LOSEC 20 MG RX

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

OMEPRAZOLE

متاح من:

ABIC LTD.

ATC رمز:

A02BC01

الشكل الصيدلاني:

CAPSULES

تركيب:

OMEPRAZOLE 20 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

المجموعة العلاجية:

OMEPRAZOLE

المجال العلاجي:

OMEPRAZOLE

الخصائص العلاجية:

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.

تاريخ الترخيص:

2020-05-31

نشرة المعلومات

PATIENT LEAFLET IN
ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with
a doctor’s prescription only
Losec
®
20 mg Rx
Capsules
Composition
Each capsule contains:
Omeprazole 20 mg
For information regarding inactive
ingredients and allergens, see
section 2 “Important information
about some of the ingredients of the
medicine” and section 6 – “Additional
information”.
Read the entire leaflet carefully
before using the medicine. This
leaflet contains concise information
about the medicine. If you have
additional questions, refer to the
doctor or the pharmacist.
This medicine has been prescribed
for your treatment. Do not pass it on
to others. It may harm them even if
it seems to you that their medical
condition is similar.
This medicine is intended for
children over the age of one and
weighing 10 kg or more.
1. WHAT IS THE MEDICINE
INTENDED FOR?
This medicine inhibits acid secretion
in the gastrointestinal tract.
The medicine is intended for:
• Treatment of stomach ulcer and
duodenal ulcer.
• Combination therapy with an
antibiotic for Helicobacter pylori
associated with gastric ulcer.
• Treatment of reflux esophagitis.
• Long-term treatment of reflux
esophagitis and Zollinger Ellison
syndrome. Maintenance treatment
for the prevention of relapse in
patients with a gastric ulcer that
responds poorly or for severe reflux
esophagitis.
• Treatment of severe reflux
esophagitis in children aged one
year and above.
• Treatment and prevention of
stomach ulcer or duodenal ulcer
as a result of NSAIDs treatment
(non-steroidal anti-inflammatory
drugs) in high-risk patients.
Therapeutic class:
Proton pump inhibitors (PPI).
2.
B E F O R E
U S I N G
T H E
MEDICINE
Do not use the preparation if:
• You are sensitive (allergic)
to
the
active
ingredient
omeprazole or to any of the
other ingredients this medicine
contains (see section 6 –
“Additional information”).
• You are sensitive (allergic)
to medicines that contain
other proton pump inhibitors
(PPI)

خصائص المنتج

LOSEC_Capsules_20mg_SPC_S.Z Notification_9.2023
SUMMARY OF PRODUCT CHARACTERISTICS
LOSEC
®
1.
NAME OF THE MEDICINAL PRODUCT
LOSEC
®
20 mg
LOSEC
®
20 mg Rx
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20 mg omeprazole.
Excipients with known effect: each capsule contains 8 mg lactose and
0.25 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant hard gelatin capsules.
Hard gelatine capsules with an opaque pink body marked 20 and an
opaque reddish-brown cap
marked "A Losec
®
" in black ink. Each capsule contains white to slightly beige
enteric-coated
pellets.
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

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.

Losec 20 mg (OTC): Relief of reflux-like symptoms (e.g. heartburn)
with frequency of two
or more days a week in sufferers aged 18 years and over.
LOSEC_Capsules_20mg_SPC_S.Z Notification_9.2023
4.2
Posology and method of administration
Posology
_Adults_
Acute Duodenal Ulcer
The recommended dosage is Losec 20 mg once daily. Symptom resolution
is rapid and in most
patients, healing occurs within 4 weeks. For those patients who may
not be fully healed after the
initial course, healing usually occurs during a further 4 weeks
treatment period. In patients with
poorly responsive duodenal ulcer, Losec 40 mg once daily is
recommended and healing is usually
achieved within 4 weeks.
The effectiveness of Losec is not affect