JARDIANCE 10 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

EMPAGLIFLOZIN

متاح من:

BOEHRINGER INGELHEIM ISRAEL LTD.

ATC رمز:

A10BD19

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

EMPAGLIFLOZIN 10 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BOEHRINGER INGELHEIM INTERNATIONAL GMBH, GERMANY

المجال العلاجي:

LINAGLIPTIN AND EMPAGLIFLOZIN

الخصائص العلاجية:

JARDIANCE 10mg is indicated: •to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.•as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus •to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease

تاريخ الترخيص:

2020-07-31

نشرة المعلومات

Inactive ingredients and allergens in the medicine - see section
2 'Important information about some of the ingredients of the
medicine' and section 6 ‘Additional information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THE
MEDICINE. This leaflet contains concise information about the
medicine. If you have further questions, contact your physician
or pharmacist. This medicine has been prescribed for treating
your illness. Do not pass it on to others. It may harm them, even
if it seems to you that their illness is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Jardiance is indicated for:
•
improvement of blood sugar level control in adults with
type 2 diabetes, along with diet and exercise.
•
reducing the risk of cardiovascular death in adults with type
2 diabetes and established cardiovascular disease.
•
JARDIANCE 10 MG is intended to reduce the risk of
cardiovascular death and hospitalization for heart failure in
adults with heart failure.
Jardiance is not indicated for the treatment of type 1 diabetes or
diabetic ketoacidosis.
Jardiance is not recommended for use to improve glycemic
control in adults with type 2 diabetes mellitus and estimated
glomerular filtration rate (eGFR) less than 30 ml/min/1.73m
2
.
THERAPEUTIC GROUP: SGLT2 (sodium-glucose co-transporter 2)
inhibitors.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient
empagliflozin or to any of the additional ingredients
that the medicine contains (please refer to section
6 – ‘Additional information’, for the list of inactive
ingredients). Symptoms of a serious allergic reaction to
Jardiance may include:
o swelling of your face, lips, throat or other areas of your
skin
o difficulty with swallowing or breathing
o raised, red areas on your skin (hives)
If you experience any of the symptoms on the list, stop
taking Jardiance and contact your physician right away or
go to the nearest hospital emergency room.
•
You are on dialysis.
SPECIAL WARNINGS REGARDING THE

خصائص المنتج

Jardiance
Updated Prescribing Information
10 mg, 25 mg
Nov 2022
Boehringer Ingelheim Israel Page 1 of 41
JARDIANCE
PRESCRIBING INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
Jardiance 10 mg film-coated tablets
Jardiance 25 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of Jardiance 10 mg contains 10 mg
empagliflozin.
Each film-coated tablet of Jardiance 25 mg contains 25 mg
empagliflozin.
3
PHARMACEUTICAL FORM
Film-coated tablet.
For more information on pharmaceutical form see sections 6 & 18
“DOSAGE FORM“ & “ HOW
SUPPLIED/STORAGE AND HANDLING”.
4
INDICATIONS AND USAGE
JARDIANCE 10MG AND 25MG ARE INDICATED:

as an adjunct to diet and exercise to improve glycemic control in
adults with type 2 diabetes
mellitus

to reduce the risk of cardiovascular death in adult patients with type
2 diabetes mellitus and
established
cardiovascular disease.
JARDIANCE 10MG IS INDICATED:
to reduce the risk of cardiovascular death and hospitalization for
heart failure in adults with heart
failure.
LIMITATIONS OF USE
JARDIANCE is not recommended for patients with type 1 diabetes or for
the treatment of diabetic
ketoacidosis .
JARDIANCE is not recommended for use to improve glycemic control in
adults with type 2 diabetes
mellitus with an eGFR less than 30 mL/min/1.73 m
2
. JARDIANCE is likely to be ineffective in this
setting based upon its mechanism of action.
5
DOSAGE AND ADMINISTRATION
5.1 PRIOR TO INITIATION OF JARDIANCE

Assess renal function before initiating JARDIANCE and as clinically
indicated [see Warnings and
Precautions (8)].
Jardiance
Updated Prescribing Information
10 mg, 25 mg
Nov 2022
Boehringer Ingelheim Israel Page 2 of 41

In patients with volume depletion, correct this condition before
initiating JARDIANCE
_[see _
_Warnings and Precautions (8.2), Use in Specific Populations (11.5,
11.6)]._
_ _
5.
2 RECOMMENDED DOSAGE

The recommended dose of JARDIANCE is 10 mg once daily in the morning,
taken with or without
food.

For additional glycemic control, the