Vitile MR 30 mg Modified Release Tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Gliclazide

Tilgængelig fra:

Actavis Group PTC ehf

ATC-kode:

A10BB; A10BB09

INN (International Name):

Gliclazide

Dosering:

30 milligram(s)

Lægemiddelform:

Modified-release tablet

Indgivelsesvej:

Oral use

Enheder i pakken:

Blisters: 10, 14, 28, 30, 56, 60, 90, 120, 180

Recept type:

Product subject to prescription which may be renewed (B)

Fremstillet af:

Actavis ehf, Balkanpharma-Dupnitsa AD

Terapeutisk gruppe:

Blood glucose lowering drugs, excl. insulins: Sulfonylureas

Terapeutisk område:

Sulfonamides, urea derivatives; gliclazide

Terapeutiske indikationer:

Non insulin-dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose.

Autorisation status:

Marketed

Autorisation dato:

2015-05-22

Indlægsseddel

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VITILE 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.
WHAT IS IN THIS LEAFLET
1.
What Vitile MR is and what it is used for
2.
What you need to know before you take Vitile MR
3.
How to take Vitile MR
4.
Possible side effects
5.
How to store Vitile MR
6.
Contents of the pack and other information
1.
WHAT VITILE MR IS AND WHAT IT IS USED FOR
Vitile MR is a medicine that reduces blood sugar levels (oral
anti-diabetic medicine belonging to the
sulphonylurea group).
Vitile 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 VITILE MR
DO NOT TAKE VITILE MR:
-
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 taking medicines to treat fungal infections (miconazole,
see section ‘Other medicines
and Vitile MR’)
-
if you are breastfeeding (see Section ‘Pregnancy and
breastfeeding’).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pha

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vitile 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 54 mg lactose (as the
monohydrate) (see section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release tablet.
Vitile MR 30 mg modified-release tablets are white, oval, biconvex 5 x
11 mm tablets marked “G” 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.
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 Vitile MR 30mg
modified-release tablets_
1 tablet of gliclazide 80 mg is comparable to 1 tablet of Vitile MR 30
mg modified-release. Consequently, the switch
can be performed provided careful blood monitoring is undertaken.
_Switching from another oral anti-diabetic agent to Vitile MR_
Vitile