LOSEC 20 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

OMEPRAZOLE

Available from:

ABIC LTD.

ATC code:

A02BC01

Pharmaceutical form:

CAPSULES

Composition:

OMEPRAZOLE 20 MG

Administration route:

PER OS

Prescription type:

Not required

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutic group:

OMEPRAZOLE

Therapeutic area:

OMEPRAZOLE

Therapeutic indications:

Relief of reflux-like symptoms (e.g. heartburn) with frequency of two or more days a week in sufferers aged 18 and over.

Authorization date:

2020-12-31

Patient Information leaflet

PATIENT LEAFLET IN
ACCORDANCE WITH
THE PHARMACISTS’
REGULATIONS
(PREPARATIONS) – 1986
This medicine is dispensed
without a doctor’s prescription
Losec
®
20 mg
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.
You should take this medicine in
accordance with the instructions in
the dosage section of this leaflet.
Consult the pharmacist if you
need more information. Refer to
the doctor if signs of the ailment
(symptoms) worsen or do not
improve.
1.
WHAT IS THE MEDICINE
INTENDED FOR?
This medicine inhibits acid
secretion in the gastrointestinal
tract.
Losec is intended for the relief
of reflux symptoms (such as
heartburn)
that
occur
at
a
frequency of twice a week or more
in patients over 18 years old.
Therapeutic class:
Proton pump inhibitors (PPI).
2.
BEFORE
USING
THE
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) (such as: pantoprazole,
lansoprazole, rabeprazole,
esomeprazole).
• You are taking a medicine
that contains nelfinavir (a
medicine for treatment of HIV
infections).
• You suffer from difficulty or
pain while swallowing food,
bloody vomit or bloody or
black stool.
• Yo u
h a v e
h e a r t b u r n
a c c o m p a n i
e d
b y
lightheadedness, sweating
or dizziness.
• You have pain in the chest or
shoulders accompanied by
shortness of breath, sweating,
pain that radiates to the
arms, neck or shoulders, or
dizziness.
• You frequently have

Summary of Product characteristics

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