Zoton Fastab 30 mg Oro-dispersible tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Lansoprazole

제공처:

IMED Healthcare Ltd.

ATC 코드:

A02BC; A02BC03

INN (국제 이름):

Lansoprazole

복용량:

30 milligram(s)

약제 형태:

Orodispersible tablet

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

Proton pump inhibitors; lansoprazole

승인 상태:

Authorised

승인 날짜:

2008-03-28

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 TAKE ZOTON
DO NOT TAKE ZOTON:

if you

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoton Fastab 30 mg Oro-dispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each oro-dispersible tablet contains 30mg of lansoprazole.
Excipients
Product imported from the UK: Each oro-dispersible tablet contains
30mg of lactose and 9.0mg of aspartame (E951)
Product imported from Italy: Each 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 the UK and Italy._
White to yellowish-white, circular, flat bevelled-edge oro-dispersible
tablet. Each oro-dispersible tablet contains orange to dark
brown microgranules. Each oro-dispersible tablet
is imprinted with '30'
on one side and is strawberry flavoured.
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 hydroxypropyl cellulose
Hydroxypropyl cellulose
Hypromellose
Titanium dioxide
Talc
Mannitol (E421)
Methacrylic acid – ethyl acrylate copolymer
Polyacrylate dispersion
Macrogol 8000
Glyceryl monostearate
Polysorbate 80
Triethyl citrate
Citric acid anhydrous
Crospovidone
Magnesium stearate
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