Glimepiride 4mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Glimepiride

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

A10BB; A10BB12

INN (International Name):

Glimepiride

Dosage:

4 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

Sulfonamides, urea derivatives; glimepiride

Authorization status:

Not marketed

Authorization date:

2008-10-10

Patient Information leaflet

NL/H/3505/001-004/IB/042, ver 01, AUG 2023
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 medicine. This
medicine belongs to a blood sugar
lowering group of medicines called sulfonylurea. 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 are 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 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 this medicine (listed in section 6).
•
You have insulin dependent diabetes (type 1

Summary of Product characteristics

Health Products Regulatory Authority
11 September 2023
CRN00DKSR
Page 1 of 10
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
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
Dose 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 dose should be used for maintenance therapy.
For the different dose regimens appropriate strengths are available.
If control is unsatisfactory, the dose 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 dose 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 shoul