Gliclazide Sandoz retard 60 mg, tabletten met gereguleerde afgifte

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

GLICLAZIDE 60 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

A10BB09

INN (Algemene Internationale Benaming):

GLICLAZIDE 60 mg/stuk

farmaceutische vorm:

Tablet met gereguleerde afgifte

Samenstelling:

CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; HYPROMELLOSE (Release controlling polymer)(E 464) ; HYPROMELLOSE, type 2208 (Release controlling polymer), K4M (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Gliclazide

Product samenvatting:

Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341); HYPROMELLOSE (Release controlling polymer)(E 464); HYPROMELLOSE, type 2208 (Release controlling polymer), K4M (E 464); MAGNESIUMSTEARAAT (E 470b); POVIDON K 30 (E 1201);

Autorisatie datum:

2016-02-15

Bijsluiter

Sandoz B.V.
Page 1/8
Gliclazide Sandoz retard 60 mg, tabletten met
gereguleerde afgifte
RVG 116611
1313-v2
1.3.1.3 Bijsluiter
Oktober 2019
PACKAGE LEAFLET: INFORMATION FOR THE USER
GLICLAZIDE SANDOZ RETARD 60 MG, TABLETTEN MET GEREGULEERDE AFGIFTE
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 Gliclazide Sandoz is and what it is used for
2. What you need to know before you take Gliclazide Sandoz
3. How to take Gliclazide Sandoz
4. Possible side effects
5. How to store Gliclazide Sandoz
6. Contents of the pack and other information
1. WHAT GLICLAZIDE SANDOZ IS AND WHAT IT IS USED FOR
Gliclazide Sandoz is a medicine that reduces blood sugar levels (an
oral antidiabetic medicine
belonging to the sulphonylurea group).
Gliclazide Sandoz 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 GLICLAZIDE SANDOZ
DO NOT TAKE GLICLAZIDE SANDOZ:
•
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

Productkenmerken

Sandoz B.V.
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Gliclazide Sandoz retard 60 mg, tabletten met
gereguleerde afgifte
RVG 116611
1313-v3
1.3.1.1 SmPC
Juni 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gliclazide Sandoz retard 60 mg, tabletten met gereguleerde afgifte
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains gliclazide 60 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified-release tablet.
White to off-white oval shape, uncoated tablet, 13.5 mm long, 6.5 mm
wide and 4.2 mm thick,
with break line on both the surface and debossed '60' on one side of
the break line on one surface.
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
osology For adult use only.
The daily dose of Gliclazide Sandoz may vary from one half to two
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
Gliclazide Sandoz).
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.
Sandoz B.V.
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