Pariet 10 mg Enterotablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

rabeprazolnatrium (vattenfri)

Tillgänglig från:

Orifarm AB

ATC-kod:

A02BC04

INN (International namn):

rabeprazole sodium (anhydrous)

Dos:

10 mg

Läkemedelsform:

Enterotablett

Sammansättning:

rabeprazolnatrium (vattenfri) 10 mg Aktiv substans; mannitol Hjälpämne; propylenglykol Hjälpämne

Receptbelagda typ:

Receptbelagt

Terapiområde:

Rabeprazol

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2005-09-21

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
PARIET
™ 10 MG AND 20 MG GASTRO-RESISTANT TABLETS
Rabeprazole sodium
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 Pariet is and what it is used for
2.
What you need to know before you take Pariet
3.
How to take Pariet
4.
Possible side effects
5.
How to store Pariet
6.
Contents of the pack and other information
1.
WHAT PARIET IS AND WHAT IT IS USED FOR
Pariet tablets contain the active ingredient rabeprazole sodium. This
belongs to a group of medicines called
‘Proton Pump Inhibitors’ (PPIs). They work by lowering the amount
of acid that your stomach produces.
Pariet tablets are used to treat the following conditions:
-
‘Gastro-oesophageal reflux disease’ (GORD), which can include
heartburn. GORD is caused when acid and
food from your stomach escapes into your food pipe (oesophagus).
-
Ulcers in your stomach or the upper part of your gut (intestine). If
these ulcers are infected with bacteria
called ‘Helicobacter pylori’ (H. Pylori), you will also be given
antibiotics. Using Pariet tablets and antibiotics
together gets rid of the infection and makes the ulcer heal. It also
stops the infection and ulcer from coming
back.
-
Zollinger-Ellison Syndrome where your stomach produces too much acid.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARIET
DO NOT TAKE PARIET IF
-
You are allergic (hypersensitive) to rabeprazole sodium, or any of the
other ingredients of this medicine
(listed in Section 6).
-
You are pregnant or think that you are pregnant
-

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PARIET 10 mg gastro-resistant tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg rabeprazole sodium, equivalent to 9.42 mg rabeprazole.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
Pink, film coated biconvex tablet with ‘E 241’ printed on one
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PARIET tablets are indicated for the treatment of:
•
active duodenal ulcer.
•
active benign gastric ulcer.
•
symptomatic erosive or ulcerative gastro-oesophageal reflux disease
(GORD).
•
Gastro-Oesophageal Reflux Disease Long-term Management (GORD
Maintenance).
•
Symptomatic treatment of moderate to very severe gastro-oesophageal
reflux disease
(symptomatic GORD).
•
Zollinger-Ellison Syndrome.
•
In combination with appropriate antibacterial therapeutic regimens for
the eradication of
Helicobacter pylori (H. pylori) in patients with peptic ulcer disease.
See section 4.2.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults /older people_
Active Duodenal Ulcer and Active Benign Gastric Ulcer: The recommended
oral dose for both active
duodenal ulcer and active benign gastric ulcer is 20 mg to be taken
once daily in the morning.
Most patients with active duodenal ulcer heal within four weeks.
However a few patients may require
an additional four weeks of therapy to achieve healing. Most patients
with active benign gastric ulcer
heal within six weeks. However again a few patients may require an
additional six weeks of therapy to
achieve healing.
Erosive or Ulcerative Gastro-Oesophageal Reflux Disease (GORD): The
recommended oral dose for
this condition is 20 mg to be taken once daily for four to eight
weeks.
Gastro-Oesophageal Reflux Disease Long-term Management (GORD
Maintenance): For long-term
management, a maintenance dose of PARIET 20 mg or 10 mg once daily can
be used depending upon
patient response.
2
Symptomatic treatment of moderate to very severe gastro-oesophageal
reflux