Gliclazide Sandoz retard 30 mg, tabletten met gereguleerde afgifte

Pajjiż: Olanda

Lingwa: Olandiż

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

Ingredjent attiv:

GLICLAZIDE 30 mg/stuk

Disponibbli minn:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Kodiċi ATC:

A10BB09

INN (Isem Internazzjonali):

GLICLAZIDE 30 mg/stuk

Għamla farmaċewtika:

Tablet met verlengde afgifte

Kompożizzjoni:

CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; HYPROMELLOSE (Release controlling polymer)(E 464) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; NATRIUMSTEARYLFUMARAAT ; SILICIUMDIOXIDE (E 551),

Rotta amministrattiva:

Oraal gebruik

Żona terapewtika:

Gliclazide

Sommarju tal-prodott:

Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341); HYPROMELLOSE (Release controlling polymer)(E 464); LACTOSE 0-WATER; LACTOSE 1-WATER; NATRIUMSTEARYLFUMARAAT; SILICIUMDIOXIDE (E 551);

Data ta 'l-awtorizzazzjoni:

1900-01-01

Fuljett ta 'informazzjoni

Sandoz B.V.
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Gliclazide Sandoz retard 30 mg
RVG 105042
1313-v6
1.3.1.3 Bijsluiter
Oktober 2019
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GLICLAZIDE SANDOZ
® RETARD 30 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 [Nationally completed name] is and what it is used for
2. What you need to know before you take [Nationally completed name]
3. How to take [Nationally completed name]
4. Possible side effects
5. How to store [Nationally completed name]
6. Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR_ _
[Nationally completed name] is a medicine that reduces blood sugar
levels (an oral antidiabetic
medicine belonging to the sulphonylurea group).
[Nationally completed name] 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 [NATIONALLY COMPLETED NAME]_
_
_ _
DO NOT TAKE [NATIONALLY COMPLETED NAME]:
•
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 COM

Karatteristiċi tal-prodott

Sandoz B.V.
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Gliclazide Sandoz retard 30 mg
RVG 105042
1311-V4
1.3.1.1 Samenvatting van de Productkenmerken
Oktober 2019
1.3.1 SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gliclazide Sandoz retard 30 mg, tabletten met gereguleerde afgifte
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified release tablet contains 30mg of gliclazide.
Excipient with known effect
Each modified release tablet contains 48 mg of lactose spray dried.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified release tablet
White, oval, biconvex tablet, imprinted with “GLI 30” on one side.
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 TABLETS CONTAINING 80 MG OF GLICLAZIDE TO [NATIONALLY
COMPLETED NAME] MODIFIED
RELEASE TABLETS:
Sandoz B.V.
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Gliclazide Sandoz retard 30 mg
RVG 105042
1311-V4
1