Glimepiride 4mg Tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Glimepiride

可用日期:

Accord Healthcare Limited

ATC代码:

A10BB; A10BB12

INN（国际名称）:

Glimepiride

剂量:

4 milligram(s)

药物剂型:

Tablet

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Sulfonamides, urea derivatives; glimepiride

授权状态:

Marketed

授权日期:

2008-10-10

资料单张

Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size
Version No.
Date
-
Accord
Glimepiride
UK-IE
English
170 x 550 mm (PIL)
9
9 (Page 1 of 2) (IB026)
11_06_14 (
Glimepiride (ACC-UK-IE)NEW-IB026-VAR-PIL
)
Colours Used
Pantone Black
Prepared By
Regulatory Affairs
Checked By
Regulatory Affairs
Approved By
Quality Assurance
PACKAGE LEAFLET: INFORMATION FOR THE USER
GLIMEPIRIDE 1 MG TABLETS
GLIMEPIRIDE 2 MG TABLETS
GLIMEPIRIDE 3 MG TABLETS
GLIMEPIRIDE 4 MG TABLETS
GLIMEPIRIDE
Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your
doctor or pharmacist.
•
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Glimepiride Tablets is and what it is used for
2. What you need to know before you take
Glimepiride Tablets
3. How to take Glimepiride Tablets
4. Possible side effects
5. How to store Glimepiride Tablets
6. Contents of the pack and other information 1. WHAT GLIMEPIRIDE TABLETS IS
AND WHAT IT IS USED FOR
Glimepiride is an orally active blood sugar
lowering drug. This drug belongs to a blood sugar
lowering group of medicines called sulfonylureas.
Glimepiride works by increasing the amount of
insulin released from your pancreas. The insulin
then lowers your blood sugar levels.
WHAT GLIMEPIRIDE TABLETS IS USED FOR:
Glimepiride Tablets 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. 2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE GLIMEPIRIDE TABLETS
DO NOT TAKE GLIMEPIRIDE TABLETS AND TELL YOUR
DOCTOR IF:
•
You are allergic (hypersensit

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glimepiride 4mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg of glimepiride.
Each tablet contains 154.80 mg of lactose monohydrate.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White coloured oval shaped, uncoated tablet with score line on one
side & plain on other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Glimepiride is indicated for the treatment of type 2 diabetes
mellitus, when diet, physical exercise and weight reduction alone are
not adequate.
4.2 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.
Posology
The 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.
In patients not adequately controlled with the maximum daily dose of
metformin, concomitant glimepiride therapy can
be initiated.
While maintaining the metformin dose,
the glimepiride therapy is started with a low dose,
and is then
titrated up depending on the desired level of metabolic control up to
the maximum daily dose. The combination therapy
should be initiated under close medical sup