Vokanamet (Canagliflozin 150mg/ Metformin 1000mg) Film-Coated Tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Canagliflozin Hemihydrate; Metformin Hydrochloride

Boleh didapati daripada:

JOHNSON & JOHNSON SDN BHD

INN (Nama Antarabangsa):

Canagliflozin Hemihydrate; Metformin Hydrochloride

Unit dalam pakej:

60 Tablets

Dikeluarkan oleh:

JANSSEN CILAG SPA

Risalah maklumat

VOKANAMET
TM
Canagliflozin/Metformin Tablets: 150mg/500mg, 150mg/850mg,
150mg/1000mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What VOKANAMET
TM
is used for
2.
How VOKANAMET
TM
works
3.
Before you use VOKANAMET
TM
4.
How to use VOKANAMET
TM
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
VOKANAMET
TM
8.
Product description
9.
Manufacturer
10.
Product registration holder
11.
Date of revision
WHAT VOKANAMET
TM IS USED FOR
VOKANAMET
TM
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 that
lower blood sugar levels.
VOKANAMET
TM
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
TM
can replace them in
one tablet.
It is important to keep following advice
about diet and exercise given by your
doctor or nurse.
HOW VOKANAMET
TM WORKS
The two medicines in VOKANAMET
TM
work together to control blood sugar
levels by increasing the amount of sugar
removed from the body in the urine,
which reduces the amount of sugar in the
blood, and by reducing the amount of
sugar produced and absorbed after a
meal.
BEFORE YOU USE VOKANAMET
TM
-
_When you must not use it_
_ _
Do not take VOKANAMET
TM
if you:
_ _
•
Allergic to canagliflozin,
metformin or any of the other
ingredients of this medicine
•
Have diabetic pre-coma
•
Have liver problems
•
Have a severe infection
•
Have lost a lot of water from your
body (dehydration), e.g. due to
long-lasting or severe diarrhea, or
if you have vomited several times
in a row
•
Have recently had a heart attack or
have severe blood circulation
problems, such as ‘shock’ or
breat

Ciri produk

1
1.
NAME OF THE MEDICINAL PRODUCT
VOKANAMET
TM
150 mg/500 mg film-coated tablets
VOKANAMET
TM
150 mg/850 mg film-coated tablets
VOKANAMET
TM
150 mg/1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
VOKANAMET
TM
150 mg/500 mg film-coated tablets
Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg
of canagliflozin, and 500 mg
of metformin hydrochloride.
VOKANAMET
TM
150 mg/850 mg film-coated tablets
Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg
of canagliflozin, and 850 mg
of metformin hydrochloride.
_Excipient(s) with known effect _
Each tablet contains less than 1 mmol sodium (23 mg), and is
essentially sodium-free
_(see section _
_6)_
.
VOKANAMET
TM
150 mg/1000 mg film-coated tablets
Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg
of canagliflozin, and
1000 mg of metformin hydrochloride.
_ _
_Excipient(s) with known effect _
Each tablet contains less than 1 mmol sodium (23 mg), and is
essentially sodium-free
_(see section _
_6)_
.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
VOKANAMET
TM
150 mg/500 mg film-coated tablets
The tablet is yellow, capsule-shaped, 18.03 mm in length, film-coated,
and debossed with “CM”
on one side and “215” on the other side.
VOKANAMET
TM
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.
2
VOKANAMET
TM
150 mg/1000 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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VOKANAMET
TM
is indicated to improve glycemic control as an adjunct to diet and
exercise in
adult patients with type 2 diabetes mellitus inadequately controlled
on:
•
metformin
•
a sulfonylurea in combination with metformin
•
pioglitazone in combination with metformin
•
insulin in combinatio