Amaryl M SR 2500mg Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

METFORMIN HYDROCHLORIDE; GLIMEPIRIDE

Boleh didapati daripada:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

METFORMIN HYDROCHLORIDE; GLIMEPIRIDE

Unit dalam pakej:

30Tablet Tablets

Dikeluarkan oleh:

Handok Inc.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
AMARYL M SR 2/500MG TABLET
Glimepiride/ Metformin Hydrochloride (2mg/500mg)
_1 _
_ _
WHAT IS IN THIS LEAFLET
1. What Amaryl M SR is used for
2. How Amaryl M SR works
3. Before you use Amaryl M SR
4. How to use Amaryl M SR
5. While you are using it
6. Side effects
7. Storage and disposal of Amaryl M
SR
8. Product description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT AMARYL M SR IS USED FOR
Amaryl M SR is used, with diet and
physical exercise, to treat a certain form
of diabetes (type 2 diabetes mellitus), in
patients who are:
-
unable to achieve sufficient control
of blood sugar level with glimepiride
or metformin alone, or
-
already treated with the combination of
glimepiride and metformin as separate
tablets.
HOW AMARYL M SR WORKS
Both active substances, glimepiride and
metformin, help to control the level of
sugar in blood.
Glimepiride works by making the
pancreas produce more insulin.
Metformin works by reducing glucose
production by the liver, helping the
body to make better use of insulin and
delaying glucose absorption in
intestines.
BEFORE YOU USE AMARYL M SR
_- When you must not use it _
Do not take Amaryl M SR:
-
if you have insulin-dependent
diabetes (type 1 diabetes requiring
insulin therapy)
-
if you are allergic (hypersensitive) to
glimepiride, metformin, or any of the
other ingredients of Amaryl M SR, to
sulphonamides (medicines for
bacterial infections such as
sulfamethoxazole) or other
sulfonylureas (medicines used to
lower your blood sugar such as
glibenclamide)
-
if you have severely reduced kidney
function
-
if you have lactic acidosis [too much
lactic acid in the blood (see “Risk of
lactic acidosis” below)] or
ketoacidosis. Ketoacidosis is a
condition in which substances called
‘ketone bodies’ accumulate in the
blood and which can lead to diabetic
pre-coma. Symptoms of acidosis may
include stomach pain, abdominal
breathing and drowsiness (if severe)
-
if you are pregnant, planning to get
pregnant or are

Ciri produk

1
MY/AMA-M/0220/CCDSV6,7,9,10
AMARYL M
 SR FILM COATED TABLET
GLIMEPIRIDE / METFORMIN
2MG / 500MG
DESCRIPTION
Prolonged-release tablet.
White oblong biconvex film coated tablet, engraved with “SR25” on
one side. Each tablet
contains 2mg of glimepiride and 500mg of metformin hydrochloride.
PHARMACOKINETICS
Glimepiride pharmacokinetics (T
max
and AUC) after meal was similar between a sustained-
release formulation of Amaryl-M SR 2/500 mg and an immediate-release
formulation of single
Amaryl-M 2/500 mg or B.I.D. Amaryl-M 1/250 mg. Meanwhile, metformin t
max
was delayed in
sustained-release formulation compared to immediate-release
formulation, but its elimination
half-life was not prolonged. The extent of metformin exposure after
meal was lower in sustained-
release formulation than in immediate-release formulation and its
B.I.D. treatment in divided
doses by 14% and 23% on average respectively. This effect on exposure
is not considered
clinically significant as there was no significant difference in
safety between treatment groups.
_ _
_The following supplementary information is provided: _
An open label, 3-period, 3-treatment, 3-way crossover study was
conducted in 12 healthy Korean male
subjects to evaluate the pharmacokinetic and safety profiles of
Amaryl-M and Amaryl-M SR tablets.
Subjects were randomized to one of 3 treatment arms (Group A, B, or
C). Subjects in group A received a
single Amaryl-M SR 2/500 mg after breakfast. Group B received a single
Amaryl-M 2/500 mg after
breakfast. Group C received Amaryl-M 1/250 mg after breakfast and 12
hours later after dinner. There
was a 7-day washout period between each treatment period.
Pharmacokinetic parameters:
2
MY/AMA-M/0220/CCDSV6,7,9,10
Values are presented as mean ± SD except T
max
: median [min – max]
PHARMACODYNAMICS
GLIMEPIRIDE
Pharmacotherapeutic group: Oral blood glucose lowering drugs:
Sulfonamides, urea derivatives.
ATC Code: A10B B12.
Glimepiride is an orally active hypoglycaemic substance belonging to
the sulfonylurea group. It
may be used