LOSEC 20MG RX

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

OMEPRAZOLE

Disponible depuis:

ABIC LTD.

Code ATC:

A02BC01

forme pharmaceutique:

CAPSULES

Composition:

OMEPRAZOLE 20 MG

Mode d'administration:

PER OS

Type d'ordonnance:

Required

Fabriqué par:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Domaine thérapeutique:

OMEPRAZOLE

indications thérapeutiques:

Acute duodenal ulcer. Acute gastric ulcer. Helicobacter pylori-associated peptic ulcer disease in combination with antibiotics. Reflux esophagitis:- Treatment ; - Long-term management; - Maintenance treatment for the prevention of relapse in patients with severe reflux esophagitis. Treatment of severe reflux oesophagitis in children from one year of age and older. - Maintenance treatment for the prevention of relapse in patients with poorly responsive peptic ulcer. - Zollinger-ellison syndrome. - Treatment and prevention of NSAID - associated duodenal and gastric ulcers or erosions in high risk patients.

Date de l'autorisation:

2020-05-31

Notice patient

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986
The dispensing of this medicine is
upon doctor's prescription only
LOSEC
®
CAPSULES
10 MG AND 20 MG
COMPOSITION
LOSEC
® 10 MG
LOSEC
® 20 MG
CAPSULES
CAPSULES
Each capsule contains:
Each capsule contains:
Omeprazole 10 mg
Omeprazole 20 mg
For a list of the inactive ingredients in this preparation, see
section 6 – "Further information".
READ THE PACKAGE INSERT CAREFULLY AND IN ITS ENTIRETY
BEFORE USING THE MEDICINE. This package insert includes
concise information about the medicine. If you have further
questions, refer to your doctor or to a pharmacist.
THIS MEDICINE WAS PRESCRIBED TO TREAT YOUR AILMENT. DO
NOT PASS IT ON TO OTHERS. IT MAY HARM THEM, EVEN IF THEIR
MEDICAL STATE SEEMS SIMILAR TO YOURS.
THIS MEDICINE IS NOT INTENDED FOR ADMINISTRATION IN
CHILDREN UNDER 1 YEAR OF AGE.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Inhibits acid secretion in the gastro intestinal tract.
This medicine is indicated for the treatment of gastric ulcer
and duodenal ulcer.
Combined treatment with antibiotics in Helicobacter pylori
associated peptic ulcer disease.
Long term management of reflux oesophagitis and in
Zollinger-Ellison syndrome.
Severe reflux oesophagitis in children from one year of age
and older.
Maintenance treatment for the prevention of relapse in
patients with poorly responsive peptic ulcer or severe reflux
oesophagitis.
For the treatment and prevention of gastric ulcer and
duodenal ulcer caused by the treatment with NSAID in
high-risk patients.
THERAPEUTIC GROUP:
Proton pump inhibitors (PPI).
2.
BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:
•
you are sensitive (allergic) to the active ingredient or to
any other ingredient in the preparation (see section 6), or
to other proton pump inhibitors (PPI) e.g., pantoprazole,
lansoprazole, rabeprazole, esomeprazole).
• you suffer from pain while swallowing food, vomiting
with blood, bloody or black stools.
•
you are taking nelfinavir (a medicine used to treat

Résumé des caractéristiques du produit

LOSEC 05/2016 SK
."רשואו קדבנ ונכותו תואירבה דרשמ י"ע
עבקנ הז ןולע טמרופ"
:רשואמ ןולע
05/2016
“This leaflet format has been determined by the Ministry of Health
and the content thereof has been
checked and approved.” Date of approval: May 2016.
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
LOSEC
® CAPSULES
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains omeprazole 10 or 20 mg.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Hard gelatin capsules.
Losec Capsules 10 mg: hard gelatin capsules with an opaque pink body,
marked 10 and an
opaque pink cap marked A/OS in black ink. Each capsule contains
omeprazole 10 mg as
enteric coated pellets, with an aqueous based coating.
Losec Capsules 20 mg: hard gelatin capsules with an opaque pink body,
marked 20 and an
opaque reddish-brown cap marked A/OM in black ink. Each capsule
contains omeprazole 20
mg as enteric coated pellets, with an aqueous based coating.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Acute Duodenal Ulcer.
•
Acute Gastric Ulcer.
•
_Helicobacter Pylori_-Associated Peptic Ulcer Disease in combination
with antibiotics.
•
Reflux Esophagitis.


Treatment


Long-Term Management


Maintenance Treatment for the Prevention of Relapse in Patients with
Severe
Reflux Esophagitis


Severe Reflux Esophagitis in Children from One Year of Age and Older
LOSEC 05/2016 SK
Page 2 of 15
2
•
Maintenance
Treatment
for
the
Prevention
of
Relapse
in
Patients
with
Poorly
Responsive Peptic Ulcer.
•
Zollinger-Ellison Syndrome.
•
Treatment
and
prevention
of
NSAID-associated
duodenal
and
gastric
ulcers
or
erosions in high risk patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Losec capsules should be taken before meals, and are recommended to be
given in the
morning and swallowed whole with liquid.
For patients with swallowing difficulties the capsule might be opened
and the contents
swallowed or suspended in a slightly acidic fluid e.g. fruit juice,
yoghurt soured