Segluromet
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
07-06-2023
Summary of Product characteristics
(SPC)
07-06-2023
Public Assessment Report
(PAR)
16-02-2022
Active ingredient:
ertugliflozin l-pyroglutamic acid, metformin hydrochloride
Available from:
Merck Sharp & Dohme B.V.
ATC code:
A10BD23
INN (International Name):
ertugliflozin, metformin hydrochloride
Therapeutic group:
Drugs used in diabetes, Combinations of oral blood glucose lowering drugs
Therapeutic area:
Diabetes Mellitus, Type 2
Therapeutic indications:
Segluromet 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:in patients not adequately controlled on their maximally tolerated dose of metformin alonein patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetesin patients already being treated with the combination of ertugliflozin and metformin as separate tablets.
Product summary:
Revision: 7
Authorization status:
Authorised
Authorization date:
2018-03-23
Patient Information leaflet
56
B. PACKAGE LEAFLET
57
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SEGLUROMET 2.5 MG/850 MG FILM-
COATED TABLETS
SEGLUROMET 2.5 MG/1 000 MG FILM-
COATED TABLETS
SEGLUROMET 7.5 MG/850 MG FILM-
COATED TABLETS
SEGLUROMET 7.5 MG/1 000 MG FILM-
COATED TABLETS
ertugliflozin/metformin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPO
RTANT INFORMATION FOR YOU.
-
Keep this leaflet. Y
ou 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 only. 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,
pharmacist, or nurse.
This includes any possible
side effects not listed in this leaflet
. See section
4.
WHAT IS IN THIS LEAFLET
1.
What
Segluromet
is and wha
t it is used for
2.
What you need to know before you take
Segluromet
3.
How to take
Segluromet
4.
Possible side effects
5.
How to store
Segluromet
6.
Contents of the pack and other information
1.
WHAT
SEGLUROMET IS
AND WHAT IT IS USED FOR
WHAT
SEGLUROMET IS
Segluromet contains two
active substances
,
ertugliflozin and metformin.
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 ca
lled
sodium glucose co
-transporter-2 (SGLT2)
inhibitors.
-
Metformin belongs to a
group
of medicines called biguanides.
WHAT
SEGLUROMET
IS USED FOR
-
Segluromet 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
.
-
Segluromet
can be used instead of taking both ertugliflozin and metformin as
separate tablets.
-
Segluromet 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
Segluromet.
HOW SEGLUROMET WORKS
-
Ertuglifl
Read the complete document
Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Segluromet 2.5
mg/850 mg film-coated tablets
Segluromet 2.5
mg/1 000 mg film-coated tablets
Segluromet 7.5
mg/850 mg film-coated tablets
Segluromet 7.5
mg/1 000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Segluromet 2.5
mg/850 mg film-coated tablets
Each tablet contains ertugliflozin L
-
pyroglutamic
acid
, equivalent to
2.5 mg of
ertugliflozin
, and
850
mg of metformin hydrochloride.
Segluromet 2.5
mg/1 000 mg film-coated tablets
Each tablet contains ertugliflozin L
-
pyroglutamic acid
,
equivalent to
2.5 mg of
ertugliflozin
, and
1 000
mg of metformin hy
drochloride.
Segluromet 7.5
mg/850 mg film-coated tablets
Each tablet contains ertugliflozin L
-
pyroglutamic acid
,
equivalent to
7.5 mg of
ertugliflozin
, and
850
mg metformin hydrochloride.
Segluromet 7.5
mg/1 000 mg film-coated tablets
Each tablet
contains ertugliflozin L
-
pyroglutamic acid
,
equivalent to
7.5
mg of ertugliflozin, and
1 000
mg metformin hydrochloride.
For the full list of excipients, see section
6.1.
3.
PHARMACEUTICAL
FORM
Film-coated tablet (tablet)
Segluromet 2.5
mg/850 mg film-coated tablets
Beige, 18 x 10
mm oval, film
-
coated tablet debossed with “2.5/850” on one side and plain on the
other
side.
Segluromet 2.5
mg/1 000 mg film-coated tablets
Pink, 19.1 x 10.6
mm oval, film
-
coated tablet debossed with “2.5/1000” on one
side and plain on the
other side.
Segluromet 7.5
mg/850 mg film-coated tablets
Dark brown, 18 x 10
mm oval, film
-
coated tablet debossed with “7.5/850” on one side and plain on
the other side.
Segluromet 7.5
mg/1 000 mg film-coated tablets
Red, 19.1 x 1
0.6
mm oval, film
-
coated tablet debossed with “7.5/1000” on one side and plain on
the
other side.
3
4.
C
LINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Segluromet
is indicated in adults
for the treatment of
type 2 diabetes mellitus as an adjunct to diet and
exercise:
•
in patients
insufficiently
controlled on their maximally tolerated dose of me
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