DEXILANT 30 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

DEXLANSOPRAZOLE

متاح من:

TAKEDA ISRAEL LTD

ATC رمز:

A02BC06

الشكل الصيدلاني:

MODIFIED RELEASE CAPSULES

تركيب:

DEXLANSOPRAZOLE 30 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

TAKEDA GMBH, GERMANY

المجال العلاجي:

DEXLANSOPRAZOLE

الخصائص العلاجية:

Dexilant 30 is indicated in adults and in adolescents aged 12 to 17 years for the following:• Maintenance of healed erosive reflux oesophagitis and maintenance of relief of heartburn• Short-term treatment of heartburn and acid regurgitation associated with symptomatic non-erosive gastro-oesophageal reflux disease (GORD).

تاريخ الترخيص:

2021-01-31

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) - 1986
This medicine is to be supplied upon physician’s prescription only
DEXILANT™ 30 MG, MODIFIED-RELEASE CAPSULES
DEXILANT™ 60 MG, MODIFIED-RELEASE CAPSULES
COMPOSITION:
ACTIVE INGREDIENT _ _
-
each capsule of Dexilant 30 mg contains 30 mg of dexlansoprazole._ _
-
each capsule of Dexilant 60 mg contains 60 mg of dexlansoprazole._ _
INACTIVE INGREDIENTS AND ALLERGENS: See chapter 2 “BEFORE USING THIS
MEDICINE” under
“Important information about some of this medicine’s
ingredients” and chapter 6 “ADDITIONAL
INFORMATION”.
_ _
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains summary information about this medicine. If you have any
further questions, refer to
the physician or the pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their illness is similar to yours.
The medicine is intended for adults and adolescents over the age of 12
years.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Dexilant 60 mg is intended for the use of adults and adolescents aged
12 to 17 years for the
following:
-
Treatment of erosive reflux oesophagitis (inflammation with damage to
the lining of the
oesophagus (food pipe)).
Dexilant 30 mg is intended for the use of adults and adolescents aged
12 to 17 years for the
following:
-
Maintenance treatment of healed erosive reflux oesophagitis and
maintenance treatment
following relief of heartburn.
-
Short-term treatment of heartburn and acid regurgitation associated
with symptomatic
non-erosive gastro-oesophageal reflux disease (GORD). GORD is a
condition where
stomach acid leaks out of the stomach and comes up into the oesophagus
(acid reflux).
Such leakage may cause a sensation of burning in the chest or throat,
may create a sour
taste or cause belching.
By reducing the amount of stomach acid, Dexilant can heal the damage
caused to the
oesophagus and relieve symptoms that can ha

خصائص المنتج

PRESCRIBING INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
DEXILANT (dexlansoprazole) modified-release capsules, for oral use.
DEXILANT is
available as capsules in 30 mg and 60 mg strengths.
2 THERAPEUTIC INDICATIONS
Dexilant 30 mg is indicated in adults and in adolescents aged 12 to 17
years for the
following:
•
Maintenance of healed erosive reflux oesophagitis and maintenance of
relief of
heartburn
•
Short-term
treatment
of
heartburn
and
acid
regurgitation
associated
with
symptomatic non-erosive gastro-oesophageal reflux disease (GORD).
Dexilant 60 mg is indicated in adults and in adolescents aged 12 to 17
years for the
following:
•
Treatment of erosive reflux oesophagitis
3
DOSAGE AND ADMINISTRATION
3.1
Recommended Dosage in Adults and adolescents aged 12 to 17 years
DEXILANT is available as capsules in 30 mg and 60 mg strengths for
adult and
adolescents aged 12 to 17 years use. Directions for use in each
indication are
summarized in Table 1.
Table 1. Recommended DEXILANT Capsules dosage regimen by
indication in Adults and adolescents aged 12 to 17 years
Indication
Dosage of DEXILANT
Capsules
Duration
Treatment of
erosive reflux
oesophagitis
One 60 mg capsule once
daily
.
Up to 8 weeks
.
Maintenance of
healed erosive
reflux
oesophagitis
and
maintenance of
relief of
heartburn
One 30 mg capsule once
daily
.
Controlled studies did not
extend beyond 6 months in
adults and 16 weeks in
patients 12 to 17 years of
age
.
Symptomatic
non-erosive
gastro-
oesophageal
reflux disease
(GORD)
One 30 mg capsule once
daily
.
4 weeks
.
_ _
3.2
Dosage Adjustment in Patients with Hepatic Impairment
For the treatment of erosive reflux oesophagitis
For patients with moderate hepatic impairment (Child-Pugh Class B),
the
recommended dosage is 30 mg DEXILANT once daily for up to eight weeks.
DEXILANT is not recommended in patients with severe hepatic impairment
(Child-
Pugh Class C) [
_see_
_Use in Specific Populations (9.5)_
].
3.3
Important Administration Information
•
Take without regard to food.
•
Missed doses: If a dose is