Glimepiride 3mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Glimepiride

Available from:

Accord-UK Ltd

ATC code:

A10BB12

INN (International Name):

Glimepiride

Dosage:

3mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010201; GTIN: 5060149311615

Patient Information leaflet

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 (hypersensitive) 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 what Glimepiride
tablets contains).
• You have insulin dependent diabetes
(type 1 diabetes mellitus)
• You have diabetic ketoacidosis ( a complication of
diabetes when your acid level is raised in your body
and you may have some of

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Glimepiride 3 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 3 mg of glimepiride.
Each tablet contains 155.70 mg of lactose monohydrate.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Tablet.
GLIMEPIRIDE TABLETS 1 MG: Pink coloured round, flat uncoated tablets
with bevelled edges
and score line one side & plain on other side.
GLIMEPIRIDE TABLETS 2 MG: Light pink coloured oval shaped, uncoated
tablets with score line
on one side & plain on other side.
GLIMEPIRIDE TABLETS 3 MG: Pale yellow, oval shaped uncoated tablets
with score line one
side & plain on other side.
GLIMEPIRIDE TABLETS 4 MG: 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 glim