BROT 500MG TABLET

국가: 말레이시아

언어: 영어

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

유효 성분:

METFORMIN HYDROCHLORIDE

제공처:

KOMEDIC SDN BHD

INN (국제 이름):

METFORMIN HYDROCHLORIDE

패키지 단위:

50 x 10 Tablets

Manufactured by:

MEDOCHEMIE (FAR EAST) LTD - ORAL FACILITY

환자 정보 전단

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
BROT TABLET
_Metformin hydrochloride 500mg, 850mg _
1
WHAT IS IN THIS LEAFLET
1.
What BROT is used for
2.
How it works
3.
Before you use BROT
4.
How to use BROT
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of BROT
8.
Product description
9.
Manufacturer and Product registration
holder
10.
Date of revision
WHAT BROT IS USED FOR
-
Treatment of type 2 mellitus in adults,
particularly in overweight individuals,
when
dietary
management
and
exercise
alone
does
not
result
in
adequate glycaemic control.
-
BROT may be used as monotherapy
or
in
combination
with
other
antidiabetic agents, or with insulin.
HOW BROT WORKS
-
BROT contains the active substance
metformin hydrochloride which is a
member of a class of medicines called
biguanide
that
lowers
blood
sugar
levels
in
individual
with
type
2
diabetes mellitus.
BEFORE YOU USE BROT
_When you must not use it _
Do not take BROT:
-
If you are allergic (hypersensitive) to
metformin or any other ingredients of
this medicine.
-
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 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, abnormal breathing and
drowsiness (if severe).
_ _
_Before you start to use it _
Talk to your doctor or pharmacist before
taking BROT if you have or have had:
-
allergic reaction to metformin or any
of the ingredients in the tablet. (An
allergic reaction may include a rash,
itching or difficulty breathing)
-
diabetic
ketoacidosis,
diabetic
pre-
coma
-
liver problems or you have severely
reduced kidney function
-
treated for acute heart failure or have
recently had a heart attack
During treatment with BROT, your doctor
will check your kidney function at least
once a year or more frequently if you are
elderly
and/or
if
you
have
worsening
kidney functi

제품 특성 요약

BROT
METFORMIN HYDROCHLORIDE
1. NAME OF THE MEDICINAL PRODUCT
BROT 500mg film-coated tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains metformin hydrochloride 500mg corresponding to
metformin base 390mg.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White, oval, film-coated tablets, plain on both sides, with dimensions
16mm x 8mm
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of type 2 diabetes mellitus, particularly in overweight
patients, when dietary management and exercise alone
does not result in adequate glycaemic control.
In adults, BROT may be used as monotherapy or in combination with
other oral antidiabetic agents, or with insulin.
In children from 10 years of age and adolescents, BROT may be used as
monotherapy or in combination with insulin.
A reduction of diabetic complications has been shown in overweight
type 2 diabetic adult patients treated with
metformin as first-line therapy after diet failure (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults with normal renal function (GFR ≥ 90ml/min)
Monotherapy and combination with other oral antidiabetic agents
The usual starting dose is one tablet 2 or 3 times daily given during
or after meals.
After 10 to 15 days the dose should be adjusted on the basis of blood
glucose measurements. A slow increase of dose
may improve gastrointestinal tolerability.
The maximum recommended dose of metformin is 3 g daily, taken as 3
divided doses.
If transfer from another oral antidiabetic agent is intended:
discontinue the other agent and initiate metformin at the
dose indicated above.
Combination with insulin
Metformin and insulin may be used in combination therapy to achieve
better blood glucose control. Metformin is given
at the usual starting dose of one tablet 2-3 times daily, while
insulin dosage is adjusted on the basis of blood glucose
measurements.
Elderly
Due to the potential for decreased renal function in elderly subjects,
the metformin dosage should be adjusted based