Gliclazide 80mg tablets

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Gliclazide

Dostupné s:

Kent Pharma (UK) Ltd

ATC kód:

A10BB09

INN (Mezinárodní Name):

Gliclazide

Dávkování:

80mg

Léková forma:

Oral tablet

Podání:

Oral

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 06010201

Informace pro uživatele

1
CCRF22070
Seq: 0002
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GLICLAZIDE 80MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, 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.
IN THIS LEAFLET:
1.
What Gliclazide Tablets are and what they are used for
2.
What you need to know before you take Gliclazide Tablets
3.
How to take Gliclazide Tablets
4.
Possible side effects
5.
How to store Gliclazide Tablets
6.
Contents of the pack and other information
1. WHAT GLICLAZIDE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Gliclazide Tablets. Gliclazide Tablets
contain a medicine called gliclazide. This
belongs to a group of medicines called ‘sulphonylureas’. It works
by controlling sugar (glucose) levels in the
blood.
Gliclazide Tablets are used for the sort of diabetes called ‘Type 2
diabetes’. This is when insulin is not needed,
but diet and exercise alone do not lower sugar levels in the blood.
People usually need treatment for diabetes for
the rest of their life.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLICLAZIDE TABLETS
DO NOT TAKE GLICLAZIDE TABLETS IF:
•
if you are allergic to gliclazide or any of the other ingredients of
this medicine (listed in section 6)
•
if you are allergic to ‘sulphonylureas’, ‘sulphonamides’ or
any other similar medicines
•
if you have used ‘sulphonylureas’ before, but they have stopped
working for you
•
if you have ‘Type 1 diabetes’ (this is when you need to use
insulin to control your diabetes)
•
if you have a very high blood sugar which is life threatening
(‘diabetic ketoacid

Charakteristika produktu

1
NAME OF THE MEDICINAL PRODUCT
Gliclazide 80 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: gliclazide 80 mg.
Excipient(s): each tablet contains lactose monohydrate 33 mg.
For a full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White, round tablets with a breakline on one side.
The tablet can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of type 2 diabetes mellitus, inadequately controlled by
non-pharmacological means
(balanced diet and regular physical exercise).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Tablets for oral use.
The desired blood glucose levels and the Gliclazide dosage must be
determined
individually in relation to the degree of diabetes.
ADULTS: the usual initial dose is 40-80 mg/day (half to one tablet)
before
breakfast. If necessary, the dosage may be increased by 40-80 mg every
7-14
days, until a satisfactory metabolic control is achieved. The maximum
dose is
320 mg/day. The usual maintenance dose is 80-160 mg in two daily
administrations (before breakfast and before dinner); higher doses (up
to 320
mg/day) may be used, although it has not been demonstrated that the
increase of
doses over 160 mg/day necessarily leads to an improvement of glycemic
control.
ELDERLY: the usual initial dose is 40 mg (half tablet) before
breakfast,
increasing the dose of 40 mg every 7-14 days if necessary. Caution
should be
used when prescribing doses over 160 mg/day, particularly if renal
function is
impaired.
CHILDREN: Gliclazide is contraindicated in children (see section 4.3).
Gliclazide is not indicated in the treatment of type 1 diabetes
mellitus.
Gliclazide tablets must be swallowed without chewing preferably 30
minutes
before the meal.
4.3
CONTRAINDICATIONS
Gliclazide must not be used in:
- insulin-dependent (type 1) diabetes mellitus,
- diabetic ketoacidosis,
- diabetic pre-coma and coma,
- in patients with complete secondary failure to
sulphonylurea-therapy,
- in patients with severe renal and/or hepatic failu