VOCINTI FILM-COATED TABLET 20MG

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

Ingredientes activos:

Vonoprazan fumarate 26.72mg eqv vonoprazan

Disponible desde:

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

Código ATC:

A02BX

formulario farmacéutico:

TABLET, FILM COATED

Composición:

Vonoprazan fumarate 26.72mg eqv vonoprazan 20mg

Vía de administración:

ORAL

tipo de receta:

Prescription Only

Fabricado por:

TAKEDA PHARMACEUTICAL COMPANY LIMITED (HIKARI PLANT)

Estado de Autorización:

ACTIVE

Fecha de autorización:

2018-03-08

Información para el usuario

1. NAME OF THE MEDICINAL PRODUCT
VOCINTI Film-coated Tablet 10mg
VOCINTI Film-coated Tablet 20mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg or 20 mg of vonoprazan (as
13.36 mg or 26.72 mg vonoprazan
fumarate respectively)
For excipients, see section 6.1.
3. PHARMACEUTICAL FORM
AVAILABLE
PHARMACEUTICAL FORMS
STRENGTH
COLOR
SHAPE
MARKINGS
(UPPERSIDE)
FILM-COATED TABLET
10 mg
Pale yellow
Oval tablet
B217
20 mg
Pale red
Oval scored tablet
B218
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of gastric ulcer (GU)
Treatment of duodenal ulcer (DU)
Treatment of reflux esophagitis (RE) (erosive esophagitis EE)
Maintenance treatment of reflux esophagitis (erosive esophagitis)
Prevention of recurrence of gastric ulcer or duodenal ulcer during
NSAIDs administration.
Adjunct to _Helicobacter pylori_ eradication
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
ADULTS
_GASTRIC ULCER_
The usual dose is 20 mg of vonoprazan once a day. Administration
should be limited to 8 weeks.
_DUODENAL ULCER_
The usual dose is 20 mg of vonoprazan once a day. Administration
should be limited to 6 weeks.
_REFLUX ESOPHAGITIS (EROSIVE ESOPHAGITIS)_
The usual dose is 20 mg of vonoprazan once a day. Administration
should be limited to 4 weeks.
However, when the effect is insufficient, treatment may be continued
for up to 8 weeks. In addition, for
the maintenance of healing of reflux esophagitis in patients with
repeat recurrence and relapse of the
condition, a dose of 10 mg is administered once a day; however, when
the efficacy is inadequate, a dose
of 20 mg may be administered once a day.
_PREVENTION OF RECURRENCE OF GASTRIC ULCER OR DUODENAL ULCER DURING
NSAIDS ADMINISTRATION _
The usual dose is 10 mg of vonoprazan once a day.
_ADJUNCT TO HELICOBACTER PYLORI ERADICATION _
When selecting antibacterial agents to be used in combination therapy,
consideration should be given
to official national, regional and local guidance regarding bacterial
resistance, duration of treatment
and appropriate use o

Ficha técnica

1. NAME OF THE MEDICINAL PRODUCT
VOCINTI Film-coated Tablet 10mg
VOCINTI Film-coated Tablet 20mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg or 20 mg of vonoprazan (as
13.36 mg or 26.72 mg vonoprazan
fumarate respectively)
For excipients, see section 6.1.
3. PHARMACEUTICAL FORM
AVAILABLE
PHARMACEUTICAL FORMS
STRENGTH
COLOR
SHAPE
MARKINGS
(UPPERSIDE)
FILM-COATED TABLET
10 mg
Pale yellow
Oval tablet
B217
20 mg
Pale red
Oval scored tablet
B218
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of gastric ulcer (GU)
Treatment of duodenal ulcer (DU)
Treatment of reflux esophagitis (RE) (erosive esophagitis EE)
Maintenance treatment of reflux esophagitis (erosive esophagitis)
Prevention of recurrence of gastric ulcer or duodenal ulcer during
NSAIDs administration.
Adjunct to _Helicobacter pylori_ eradication
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
ADULTS
_GASTRIC ULCER_
The usual dose is 20 mg of vonoprazan once a day. Administration
should be limited to 8 weeks.
_DUODENAL ULCER_
The usual dose is 20 mg of vonoprazan once a day. Administration
should be limited to 6 weeks.
_REFLUX ESOPHAGITIS (EROSIVE ESOPHAGITIS)_
The usual dose is 20 mg of vonoprazan once a day. Administration
should be limited to 4 weeks.
However, when the effect is insufficient, treatment may be continued
for up to 8 weeks. In addition, for
the maintenance of healing of reflux esophagitis in patients with
repeat recurrence and relapse of the
condition, a dose of 10 mg is administered once a day; however, when
the efficacy is inadequate, a dose
of 20 mg may be administered once a day.
_PREVENTION OF RECURRENCE OF GASTRIC ULCER OR DUODENAL ULCER DURING
NSAIDS ADMINISTRATION _
The usual dose is 10 mg of vonoprazan once a day.
_ADJUNCT TO HELICOBACTER PYLORI ERADICATION _
When selecting antibacterial agents to be used in combination therapy,
consideration should be given
to official national, regional and local guidance regarding bacterial
resistance, duration of treatment
and appropriate use o