ZOTON FASTAB 30 Milligram Orodispersible Tablet

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

LANSOPRAZOLE

Beszerezhető a:

Clear Pharmacy

ATC-kód:

A02BC03

INN (nemzetközi neve):

LANSOPRAZOLE

Adagolás:

30 Milligram

Gyógyszerészeti forma:

Orodispersible Tablet

Recept típusa:

Product subject to prescription which may be renewed (B)

Terápiás terület:

Proton pump inhibitors

Engedélyezési státusz:

Authorised

Engedély dátuma:

2010-08-13

Betegtájékoztató

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 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

Termékjellemzők

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 30 mg of lansoprazole.
Excipient(s) with known effect
Each 30 mg oro-dispersible tablet contains lactose and aspartame
(E951).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oro-Dispersible Tablet.
_Product imported from_ the UK and Italy:
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
Heavy magnesium carbonate
Low-substituted hyprolose
Hyprolose
Hypromellose
Titanium dioxide
Talc
Mannitol
Methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30 per
cent
Polyacrylate dispersion 30 per cent
Macrogol 8000
Citric acid anhydrous
Glycerol monostearate
Polysorbate 80
Iron oxide yellow (E172)
Iron oxide red (E172)
Crospovidone
Magnesium stearate
Strawberry flavour
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_D_
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Aspartame (E951)
Triethyl citrate
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The she