OMEPRADEX - Z

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

OMEPRAZOLE

متاح من:

DEXCEL LTD, ISRAEL

ATC رمز:

A02BC01

الشكل الصيدلاني:

CAPLETS

تركيب:

OMEPRAZOLE 20 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

DEXCEL LTD, ISRAEL

المجموعة العلاجية:

OMEPRAZOLE

المجال العلاجي:

OMEPRAZOLE

الخصائص العلاجية:

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

تاريخ الترخيص:

2020-10-31

نشرة المعلومات

PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS' REGULATIONS
(PREPARATIONS) –
1986
This medicine can be sold with
out a physician’s prescription
OMEPRADEX-Z
®
, CAPLETS, 20 MG
Each caplet contains: Omeprazole 20 mg.
Inactive ingredients and allergens in the medicine
–
see section 6 "Additional information" and in
section 2 "Important information about some of the ingredients of the
medicine".
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise
information about the medicine. If you have any further questions, ask
the doctor or pharmacist.
Take this medicine according to the instructions in section 3 "How to
use the medicine?" in this
leaflet. Consult the pharmacist if you need additional information.
Refer to a doctor if the
symptoms of your illness get worse or if they do not improve after 14
days.
1.
WHAT IS THE MEDICINE INTENDED FOR?
The medicine inhibits acid secretion in the gastrointestinal tract.
OMEPRADEX-Z is intended for the relief of reflux symptoms (e.g.,
heartburn) which occur at a
frequency of two or more days a week in patients over 18 years of age.
THERAPEUTIC GROUP:
Proton pump inhibitors (PPIs).
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:

You are hypersensitive (allergic) to the active ingredient
(omeprazole) or to any of the other
ingredients this medicine contains (see section 6).

You are hypersensitive (allergic) to medicines that contain other
proton pump inhibitors (PPI)
(e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole).

You are taking a medicine that contains nelfinavir (a medicine used to
treat HIV infections).

You suffer from difficulty or pain while swallowing food, from bloody
vomiting or bloody or
black stools.

You have heartburn accompanied by 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 chest pain.

You are under 18 ye

خصائص المنتج

1
_ _
_SUMMARY OF PRODUCT CHARACTERISTICS _
1. NAME OF THE MEDICINAL PRODUCT
Omepradex-Z 20mg caplets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each caplet contains Omeprazole 20mg.
Excipients: each caplet contains about 193mg lactose.
For the full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Omepradex-Z are brownish pink, Gastro-resistant coated caplets.
4. CLINICAL PARTICULARS
4.1 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose is 20mg once daily up to 14 days.
_Use in the Elderly _
No dosage adjustment is necessary in the elderly.
_Use in Patients with Impaired Hepatic Function_
As bioavailability and half-life can increase in patients with
impaired hepatic function, the dose requires adjustment
with a maximum daily dose of 20 mg.
_Use in Patients with Impaired Renal Function_
Dose adjustment is not required in patients with impaired renal
function.
Method of administration:
Omepradex-Z should be taken in the morning, preferably without food,
swallowed whole with half a glass of water
The caplets should not be chewed, crushed or halved.
4.3 CONTRAINDICATIONS

Known hypersensitivity to omeprazole, substituted benzimidazoles, or
to any of the other constituents of the
formulation.

Omeprazole like other proton pump inhibitors (PPIs) should not be
administered with nelfinavir (see section
4.5).
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
In the presence of any alarm symptom (e.g. significant unintentional
weight loss, recurrent vomiting, dysphagia,
haematemesis or melena) and when gastric ulcer is suspected or
present, malignancy should be excluded, as
treatment may alleviate symptoms and delay diagnosis.
2
Co-administration of atazanavir with proton pump inhibitors is not
recommended (see section 4.5). If the
combination of atazanavir with a proton pump inhibitor is judged
unavoidable, close clinical monitoring (e.g virus
lo