Vitile MR 30 mg modified-release tablets

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Gliclazide

Sẵn có từ:

Accord Healthcare Ireland Ltd.

Mã ATC:

A10BB; A10BB09

INN (Tên quốc tế):

Gliclazide

Liều dùng:

30 milligram(s)

Dạng dược phẩm:

Modified-release tablet

Khu trị liệu:

Sulfonamides, urea derivatives; gliclazide

Tình trạng ủy quyền:

Marketed

Ngày ủy quyền:

2015-05-22

Tờ rơi thông tin

1
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 pharmacist before tak

Đặc tính sản phẩm

Health Products Regulatory Authority
06 November 2020
CRN00C0FV
Page 1 of 8
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 under