OMPRANYT 20MG GASTRO-RESISTANT CAPSULE, HARD

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

OMEPRAZOLE

Διαθέσιμο από:

BIAL-PORTELA & CA, SA (0000003750) A AV. DA SIDERURGIA NACIONAL, S. MAMEDE DO CORONADO, 4745-457

Φαρμακολογική κατηγορία (ATC):

A02BC01

INN (Διεθνής Όνομα):

OMEPRAZOLE

Δοσολογία:

20MG

Φαρμακοτεχνική μορφή:

GASTRO-RESISTANT CAPSULE, HARD

Σύνθεση:

OMEPRAZOLE (0073590586) 20MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

OMEPRAZOLE

Περίληψη προϊόντος:

Νομικό καθεστώς: Χωρίς Ιατρική Συνταγή Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 14 CAPS IN BLISTER(S) (200036201) 14 CAPSULE - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 28 CAPS IN BLISTER(S) (200036202) 28 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
OMPRANYT, 20 MG, TABLETS
OMEPRAZOLE
OMPRANYT, 20 MG, CAPSULES
OMEPRAZOLE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor or your pharmacist.
-
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.
-
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 OMPRANYT is and what it is used for
2.
Before you take OMPRANYT
3.
How to take OMPRANYT
4.
Possible side effects
5
How to store OMPRANYT
6.
Further information
1.
WHAT OMPRANYT IS AND WHAT IT IS USED FOR
Pharmacotherapeutic group: Proton Pump Inhibitors.
The active substance is omeprazole, a drug that reduces gastric acid
secretion.
OMPRANYT is indicated for:

Treatment of duodenal ulcer
and benign gastric ulcer, including those which complicate the
treatments with nonsteroidal anti-inflammatory drugs (NSAIDs).

Prophylactic treatment of duodenal ulcer, benign gastric ulcer and/or
gastroduodenal
erosions resulting from nonsteroidal anti-inflammatory drugs (NSAIDs)
in patients at risk
(elderly and/ or with history of gastroduodenal erosions), requiring
continuous treatment
with NSAIDs.

Treatment of gastroesophageal reflux.

Treatment of Zollinger-Ellison syndrome, a disease where the acid
gastric secretion is highly
increased.

Treatment of gastric and duodenal ulcer associated to _Helicobacter
pylori _(a bacteria which
is associated to the establishment of the ulcer).
2.
BEFORE YOU TAKE OMPRANYT
DO NOT TAKE OMPRANYT:
If you are allergic (hypersensitive) to omeprazole or to any of the
other ingredients of
OMPRANYT.
In case of persistence of symptoms it should be excluded the
hypothesis of malignant disease,
as treatment with omeprazole may relief the symptoms and delay its
diagnosis.
TAKE SPEC

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
OMPRANYT, 20 mg, capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each capsule contains: Omeprazole, 20 mg.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM:
Gastro-resistant capsule, hard.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS:
Treatment of duodenal ulcer and benign gastric ulcer, including those
which complicate the
treatment with nonsteroidal anti-inflammatory drugs (NSAIDs).
Prophylactic treatment of duodenal ulcer, benign gastric ulcer and/or
gastroduodenal erosions
resulting from nonsteroidal anti-inflammatory drugs (NSAIDs) in
patients at risk (elderly and/ or
history of gastroduodenal erosions), requiring continuous treatment
with NSAIDs.
Treatment of gastroesophageal reflux. Omeprazole is indicated in the
treatment of reflux
esophagitis, of severe symptoms of non-inflammatory reflux, and of
mild symptoms that do not
respond to the conventional treatment.
Treatment of Zollinger-Ellison syndrome.
Treatment of gastric and duodenal ulcer associated to _Helicobacter
pylori _either as dual therapy (in
combination with amoxicillin or clarithromycin) or triple therapy
(combined treatment, with two anti-
infective agents simultaneously) whose eradication rate is
substantially higher with minimum
duration of therapy.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION:
Omeprazole will be administered orally, preferably in the morning,
taking the whole capsule with
some liquid. Patients having difficulty to swallow the capsule can
open it and either swallow the
capsule’s content or mix it with mildly acidic liquid (e.g. juice,
yoghurt or sour milk). Suspension is
recommended to be taken within 30 minutes. Patients can swallow
directly the content’s capsule but
never masticate or crash the granules.
_DUODENAL ULCER: _Recommended posology in patients with active peptic
ulcer is 20 mg once daily.
Symptom resolution is rapid and in most patients healing occurs within
2 weeks. In patients were
ulcer cicatrisation is i