Medoclazide

Country: Malta

Bahasa: Inggeris

Sumber: Medicines Authority

Bahan aktif:

GLICLAZIDE

Boleh didapati daripada:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

Kod ATC:

A10BB09

INN (Nama Antarabangsa):

GLICLAZIDE

Borang farmaseutikal:

TABLET

Komposisi:

GLICLAZIDE

Jenis preskripsi:

POM

Kawasan terapeutik:

DRUGS USED IN DIABETES

Status kebenaran:

Authorised

Tarikh kebenaran:

2007-03-13

Risalah maklumat

MEDOCHEMIE LTD gliclazpil1.1doc
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MEDOCLAZIDE 80MG 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.
IN THIS LEAFLET
:
1.
What MEDOCLAZIDE is and what it is used for
2.
Before you take What you need to know before you take MEDOCLAZIDE
3.
How to take MEDOCLAZIDE
4.
Possible side effects
5.
How to store MEDOCLAZIDE
6.
Contents of the pack and other information
1.
WHAT MEDOCLAZIDE IS AND WHAT IT IS USED FOR
MEDOCLAZIDE is a medicine that reduces blood sugar levels (oral
antidiabetic medicine belonging to the
sulphonylurea group).
MEDOCLAZIDE 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 MEDOCLAZIDE
DO NOT TAKE MEDOCLAZIDE IF:
•
you are allergic (hypersensitive) to gliclazide or any of the other
ingredients of MEDOCLAZIDE or
other related drugs that are blood sugar lowering medicines ,
so-called sulphonylurea derivatives
•
you have ketoacidosis (acid poisoning caused by diabetes),
•
you are in a diabetic coma (unconsciousness resulting from not well
controlled or untreated diabetes)
MEDOCHEMIE LTD gliclazpil1.1doc
2
•
you have severe kidney or liver disease,
•
you suffer from juvenile onset diabetes
•
you are pregnant, plan to become pregnant or you are breast feeding
•
you are diabetic and you are suffering from infection or severe trauma
or undergoing surgical
proced

Ciri produk

 
Page 1 of 8 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. TRADE NAME OF THE MEDICINAL PRODUCT  

   “Medoclazide” 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION  

    Each tablet contains 80 mg gliclazide 

3. PHARMACEUTICAL FORM 

    Modified release tablet 

CLINICAL PARTICULARS 

4.1. THERAPEUTIC INDICATIONS 

        “Medoclazide” is indicated
for the therapy of maturity onset diabetes mellitus as a 
        supplement to dietary modification where
such modification has proven ineffective on its 
        own. 

 4.2. POSOLOGY AND METHOD OF ADMINISTRATION 

“Medoclazide” tablets are for oral administration only. 

_Adult:_ 
The dosage requires adjustment according to the
response of the individual patient. Dosage 
should be initiated at 80 mg (one tablet) per day and
subsequently increased until adequate   control 
of the condition is established. The daily dosage necessary to
achieve adequate control may vary 
from 80 mg to 320 mg. A single dosage of 160 mg (two tablets)
should not be exceeded. In cases 
where a higher daily dosage is required the dose should be
administered as two equal doses 
corresponding to the main daily meals. 

Page 2 of 8 

_Children:_ 
In common with other sulphonylurea drugs, “Medoclazide”  is
not indicated for the therapy of 
juvenile onset diabetes mellitus. 

_Elderly:_ 
There is no evidence of alteration of
gliclazide plasma clearance rates in the elderly, and steady 
state plasma levels can be anticipated to
be equivalent to those obtained in adults. Caution should be 
exercised due to the possibility of an age related increased
risk of hypoglycaemia. Caution should 
also be exercised in elderly patients with hepatic
or renal impairment. 

_Hepatic impairment:_ 
Caution should be exercised
in patients with mild to moderate hepatic