Glusod 10 mg filmomhulde tabletten

Pajjiż: Olanda

Lingwa: Olandiż

Sors: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingredjent attiv:

EMPAGLIFLOZINE 10 mg/stuk

INN (Isem Internazzjonali):

EMPAGLIFLOZINE 10 mg/stuk

Għamla farmaċewtika:

Filmomhulde tablet

Kompożizzjoni:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Rotta amministrattiva:

Oraal gebruik

Data ta 'l-awtorizzazzjoni:

2024-04-03

Fuljett ta 'informazzjoni

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Glusod 10 mg filmomhulde tabletten
Glusod 25 mg filmomhulde tabletten
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 or pharmacist.
•
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Glusod is and what it is used for
2.
What you need to know before you take Glusod
3.
How to take Glusod
4.
Possible side effects
5.
How to store Glusod
6.
Contents of the pack and other information
1.
WHAT GLUSOD IS AND WHAT IT IS USED FOR
WHAT GLUSOD IS
Glusod contains the active substance empagliflozin.
Glusod is a member of a group of medicines called sodium glucose
co-transporter-2 (SGLT2)
inhibitors.
WHAT GLUSOD IS USED FOR
TYPE 2 DIABETES MELLITUS
•
Empagliflozin 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.
•
Empagliflozin can be used without other medicines in patients who
cannot take metformin
(another diabetes medicine).
•
Empagliflozin 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.
Empagliflozin works by blocking the SGLT2 protein in your kidneys.
This causes blood sugar
(glucose) to be removed in your urine. Thereby empagliflozin 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 or pharmacist.
HEART FAILURE
•
Empagliflozin is used to treat

Karatteristiċi tal-prodott

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Glusod 10 mg filmomhulde tabletten
Glusod 25 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
GLUSOD 10 mg film-coated tablets
Each tablet contains 10 mg empagliflozin.
Excipient with known effect: lactose monohydrate.
Each tablet contains 59.00 mg lactose monohydrate.
GLUSOD 25 mg film-coated tablets
Each tablet contains 25 mg empagliflozin.
Excipient with known effect: lactose monohydrate.
Each tablet contains 147.50 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
GLUSOD 10 mg film-coated tablets
Yellow, round, convex, film-coated tablets with dimeter of 6 mm
debossed “E” on one side and plain
on the other side.
GLUSOD 25 mg film-coated tablets
Yellow, oval, convex, film-coated tablets with diameter of 11,5 mm x
6,2 mm, debossed “MC” on
one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Type 2 diabetes mellitus
GLUSOD 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.
Heart failure
GLUSOD is indicated in adults for the treatment of symptomatic chronic
heart failure.
Chronic kidney disease
GLUSOD is indicated in adults for the treatment of chronic kidney
disease.
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Type 2 diabetes mellitus _
The recommended starting dose is 10 mg empagliflozin once daily for
monotherapy and add-on
combination therapy with other medicinal products for the treatment of
diabetes. In patients tolerating
empagliflozin 10 mg once d