PARIET 20MG GASTRO RESISTANT TABLET

Երկիր: Կիպրոս

Լեզու: հունարեն

Աղբյուրը: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Ակտիվ բաղադրիչ:

RABEPRAZOLE SODIUM

Հասանելի է:

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

ATC կոդը:

A02BC04

INN (Միջազգային անվանումը):

RABEPRAZOLE

Դոզան:

20MG

Դեղագործական ձեւ:

GASTRO RESISTANT TABLET

Կազմը:

RABEPRAZOLE SODIUM (8000001712) 20MG

Կառավարման երթուղին:

ORAL USE

Ռեկվիզորի տեսակը:

Εθνική Διαδικασία

Թերապեւտիկ տարածք:

RABEPRAZOLE

Ապրանքի ամփոփագիր:

Νομικό καθεστώς: Χωρίς Ιατρική Συνταγή; PACK WITH 14 TABS IN BLISTER(S) (990054701) 14 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή

Ապրանքի հատկությունները

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