Glimepiride 4mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Glimepiride

Available from:

Phoenix Healthcare Distribution Ltd

ATC code:

A10BB12

INN (International Name):

Glimepiride

Dosage:

4mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010201

Patient Information leaflet

Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size
Version No.
Date
-
Accord
Glimepiride
UK-IE
English
170 x 550 mm (PIL)
9
10 (Page 1 of 2) (IB026)
25/07/14 (
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 (hypersensi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Glimepiride 4mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Glimepiride 4mg
Excipient with known effect: Also contains lactose monohydrate
146.30mg
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets.
Blue coloured, elongated with notch in center, flat bevelled edged,
uncoated tablets
with “B” & “L” embossing on either side of breakline on one
side & only breakline
on other side.
The breakline 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
Posology
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 can
not 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.
In
patients
not
adequately
controlled
with
the
maximum
daily
dose
of
metformin, concomitant glimepiride therapy can be initiated.
While maintaining the metformin dose, 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 dail