Vocinti 20mg Film-Coated Tablet

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Vonoprazan Fumarate

Available from:

Takeda Malaysia Sdn Bhd

INN (International Name):

Vonoprazan Fumarate

Units in package:

3 x 10 Tablets; 1 x 10 Tablets

Manufactured by:

Takeda Pharmaceutical Company Limited.,

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP) _
VOCINTI FILM-COATED TABLET
_ _
VONOPRAZAN 10MG AND 20MG
__________________________________________________________________________________________
pg. 1
WHAT IS IN THIS LEAFLET
1.
What Vocinti is used for
2.
How Vocinti works
3.
Before you use Vocinti
4.
How to use Vocinti
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Vocinti
8.
Manufacturer and Product
Registration Holder
9.
Date of Revision
WHAT VOCINTI IS USED FOR
Your doctor may prescribe
Vocinti for the following
indication in adults:
•
Treatment of stomach and
duodenal ulcer.
•
Treatment and maintenance
of inflammation of your
esophagus (reflux
esophagitis) up to52 weeks.
•
Prevention of recurrence of
stomach or duodenal ulcer
in patients requiring
continued NSAID treatment
(NSAID treatment is used
against pain or
inflammation)
•
Treatment of infections
caused by the bacteria
Helicobacter pylori when
given in combination with
antibiotic therapy
HOW VOCINTI WORKS
Vocinti is a Vonoprazan is a
potassium competitive acid
blocker (PCAB) and inhibits
H+, K+-ATPase in a reversible
and potassium-competitive
manner. It does not require
activation by acid.
BEFORE YOU USE VOCINTI
•
When you must not use it
Do not take Vocinti if you are
allergic to vonoprazan or any
of the other ingredients of this
medicine. (see Product
Description).
If you are currently taking a
medicine containing the active
substance atazanavir or
rilpivirine.
•
Before you start to use it
Warning and precautions
Before you take Vocinti, tell
your doctor if you
:
•
Have liver problems
•
Have kidney problems
•
Are pregnant or plan to
become pregnant.
•
Are breastfeeding or plan
to breastfeed. It is not
known if Vocinti passes
into breast milk. Do not
breastfeed during
treatment with Vocinti.
•
Taking other medicines
•
Tell your doctor about
all the medicines you
take, including
prescription and non-
prescription medicines,
vitamins, and herbal
supplements. Contact
your doctor before you
start or stop ot

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
Vocinti Film-Coated Tablet 10mg
Vocinti Film-Coated Tablet 20mg
NAME AND STRENGTH OF ACTIVE SUBSTANCES
Each tablet contains 10mg and 20mg of Vonoprazan.
Excipients: D-Mannitol, Crystalline Cellulose, Croscarmellose Sodium,
Hydroxypropyl Cellulose, Fumaric Acid,
Magnesium Stearate, Hypromellose, Macrogol 6000, Titanium Oxide
(contained in all products), Yellow Ferric Oxide
(contained Vocinti 10 mg Film-Coated Tablet only), Iron Sesquioxide
(contained Vocinti 20 mg Film-Coated Tablet
only)._ _
PRODUCT DESCRIPTION
Vocinti is supplied as a film-coated tablet containing 10mg or 20mg of
vonoprazan:
•
10mg tablet is pale yellow, oval in shape and are printed with
“B217” on the upperside
•
20mg tablet is pale red, oval in shape with scored and is printed with
“B218” on the upperside
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Proton Pump Inhibitor
ATC code: A02BC08
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Vonoprazan is a potassium competitive acid blocker (PCAB) and inhibits
H+, K+-ATPase in a reversible and
potassium-competitive manner. It does not require activation by acid.
Vonoprazan is a strong base with a high affinity
for the acid pump of gastric cells inhibiting gastric acid production.
SERUM GASTRIN AND SERUM PEPSINOGEN EFFECTS
Increased serum gastrin and serum pepsinogen concentrations are
physiological responses to treatment with acid
suppression therapy, including vonoprazan. Increased serum gastrin and
serum pepsinogen concentrations were
reported with a higher incidence in the vonoprazan treatment groups
compared with lansoprazole treatment groups.
Serum gastrin and serum pepsinogen concentrations returned to baseline
over time upon discontinuation of
vonoprazan. The increase in serum gastrin concentration occurred early
in treatment with vonoprazan and
remained stable for the remainder of treatment.
PHARMACOKINETIC PROPERTIES
PHARMACOKINETICS AT SINGLE ADMINISTRATION
Following 7 day repeat once daily doses of vonoprazan at doses of
10-40 mg, in healthy