Pantoprazole 40mg gastro-resistant Tablets

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

PANTOPRAZOLE

Prieinama:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

ATC kodas:

A02BC02

INN (Tarptautinis Pavadinimas):

PANTOPRAZOLE 40 mg

Vaisto forma:

GASTRO-RESISTANT TABLET

Sudėtis:

PANTOPRAZOLE 40 mg

Recepto tipas:

POM

Gydymo sritis:

DRUGS FOR ACID RELATED DISORDERS

Autorizacija statusas:

Withdrawn

Leidimo data:

2010-05-18

Pakuotės lapelis

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PANTOPRAZOLE 40MG GASTRO-RESISTANT
TABLETS
Pantoprazole
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. 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 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. Contents of the pack and other information
1.
WHAT PANTOPRAZOLE TABLET ARE AND WHAT THEY ARE USED FOR
Pantoprazole Tablets are selective “proton pump inhibitors”, which
are medicines that reduce
the amount of acid produced in your stomach. They are used for
treating acid-related diseases
of the stomach and intestine.
PANTOPRAZOLE TABLETS ARE 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 PANTOPRAZOLE TABLETS
DO NOT TAKE PANTOPRAZOLE TABLETS:
• If you are allergic to pantoprazole or to any of the other
ingredi

Prekės savybės

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SUMMARY OF PRODUCT CHARACTERSITICS
1.
NAME OF THE MEDICINAL PRODUCT
Pantoprazole 40 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSTION
One gastro-resistant tablet contains:
40 mg Pantoprazole (as pantoprazole sodium sesquihydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
A yellow, oval, biconvex gastro-resistant tablet; 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
Posology
_Adults and adolescents 12 years of age and above: _
Reflux oesophagitis
One pantoprazole 40 mg gastro-resistant tablet per day. In individual
cases the dose may be
doubled (increase to two tablets daily) especially when there has been
no response to other
treatment. A four week period is usually required for the treatment of
reflux oesophagitis. If
this is not sufficient, healing will usually be achieved within a
further four weeks.
_Adults: _
Eradication of _H. pylori_ in combination with two appropriate
antibiotic:
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
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use and prescription of antibacterial agents. Depending upon the
resistance patter, the
following combinations can be recommended for the eradication of _H.
pylori_:
a)
twice daily one Pantoprazole 40 mg gastro-resistant tablet
+ twice daily 1000 mg amoxicillin
+ twice daily 500 mg clarithromycin
b)
twice daily one Pantoprazole 40 mg gastro-resistan