Sitavio 100mg Film Coated Tablets

Riik: Malaisia

keel: inglise

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

Toimeaine:

Sitagliptin Phosphate Monohydrate

Saadav alates:

NOVUGEN PHARMA SDN. BHD.

INN (Rahvusvaheline Nimetus):

Sitagliptin Phosphate Monohydrate

Ühikuid pakis:

3X10 Tablets; 1X10 Tablets; 6X10 Tablets; 10X10 Tablets; 50X10 Tablets; 100X10 Tablets

Valmistatud:

NOVUGEN PHARMA SDN. BHD.

Infovoldik

_Consumer Medication Information Leaflet (RiMUP) _
SITAVIO FILM COATED TABLETS
Sitagliptin 50mg, 100mg
1
WHAT IS IN THIS LEAFLET
1.
What Sitavio is used for
2.
How Sitavio works
3.
Before you use Sitavio
4.
How to use Sitavio
5.
While you are using Sitavio
6.
Side effects
7.
Storage and Disposal of Sitavio
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT SITAVIO IS USED FOR
Sitavio is a tablet that contains 50
or
100
mg
of
sitagliptin
as
the
active ingredient.
•
Sitavio
helps
to
improve
the
levels of insulin after a meal.
•
Sitavio decreases the amount of
sugar made by the body.
•
Sitavio works when blood sugar
is high, especially after a meal.
This is when the body needs the
greatest
amount
of
help
in
lowering
blood
sugar.
Sitavio
also lowers blood sugar between
meals.
•
Sitavio by itself is unlikely to
cause
low
blood
sugar
(hypoglycemia) because it does
not work when your blood sugar
is low.
HOW SITAVIO WORKS
Sitavio 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 SITAVIO
−
_When you must not use it _
Do not take Sitavio:
•
If you have allergic toward any
of the component in Sitavio.
−
_ 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 Sitavio
•
gallstones, alcohol dependence or
very high levels of triglycerides (a
form of fat) in your blood. These
medical
conditions
can
increase
your
chance
of
getting
pancreatitis.
−
_Taking other medicines _
Sitavio
may
be
taken
with
most
medicines. Tell your doctor about all
the
medicines
you
take.
This
includes
presc

Toote omadused

1. NAME OF THE MEDICINAL PRODUCT
Sitavio 50mg Film Coated Tablets
Sitavio 100mg Film Coated Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
SITAVIO 50MG FILM COATED TABLETS: Each tablet contains 64.250mg of
Sitagliptin Phosphate Monohydrate
equivalent to 50mg Sitagliptin.
SITAVIO 100MG FILM COATED TABLETS: Each tablet contains 128.500mg of
Sitagliptin Phosphate Monohydrate
equivalent to 100mg Sitagliptin.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film Coated Tablets.
SITAVIO 50MG FILM COATED TABLETS: Beige, round shaped film coated
tablet debossed with ‘C 33’ on one side
of the tablet and plain on the other side
SITAVIO 100MG FILM COATED TABLETS: Beige, round shaped film coated
tablet debossed with ‘C 32’ on one side
of the tablet and plain on the other side
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MONOTHERAPY
Sitavio is indicated as an adjunct to diet and exercise to improve
glycemic control in patients with type 2 diabetes
mellitus.
COMBINATION WITH METFORMIN
Sitavio is indicated in patients with type 2 diabetes mellitus to
improve glycemic control in combination with
metformin as initial therapy or when the single agent alone, with diet
and exercise, does not provide adequate
glycemic control. Initial combination therapy or maintenance of
combination therapy may not be appropriate for
all patients. These management options are left to the discretion of
the health care provider.
COMBINATION WITH A SULPHONYLUREA
Sitavio is indicated in patients with type 2 diabetes mellitus to
improve glycemic control in combination with a
sulphonylureas when treatment with maximal tolerated dose of
sulphonylurea alone, with diet and exercise, does
not provide adequate glycemic control and when metformin is
inappropriate due to contraindications or
intolerance.
COMBINATION WITH METFORMIN AND A SULPHONYLUREA
Sitavio is indicated in patients with type 2 diabetes mellitus to
improve glycemic control in combination with
metformin and a sulphonylurea when dual therapy with these t