PROTIUM 40 Milligram Tablets Gastro-Resistant

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Commercializzato da:

Takeda UK Limited

Codice ATC:

A02BC02

INN (Nome Internazionale):

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Dosaggio:

40 Milligram

Forma farmaceutica:

Tablets Gastro-Resistant

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Proton pump inhibitors

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2016-09-30

Foglio illustrativo

Protium
®
40 mg gastro-resistant tablets
Pantoprazole
PACKAGE LEAFLET:
Information for the user
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, pharmacist or nurse.
-
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, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Protium is and what it is used for
2. What you need to know before you take
Protium
3. How to take Protium
4. Possible side effects
5. How to store Protium
6. Contents of the pack and other information
1. What Protium is and what it is used for
Protium contains the active substance
pantoprazole. Protium 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.
Protium is used to treat adults and adolescents
12 years of age and above for
•
Reflux oesophagitis. An inflammation of your
oesophagus (the tube which connects your
throat to your stomach) accompanied by the
regurgitation of stomach acid.
Protium is used to treat adults for
•
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
Protium
Do not take Protium
-
If you are allergic to pantoprazole or to any
of the other ingredients of this medicine
(listed in section 6)._ _
-
If you a

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Protium 40 mg gastro-resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium
sesquihydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet (tablet).
Yellow, oval, biconvex film-coated tablets imprinted with "P 40" in
brown ink on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Protium is indicated for use in adults and adolescents 12 years of age
and above for:
Reflux oesophagitis.
Protium is indicated in adults 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 tablet of Protium per day. In individual cases the dose may be
doubled (increase to 2 tablets Protium 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 Protium
+ twice daily 1000 mg amoxicillin
+ twice daily 500 mg clarithromycin
b)
Twice daily one tablet Protium
+ twice daily 400
-
500 mg metronidazole (