PARIET 10MG GASTRO RESISTANT TABLET

Kraj: Cypr

Język: grecki

Źródło: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Składnik aktywny:

RABEPRAZOLE SODIUM

Dostępny od:

JANSSEN-CILAG INTERNATIONAL NV (0000003494) TURNHOUTSEWEG 30, BEERSE, B-2340

Kod ATC:

A02BC04

INN (International Nazwa):

RABEPRAZOLE

Dawkowanie:

10MG

Forma farmaceutyczna:

GASTRO RESISTANT TABLET

Skład:

RABEPRAZOLE SODIUM (8000001712) 10MG

Droga podania:

ORAL USE

Typ recepty:

Εθνική Διαδικασία

Dziedzina terapeutyczna:

RABEPRAZOLE

Podsumowanie produktu:

Νομικό καθεστώς: Χωρίς Ιατρική Συνταγή; PACK WITH 14 TABS IN BLISTER(S) (990054601) 14 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 28 TABS IN BLISTER(S) (990054602) 28 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 7 TABS IN BLISTER(S) (990054603) 7 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PARIET
®
10 mg gastro-resistant tablet
PARIET
®
20 mg gastro-resistant tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg rabeprazole sodium, equivalent to 9.42 mg rabeprazole.
20 mg rabeprazole sodium, equivalent to 18.85 mg rabeprazole.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
10 mg: Pink, film coated biconvex tablet with 'E 241' printed on one
side.
20 mg: Yellow, film coated biconvex tablet with 'E 243' 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
managemen