Glibenclamide 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Glibenclamide

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

A10BB01

INN (International Name):

Glibenclamide

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010201

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

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Glibenclamide 5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glibenclamide 5mg
For excipients, see 6.1
3
PHARMACEUTICAL FORM
Tablet for oral use
Glibenclamide 5mg Tablets are white, dragee shaped tablets marked
‘GL’ and
‘5’ on either side of a break-line on one face and plain on the
reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Glibenclamide is a hypoglycaemic agent indicated in the treatment of
noninsulin 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 effect.
The total daily requirement should normally be given as a single dose
at
breakfast, or with the first main meal. The patient’s diet and
activity should be
taken into account.
Children: Glibenclamide is not recommenced for use in children.
Elderly: In debilitated patients or aged patients who may be more
liable to
hypoglycaemia, treatment should be initiated with one 2.5mg tablet
daily.
_Changeover from other sulphonylureas: _
The changeover to glibenclamide from other drugs with similar mode 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.