FORTREAS FILM COATED TABLET 100MG

Šalis: Malaizija

kalba: anglų

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

Veiklioji medžiaga:

Sitagliptin Hydrochloride Monohydrate

Prieinama:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

INN (Tarptautinis Pavadinimas):

Sitagliptin Hydrochloride Monohydrate

Vienetai pakuotėje:

3x10 Tablets

Pagaminta:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

Pakuotės lapelis

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
FORTREAS FILM COATED TABLET 100MG
Sitagliptin (as HCl Monohydrate) 100mg
1
WHAT IS IN THIS LEAFLET
1.
What Fortreas is taken for
2.
How Fortreas works
3.
Before you take Fortreas
4.
How to take Fortreas
5.
While you are taking it
6.
Side effects
7.
Storage
and
Disposal
of
Fortreas
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
11.
Serial Number
Please read this information carefully
before
you
start
to
take
your
medicine,
even
if
you
have
just
refilled your prescription. Some of
the information may have changed.
Remember
that
your
doctor
has
prescribed
this
medicine
only
for
you. Never give it to anyone else.
WHAT FORTREAS IS TAKEN FOR
Fortreas
is
a
tablet
that
contains
113.38
mg
of
Sitagliptin
HCl
monohydrate, which is equivalent to
100 mg, respectively of free base.
•
Fortreas
helps
to
improve
the levels of insulin after a
meal.
•
Fortreas
decreases
the
amount of sugar made by
the body.
•
Fortreas works when blood
sugar
is
high,
especially
after a meal. This is when
the body needs the greatest
amount of helps in lowering
blood sugar.
Fortreas also
lowers blood sugar between
meals.
•
Fortreas by itself is unlikely
to
cause
low
blood
sugar
(hypoglycemia) because is
does not work when your
blood sugar is low.
HOW FORTREAS WORKS
Fortreas 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.
WHY
HAS
MY
DOCTOR
PRESCRIBED
FORTREAS?
Your doctor has prescribed Fortreas
to help lower your blood sugar, which
is too high because of your type 2
diabetes. Fortreas can be used alone
or in combination with certain other
medicines
that
lower
blood
sugar,
along with a recommended diet and
exercise program.
WHAT IS TYPE 2 DIABETES?
Type 2 diabetes is a combination in
which
your
body
does
not
make
enough insulin and

Prekės savybės

FORTREAS
FILM
COATED
TABLET 100MG
Sitagliptin (as Hydrochloride Monohydrate)
100mg
DESCRIPTION
Yellow, round, biconvex, film coated tablet with
“100” on one side and scored on the other. Tablet
can be split into half when necessary
THERAPEUTIC CLASS
Fortreas
is
an
orally-active,
potent,
and
highly
selective
inhibitor
of
the
dipeptidyl
peptidase
4
(DPP-4)
enzyme
for
the
treatment
of
type
2
diabetes. The DPP-4 inhibitors are a class of agents
that act as incretin enhancers. By inhibiting the
DPP-4 enzyme, sitagliptin increases the levels of
two known active incretin hormones, glucagon-like
peptide-1
(GLP-1)
and
glucose-dependent
insulinotropic polypeptide (GIP). The incretins are
part
of
an
endogenous
system
involved
in
the
physiologic
regulation
of
glucose
homeostasis.
When blood glucose concentrations are normal or
elevated, GLP-1 and GIP increase insulin synthesis
and release from pancreatic beta cells. GLP-1 also
lowers glucagon secretion from pancreatic alpha
cells,
leading
to
reduced
hepatic
glucose
production.
This
mechanism
is
unlike
the
mechanism seen with sulfonylureas; sulfonylureas
cause insulin release even when glucose levels are
low,
which
can
lead
to
sulfonylurea-induced
hypoglycaemia in patients with type 2 diabetes and
in normal subjects. Sitagliptin is a potent and highly
selective inhibitor of the enzyme DPP-4 and does
not inhibit the closely-related enzymes DPP-8 or
DPP-9
at
therapeutic
concentrations.
Sitagliptin
differs in chemical structure and pharmacological
action from GLP-1 analogues, insulin, sulfonylureas
or
meglitinides,
biguanides,
peroxisome
proliferator-activated
receptor
gamma
(PPARγ)
agonists, alpha-glucosidase inhibitors, and amylin
analogues.
COMPOSITION
ACTIVE INGREDIENTS
Each film coated of Fortreas Tablet contains 113.38
mg Sitagliptin Hydrochloride contains 100 mg of
Sitagliptin.
MECHANISM OF ACTION
Fortreas
is
a
member
of
a
class
of
oral
anti-
hyperglycaemic agents called dipeptidyl peptidase
4
(DPP-4)
inhibitors,
which
improve
glycaemic
control
in
patients
with
type