Glibenclamide Tablets 5mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GLIBENCLAMIDE

Available from:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

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:

Withdrawn

Authorization date:

2006-08-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
GLIBENCLAMIDE 2.5MG TABLETS/
GLIBENCLAMIDE 5MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE THIS
MEDICINE.
- Keep this leaflet. You may need to read it again while you are
receiving your treatment.
- If you have any further questions, please ask your doctor or
pharmacist.
- This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1. What Glibenclamide Tablets are and what they are used for
2. Before you take Glibenclamide Tablets
3. How to take Glibenclamide Tablets
4. Possible side effects
5. How to store Glibenclamide Tablets
6. Further information
1. WHAT GLIBENCLAMIDE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Glibenclamide Tablets. These tablets
belong to a group of medicines called
sulphonylureas.
Glibenclamide Tablets are used to lower blood sugar levels and are
used in the treatment of late-onset
diabetes (type II diabetes mellitus) in patients whose blood sugar is
not controlled by diet alone and who are
not suitable for insulin injections.
2. BEFORE YOU TAKE GLIBENCLAMIDE TABLETS
YOU SHOULD NOT TAKE GLIBENCLAMIDE TABLETS IF YOU:
• are allergic (hypersensitive) to glibenclamide, other
sulphonylureas or any of the other ingredients in
Glibenclamide Tablets (see section 6, Further information)
• suffer from early onset or type I diabetes (requiring insulin)
• suffer from severe kidney disease
• suffer from liver problems
• are suffering from ketoacidosis (caused by excessively high blood
sugars in diabetics)
• are suffering from a severe infection
• are suffering from stress
• are suffering from any condition likely to make controlling your
blood sugar difficult
• are due to undergo surgery
• are pregnant
• have reduced consciousness or coma resulting from your

Summary of Product characteristics

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Glibenclamide 5mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glibenclamide 5.0mg_ _
3.
PHARMACEUTICAL FORM
Tablet
White dragee-shaped tablets marked CP on one face and GL and 5 on
either
side of a breakline on the other face.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Glibenclamide is a hypoglycaemic agent indicated in the treatment of
non-
insulin dependent diabetes in patients who respond inadequately to
dietary
measures alone.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_Treatment of previously untreated diabetes: _
Stabilisation can be started with one 5mg tablet daily with or
immediately after
breakfast or the first main meal. If control is satisfactory one
tablet is
continued as the maintenance dose. If control is unsatisfactory, the
dose can be
adjusted by increments of 2.5 or 5mg at weekly intervals. The total
daily
dosage rarely exceeds 15mg and increasing the daily dosage above this
does
not generally produce any additional affect.
The total daily requirement should normally be given as a single dose
at
breakfast, or with the first main meal. The patients diet and activity
should be
taken into account.
Children: Glibenclamide is not recommenced for use in children.
In debilitated patients_ _who may be more liable to hypoglycaemia,
treatment
should be initiated with one 2.5mg tablet daily._ _
Page 2 of 7
_Changeover from other sulphonylureas: _
The changeover to glibenclamide from other drugs with similar modes of
action
can be carried out without any break in therapy.
Treatment is commenced with the equivalent dose of glibenclamide
without
exceeding an initial dose of 10mg. If response is inadequate, the dose
can be
raised in a stepwise fashion to 15mg daily. One 5mg tablet of
glibenclamide is
approximately equivalent to 1g tolbutamine or glymidine, 250mg
chlorpropamide or tolazamide, 500mg acetohexamide, 25mg glibornuride
or
5mg glipizide.
Changeover from biguanides: The biguanide should be withdrawn and
g