Zoton FasTab 15 mg Oro-Dispersible Tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Lansoprazole

Dostępny od:

Pfizer Healthcare Ireland

Kod ATC:

A02BC; A02BC03

INN (International Nazwa):

Lansoprazole

Dawkowanie:

15 milligram(s)

Forma farmaceutyczna:

Orodispersible tablet

Typ recepty:

Product subject to prescription which may be renewed (B)

Dziedzina terapeutyczna:

Proton pump inhibitors; lansoprazole

Status autoryzacji:

Marketed

Data autoryzacji:

2001-11-16

Ulotka dla pacjenta

Page 1 of 9
2022-0078691, 2022-0081189
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOTON* FASTAB 15 MG ORO-DISPERSIBLE TABLETS
ZOTON* FASTAB 30 MG ORO-DISPERSIBLE TABLETS
Lansoprazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Zoton is and what it is used for
2.
What you need to know before you take Zoton
3.
How to take Zoton
4.
Possible side effects
5.
How to store Zoton
6.
Contents of the pack and other information
1.
WHAT ZOTON IS AND WHAT IT IS USED FOR
The active ingredient in Zoton is lansoprazole, which is a proton pump
inhibitor. Proton pump inhibitors
reduce the amount of acid that your stomach makes.
_ _
Your doctor may prescribe Zoton for the following indications:
-
Treatment of duodenal and stomach ulcer
-
Treatment of inflammation in your oesophagus (reflux oesophagitis)
-
Prevention of reflux oesophagitis
-
Treatment of heartburn and acid regurgitation
-
Treatment of infections caused by the bacteria
_Helicobacter pylori_
when given in combination
with antibiotic therapy
-
Treatment or prevention of duodenal or stomach ulcer in patients
requiring continued non-
steroidal anti-inflammatory drugs (NSAID) treatment (NSAID treatment
is used against pain or
inflammation)
-
Treatment of Zollinger-Ellison syndrome.
Your doctor may have prescribed Zoton for another indication or with a
dose different from that which is
written in this information leaflet. Please take your medicine in
consultation with your doctor.
You must talk to a doctor if you do not feel better or if you feel
wor

Charakterystyka produktu

Health Products Regulatory Authority
10 August 2023
CRN00D9Q0
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoton FasTab 15 mg Oro‐Dispersible Tablets
2 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.
3 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.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Treatment of duodenal and gastric ulcer

Treatment of reflux oesophagitis

Prophylaxis of reflux oesophagitis

Eradication of _Helicobacter pylori_ (_H. pylori_) concurrently given
with appropriate antibiotic therapy for treatment of
_H.pylori_‐associated ulcers

Treatment of non‐steroidal anti‐inflammatory drug
(NSAID)‐associated benign gastric and duodenal ulcers in
patients requiring continued NSAID treatment

Prophylaxis of NSAID‐associated gastric ulcers and duodenal ulcers
in patients at risk (see section 4.2) requiring
continued therapy

Symptomatic gastroesophageal reflux disease

Zollinger‐Ellison syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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