Azildor 60mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GLICLAZIDE

Available from:

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

ATC code:

A10BB09

INN (International Name):

GLICLAZIDE 60 mg

Pharmaceutical form:

MODIFIED-RELEASE TABLET

Composition:

GLICLAZIDE 60 mg

Prescription type:

POM

Therapeutic area:

DRUGS USED IN DIABETES

Authorization status:

Withdrawn

Authorization date:

2015-05-14

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AZILDOR 30 MG MODIFIED-RELEASE TABLETS
AZILDOR 60 MG MODIFIED-RELEASE TABLETS
Gliclazide
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 Azildor is and what it is used for
2.
What you need to know before you take Azildor
3.
How to take Azildor
4.
Possible side effects
5.
How to store Azildor
6.
Contents of the pack and other information
1.
WHAT AZILDOR IS AND WHAT IT IS USED FOR
Azildor is a medicine that reduces blood sugar levels (oral
anti-diabetic medicine belonging to the
sulphonylurea group).
Azildor 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 AZILDOR
DO NOT TAKE AZILDOR:
-
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 Azildor’)
-
if you are breastfeeding (see Section ‘Pregnancy and
breastfeeding’).
WARNINGS AND PRECAUTIONS
Talk to your doct

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Azildor 30 mg modified-release tablets
Azildor 60 mg 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).
Each modified-release tablet contains 60 mg gliclazide.
Excipient with known effect:
Each modified-release tablet contains 108 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.
Azildor 30 mg modified-release tablets are white, oval, biconvex 5 x
11 mm tablets marked “G” on
one side.
Azildor 60 mg modified-release tablets are white, oval, biconvex 7 x
15 mm tablets scored on both
sides, marked with “G” on one side of the score and “60” on
the other side of the score. The tablet
can be divided into equal doses.
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.
The daily dose may vary from one half to 2 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).
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_Initial dose _
The recommended starting dose is 30 mg daily.
The recommended starting dose is 30 mg daily (half a 60 mg tablet).
If blood glucose is effectively controlled, this dose may be used for
maintenance treatment. If blood
glucose is not adequately controlled