STEGLATRO 5 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ERTUGLIFLOZIN (L-PGA)

Available from:

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

ATC code:

A10BK04

Pharmaceutical form:

FILM COATED TABLETS

Composition:

ERTUGLIFLOZIN (L-PGA) 5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

MERCK SHARP & DOHME LLC, USA

Therapeutic area:

ERTUGLIFLOZIN

Therapeutic indications:

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.

Authorization date:

2023-12-31

Patient Information leaflet

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS
REGULATIONS (PREPARATIONS) 1986
This medicine is to be supplied upon physician’s prescription only
STEGLATRO
® 5 MG
STEGLATRO
® 15 MG
FILM-COATED TABLET
Each Steglatro 5 mg film-coated tablet contains:
5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid)
Each Steglatro 15 mg film-coated tablet contains:
15 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid)
For a list of inactive ingredients see section 6 “Further
information”. See also section 2.8
“Important information about some of the ingredients of the
medicine”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY 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 ailment is similar.
1. WHAT THE MEDICINE IS INTENDED FOR?
Steglatro is intended, in addition to diet and exercise, to improve
the control of sugar levels in
the blood in adults aged 18 years and older with type 2 diabetes: as a
single treatment in
patients which can’t receive treatment with metformin or as an
addition to other medicines
which are intended for the use in diabetes.
THERAPEUTIC GROUP:
Steglatro contains the active substance ertugliflozin.
Steglatro is a member of a group of medicines called sodium glucose
co-transporter-2
(SGLT2) inhibitors.
HOW STEGLATRO WORKS
Ertugliflozin works by blocking the SGLT2 protein in your kidneys
causing increased
excretion of the glucose in the 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.
Your body can also make
too much sugar. When this happens, sugar (glucose) builds up in the
blood. This can lead to
serious medical problems like heart disease, kidney disease, blindness
and poor circulation.
2. BEFORE US

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Steglatro 5 mg
Steglatro 15 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Steglatro
5 mg
Each tablet contains 5 mg ertugliflozin (as ertugliflozin
L-pyroglutamic acid).
_Excipient(s) with known effect _
Each tablet contains 28 mg of lactose (as monohydrate).
Steglatro
15 mg
Each tablet contains 15 mg ertugliflozin (as ertugliflozin
L-pyroglutamic acid).
_Excipient(s) 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
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
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.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
(For study results with respect to combinations and effects on
glycaemic control see sections 4.4, 4.5,
and 5.1.)
2
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 hypoglycaemia (see
sections 4.4, 4.5, and 4.8).
In patients with volume depletion, correcting this condition prior to
initiation of ertugliflozin is
recommended (see section 4.4).
If a dose is missed, it should be taken as soon