Steglatro

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

ertugliflozin l-pyroglutamic acid

Saadav alates:

Merck Sharp & Dohme B.V.

ATC kood:

A10BK04

INN (Rahvusvaheline Nimetus):

ertugliflozin

Terapeutiline rühm:

Drugs used in diabetes, Sodium-glucose co-transporter 2 (SGLT2) inhibitors

Terapeutiline ala:

Diabetes Mellitus, Type 2

Näidustused:

Steglatro is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.in addition to other medicinal products for the treatment of diabetes.

Toote kokkuvõte:

Revision: 8

Volitamisolek:

Authorised

Loa andmise kuupäev:

2018-03-21

Infovoldik

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
STEGLATRO 5 MG FILM-
COATED TABLETS
STEGLATRO 15 MG FILM-
COATED TABLETS
ertugliflozin
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor,
pharmacist
or nurse.
-
This medicine has been prescribed for you o
nly. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any
possible side effects not listed in th
is
leaflet. See sect
ion 4.
WHAT IS IN THIS LEAFLET
1.
What Steglatro
is and what it is used for
2.
What you need to know before you take
Steglatro
3.
How to take
Steglatro
4.
Possible side effects
5.
How to store
Steglatro
6.
Contents of the pack and other information
1.
WHAT STEGLATRO IS
AND WHAT IT IS USED FOR
WHAT STEGLATRO IS
Steglatro contains the active substance ertugliflozin.
Steglatro is a member of a
group
of medicines called sodium
glucose co-transporter-2 (SGLT2)
inhibitors.
WHAT STEGLATRO IS USED FOR

Steglatro lowers blood sugar levels in adult patients
(aged 18
years and older)
with type 2
diabetes.

It can also help prevent heart
failure
in patients with type 2 diabetes
.

Steglatro
can be used alone or with
some
other medicines that lower blood sugar
.

You need to keep following your food and exercise
plan
while taking Steglatro.
HOW STEGLATRO WORKS
Ertugliflozin works by blocking the SGLT2 protein in your kidney
s
. This causes blood sugar to be
removed in your urine.
WHAT IS TYPE 2 DIABETES?
Type 2
diabetes is a condition in which your body does not make enough
insulin
or
the insulin that
your body produces does not work as well as it should.
This leads to a high level of sugar in your
blood.
When this happens,
t
his can lead to serious medical proble
ms like
heart disease, kidney disease,
blindness a

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Steglatro 5 mg film-
coated tablets
Steglatro 15 mg film-
coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Steglatro 5 mg film-
coated tablets
Each tablet contains ertugliflozin L
-
pyroglutamic acid
, equivalent to 5
mg ertugliflozin.
Excipient with known effect
Each tablet contains
28 mg of lactose (as
monohydrate
).
Steglatro 15 mg film-
coated tablets
Each tablet contains
ertugliflozin L
-
pyroglutamic acid
, equivalent to
15
mg ertugliflozin
.
Excipient with known effect
Each tablet contains
85 mg of lactose (as
monohydrate
).
For the full list of excipients, see
section 6.1.
3.
PHARMACEUTICAL
FORM
Film-
coated tablet (tablet)
Steglatro 5 mg film-
coated tablets
Pink, 6.4 x 6.6 mm, triangular-shaped, film-
coated tablets debossed with “701” on one side and plain
on the other side.
Steglatro 15 mg film-
coated tablets
Red, 9.0 x 9.4 mm, triangular-shaped, film-
coated tablets debossed with “702” on one side and plain
on the other side.
4.
C
LINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Steglatro
is indicated
for the treatment of
adults with
insufficiently controlled
type 2 diabetes mellitus
as an adjunct to diet and exercise
:

as monotherapy
when
metformin is considered inappropriate due to intolerance or
contraindications.

in addition to other medicinal products for the treatment of
diabetes.
For study results with respect to combinations
of therapies,
effects on glycaemic control
,
cardiovascular events, and the populations studied,
see sections 4.4, 4.5, and 5.1.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended starting dose of
ertugliflozin
is 5
mg once daily. In patients tolerating
ertugliflozin
5
mg once daily, the dose can be increased to 15
mg once daily if additional glycaemic control is
needed.
When ertugliflozin
is used in combination with insulin or an insulin secretagogue, a
lower dose of
insulin or the insulin secretagogue may be required to reduce the risk
of hypoglyca