Glimepiride 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Glimepiride

Available from:

Bristol Laboratories Ltd

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: 5060013941764

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
GLIMEPIRIDE 1MG, 2MG, 3MG AND 4MG TABLETS
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, 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 signs of illness are
the same as
y o u r s .
•
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 are and what they are 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 ARE AND WHAT THEY ARE USED FOR
•
The name of your medicine is Glimepiride 1mg or 2mg or 3mg or 4mg
tablets.
The active ingredient is Glimepiride
•
Glimepiride belongs to a group of medicines called oral sulphonylurea,
which
helps to control blood sugar levels.
•
Glimepiride works by increasing the amount of insulin released from
your
pancreas. The insulin then lowers your blood sugar levels.
•
Glimepiride 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 THESE TABLETS IF YOU:
•
have ever had an allergic reaction to glimepiride, any of the
ingredients (these
are listed in Section 6,), other sulphonylureas (e.g. glibenclamide,
gliclazide,
tolbutamide) or sulphonamides (e.g. sulfamethoxazole). An allergic
reaction
may include a rash, itching, difficulty breathing or swelling of the
face, lips,
throat or tongue.
•
have insulin dependant

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Glimepiride 1mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Glimepiride 1mg
Excipient with known effect: Also contains lactose monohydrate 74.15mg
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet.
Pink 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 daily