Gliclazide 80mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gliclazide

Available from:

Wockhardt UK 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: 5012727903385 5012727904740

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 80mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Gliclazide 80mg
Excipients with known effect
Lactose
For the full list excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
White, circular tablets with GZ80 and a breakline on one face and CP
on the
other.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non insulin-dependent diabetes mellitus (type 2) in adults when
dietary
measures, physical exercise and weight loss alone are not sufficient
to control
blood glucose.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
•
Initial dose_ _
_ _
The total daily dose may vary from 40 to 320mg taken orally. The dose
should be adjusted according to the individual patient’s response,
commencing
with 40-80mg daily (
1
/
2
– 1 tablet) and increasing until adequate control is
achieved. A single dose should not exceed 160mg (two tablets). When
higher
doses are required, gliclazide tablets should be taken twice daily
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.
• Switching from another oral antidiabetic agent to Gliclazide 80
mg:
Gliclazide 80 mg can be used to replace other oral antidiabetic
agents.
The dosage and the half-life of the previous antidiabetic agent should
be taken
into account when switching to Gliclazide 80 mg.
A transitional period is not generally necessary. A starting dose of
40-80 mg
(½ to 1 tablet) should be used and this should be adjusted to suit
the patient's
blood glucose response, as described above.
When switching from a hypoglycaemic sulfonylurea with a prolonged
half-
life, a treatment free period of a few days may be necessary to avoid
an
additive effect of the two products, which might cause hypoglycaemia.
• Combination treatment with other antidiabetic agents:
Gliclazide 80 mg can be given in combination with biguani