Zoton FasTab 30mg oro-dispersible tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lansoprazole

Available from:

Primecrown 2010 Limited

ATC code:

A02BC; A02BC03

INN (International Name):

Lansoprazole

Dosage:

30 milligram(s)

Pharmaceutical form:

Orodispersible tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Proton pump inhibitors; lansoprazole

Authorization status:

Authorised

Authorization date:

2010-06-04

Patient Information leaflet

ZOTON
® FASTAB 15 MG ORO-DISPERSIBLE TABLETS
ZOTON
® FASTAB 30 MG ORO-DISPERSIBLE TABLETS
Lansoprazole
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 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 follow
your doctor’s instructions for taking your medicine.
You must talk to a doctor if you do not feel better or if you feel
worse after 14
days.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOTON
DO NOT

Summary of Product characteristics

Health Products Regulatory Authority
18 January 2019
CRN008QDJ
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoton FasTab 30mg oro-dispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each oro-dispersible tablet contains 30mg of lansoprazole.
Excipient(s) with known effect:
Each 30 mg oro-dispersible tablet contains lactose and aspartame
(E951).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oro-dispersible tablet
_Product imported from UK:_
White to yellowish white, circular, flat bevelled-edge oro-dispersible
tablet with ‘30’
debossed on one side.
Each oro-dispersible tablet contains orange to dark brown
microgranules.
4 CLINICAL PARTICULARS
As per PA0822/101/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/101/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Microcrystalline cellulose
Magnesium carbonate
Low substituted hyprolose
Hyprolose
Hypromellose
Titanium dioxide (E171)
Talc
Mannitol
Health Products Regulatory Authority
18 January 2019
CRN008QDJ
Page 2 of 3
Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 per cent
Polyacrylate dispersion 30 per cent
Macrogol 8000
Glycerol monostearate
Polysorbate 80
Triethyl citrate
Citric acid anhydrous
Crospovidone
Magnesium Stearate
Aspartame (E951)
Strawberry Flavour
Iron oxide red (E172)
Iron oxide yellow (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister strips and
outer carton of the product on the market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25˚C.
Store in the original package in order to protect from moisture
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium blisters in an over-labelled cardboard carton containing 28
tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Primecrown 2010 Limited
4/5 Northolt Trading Estate
Belvue Road
Northolt
Middlesex
UB5 5QS