Gliclazide 80mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gliclazide

Available from:

A A H 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; GTIN: 5025903003571 5025903003564

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 80mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gliclazide, BP 80.00 mg
For excipients, see 6.1
3
PHARMACEUTICAL FORM
Tablet
White, biscored, oblong tablet marked 'GLI 80' on one side
4
CLINICAL PARTICULARS
4.1_ _
THERAPEUTIC INDICATIONS_ _
Non insulin dependent diabetes (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
•
Initial dose
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 tablet) and increasing until adequate
control is
achieved. A single dose should not exceed 160 mg (2 tablets) and when
higher doses are required, a twice daily dosage is advised, which
should be
divided according to the main meals of the day.
In obese patients or those not showing adequate response to GLICLAZIDE
alone, additional therapy may be added.
•
Switching
from
another
oral
antidiabetic
agent
to
Gliclazide
80mg
tablets:
GLICLAZIDE 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.
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
can
be
given
in
combination
with
biguanides,
alpha
glucosidase inhibitors or insulin.
In patients not adequately controlled with GLICLAZIDE, concomitant
insulin
therapy can be initiated under close medica