Vokanamet
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
28-07-2023
Charakterystyka produktu
(SPC)
28-07-2023
Sprawozdanie z oceny publicznego
(PAR)
15-05-2014
Składnik aktywny:
canagliflozin, metformin hydrochloride
Dostępny od:
Janssen-Cilag International NV
Kod ATC:
A10BD16
INN (International Nazwa):
canagliflozin, metformin
Grupa terapeutyczna:
Drugs used in diabetes
Dziedzina terapeutyczna:
Diabetes Mellitus, Type 2
Wskazania:
Vokanamet 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:in patients not adequately controlled on their maximally tolerated doses of metformin alonein patients on their maximally tolerated doses of metformin along with other glucose lowering medicinal products including insulin, when these do not provide adequate glycaemic control.in patients already being treated with the combination of canagliflozin and metformin as separate tabletsFor study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Podsumowanie produktu:
Revision: 22
Status autoryzacji:
Authorised
Data autoryzacji:
2014-04-23
Ulotka dla pacjenta
50
B. PACKAGE LEAFLET
51
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VOKANAMET 50 MG/850 MG FILM-COATED TABLETS
VOKANAMET 50 MG/1,000 MG FILM-COATED TABLETS
VOKANAMET 150 MG/850 MG FILM-COATED TABLETS
VOKANAMET 150 MG/1,000 MG FILM-COATED TABLETS
canagliflozin/metformin hydrochloride
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 Vokanamet is and what it is used for
2.
What you need to know before you take Vokanamet
3.
How to take Vokanamet
4.
Possible side effects
5.
How to store Vokanamet
6.
Contents of the pack and other information
1.
WHAT VOKANAMET IS AND WHAT IT IS USED FOR
Vokanamet contains two different active substances, canagliflozin and
metformin. These are two
medicines that work together in different ways to lower blood glucose
(sugar) levels and can help
prevent heart disease in adults with type 2 diabetes.
This medicine can be used by itself or along with other medicines you
may be using to treat your
type 2 diabetes (such as 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. Vokanamet is used when
your blood sugar cannot be adequately controlled by metformin alone or
together with other diabetes
medicines. If you are already taking both canagliflozin and metformin
as single tablets, Vokanamet
can replace them in one tablet.
It is important to keep following adv
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Vokanamet 50 mg/850 mg film-coated tablets
Vokanamet 50 mg/1,000 mg film-coated tablets
Vokanamet 150 mg/850 mg film-coated tablets
Vokanamet 150 mg/1,000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vokanamet 50 mg/850 mg film-coated tablets
Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg of
canagliflozin, and 850 mg of
metformin hydrochloride.
Vokanamet 50 mg/1,000 mg film-coated tablets
Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg of
canagliflozin, and 1,000 mg of
metformin hydrochloride.
Vokanamet 150 mg/850 mg film-coated tablets
Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg
of canagliflozin, and 850 mg of
metformin hydrochloride.
Vokanamet 150 mg/1,000 mg film-coated tablets
Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg
of canagliflozin, and 1,000 mg
of metformin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Vokanamet 50 mg/850 mg film-coated tablets
The tablet is pink, capsule-shaped, 20 mm in length, film-coated, and
debossed with “CM” on one side
and “358” on the other side.
Vokanamet 50 mg/1,000 mg film-coated tablets
The tablet is beige, capsule-shaped, 21 mm in length, film-coated, and
debossed with “CM” on one
side and “551” on the other side.
Vokanamet 150 mg/850 mg film-coated tablets
The tablet is light yellow, capsule-shaped, 21 mm in length,
film-coated, and debossed with “CM” on
one side and “418” on the other side.
Vokanamet 150 mg/1,000 mg film-coated tablets
The tablet is purple, capsule-shaped, 22 mm in length, film-coated,
and debossed with “CM” on one
side and “611” on the other side.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vokanamet is indicated in adults with type 2 diabetes mellitus as an
adjunct to diet and exercise:
in patients insufficiently controlled on their maximally tolerated
dose
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