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

Posology

Treatment of duodenal ulcer

The recommended dose is 30 mg once daily for 2 weeks. In patients not fully healed within this time, the medication is continued at the same dose for another two weeks.

Treatment of gastric ulcer

The recommended dose is 30 mg once daily for 4 weeks. The ulcer usually heals within 4 weeks, but in patients not fully healed within this time, the medication may be continued at the same dose for another 4 weeks.

Reflux oesophagitis

The recommended dose is 30 mg once daily for 4 weeks. In patients not fully healed within this time, the treatment may be continued at the same dose for another 4 weeks.

Prophylaxis of reflux oesophagitis

15 mg once daily. The dose may be increased up to 30 mg daily as necessary.

Eradication of Helicobacter pylori

When selecting appropriate combination therapy consideration should be given to official local guidance regarding bacterial resistance, duration of treatment, (most commonly 7 days but sometimes up to 14 days), and appropriate use of antibacterial agents.

The recommended dose is 30 mg of Zoton FasTab twice daily for 7 days in combination with one of the following:

clarithromycin 250-500 mg twice daily + amoxicillin 1 g twice daily

clarithromycin 250 mg twice daily + metronidazole 400-500 mg twice daily

H. pylori eradication rates of up to 90% are obtained when clarithromycin is combined with Zoton FasTab and amoxicillin or metronidazole.

Six months after successful eradication treatment, the risk of re infection is low and relapse is therefore unlikely.

Use of a regimen including lansoprazole 30 mg twice daily, amoxicillin 1 g twice daily and metronidazole 400-500 mg twice daily has also been examined. Lower eradication rates were seen using this combination than in regimens involving clarithromycin. It may be suitable for those who are unable to take clarithromycin as part of an eradication therapy, when local resistance rates to metronidazole are low.

Treatment of NSAID associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment

30 mg once daily for four weeks. In patients not fully healed the treatment may be continued for another four weeks. For patients at risk or with ulcers that are difficult to heal, a longer course of treatment and/or a higher dose should probably be used.

Prophylaxis of NSAID associated gastric and duodenal ulcers in patients at risk (such as age >65 or history of gastric or duodenal ulcer) requiring prolonged NSAID treatment

15 mg once daily. If the treatment fails the dose 30 mg once daily should be used.

Symptomatic gastro-oesophageal reflux disease

The recommended dose is 15 mg or 30 mg daily. Relief of symptoms is obtained rapidly. Individual adjustment of dosage should be considered. If the symptoms are not relieved within 4 weeks with a daily dose of 30 mg, further examinations are recommended.

Zollinger-Ellison syndrome

The recommended initial dose is 60 mg once daily. The dose should be individually adjusted and the treatment should be continued for as long as necessary. Daily doses of up to 180 mg have been used. If the required daily dose exceeds 120 mg, it should be given in two divided doses.

Renal impairment

There is no need for a dose adjustment in patients with impaired renal function.

Hepatic impairment

Patients with moderate or severe liver disease should be kept under regular supervision and a 50% reduction of the daily dose is recommended (see section 4.4 and 5.2).

Elderly

Due to reduced clearance of lansoprazole in the elderly an adjustment of dose may be necessary based on individual requirements. A daily dose of 30 mg should not be exceeded in the elderly unless there are compelling clinical indications.

Paediatric population

The use of Zoton FasTab is not recommended in children as clinical data are limited (see section 5.2) and juvenile animal studies have findings of currently unknown human relevance (see section 5.3). Treatment of small children below one year of age should be avoided as available data have not shown beneficial effects in the treatment of gastro-oesophageal reflux disease.

Method of administration

For optimal effect, Zoton FasTab should be taken once daily in the morning, except when used for H. pylori eradication when treatment should be twice a day, once in the morning and once in the evening. Zoton FasTab should be taken at least 30 minutes before food (see section 5.2). Zoton FasTab is strawberry flavoured and should be placed on the tongue and gently sucked. The tablet rapidly disperses in the mouth, releasing gastro-resistant microgranules which are swallowed with the patient’s saliva. Alternatively, the tablet can be swallowed whole with a drink of water.

The orodispersible tablets can be dispersed in a small amount of water and administered via a naso-gastric tube or oral syringe.

The effects of overdose on lansoprazole in humans are not known (although the acute toxicity is likely to be low) and, consequently, instruction for treatment cannot be given. However, daily doses of up to 180 mg of lansoprazole orally and up to 90 mg of lansoprazole intravenously have been administered in trials without significant undesirable effects.

Please refer to section 4.8 for possible symptoms of lansoprazole overdose.

In the case of suspected overdose the patient should be monitored. Lansoprazole is not significantly eliminated by haemodialysis. If necessary, gastric emptying, charcoal and symptomatic therapy is recommended.

3 years.

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

Aluminium blister packs of 28 or 56 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.