GLUCOVANCE 500MG5MG FILM-COATED TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

METFORMIN HYDROCHLORIDE; GLIBENCLAMIDE

Boleh didapati daripada:

MERCK SDN. BHD.

INN (Nama Antarabangsa):

METFORMIN HYDROCHLORIDE; GLIBENCLAMIDE

Unit dalam pakej:

120Tablet Tablets; 120 Tablets

Dikeluarkan oleh:

MERCK SANTE S.A.S.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
1
GLUCOVANCE FILM COATED TABLET
Metformin Hydrochloride/Glibenclamide ( 500/2.5mg, 500/5mg)
WHAT IS IN THIS LEAFLET
1.
What Glucovance
is used for
2.
How Glucovance
works
3.
Before you use Glucovance
4.
How to take Glucovance
5.
While you are using Glucovance
6.
Side effects
7.
Storage and disposable of
Glucovance
8.
Product description
9.
Manufacturer and Product
registration holder
10.
Date of revision
WHAT IS GLUCOVANCE USED FOR
Glucovance is made up of two
antidiabetic medicines, which belong
to the groups of medicines called
biguanide (metformin hydrochloride)
and sulphonylurea (glibenclamide).
Glucovance is taken orally for the
treatment of type 2 diabetes mellitus
in adult patients. It is used to replace
the combination of the two active
substances, metformin hydrochloride
and glibenclamide given separately
in patients previously treated with
this combination.
HOW GLUCOVANCE WORKS
Insulin is a hormone that enables
body tissues to take up glucose
(sugar) from the blood and to use it
for producing energy or to store it for
future use. Patients with type 2
diabetes mellitus (i.e. non-insulin
dependent diabetes) do not produce
enough insulin in their pancreas or
their body does not respond properly
to the insulin it produces. This causes
an increased level of glucose in the
blood. Glucovance helps to reduce
their blood sugar towards a normal
level.
BEFORE YOU USE GLUCOVANCE
_When you must not use it _
Do not take Glucovance
•
if you are allergic (hypersensitive)
to metformin hydrochloride,
glibenclamide or other
sulphonamides or any of the other
ingredients of Glucovance
•
if you have kidney or liver
function problems
•
if you have a severe infection (for
example an infection of the air
passages or an urinary tract
infection)
•
if you suffer from type 1 diabetes
mellitus (i.e. insulin-dependent) or
if you have severe loss of diabetes
control with either pre-coma or
ketosis (a condition caused by
substances called ‘ketone bodies’
accumulating in the

Ciri produk

NAME OF THE MEDICINAL PRODUCT
GLUCOVANCE 500 mg/2.5 mg, film-coated tablets
GLUCOVANCE 500 mg/5 mg, film-coated tablets
Metformin hydrochloride and Glibenclamide
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg metformin hydrochloride,
equivalent to 390 mg metformin,
and 2.5 mg glibenclamide.
Each film-coated tablet contains 500 mg metformin hydrochloride,
equivalent to 390 mg metformin,
and 5 mg glibenclamide.
Excipients: Contains lactose, see Special warnings and precautions for
use.
For a full list of excipients, see List of excipients.
PHARMACEUTICAL FORM
Film-coated tablets are orange capsule-shaped, biconvex, with '2.5'
engraved on one side.
Film-coated tablets are yellow capsule-shaped, biconvex, with '5'
engraved on one side.
ROUTE OF ADMINISTRATION
Oral
CLINICAL PARTICULARS
Therapeutic indications
Glucovance is indicated as second-line therapy when diet, exercise,
and initial treatment with a
sulphonylurea or metformin do not result in adequate glycaemic control
in patients with type 2 diabetes.
Posology and method of administration
General Consideration
Dosage of Glucovance must be individualized on the basis of both
effectiveness and tolerance while
not exceeding the maximum recommended daily dose of 2000 mg
metformin/20 mg glibenclamide.
Glucovance should be given with meals with a sufficiently high
carbohydrate content to prevent the onset
of hypoglycaemic episode. Glucovance should be initiated at a low
dose, with gradual dose escalation as
described below, in order to avoid hypoglycaemia (largely due to
glibenclamide), to reduce GI side effects
(largely due to metformin), and to permit determination of the minimum
effective dose for adequate
control of blood glucose for the individual patient.
With initial treatment and during dose titration, appropriate blood
glucose monitoring should be used to
determine the therapeutic response to Glucovance and to identify the
minimum effective dose for
the
patient. Thereafter, HbA
1c
(glycosylated haemoglobin) should be measured