Jardiance
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
29-01-2024
Karatteristiċi tal-prodott
(SPC)
29-01-2024
Rapport ta 'Valutazzjoni Pubblika
(PAR)
17-08-2023
Ingredjent attiv:
empagliflozin
Disponibbli minn:
Boehringer Ingelheim International GmbH
Kodiċi ATC:
A10BK03
INN (Isem Internazzjonali):
empagliflozin
Grupp terapewtiku:
Drugs used in diabetes
Żona terapewtika:
Diabetes Mellitus, Type 2; Heart Failure; Renal Insufficiency, Chronic
Indikazzjonijiet terapewtiċi:
Type 2 diabetes mellitusJardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesFor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. of the annex.Heart failureJardiance is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney diseaseJardiance is indicated in adults for the treatment of chronic kidney disease.
Sommarju tal-prodott:
Revision: 28
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2014-05-22
Fuljett ta 'informazzjoni
50
B. PACKAGE LEAFLET
51
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
JARDIANCE 10 MG FILM-COATED TABLETS
JARDIANCE 25 MG FILM-COATED TABLETS
empagliflozin
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, 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 Jardiance is and what it is used for
2.
What you need to know before you take Jardiance
3.
How to take Jardiance
4.
Possible side effects
5.
How to store Jardiance
6.
Contents of the pack and other information
1.
WHAT JARDIANCE IS AND WHAT IT IS USED FOR
WHAT JARDIANCE IS
Jardiance contains the active substance empagliflozin.
Jardiance is a member of a group of medicines called sodium glucose
co-transporter-2 (SGLT2)
inhibitors.
WHAT JARDIANCE IS USED FOR
TYPE 2 DIABETES MELLITUS
Jardiance is used to treat type 2 diabetes in adults and children aged
10 years and older that
cannot be controlled by diet and exercise alone.
Jardiance can be used without other medicines in patients who cannot
take metformin (another
diabetes medicine).
Jardiance can also be used with other medicines for the treatment of
diabetes. These may be
medicines taken by mouth or given by injection such as insulin.
Jardiance works by blocking the SGLT2 protein in your kidneys. This
causes blood sugar (glucose) to
be removed in your urine. Thereby Jardiance lowers the amount of sugar
in your blood.
This medicine can also help prevent heart disease in patients with
type 2 diabetes mellitus.
It is important that you continue with your diet and exercise plan as
told by your doctor, pharmacist or
nurse.
H
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Jardiance 10 mg film-coated tablets
Jardiance 25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Jardiance 10 mg film-coated tablets
Each tablet contains 10 mg empagliflozin.
_Excipients with known effect_
Each tablet contains lactose monohydrate equivalent to 154.3 mg
lactose anhydrous.
Jardiance 25 mg film-coated tablets
Each tablet contains 25 mg empagliflozin.
_Excipients with known effect_
Each tablet contains lactose monohydrate equivalent to 107.4 mg
lactose anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Jardiance 10 mg film-coated tablets
Round, pale yellow, biconvex, bevel-edged film-coated tablet debossed
with “S10” on one side and
the Boehringer Ingelheim logo on the other (tablet diameter: 9.1 mm).
Jardiance 25 mg film-coated tablets
Oval, pale yellow, biconvex film-coated tablet debossed with “S25”
on one side and the Boehringer
Ingelheim logo on the other (tablet length: 11.1 mm, tablet width: 5.6
mm).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Type 2 diabetes mellitus
Jardiance is indicated in adults and children aged 10 years and above
for the treatment of insufficiently
controlled type 2 diabetes mellitus as an adjunct to diet and exercise
-
as monotherapy when metformin is considered inappropriate due to
intolerance
-
in addition to other medicinal products for the treatment of diabetes
For study results with respect to combination of therapies, effects on
glycaemic control, cardiovascular
and renal events, and the populations studied, see sections 4.4, 4.5
and 5.1.
3
Heart failure
Jardiance is indicated in adults for the treatment of symptomatic
chronic heart failure.
Chronic kidney disease
Jardiance is indicated in adults for the treatment of chronic kidney
disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Type 2 diabetes mellitus
The recommended starting dose is 10 mg empagliflozin once daily for
monothe
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