Glitisol 5mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GLIBENCLAMIDE

Available from:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC code:

A10BB01

INN (International Name):

GLIBENCLAMIDE 5 mg

Pharmaceutical form:

TABLET

Composition:

GLIBENCLAMIDE 5 mg

Prescription type:

POM

Therapeutic area:

DRUGS USED IN DIABETES

Authorization status:

Authorised

Authorization date:

2006-11-23

Patient Information leaflet

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PATIENT INFORMATION LEAFLET
GLITISOL GLIBENCLAMIDE
GLITISOL 5 Tablets 5mg
PLEASE READ CAREFULLY THIS LEAFLET BEFORE YOU START TAKING THE
MEDICINE.
-
Keep this leaflet in a safe place. You may need to read it again.
-
If you have any further questions ask your doctor or your
pharmacist.
-
This medicine was prescribed for you personally and you
should not pass it on to others. It can be harmful, even when
their symptoms are the same as yours.
COMPOSITION:
_Active substance:_ Glibenclamide_ _
_Excipients:_
Microcrystalline
Cellulose,
Povidone,
Lactose,
Maize
Starch,
Sodium
Starch
Glycollate,
Colloidal
Silicon
Dioxide,
Magnesium Stearate, Talc.
MARKETING LICENCE HOLDER & MANUFACTURER:
Remedica Ltd, Limassol Industrial Estate, Limassol, Cyprus, EU.
MARKETING LICENCE NUMBER:
Glitisol 5: 19878
1.
WHAT IS GLITISOL AND WHAT ARE ITS USES
Glibenclamide, the active ingredient of Glitisol, belongs to the group
of
medicines that are called antidiabetic (it belongs to the
sulfonylureas).
This medicine causes the pancreas to secrete more insulin thus helping
in the reduction of the amount of sugar in the blood. It is used for
the
treatment of certain types of diabetes mellitus.
Usually oral antidiabetics are used in adults that develop diabetes
after
the age of 30 years and who do not need insulin in order to control
their
sugar. We say that this type of diabetic person has non-insulin
dependent diabetes mellitus or Type II. Tablets taken orally do not
help
diabetics suffering from insulin-dependent diabetes or Type I
diabetes.
INDICATIONS:
Glitisol is indicated for the treatment of non-insulin dependent
diabetes
which does not respond sufficiently only to diet.
2.
WHAT YOU SHOULD KNOW BEFORE YOU TAKE GLITISOL
BE PARTICULARLY CAREFUL WITH GLITISOL.
Since it is contra-indicated or it should be used with caution in the
following cases please inform your doctor:
•
if you are allergic to glibenclamide or to any of the excipients of
the product.
•
if you are pregnant or if you intend to get

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
_1. NAME OF THE MEDICINAL PRODUCT _
Glitisol Tablets
_2. QUALITATIVE AND QUANTITATIVE COMPOSITION _
Glibenclamide 5 mg
For a full list of excipients see section 6.1.
_ _
_3. PHARMACEUTICAL FORM _
Tablets
_4. CLINICAL PARTICULARS _
_4.1. THERAPEUTIC INDICATIONS _
Glitisol is indicated for the treatment of diabetes in non-insulin
dependent patients who do not respond
adequately to dietary measures alone.
_4.2. POSOLOGY AND METHOD OF ADMINISTRATION _
_ _
Doses of 10mg or less may be taken as a single dose immediately before
breakfast or the main meal
but if the daily dose exceeds 10mg, it must be taken immediately
before the main meal. Elderly or
debilitated patients should receive one half a tablet daily. When
adequate control is achieved, the daily
dose of one tablet may be continued. If adequate control is not
achieved, the dose can be adjusted by
increments of one half or one tablet at weekly intervals. The total
daily dose should not exceed 3 tablets
daily. The total daily dose should be given as a single dose at
breakfast, or with the first main meal.
Patients receiving other antidiabetic drugs with the same mode of
action may be shifted to Glitisol
treatment without any break in therapy. Treatment is started with one
tablet daily and adjusted by
increments of one half to one tablet until adequate control is
achieved. Patients not responding to other
antidiabetics should receive the equivalent dose of Glitisol without
exceeding an initial dose of two
tablets. If response is inadequate, the daily dose may be increased
stepwise to 3 tablets. Change-over
from biguanides to Glitisol may be achieved by starting treatment with
one half a tablet daily and adjusted
by increments of 2.5mg until adequate control is achieved.
Glitisol may be combined with biguanides.
Some patients, especially those on low dose of insulin may be
transferred from insulin to Glitisol
treatment. Glitisol is not suitable for use in children.
_4.3. CONTRA-INDICATIONS