Sitavia Film Coated Tablet 100mg

País: Malasia

Idioma: inglés

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

Ingredientes activos:

Sitagliptin Phosphate Monohydrate

Disponible desde:

Y.S.P. INDUSTRIES (M) SDN. BHD.

Designación común internacional (DCI):

Sitagliptin Phosphate Monohydrate

Unidades en paquete:

10 tablets x 3 Units

Fabricado por:

Y.S.P. INDUSTRIES (M) SDN. BHD.

Información para el usuario

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1
SITAVIA FILM COATED TABLET 100MG
_Sitagliptin phosphate monohydrate _(eq. to _sitagliptin _100mg)_ _
WHAT IS IN THIS LEAFLET
This leaflet contains information below:
1.
What
SITAVIA
FILM
COATED
TABLET 100MG is used for
2.
How
SITAVIA
FILM
COATED
TABLET 100MG works
3.
Before
you
use
SITAVIA
FILM
COATED TABLET 100MG
4.
How to use SITAVIA FILM COATED
TABLET 100MG
5.
While you are using SITAVIA FILM
COATED TABLET 100MG
6.
Side effects
7.
Storage
and
disposal
of
SITAVIA
FILM COATED TABLET 100MG
8.
Product description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
WHAT SITAVIA FILM COATED
TABLET 100MG IS USED FOR
SITAVIA
FILM
COATED
TABLET
100MG is indicated as an addition to diet
and
exercise
to
improve
blood
glucose
control
in
patients
with
type
2
diabetes
mellitus.
HOW SITAVIA FILM COATED
TABLET 100MG WORKS
SITAVIA
is
a
member
of
a
class
of
medicines
you
take
by
mouth
called
DPP-4 inhibitors (dipeptidyl peptidase-4
inhibitors)
that
lowers
blood
sugar
levels in patients with type 2 diabetes
mellitus. Type 2 diabetes is also called
non-insulin-dependent diabetes mellitus,
or NIDDM.
BEFORE YOU USE SITAVIA FILM
COATED TABLET 100MG
_When you must not use it_
Do not take SITAVIA if you have allergy
towards
any
of
the
components
in
SITAVIA.
_Before you start to use it _
Tell your doctor or pharmacist if you are
allergic to any medicines or if have had:

type 1 diabetes

diabetic ketoacidosis (increased
ketones in the blood or urine)

any kidney problems, or any past
or present medical problems

an allergic reaction to
SITAVIA
_ _
_Taking other medicines _
SITAVIA
may
be
taken
with
most
medicines. Tell your doctor about all the
medicines
you
take.
This
includes
prescription and non-prescription medicines,
and herbal supplements.
HOW TO USE SITAVIA FILM COATED
TABLET 100MG
_How much to use _
Take SITAVIA exactly as your doctor has
prescribed. The recommended dose is to
take:

one 100 mg tablet

once a day

by mouth, with or without

Ficha técnica

Renal impairment
Sitagliptin is renally excreted. To achieve plasma concentrations of
sitagliptin similar to those in
patients with normal renal function, lower dosages are recommended in
patients with GFR < 45
mL/min, as well as in ESRD patients requiring haemodialysis or
peritoneal dialysis. When
considering the use of sitagliptin in combination with another
anti-diabetic medicinal product, its
conditions for use in patients with renal impairment should be
checked.
Hypersensitivity reactions
Serious hypersensitivity reactions in patients treated with
sitagliptin have been reported. These
reactions
include
anaphylaxis,
angioedema,
and
exfoliative
skin
conditions
including
Stevens-Johnson syndrome. Onset of these reactions occurred within the
first 3 months after
initiation of treatment, with some reports occurring after the first
dose. If a hypersensitivity
reaction is suspected, SITAVIA should be discontinued. Other potential
causes for the event
should be assessed, and alternative treatment for diabetes initiated.
Bullous pemphigoid
There have reports of bullous pemphigoid in patients taking DPP-4
inhibitors including
sitagliptin. If bullous pemphigoid is suspected, SITAVIA should be
discontinued.
Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per
tablet, that is to say
essentially 'sodium-free'.
EFFECT ON ABILITY TO DRIVE OR OPERATE MACHINERY:
Sitagliptin has no or negligible influence on the ability to drive
and use machines. However,
when driving or using machines, it should be taken into account that
dizziness and somnolence
have been reported.
In addition, patients should be alerted to the risk of hypoglycaemia
when sitagliptin is used in
combination with a sulphonylurea or with insulin.
INTERACTIONS WITH OTHER MEDICAMENTS:
Effects of other medicinal products on sitagliptin
_Metformin:_ Co-administration of multiple twice-daily doses of 1,000
mg metformin with 50 mg
sitagliptin did not meaningfully alter the pharmacokinetics of
sitagliptin in patients with type 2
diabetes.
_Cicl