AMARYL 3.0

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

GLIMEPIRIDE

Boleh didapati daripada:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

GLIMEPIRIDE

Unit dalam pakej:

30Tablet Tablets

Dikeluarkan oleh:

Sanofi S.p.A.

Risalah maklumat

AMARYL®
Glimepride (2mg, 3mg)
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1. What Amaryl is used for
2. How Amaryl works
3. Before you use Amaryl
4. How to use Amaryl
5. While you are using it
6. Possible side effects
7. Storage and disposal of Amaryl
8. Product description
9. Manufacturer and Product
Registration Holder
10. Date of revision
11. Serial number
WHAT AMARYL IS USED FOR
Amaryl is used to treat a certain form
of diabetes (type 2 diabetes mellitus)
when diet, physical exercise and
weight reduction alone have not been
able to control your blood sugar levels
HOW AMARYL WORKS
Amaryl is an orally active blood sugar
lowering drug. This drug belongs to a
blood sugar lowering
group of medicines called sulfonylurea.
Amaryl works by increasing the
amount of insulin released from your
pancreas. The insulin then lowers your
blood sugar levels.
BEFORE YOU USE AMARYL
-
_ When you must not use it _
DO NOT TAKE AMARYL AND TELL YOUR
DOCTOR IF:
•
You are allergic
(hypersensitive) to:
Glimepiride or other
sulfonylureas (medicines
used to lower your blood
sugar such as glibenclamide)
or sulfonamides (medicines
for bacterial infections such
as sulfamethoxazole
)
or any
of the other ingredients of
Amaryl
•
You have insulin dependent
diabetes (type 1 diabetes
mellitus)
•
You have diabetic
ketoacidosis (a complication
of diabetes when your acid
level is raised in your body
and you may have some of
the following signs: fatigue,
feeling sick (nausea),
frequent urination and
muscular stiffness)
•
You are in a diabetic coma
•
You have severe kidney
disease
•
You have a severe liver
disease
Do not take this medicine if any of the
above apply to you. If you are not sure,
talk to your doctor or
pharmacist before taking Amaryl.
-
_ Before you start to take it _
CHECK WITH YOUR DOCTOR OR
PHARMACIST BEFORE TAKING YOUR
MEDICINE IF:
- You are recovering from an injury,
operation, infections with fever, or
from other forms of stress, inform your
doctor as temporary change of
treatment may b

Ciri produk

1
This package insert is continually updated: please read carefully
before using a new pack!
NAME OF THE MEDICINAL PRODUCT
AMARYL® 2.0
AMARYL® 3.0
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet
AMARYL 2.0
contains, as active ingredient, 2 mg glimepiride.
Each tablet
AMARYL 3.0
contains, as active ingredient, 3 mg glimepiride.
_ _
Excipients:
Lactose
monohydrate,
sodium
starch
glycolate,
povidone
25000,
microcrystalline
cellulose, magnesium stearate, yellow iron oxide (
AMARYL 2.0
and
AMARYL 3.0
), indigo carmine
aluminium lake (
AMARYL 2.0
).
PHARMACEUTICAL FORM
Tablet
[Amaryl 2 mg] The tablets are green, oblong and scored on both sides.
[Amaryl 3 mg] The tablets are pale yellow, oblong and scored on both
sides.
The tablet can be divided into equal doses.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
As an adjunct to diet and exercise in Non-insulin-dependent (type II)
diabetes, whenever blood sugar
levels cannot be controlled adequately by diet, physical exercise and
weight reduction alone. Amaryl
may also be used in combination with an oral antidiabetic containing
metformin or with insulin.
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration
The basis for successful treatment of diabetes is a good diet, regular
physical activity, as well as
routine checks of blood and urine. Tablets or insulin cannot
compensate if the patient does not keep to
the recommended diet.
Dosage is determined by the results of blood and urinary glucose
determinations.
The starting dose is 1 mg glimepiride per day. If good control is
achieved this dosage should be used
for maintenance therapy.
For the different dosage regimens appropriate strengths are available.
If control is unsatisfactory the dosage should be increased, based on
the glycaemic control, in a
stepwise manner with an interval of about 1 to 2 weeks between each
step, to 2, 3 or 4 mg glimepiride
per day.
A dosage of more than 4 mg glimepiride per day gives better results
only in exceptional cases. The
maximum recommended dose is 6 mg glimepiride per day.
I