Diaclide MR 30 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:

30 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:

2009-07-24

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DIACLIDE MR 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.
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 is a medicine to reduce blood sugar levels (oral
antidiabetic medicine belonging to
the sulfonylurea group of medicines).
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIACLIDE MR
DO NOT TAKE DIACLIDE MR
•
if you are allergic to gliclazide or to any of the other ingredients
of this medicine (listed in
section 6), or to other medicines of the same group (sulfonylureas),
or to other related
medicines (hypoglycaemic sulfonamides),
•
if you have insulin-dependent (type 1) diabetes,
•
if you have ketone bodies and sugar in the urine (this may mean you
have diabetic keto-
acidosis), 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 Diaclide MR’
)
•
if you are breast feeding.
If you think any of the above situations applies to you, tell your
doctor or pharmacist.
WARNINGS AND PRECA

Summary of Product characteristics

Health Products Regulatory Authority
10 March 2021
CRN00C4H7
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diaclide MR 30 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 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 to almost white, oval, slightly
biconvex (length: 11 mm x width: 5.5 mm) with bevelled
edges.
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 without
chewing or crushing.
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 Diaclide MR 30 mg modified-release tablets
1 tablet of gliclazide 80 mg is comparable to 1 modified-release