Diaglyc 30 mg modified-release tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Gliclazide

Dostupno od:

Teva Pharma B.V.

ATC koda:

A10BB; A10BB09

INN (International ime):

Gliclazide

Doziranje:

30 milligram(s)

Farmaceutski oblik:

Modified-release tablet

Tip recepta:

Product subject to prescription which may be renewed (B)

Područje terapije:

Sulfonamides, urea derivatives; gliclazide

Status autorizacije:

Marketed

Datum autorizacije:

2008-08-01

Uputa o lijeku

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIAGLYC 30 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 Diaglyc is and what it is used for
2.
What you need to know before you take Diaglyc
3.
How to take Diaglyc
4.
Possible side effects
5.
How to store Diaglyc
6.
Contents of the pack and other information
1.
WHAT DIAGLYC IS AND WHAT IT IS USED FOR
Diaglyc is a medicine that reduces blood sugar levels (oral
antidiabetic medicine belonging to the
sulfonylurea group).
Diaglyc 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 DIAGLYC
DO NOT TAKE DIAGLYC
-
if you are allergic to gliclazide, to other medicines of the same
group (sulfonylureas), to other
related medicines (sulfonamides) or any of the other ingredients of
this medicine (listed in
section 6),
-
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 Diaglyc’),
-
if you are breast-feeding (see section ‘Pregnancy and
breast-feeding’).
If you think any of the above situations applies to you, tell your
doctor or pharmacist.
WARNINGS AND PRECAUTION

Svojstava lijeka

Health Products Regulatory Authority
25 January 2022
CRN00CKKV
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diaglyc 30 mg modified-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains 30 mg gliclazide.
Excipient(s) with know effect:
Each modified-release tablet contains 73.5 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release tablet.
The modified-release tablets are white, oval, biconvex.
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.
It is recommended that the tablet(s) be swallowed whole.
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, HbA
1C
).
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 (immediate release
formulation) to Diaglyc 30 mg Modified-release Tablets
1 tablet of gliclazide 80 mg is comparable to 1 modified-release
tablet of Diaglyc 30 mg Modified-release Tablets.
Consequently, the switch can be performed provided a carefu