Gliclazide 80mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gliclazide

Available from:

PLIVA Pharma 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

Gliclazide 80mg tablets
gliclazide
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
•
Your doctor has prescribed these tablets for you. Do not pass them 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 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
Gliclazide is one of a group of medicines called oral hypoglycaemics
which work by
reducing the level of sugar in the blood.
What are Gliclazide Tablets for?
Gliclazide is an antidiabetic medicine used to treat Type2
(non-insulin dependent)
diabetes. This is the type of diabetes that usually develops in
adulthood. This type of
diabetes is not severe enough to need insulin but does not respond to
dietary measures
alone.
2. BEFORE YOU TAKE GLICLAZIDE TABLETS
Do not take Gliclazide Tablets
•
if you have severe liver or kidney disease
•
if you are allergic (hypersensitive) to gliclazide or any of the other
ingredients of
Gliclazide Tablets or to sulphonylureas or related drugs with symptoms
such as skin
rash, hives, swelling of face, or throat or difficulty breathing.
•
if you have diabetic ketoacidosis (complication of diabetes with rapid
weigh loss,
nausea or vomiting), or have suffered a diabetic coma
•
if you are pregnant
•
if you have juvenile onset diabetes
•
if you have recently had or about to have surgery under general
anaesthetic after
severe trauma or infection. Your doctor will advise you when it is
safe to start taking
them again after the surgery
Tak

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