Diaclide MR 60 mg modified-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Gliclazide

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

A10BB; A10BB09

INN (International Name):

Gliclazide

Dosage:

60 milligram(s)

Pharmaceutical form:

Modified-release tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Sulfonamides, urea derivatives; gliclazide

Authorization status:

Marketed

Authorization date:

2015-02-13

Patient Information leaflet

Page
21
of
27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DIACLIDE MR 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 Diaclide MR is and what it is used for
2.
What you need to know before you take Diaclide MR
3.
How to take Diaclide MR
4.
Possible side effects
5.
How to store Diaclide MR
6.
Contents of the pack and other information
1.
WHAT DIACLIDE MR IS AND WHAT IT IS USED FOR
Diaclide MR contains the active substance gliclazide.
Gliclazide is a medicine that reduces blood sugar levels (oral
antidiabetic medicine belonging to the
sulfonylurea group).
Diaclide MR 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 DIACLIDE MR
DO NOT TAKE DIACLIDE MR:
-
if you are allergic to gliclazide or any of the other ingredients of
this medicine (listed in section 6).
-
if you are allergic to other medicines of the same group
(sulfonylureas i.e. glipizide), or to other related
medicines (sulfonamides i.e. hydrochlorothiazide)
-
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 miconazole to treat fungal infections (see section
Other medicines and Diaclide MR")
-
if you are breast-feeding (see se

Summary of Product characteristics

Health Products Regulatory Authority
01 December 2022
CRN00D46V
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diaclide MR 60 mg modified-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 60 mg of gliclazide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release tablet
A white to offwhite, oblong biconvex tablet, debossed with M on left
side of the breakline on one side and GL on left side of
the breakline, 60 on the right side of the breakline onother side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Diaclide MR is indicated for 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 of Diaclide MR 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.
It is recommended to swallow the dose without crushing or chewing.
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 (half a tablet of
Diaclide MR). 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.
One gliclazide 60 mg modified release tablet is equivalent to two
gliclazide 30 mg modified release tablets. The breakability