Invokana

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

canagliflozin

Dostupné z:

Janssen-Cilag International NV

ATC kód:

A10BK02

INN (Medzinárodný Name):

canagliflozin

Terapeutické skupiny:

Drugs used in diabetes

Terapeutické oblasti:

Diabetes Mellitus, Type 2

Terapeutické indikácie:

Invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin 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.

Prehľad produktov:

Revision: 23

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2013-11-15

Príbalový leták

39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
INVOKANA 100 MG FILM-COATED TABLETS
INVOKANA 300 MG FILM-COATED TABLETS
canagliflozin
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 Invokana is and what it is used for
2.
What you need to know before you take Invokana
3.
How to take Invokana
4.
Possible side effects
5.
How to store Invokana
6.
Contents of the pack and other information
1.
WHAT INVOKANA IS AND WHAT IT IS USED FOR
Invokana contains the active substance canagliflozin which belongs to
a group of medicines called
“blood-glucose lowering drugs.”
Invokana is used:

to treat adults with type 2 diabetes.
This medicine works by increasing the amount of sugar removed from
your body in your urine. This
reduces the amount of sugar in your blood and can help prevent heart
disease in patients with type 2
diabetes mellitus (T2DM). It also helps to slow down deterioration of
kidney function in patients with
T2DM by a mechanism beyond blood glucose lowering.
Invokana can be used by itself or along with other medicines you may
be using to treat your type 2
diabetes (such as metformin, insulin, a DPP-4 inhibitor [such as
sitagliptin, saxagliptin, or linagliptin],
a sulphonylurea [such as glimepiride or glipizide], or pioglitazone)
that lower blood sugar levels. You
may already be taking one or more of these to treat your type 2
diabetes.
It is also important to keep following advice about diet and exercise
given by your doctor or nurse.
WHAT IS TYPE 2 DIABE

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Invokana 100 mg film-coated tablets
Invokana 300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Invokana 100 mg film-coated tablets
Each tablet contains canagliflozin hemihydrate, equivalent to 100 mg
canagliflozin.
_Excipient(s) with known effect_
Each tablet contains 39.2 mg lactose.
Invokana 300 mg film-coated tablets
Each tablet contains canagliflozin hemihydrate, equivalent to 300 mg
canagliflozin.
_Excipient(s) with known effect_
Each tablet contains 117.78 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Invokana 100 mg film-coated tablets
The tablet is yellow, capsule-shaped, approximately 11 mm in length,
immediate-release and
film-coated, with “CFZ” on one side and “100” on the other
side.
Invokana 300 mg film-coated tablets
The tablet is white, capsule-shaped, approximately 17 mm in length,
immediate-release and
film-coated, with “CFZ” on one side and “300” on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Invokana is indicated for the treatment of adults with insufficiently
controlled type 2 diabetes mellitus
as an adjunct to diet and exercise:
-
as monotherapy when 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 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
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended starting dose of canagliflozin is 100 mg once daily.
In patients tolerating
canagliflozin 100 mg once daily who have an estimated glomerular
filtration rate
(eGFR) ≥ 60 mL/min/1.73 m
2
or CrCl ≥ 60 mL/min and need tighter glycaemic control, the dose can
be increased to 300 mg once daily (see section 4.4). For dose
adjustment recommendations a