Gliclazide 80mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gliclazide

Available from:

Genus Pharmaceuticals Ltd

ATC code:

A10BB09

INN (International Name):

Gliclazide

Dosage:

80mg

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

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
GLICLAZIDE 80MG 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 any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do 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.
See section 4.
IN THIS LEAFLET:
1.
What Gliclazide Tablets are and what they are used for
2.
Before you take Gliclazide Tablets
3.
How to take Gliclazide Tablets
4.
Possible side effects
5.
How to store Gliclazide Tablets
6.
Further information
1. WHAT GLICLAZIDE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Gliclazide Tablets. Gliclazide Tablets
contain a medicine called gliclazide.
This
belongs to a group of medicines called ‘sulphonylureas’. It works
by controlling sugar (glucose) levels in the
blood.
Gliclazide Tablets are used for the sort of diabetes called ‘Type 2
diabetes’. This is when insulin is not needed,
but diet and exercise alone do not lower sugar levels in the blood.
People usually need treatment for diabetes for
the rest of their life.
2. BEFORE YOU TAKE GLICLAZIDE TABLETS
DO NOT TAKE GLICLAZIDE TABLETS IF:
•
you are allergic to gliclazide or any of the other ingredients in
Gliclazide Tablets (listed in section 6)
•
you are allergic to ‘sulphonylureas’, ‘sulphonamides’ or any
other similar medicines
•
you have used ‘sulphonylureas’ before, but they have stopped
working for you
•
you have ‘Type 1 diabetes’ (this is when you need to use insulin
to control your diabetes)
•
you have a very high blood sugar which is life threatening
(‘diabetic ketoacidosis’)
•
you are going to have an operation, have recently had a serious
accident or been very stressed
•
you have a serious infection
•
you have

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gliclazide 80 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg of gliclazide.
Excipient(s) with known effect:
This product contains lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White, flat, round tablets marked with a double score line on one side
and
‘3G5’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gliclazide tablets are indicated for the treatment of non insulin
dependent
diabetes mellitus.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
_Adults _
The total daily dose may vary from 40 to 320 mg taken orally. The dose
should be adjusted according to the individual patient’s response,
commencing
with 40-80 mg daily (½-1 tablets) and increasing until adequate
control is
achieved. A single dose should not exceed 160 mg (2 tablets). When
higher
doses are required, gliclazide should be taken twice daily and
according to the
main meals of the day.
In obese patients or those not showing adequate response to gliclazide
alone,
additional therapy may be required.
_Children _
Gliclazide, as with other sulphonylureas, is not indicated for the
treatment of
juvenile onset diabetes mellitus.
_Older people _
Plasma clearance of gliclazide is not altered in the older people and
steady
state plasma levels can therefore be expected to be similar to those
in adults
under 65 years. Clinical experience in the older people to date shows
that
gliclazide is effective and well tolerated. Care should be exercised,
however,
when prescribing sulphonylureas in the older people due to a possible
age-
related risk of hypoglycaemia.
In patients with mild to moderate renal impairment
In these patients, the same dosing regimen can be used as in patients
with
normal renal function with careful patient monitoring. These data have
been
confirmed in clinical trials.
In patients at risk of hypoglycaemia
Higher risk of hypoglycaemia exists in follo