Pantoprazole 40mg gastro-resistant tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Pantoprazole sodium sesquihydrate

Dostupné z:

Wockhardt UK Ltd

ATC kód:

A02BC02

INN (Medzinárodný Name):

Pantoprazole sodium sesquihydrate

Dávkovanie:

40mg

Forma lieku:

Gastro-resistant tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 01030500; GTIN: 5012727905761

Príbalový leták

PATIENT INFORMATION LEAFLET
PANTOPRAZOLE 40mg
GASTRO-RESISTANT TABLETS
pantoprazole (as sodium sesquihydrate)
The name of this medicine is Pantoprazole 40mg 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.
Ÿ
KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.
Ÿ
IF YOU HAVE FURTHER QUESTIONS, ASK YOUR DOCTOR OR YOUR PHARMACIST.
Ÿ
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.
Ÿ
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.
IN THIS LEAFLET:
1.
What Pantoprazole Tablets are and what they are used for
2.
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:_
Ÿ
Reflux oesophagitis. An inflammation of your oesophagus (the tube
which connects your throat to your stomach) accompanied by the
regurgitation of stomach acid.
_Adults:_
Ÿ
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.
Ÿ
Stomach and duodenal ulcers.
Ÿ
Zollinger-Ellison-Syndrome and other conditions producing too much
acid in the stomach.
2. BEFORE YOU TAKE PANTOPRAZOLE TABLETS
DO NOT TAKE PANTOPRAZOLE TABLETS IF YOU:
Ÿ
ARE ALLERGIC (HYPERSENSITIVE) to PANTOPRAZOLE, or to any of the OTHER
INGR

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pantoprazole 40 mg gastro-resistant tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 40 mg of pantoprazole (as 45.16
mg
pantoprazole sodium sesquihydrate).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant tablet
Elliptical, biconvex, dark yellow gastro-resistant tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Pantoprazole is indicated for use in adults and adolescents 12 years
of age and _
_above for: _
-Reflux oesophagitis.
_Pantoprazole is indicated in adult for: _
-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 2 Pantoprazole 40 mg tablets 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)
Pantoprazole 40 mg gastro-resistant tablet twice daily one
+ twice daily 1000 mg amoxicillin
+ twice daily 500 mg clarithromy