Glimepiride 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Glimepiride

Available from:

Somex Pharma

ATC code:

A10BB12

INN (International Name):

Glimepiride

Dosage:

1mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010201; GTIN: 15060089610257

Patient Information leaflet

PATIENT INFORMATION LEAFLET
GLIMEPIRIDE 1MG, 2MG, 3MG AND 4MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE.
!
Keep this leaflet. You may need to read it
again.
!
If you have further questions, please ask your
doctor or your pharmacist.
!
This medicine has been prescribed for you
personally and you should not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
!
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Glimepiride Tablets are and what they
are used for
2.
Before you take Glimepiride Tablets
3.
How to take Glimepiride Tablets
4.
Possible side effects
5.
Storing Glimepiride Tablets
6.
Further Information
Glimepiride is one of a group of medicines called
sulphonylurea hypoglycaemics, which are used
for the treatment of diabetes by helping to control
blood sugar levels (glucose). Diabetes is a
condition where the body does not produce
enough insulin to control the level of blood
glucose.
Glimepiride Tablets are used to treat non-insulin
dependent (Type II) diabetes mellitus, in addition
to a recommended diet, regular physical exercise
and weight reduction when these have not worked
on their own.
DO NOT TAKE GLIMEPIRIDE TABLETS IF YOU:
!
are allergic (hypersensitive) to glimepiride,
any of the other ingredients (listed in Section
6) or to other oral sulphonylurea anti-diabetics
or sulphonamide antibiotics
!
have type I insulin-dependent diabetes
!
have suffered from confusion, fainting or
coma as a result of your diabetes
!
have been told by your doctor you have
'ketoacidosis' (your breath may smell of pear
drops)
!
have severe kidney or liver disease, as your
diabetes will need to be treated with insulin
!
are pregnant or breastfeeding.
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE
TAKING THE TABLETS IF:
!
you are suffering from an infection with or
without fever
!
you have had a recent accident, are to have
an operation or other

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Glimepiride 1 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg glimepiride
For excipients see section 6.1
3.
PHARMACEUTICAL FORM
Tablet
The tablet is pink, flat, oblong tablets with bevelled edges and a
score on one
side and marked with “G” on the other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Glimepiride Tablet 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 use.
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.
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 may 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 daily dose. The combination therapy should
be
initiated under close medical supervision.
In patients not adequately controlled with the maximum daily dose of
Glimepiride Tablet, concomitant insulin therapy can be initiated if
necessary.
While maintaining the glimepiride dose, insulin treatment is started
at low
do