Lansoptol capsules

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

lansoprazole

Available from:

KRKA d.d.

ATC code:

A02BC03

INN (International Name):

lansoprazole

Dosage:

30mg

Pharmaceutical form:

capsules

Units in package:

(14/2x7/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-02-07

Patient Information leaflet

Lansoptol
capsules
30 mg
VOL:
1; P: 94
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_1277_
SPC,
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30
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Summary of Product characteristics

Lansoptol
capsules
30 mg
VOL:
1; P: 82/1277
1.3.1
e Leaflet
1.
NAME OF THE MEDICINAL PRODUCT
Lansoptol30
mg capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule
contains
30 mg lansoprazole.
30 mg capsules
149.11
mg
For
a full
list
of excipients,
see section
6.1.
3.
PHARMACEUTICAL FORM
Capsule
White capsules
containing
white
to slightly
brown or slightly
pink pellets.
4.
CLlNlCAL PARTICULARS
4.1
Therapeutic
indications
Treatment
of duodenal
and gastric
ulcer.
Treatment
and prophylaxis
of reflux oesophagitis.
Eradication
of
_Helicobacter pylori_
_(H pylori)_
concurrently
given
with appropriate
antibiotic
therapy
for treatment
of
_Hpylori-associated_
ulcers.
Treatment
and prophylaxis
ofNSAID-associated
benign
gastric
and duodenal
ulcers
in patients
requiring
continued
NSAID treatment.
Symptomatic
gastroesophageal
reflux
disease.
Zollinger-Ellison
syndrome.
4.2
Posology
and
method
of administration
Posology
For optimal
effect.
Lansoptol
should
be taken once
daily in the morning.
except
when
used for
_H_
_pylori_
eradication
when
treatment
should
be twice
a day,
once
in the morning
and once
in the evening.
Treatment
of duodenal
ulcer:
The recommended
dose
is 30 mg once daily for 2 weeks.
In patients
not
fully healed
within
this
time,
the medication
is continued
at
the same dose for
another
two weeks.
Treatment
of gastric
ulcer:
The recommended
dose
is 30 mg once daily for 4 weeks.
The
ulcer
usually
heals
within
4 weeks,
but
in patients
not
fully healed
within
this
time,
the medication
may be continued
at
the same
dose for
another
4 weeks.
Reflux oesophagitis:
The recommended
dose
is 30 mg once daily for 4 weeks.
In patients
not
fully healed
within
this time,
the treatment
may
be continued
at the same dose
for another
4 weeks.
CONFIDENTIAL
Lansoptol
capsules
30
mg
VOL:
I; P: 83 /
1277
SPC,
Labelin
1.3.1
Prophylaxis
of reflux
oesoDhagitis:
_30_
mg once daily.
Eradication
of
_Helicobacter_
_pylori:_
When selecting
appropriate
combination
therapy,
consideration
should
be given to official
local
guidance
regar