Normodiab 80mg Tablets

País: Malta

Idioma: inglés

Fuente: Malta Medicines Authority

Ingredientes activos:

GLICLAZIDE

Disponible desde:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Código ATC:

A10BB09

Designación común internacional (DCI):

GLICLAZIDE

formulario farmacéutico:

TABLET

Composición:

GLICLAZIDE

tipo de receta:

POM

Área terapéutica:

DRUGS USED IN DIABETES

Estado de Autorización:

Withdrawn

Fecha de autorización:

2012-04-30

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER 

NORMODIAB 80 MG TABLETS 

Gliclazide 

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. 
- 
This medicine has been prescribed for you. Do not pass
it 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 Normodiab is and what it is used for 
2. 
Before you take Normodiab 
3. 
How to take Normodiab 
4. Possible 
side 
effects 
5. 
  How to store Normodiab 
6. Further 
information 

1. 
WHAT NORMODIAB IS AND WHAT IT IS USED FOR 

Normodiab is a medicine that reduces blood sugar
levels (oral antidiabetic medicine belonging to the 
sulfonylurea group). 
Normodiab is used in a certain form of diabetes (type 2
diabetes mellitus) in adults, when diet, exercise and 
weight loss alone do not have an adequate
effect on keeping blood sugar at the correct level. 

2. 
BEFORE YOU TAKE NORMODIAB 

DO NOT TAKE NORMODIAB 
- 
if you are allergic (hypersensitive) to gliclazide, to any
of the other ingredients of Normodiab (see 
section 6 for a list of the ingredients) or
to other sulfonylureas and other related medicinal products 
(sulfonamides)  
- 
if you have insulin dependent (type 1) diabetes 
- 
if you have ketone bodies and sugar in your urine
(this may mean you have keto-acidosis), diabetic 
pre-coma or coma (usually a result of severe hypoglycaemia,
see “Take special care with Normodiab” 
and section 4) 
- 
if you have severe kidney or liver disease 
- 
if you are taking miconazole (a treatment for fungal
infe

Ficha técnica

 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Normodiab 80 mg tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains gliclazide 80 mg. 

For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Tablet. 

White, flat, round 8.0 mm tablet with bevelled-edges and a
central break line on both faces. On one face, “GZ” is 
engraved on either side of the break line. 
The tablet can be divided into equal halves. 

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 

Tablets for oral use. 
As with any hypoglycaemic agent, the dose should be adjusted
according to the individual patient's metabolic 
response (blood glucose, HbA
lc
). 
Normodiab tablets should be swallowed with a glass of water
preferably 30 minutes before a meal. 

_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, until a satisfactory metabolic control is
achieved. A single dose should not exceed 160 
mg (2 tablets). When higher doses are required, Normodiab should be
taken twice daily and in connection with 
the main meals of the day. 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 glycaemic control. 
For obese patients or those not showing adequate response
to gliclazide alone, additional therapy may be 
required. 

Page 1 of 8 
_Elderly _
The usual initial dose is 40 mg (half a tablet) be