Omeprazole

Ülke: Ermenistan

Dil: İngilizce

Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktif bileşen:

omeprazole

Mevcut itibaren:

Teva Pharma

INN (International Adı):

omeprazole

Doz:

20mg

Farmasötik formu:

capsules

Reçete türü:

Prescription

Bilgilendirme broşürü

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, please ask
your doctor or your pharmacist.
•
This medicine has been prescribed for you
personally and you should 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 you doctor or pharmacist
IN THIS LEAFLET
1. What Omeprazole 20 mg Capsules are and
what they are used for
2. Befo
re you take Omeprazole 20 mg Caps
ules
3. How to take Omeprazole 20 mg Capsules
4. Possible side effects
5. How to store Omeprazole 20 mg Capsules
6. Further Information
1. WHAT OMEPRAZOLE 20 MG CAPSULES
ARE AND WHAT THEY ARE USED FOR
The active ingredient, omeprazole, belongs to
a group of medicines called “proton pump
inhibitors”. It works by reducing the production
of acid in your stomach.
Omeprazole
is
used
to
treat
the
following
conditions:
_- _
_Reflux _
_oesophagitis _
_and _
_Oesophageal _
_reflux _
_disease, _
_where _
_acid _
_from _
_the _
_stomach _
_escapes _
_into _
_the _
_food _
_pipe _
_causing pain, inflammation and heartburn._
_- _
_Acid _
_indigestion _
_(dyspepsia) _
_which _
_can _
_cause stomach pain and/or discomfort._
-
Ulcers in the upper part of the intestine
(duodenal ulcer) or stomach (gastric ulcer).
For patients who have had previous trouble
with an ulcer and need to continue therapy
with a non-steroidal anti-inflammatory drug
(NSAID), omeprazole can heal ulcers or
prevent
an
ulcer
developing.
In
such
patients, omeprazole protects the stomach
or
duodenum
whilst
they
are
taking
NSAIDs.
-
Ulcers
which
are
infected
with
bacteria
called _Helicobacter pylori_
-
Prevention of damage to the lungs caused
by
breathing
in
stomach
fluids
(acid
aspiration), e.g. before an operation.
-
_Zollinger-Ellison syndrome_, when excess
stomach
acids
are
produced
due
to
a
growth in the pancre_as._
2. BEFORE YOU

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Omeprazole 20 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains omeprazole 20 mg.
For excipients, see 6.1
3
PHARMACEUTICAL FORM
Capsule, hard containing gastro-resistant granules
Each capsule consists of an orange body and blue cap and contains
white to
beige granules marked with O20.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
Treatment
of
reflux
oesophagitis
disease.
In
reflux
oesophagitis
the
majority of patients are healed after 4 weeks. Symptom relief is
rapid.
2. Treatment of duodenal and benign gastric ulcers including
complicating
NSAID therapy.
3. Relief of reflux-like symptoms (e.g. heartburn) and/or ulcer-like
symptoms
(e.g. epigastric pain) associated with acid-related dyspepsia.
4. Treatment and prophylaxis of NSAID-associated benign gastric
ulcers,
duodenal ulcers and
gastroduodenal erosions in patients with a previous
history of gastroduodenal lesions who require continued NSAID
treatment.
5. Relief of associated dyspeptic symptoms.
6_. Helicobacter pylori_ eradication: When used with in combination
with
antibiotics, Omeprazole proves effective in the eradication of _
Helicobacter _
_pylori_ (_Hp_) in peptic ulcer disease.
7. Prophylaxis of acid aspiration.
8. Zollinger-Ellison syndrome.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
OESOPHAGEAL REFLUX DISEASE INCLUDING REFLUX OESOPHAGITIS:
The usual starting dose is 20 mg omeprazole taken once a day for 4
weeks. For
those patients not fully healed after the initial 4 week course,
healing usually
occurs during a further 4-8 weeks treatment.
Omeprazole has also been used in a dose of 40mg once a day in patients
with
reflux oesophagitis refractory to other therapy. Healing usually
occurred
within 8 weeks. Continuation of therapy can be considered at a dosage
of 20
mg once daily.
ACID REFLUX DISEASE:
For long-term management, a dose of 10 mg once daily is recommended,
increasing to 20 mg if symptoms return.
DUODENAL AND BENIGN GASTRIC ULCERS:
The usual d