Gliclazide 80mg tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Gliclazide

MAH:

Genesis Pharmaceuticals Ltd

ATC_code:

A10BB09

INN:

Gliclazide

dosage:

80mg

pharmaceutical_form:

Oral tablet

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 06010201; GTIN: 5060014442031 5060014442024

PIL

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

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gliclazide Tablets BP 80mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gliclazide Tablets BP contain Gliclazide 80 mg.
3.
PHARMACEUTICAL FORM
Tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Gliclazide Tablets are used for the treatment of maturity onset
diabetes
mellitus.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Gliclazide Tablets are for oral administration.
Adults
The total daily dose may vary from 40-320 mg taken orally. The dose
should
be adjusted according to the 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 split dosage is advised and 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 should be considered.
Elderly
Plasma clearance of Gliclazide is not altered in the elderly and
steady state
plasma levels can therefore be expected to be similar to those in
adults under
65 years. There is evidence to indicate that Gliclazide is effective
and well
tolerated in elderly patients. Care should be exercised however, when
prescribing sulphonylureas in the elderly due to a possible age
related
increased tendency for hypoglycaemia.
Children
Gliclazide as with other sulphonylureas is not indicated for the
treatment of
juvenile onset diabetes mellitus.
4.3.
CONTRA-INDICATIONS
Gliclazide should not be used in juvenile onset diabetes, diabetes
complicated
by ketosis and acidosis, porphyria, during pregnancy and breast
feeding,
diabetics undergoing surgery, after severe trauma or during
infections, patients
with known hypersensitivity to Gliclazide or chemically related drugs
(including other sulphonylureas), diabetic pre-coma and coma and
severe renal
or hepatic insufficiency.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Care should be exercised in patients with hepatic