PANTOPRAZOLE 40 Milligram Tablets Gastro-Resistant

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Mevcut itibaren:

Fannin (UK) Ltd

ATC kodu:

A02BC02

INN (International Adı):

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Doz:

40 Milligram

Farmasötik formu:

Tablets Gastro-Resistant

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

Proton pump inhibitors

Yetkilendirme durumu:

Transfer Pending

Yetkilendirme tarihi:

2011-07-22

Bilgilendirme broşürü

LABELLING 40MG TEXT TO APPEAR ON THE PATIENT INFORMATION LEAFLET
PATIENT INFORMATION LEAFLET PANTOPRAZOLE 40 MG GASTRO-RESISTANT
TABLETS
pantoprazole (as sodium sesquihydrate)
The name of this medicine is Pantoprazole 40 mg Gastro-Resistant
Tablets, which will be
referred to as Pantoprazole Tablets throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
.
• Keep this leaflet. You may need to read it again.
.
• If you have further questions, ask your doctor or your pharmacist.
.
•This medicine has been prescribed for you. Do not pass it on to
others; it may harm them, even if their
symptoms are the same as yours.
.
•If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your
doctor or pharmacist. (see Section 4)
WHAT IS IN THIS LEAFLET:
1.
What Pantoprazole Tablets are and what they are used for
2.
What you need to know before you take Pantoprazole Tablets
3.
How to take Pantoprazole Tablets
4.
Possible side effects
5.
How to store Pantoprazole Tablets
6.
Further information
1.
WHAT PANTOPRAZOLE TABLETS ARE AND WHAT THEY ARE USED FOR
Pantoprazole is a selective “proton pump inhibitor”, a medicine
which reduces the amount of acid produced in
your stomach. It is used for treating acid-related diseases of the
stomach and intestine.
PANTOPRAZOLE IS USED FOR TREATING:
_Adults and adolescents 12 years of age and above: _
- Reflux oesophagitis. An inflammation of your oesophagus (the tube
which connects your throat to your stomach)
accompanied by the regurgitation of stomach acid.
_Adults_:
-An infection with a bacterium called _Helicobacter pylori _in
patients with duodenal ulcers and stomach ulcers in
combination with two antibiotics (Eradication therapy). The aim is to
get rid of the bacteria and so reduce the likelihood
of these ulcers returning.
-Stomach and duodenal ulcers.
-Zollinger-Ellison-Syndrome and other conditions producing too much
acid in the stomach.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pantoprazole 40 mg Gastro-Resistant Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg pantoprazole (as pantoprazole sodium
sesquihydrate).
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Tablets are yellow coloured, capsule-shaped, (10 mm x 5 mm) biconvex
tablets, plain on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Adults and adolescents 12 years of age and above_
- Reflux oesophagitis
_Adults_
- Eradication of_ Helicobacter pylori_ (_H. pylori_) in combination
with appropriate
antibiotic therapy in patients with_ H._
_pylori_ associated ulcers.
- Gastric and duodenal ulcer.
- Zollinger-Ellison-Syndrome and other pathological hypersecretory
conditions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Tablets should not be chewed or crushed, and should be swallowed whole
1 hour before a meal with some water.
_Recommended dose_:
_Adults and adolescents 12 years of age and above:_
Reflux oesophagitis
One tablet of Pantoprazole 40 mg per day. In individual cases the dose
may be doubled (increase to 2 tablets
pantoprazole daily) especially when there has been no response to
other treatment.
A 4-week period is usually required
for the treatment of reflux oesophagitis.
If this is not sufficient, healing will usually be achieved within a
further 4
weeks.
_Adults_
Eradication of_ H. pylori_ in combination with two appropriate
antibiotics
In_ H. pylori_ positive patients with gastric and duodenal ulcers,
eradication of the germ by a combination therapy should
be achieved. Considerations should be given to official local guidance
(e.g. national recommendations) regarding bacterial
resistance and the appropriate use and prescription of antibacterial
agents. Depending upon the resistance pattern, the
following combinations can be recommended for the eradication of_ H.
pylori_:
a)
twice daily one tablet pantoprazole
+ twice daily 1000 mg amoxicillin
+ twice daily 500 mg cl