STEGLUJAN 15100 MG TABLETS

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

ERTUGLIFLOZIN (L-PGA); SITAGLIPTIN AS MONOHYDRATE PHOSPHATE

Beschikbaar vanaf:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

ATC-code:

A10BD24

farmaceutische vorm:

FILM COATED TABLETS

Samenstelling:

SITAGLIPTIN AS MONOHYDRATE PHOSPHATE 100 MG; ERTUGLIFLOZIN (L-PGA) 15 MG

Toedieningsweg:

PER OS

Prescription-type:

Required

Geproduceerd door:

MERCK SHARP & DOHME LLC, USA

Therapeutisch gebied:

SITAGLIPTIN AND ERTUGLIFLOZIN

therapeutische indicaties:

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.

Autorisatie datum:

2021-04-04

Bijsluiter

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS
REGULATIONS (PREPARATIONS) 1986
This medicine is marketed upon physician's prescription only
STEGLUJAN
® 5/100 MG TABLETS
STEGLUJAN
® 15/100 MG TABLETS
FILM-COATED TABLET
Each STEGLUJAN 5/100 MG film-coated tablet contains:
5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 100 mg
sitagliptin (as sitagliptin
phosphate monohydrate).
Each STEGLUJAN 15/100 MG film-coated tablet contains:
15 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 100 mg
sitagliptin (as sitagliptin
phosphate monohydrate).
For the list of inactive ingredients see section 6 “FURTHER
INFORMATION”. See also
section 2.9 “Important information about some of the ingredients of
the medicine”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
•
This leaflet contains concise information about the medicine. If you
have any further
questions, refer to the doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
1. WHAT STEGLUJAN IS INTENDED FOR?
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.
THERAPEUTIC GROUP:
•
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.
HOW STEGLUJAN WORKS
•
Ertugliflozin works by blocking the SGLT2 protein in your kidneys.
This causes blood
sugar to be removed in your urine.
•
Sitagliptin helps to increase the levels of insulin produced after a
meal. It also lowers the
amount of sugar made by yo

Productkenmerken

1
1.
NAME OF
THE
MEDICINAL PRODUCT
Steglujan
®
5/100 mg tablets
Steglujan
®
15/100 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Steglujan 5/100 mg tablets
Each tablet contains
5 mg ertugliflozin
(as ertugliflozin
L-
pyroglutamic acid
) and 100 mg sitagliptin
(as sitagliptin
phosphate monohydrate
).
Steglujan 15/100
mg tablets
Each tablet contains
15 mg
ertugliflozin
(as ertugliflozin
L-
pyroglutamic acid
) and 100 mg sitagliptin
(as sitagliptin
phosphate monohydrate
).
For the full list of excipients, see section
6.1.
3.
PHARMACEUTICAL
FORM
Film-
coated tablet (tablet).
Steglujan 5/100 mg tablets
Beige, almond
-shaped, film-
coated tablets debossed with “554” on one side and plain
on the other
side.
Steglujan 15/100
mg tablets
Brown, 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 gly
caemic 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)
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 ertugliflozin
can be maintained.
When Steglujan
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
hypoglycaemia (see se