GlyMet F.C. Tablets 5500mg

Страна: Малайзия

Език: английски

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

Активна съставка:

GLIBENCLAMIDE; METFORMIN HYDROCHLORIDE

Предлага се от:

Orient Europharma (M) Sdn Bhd

INN (Международно Name):

GLIBENCLAMIDE; METFORMIN HYDROCHLORIDE

Броя в опаковка:

56 Tablets; 56 Tablet Tablets; 112 Tablet Tablets; 112 Tablets

Произведено от:

Orient Pharma Co. Ltd.

Листовка

GLYMET F.C. TABLET
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
Glibenclamide/Metformin Hydrochloride (5/500mg)
WHAT IS IN THIS LEAFLET
1.
What Glymet is used for
2.
How Glymet works
3.
Before you use Glymet
4.
How to use Glymet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Glymet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _GLYMET _IS USED FOR
It is used to treat type 2 diabetes. It is
used along with diet and exercise.
HOW _GLYMET _WORKS
Glymet is a sulfonylurea and biguanide
antidiabetic combination. The
sulfonylurea works by causing the
pancreas to release insulin, which helps
to lower blood sugar levels. The
biguanide works by decreasing the
amount of sugar that the liver produces
and the intestines absorb. It also helps to
make your body more sensitive to the
insulin that you naturally produce.
BEFORE YOU USE _GLYMET _
-
_When you must not use it _
_ _
IF YOU ARE ALLERGIC TO THE FOLLOWING:
•
metformin hydrochloride (e.g.
Glucophage)
•
glibenclamide (e.g. Daonil)
•
any other sulfonylurea medicine
such as gliclazide (e.g. Diamicron),
glipizide (e.g. Minidiab), glimepiride
(e.g. Amaryl,) or any other
sulphonamides.
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives; swelling of the face,
lips or tongue which may cause
difficulty in swallowing or breathing;
wheezing or shortness of breath.
Do note take Glymet :
•
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. Ketoacidosisis 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).
IF YOU ARE CURRENTLY TAKING MICONAZOLE
(EG. DAKTARIN), EITHER ORALLY OR AS A
MOUTH GEL.
Taking Glymet with miconazole
ma

Данни за продукта

GLYMET F.C. TABLETS
(Film coated tablet of Glibenclamide and Metformin HCl) Used under
prescription only
【ACTIVE INGREDIENTS】
GLYMET F.C. TABLETS 5/500MG
Each tablet contains Metformin hydrochloride 500 mg
and Glibenclamide 5 mg.
【FEATURES】
GLYMET F.C. TABLETS 5/500MG
Yellow-colour biconvex, oblong film-coated tablets,
with the trademark ‘e' on one side and a score line & '03' on the
other side.
【INDICATIONS】
GLYMET is indicated as initial therapy, as an adjunct to diet and
exercise, to improve glycemic
control in patients with type 2 diabetes whose hyperglycemia cannot be
satisfactorily managed
with diet and exercise alone.
GLYMET is indicated as second-line therapy when diet, exercise, and
initial treatment with a
sulfonylurea or metformin not result in adequate glycemic control in
patient with type 2
diabetes.
【DOSAGE】
Oral and used for adults only. This drug has to be used under
prescription only.
GENERAL CONSIDERATIONS:
Dosage of GLYMET must be individualized on the basis of both
effectiveness and tolerance
while not exceeding the maximum recommended daily dose of 20 mg
glibenclamide/2000 mg
metformin.
GLYMET should be given with meals and should be initiated at a low
dose with gradual dose
escalation as described below, in order to avoid hypoglycemia (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 t titration, appropriate blood
glucose monitoring should
be used to determine the therapeutic response of GLYMET and to
identify the minimum
effective dose for the patient. Thereafter, HbA1c should be measured
at intervals of
approximately 3 months to assess the effectiveness of therapy.
1.　GLYMET AS INITIAL THERAPY

Recommended starting dose: 250/1.25 mg once or twice daily with meals.

For patient with type 2 diabetes whose hyperglycemia cannot be
satisfactorily managed

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