitol, methacrylic acid - ethyl acrylate copolymer (1:1) 30 per cent, polyacrylate dispersion 30 per cent, macrogol 8000, citric acid anhydrous, glyceryl monostearate, polysorbate 80, mannitol, 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.

Not applicable.

3 years.

Do not store above 25°C. Store in the original package.

Aluminium blister packs of 2, 7, 14 or 28 Tablets.

Not all pack sizes may be marketed.

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CN13 9NJ

United Kingdom

PL 00057/1297

17 June 2011

12/2017