Glimepiride 2mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Glimepiride

Commercializzato da:

Mawdsley-Brooks & Company Ltd

Codice ATC:

A10BB12

INN (Nome Internazionale):

Glimepiride

Dosaggio:

2mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 06010201

Foglio illustrativo

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

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Glimepiride 2 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg of glimepiride.
Each tablet contains 156.765 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 gli