Gliclazide 80mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gliclazide

Available from:

Arrow Generics 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; GTIN: 5060034830481

Patient Information leaflet

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• New regulatory text
PACKAGE LEAFLET: INFORMATION FOR THE USER GLICLAZIDE 80MG TABLETS
Gliclazide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE 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
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 Gliclazide 80mg Tablets are and what they are used for
2.
What you need to know before you take Gliclazide 80mg Tablets
3.
How to take Gliclazide 80mg Tablets
4.
Possible side effects
5.
How to store Gliclazide 80mg Tablets
6.
Contents of the pack and other information
1.
WHAT GLICLAZIDE 80MG TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Gliclazide 80mg Tablets. These tablets
contain
the active substance gliclazide, one of group of medicines called
sulphonylureas.
Gliclazide is an oral hypoglycaemic medicine (blood sugar lowering
drug), it is
used to keep blood sugar at the correct level in adults with
non-insulin
dependent diabetes when it is not controlled by diet, physical
exercise and
weight loss alone.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLICLAZIDE 80MG TABLETS
DO NOT TAKE GLICLAZIDE 80MG TABLETS:
•
if you are allergic to gliclazide or any of the other ingredients in
Gliclazide
80mg Tablets (listed in section 6), to other medicines of the same
group
(sulphonylureas), to other related medicines (hypoglycaemic
sulphonamides)
•
if you have insulin dependent diabetes (type I)
•
if you have ketone bodies and sugar in your urine (this may mean you
have
keto-acidosis), a diabetic pre-coma or coma

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