Gliclazide MR 30 mg prolonged-release tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Gliclazide

Verfügbar ab:

Brillpharma (Ireland) Limited

ATC-Code:

A10BB; A10BB09

INN (Internationale Bezeichnung):

Gliclazide

Dosierung:

30 milligram(s)

Darreichungsform:

Prolonged-release tablet

Therapiebereich:

Sulfonamides, urea derivatives; gliclazide

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2014-09-12

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER GLICLAZIDE MR
30MG PROLONGED-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.
WHAT IS IN THIS LEAFLET
1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE
3. HOW TO TAKE THIS MEDICINE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE THIS MEDICINE
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
The name of your medicine is
Gliclazide MR 30mg prolonged-release tablets. The active
ingredient is Gliclazide. It reduces blood sugar levels (oral
antidiabetic medicine belonging to the
sulfonylurea group).
This medicine 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 THIS MEDICINE
DO NOT TAKE THIS MEDICINE

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 (sulfonylureas),
or to other related
medicines (hypoglycaemic sulfonamides);

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 “Taking other
medicines”);

if you are
BREASTFEEDIN
g (see sectio

Fachinformation

Health Products Regulatory Authority
19 October 2020
CRN009XR9
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gliclazide MR 30 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 30 mg of gliclazide
Excipients with known effect: Also contains 29 mg of lactose (in the
form of lactose monohydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged -release tablet
White to off white, capsule shaped, biconvex tablets debossed with
‘C12’ on one side and plain on the other side. The tablet
dimensions are 10.00 mm x 4.00 mm.
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, 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 Gliclazide MR tablets:
1 tablet of Gliclazide 80 mg is comparable to1 tablet of Gliclazide
MRtablets. Consequently the sw