Bilxona 30mg Modified-release Tablets

Country: Ingilterra

Lingwa: Ingliż

Sors: myHealthbox

Ingredjent attiv:

gliclazide

Disponibbli minn:

Actavis Group PTC ehf

Kodiċi ATC:

A10BB09

INN (Isem Internazzjonali):

gliclazide

Dożaġġ:

30mg

Għamla farmaċewtika:

Modified-release tablet

Rotta amministrattiva:

Oral use

Unitajiet fil-pakkett:

Blisters: 10, 14, 28, 30, 56, 60, 90, 120, 180 modified-release tablets; Containers: 90, 120, 180 modified-release tablets

Tip ta 'preskrizzjoni:

POM - Prescription Only Medicine

Manifatturat minn:

Balkanpharma-Dupnitsa AD

Grupp terapewtiku:

A10BB09

Indikazzjonijiet terapewtiċi:

Non insulin-dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2015-03-01

Fuljett ta 'informazzjoni

BILXONA 30MG AND 60MG  
MODIFIED-RELEASE TABLETS
Gliclazide
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AAAH8060
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.
WHAT IS IN THIS LEAFLET
1

 WHAT BILXONA IS AND WHAT IT IS USED FOR
2

 WHAT YOU NEED TO KNOW BEFORE YOU TAKE BILXONA
3

 HOW TO TAKE BILXONA
4

 POSSIBLE SIDE EFFECTS
5

 HOW TO STORE BILXONA
6

 CONTENTS OF THE PACK AND OTHER INFORMATION
1

 WHAT BILXONA IS AND WHAT IT IS USED FOR
Bilxona is a medicine that reduces blood sugar levels (oral anti-
diabetic medicine belonging to the sulphonylurea group).
Bilxona 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

 WHAT YOU NEED TO KNOW BEFORE YOU TAKE BILXONA
DO NOT TAKE BILXONA:
•  if you are allergic to gliclazide or any of the other
ingredients 
of this medicine (listed in section 6), or to other medicines of 
the same group (sulphonylureas), or to other related medicines 
(hypoglycaemic sulphonamides)
•  if you have insulin-dependent diabetes (type 1)
•  if you have ketone bodies and sugar in your urine (this may
mean 
you have diabetic keto-acidosis), a diabetic pre-coma or coma
•  if you have severe kidney or liver disease
•  if you are taking medicines to treat fungal infections
(miconazole, 
see section ‘Other medicines and Bilxona’)
•�

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Bilxona 30mg Modified-release Tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each modified-release tablet contains 30 mg gliclazide.  

Excipient with known effect: 
Each modified-release tablet contains 54 mg lactose (as the
monohydrate) (see 
section 4.4) 

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Modified-release tablet. 

Bilxona 30mg Modified-release Tablets are white, oval, biconvex 5 x
11 mm tablets 
marked “G” 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 
The daily dose may vary from 1 to 4 tablets per day, _i.e_.
from 30 to 120 mg taken 
orally in a single intake at breakfast time.  

If a dose is forgotten, there must be no increase in the dose
taken the next day.  

As with any hypoglycaemic agent, the dose should
be adjusted according to the 
individual patient's metabolic response (blood glucose, HbAlc).  

_Initial dose  _
The recommended starting dose is 30 mg daily.  

If blood glucose is effectively controlled, this dose may be
used for maintenance 
treatment. If blood glucose is not adequately controlled, the dose
may be increased to 
60, 90 or 120 mg daily, in
successive steps. The interval between each dose increment 
should be at least 1 month except in patients whose blood
glucose has not reduced 
after two weeks of treatment. In such cases, the dose may be
increased at the end of 
the second week of treatment.  

The maximum recommended daily dose is 120 mg.  

_Switching from gliclazide 80 mg tablets to Bilxona 30mg
modified-release t