DIAPRIDE 4 glimepiride 4mg tablet blister pack

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

glimepiride, Quantity: 4 mg

Sẵn có từ:

Arrotex Pharmaceuticals Pty Ltd

INN (Tên quốc tế):

Glimepiride

Dạng dược phẩm:

Tablet, uncoated

Thành phần:

Excipient Ingredients: indigo carmine; sodium starch glycollate; microcrystalline cellulose; magnesium stearate; lactose monohydrate; povidone

Tuyến hành chính:

Oral

Các đơn vị trong gói:

30 tablets

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

As an adjunct to diet, exercise and weight loss, to lower the blood glucose in patients with non-insulin dependent (type 2) diabetes mellitus.

Tóm tắt sản phẩm:

Visual Identification: Blue capsule shaped tablet, embossed with "G4" scoreline "G4" on one side and scoreline on the other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2005-07-22

Tờ rơi thông tin

DIPRIDE- Consumer Medicine Information
Page 1 of 5
Diapride
glimepiride
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DIAPRIDE.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor, pharmacist or diabetes
educator.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking DIAPRIDE
against the benefits they expect it
will have for you.
TALK TO YOUR DOCTOR, PHARMACIST
OR DIABETES EDUCATOR IF YOU
HAVE ANY CONCERNS ABOUT TAKING
THIS MEDICINE.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT DIAPRIDE IS USED
FOR
DIAPRIDE is used to control blood
glucose in patients with diabetes
mellitus.
There are two types of diabetes
mellitus:
•
type 1, also called insulin
dependent diabetes
•
type 2, also called non-insulin
dependent diabetes mellitus or
maturity onset diabetes.
DIAPRIDE is used in the treatment
of type 2 diabetes mellitus. It is
used when diet and exercise are not
enough to control your blood
glucose levels.
It is available only with a doctor's
prescription.
How DIAPRIDE works
DIAPRIDE belongs to a group of
medicines called sulphonylureas.
The medicine lowers blood glucose
by increasing the amount of insulin
produced by your pancreas.
If your blood glucose is not properly
controlled, you may experience
hypoglycaemia (low blood glucose)
or hyperglycaemia (high blood
glucose).
Hypoglycaemia (low blood glucose)
can occur suddenly. Signs may
include:
•
weakness, trembling or shaking
•
sweating
•
lightheadedness, dizziness,
headache, lack of concentration
•
irritability, tearfulness, crying
•
hunger
•
numbness around the lips and
tongue.
If not treated promptly, these may
progress to:
•
loss of co-ordination
•
slurred speech
•
confusion
•
fits or loss of consciousness.
Hyperglycaemia (high blood
glucose) usually occurs more slowly
than hypoglycaemia. Signs may
include:
•
lethargy or tiredness
•
headache
•
thirst
•
pass

Đặc tính sản phẩm

DIAPRIDE- Product Information
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION – DIAPRIDE (GLIMEPIRIDE)
TABLETS
1
NAME OF THE MEDICINE
Glimepiride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Diapride tablets come in four strengths and contain either 1 mg, 2 mg,
3 mg or 4 mg of glimepiride.
Excipients of known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
DIAPRIDE 1
1 mg: Pink, round tablet, G1 on one side and plain on the other.
DIAPRIDE 2
2 mg: Green, capsule-shaped tablet, G2, scoreline, G2 on one side and
scoreline on
the other.
DIAPRIDE 3
3 mg: Pale yellow, capsule-shaped tablet, G3, scoreline, G3 on one
side and scoreline
on the other.
DIAPRIDE 4
4 mg: Blue, capsule-shaped tablet, G4, scoreline, G4 on one side and
scoreline on the
other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
As an adjunct to diet, exercise and weight loss, to lower the blood
glucose in patients with noninsulin
dependent type 2 diabetes mellitus.
4.2
D
OSE AND METHOD OF ADMINISTRATION
In the management of type 2 diabetes mellitus, administration of an
oral antidiabetic agent is not a
substitute for appropriate dietary control.
In initiating treatment for type 2 diabetes mellitus, diet should be
emphasised as the primary form of
treatment. Caloric restriction and weight loss are essential in the
obese diabetic patient. Proper
DIAPRIDE- Product Information
Page 2 of 14
dietary management alone may be effective in controlling the blood
glucose and symptoms of
hyperglycaemia.
The
importance
of
regular
physical
activity
should
also
be
stressed,
and
cardiovascular risk factors should be identified and corrective
measures taken where possible.
If this treatment program fails to reduce symptoms and/or blood
glucose, the use of an oral
sulfonylurea should be considered. Use of glimepiride must be viewed
by both the physician and
patient as a treatment in addition to diet, and not as a substitute
for diet or as a convenient
mechanism for avoiding dietary restraint. Furt