Steglujan

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

ertugliflozin l-pyroglutamic acid, sitagliptin phosphate monohydrate

זמין מ:

Merck Sharp & Dohme B.V.

קוד ATC:

A10BD24

INN (שם בינלאומי):

ertugliflozin, sitagliptin

קבוצה תרפויטית:

Drugs used in diabetes, Combinations of oral blood glucose lowering drugs

איזור תרפויטי:

Diabetes Mellitus, Type 2

סממני תרפויטית:

Steglujan 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:when metformin and/or a sulphonylurea (SU) and one of the monocomponents of Steglujan do not provide adequate glycaemic control.in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets.

leaflet_short:

Revision: 11

מצב אישור:

Authorised

תאריך אישור:

2018-03-23

עלון מידע

41
B. PACKAGE LEAFLET
42
PACKAG
E LEAFLET: INFORMATION FOR THE
PATIENT
STEGLUJAN 5 MG/100 MG FILM-
COATED TABLETS
STEGLUJAN 15 MG/100 MG FILM-
COATED TABLETS
ertugliflozin/sitagliptin
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, ph
armacist, or nurse
.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illne
ss
are the same as yours.
-
If you get
any side effects, talk to your doctor, pharmacist, or nurse
.
This includes
any possible
side effects not listed in this leaflet
. See section
4.
WHAT IS IN THIS LEAFLET
1.
What Steglujan
is and what it is used for
2.
Wh
at you need to know before you take
Steglujan
3.
How to take
Steglujan
4.
Possible side effects
5.
How to store
Steglujan
6.
Contents of the pack and other information
1.
WHAT STEGLUJAN IS
AND WHAT IT IS USED FOR
WHAT STEGLUJAN IS
Steglujan
contains two active substances
,
ertugliflozin and sitagliptin.
Each belongs to a group of
medicines called “oral anti
-
diabetics”. These are medicines taken by mouth to treat diabetes.
•
Ertugliflozin belongs to a
group
of medicines called
sodium glucose co
-transporter-2 (SGLT2)
inhibitors.
•
Sitagliptin belongs to a
group
of medicines called
DPP-
4 (dipeptidyl peptidase
-4) inhibitors.
WHAT STEGLUJAN IS USED FOR
•
Steglujan lowers blood sugar levels in
adult patients (aged 18
years and older)
with type 2
diabetes.
•
Steglujan
can be used instead of taking both ertugliflozin and
sitagliptin
as separate tablets.
•
Steglujan
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 Steglujan
.
HOW STEGLUJAN WORKS
•
Ertugliflozin works b
y blocking the SGLT2 protein
in your kidney
s. This
causes blood sugar to
be removed
in your urine.
•
Sitagliptin
helps to increase

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF
THE
MEDICINAL PRODUCT
Steglujan 5 mg/100 mg film-
coated tablets
Steglujan 15 mg/100 mg film-
coated tablets
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Steglujan 5 mg/100 mg film-
coated tablets
Each tablet contains
ertugliflozin
L-
pyroglutamic acid
, equivalent to 5
mg of
ertugliflozin
, and
sitagliptin
phosphate monohydrate
, equivalent to
100
mg of sitagliptin
.
Steglujan 15 mg/100 mg film-
coated tablets
Each tablet contains
ertugliflozin
L-
pyroglutamic acid
, equivalent to 15
mg of
ertugliflozin
, and
sitagliptin
phosphate monohydrate
,
equivalent to
100 mg of sitagliptin.
For the full list of excipients, see section
6.1.
3.
PHARMACEUTICAL
FORM
Film-
coated tablet (tablet)
Steglujan 5 mg/100 mg film-
coated tablets
Beige, 12 x 7.4 mm, almond-shaped, film-
coated tablets debossed with “554” on one side and plain on
the other side.
Steglujan 15 mg/100 mg film-
coated tablets
Brown, 12 x 7.4 mm, almond-shaped, film-
coated tablets debossed with “555” on one side and plain
on the other side.
4.
C
LINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Steglujan
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
when metformin and/or a sulphonylurea (SU) and one of the
monocomponents of
Steglujan
do not provide adequate glycaemic control
.
•
in patients already being treated with the combination of
ertugliflozin and sitagliptin as separate
tablets.
(For study results with respect to combinations and effects on
glycaemic control, see sections
4.4, 4.5,
and 5.1)
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended starting dose is 5
mg ertugliflozin/100
mg si
tagliptin once daily
. In patients
tolerating
the starting dose
, the dose may be increased to 15
mg
ertugliflozin/100
mg sitagliptin, once
daily, if additional glyc
a
emic control is needed.
For patients treated with ertugliflozin who are being switched to
Steglujan
, the dose of ertugli