Glibenclamide 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Glibenclamide

Available from:

IVAX Pharmaceuticals UK 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 BP
Liamid 5mg Tablets,
Gliken 5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Glibenclamide 5.0mg.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
TABLET FOR ORAL USE
Glibenclamide 5mg Tablets are white, dragee shaped tablets marked,
‘GL’ and ‘5’
either side of a breakline 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
non-
insulindependent diabetes in patients who respond inadequately to
dietary measures
alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY_ _
Glibenclamide should be taken with or immediately after food. There
were no
changes to the reference product information in the report period. The
total
daily dosage is preferably given as a single dose at breakfast or with
the first
main meal, but due consideration should be given to the patients meal
habits
and daily activity when apportioning dosage.
_ _
Adults:_ _
_New diabetes: _
In maturity-onset of mild to moderate severity, treatment should be
started at
5mg daily, or 2.5mg in debilitated or elderly patients. If this dosage
is not
sufficient for proper control it should be increased by 2.5mg at
intervals of one
week, or as directed by the clinician. The total daily dosage rarely
exceeds
15mg and increasing the daily dosage above this does not generally
produce
any additional effect.
Paediatric population: Glibenclamide is not recommended for use in
children.
_Transfer from other oral 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
tolbut