GLIBENCLAMIDE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
09-08-2016
Summary of Product characteristics
(SPC)
22-09-2016
Active ingredient:
GLIBENCLAMIDE
Available from:
Chanelle Medical
ATC code:
A10BB01
INN (International Name):
GLIBENCLAMIDE
Dosage:
2.5 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
glibenclamide
Authorization status:
Not Marketed
Authorization date:
2008-12-12
Patient Information leaflet
ID: PL 109 IE
VERSION: 07
EFFECTIVE DATE:
PACKAGE LEAFLET: INFORMATION FOR THE USER
GLIBENCLAMIDE 2.5 MG TABLETS
Glibenclamide
IN THIS LEAFLET:
1.
What Glibenclamide is and what it is used for.
2.
What you need to know before you take Glibenclamide.
3.
How to take Glibenclamide.
4.
Possible side effects.
5.
How to store Glibenclamide.
6.
Contents of the pack and other information.
The name of your medicine is Glibenclamide 5 mg Tablets
Glibenclamide is a medicine taken by mouth to help lower blood sugar.
It belongs to a group of medicines called
sulfonylureas.
Glibenclamide works by increasing the amount of insulin released from
your pancreas. The insulin then lowers
your blood sugar levels.
WHAT GLIBENCLAMIDE IS USED FOR
Glibenclamide is used to treat a certain form of diabetes (type 2
diabetes mellitus), when diet, physical
exercise and weight reduction alone have not been able to control your
blood sugar levels.
DO NOT TAKE GLIBENCLAMIDE TABLETS IF:
You are allergic (hypersensitive) to glibenclamide, sulphonamides
(medicines for bacterial infection) or any of
the other ingredients of Glibenclamide.
You have insulin dependent diabetes (type 1 diabetes mellitus)
You have diabetic ketoacidosis (a complication of diabetes with some
of the following signs: fatigue, nausea
(feeling sick), frequent urination and muscular stiffness)
You are in diabetic coma
You are pregnant
You are breast-feeding
You have severe problems with your kidneys
You have a severe liver disease
You are receiving a medicine called bosentan used to treat high blood
pressure.
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
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glibenclamide 2.5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glibenclamide 2.5 mg.
Excipient(s) with known effect: lactose 51.5 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
A plain, round, flat bevelled edge, 6.5mm white tablet, with a
breakline on one side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Glibenclamide is a sulphonylurea hypoglycaemic agent indicated for the
oral treatment of patients with non-insulin
dependent diabetes who respond inadequately to dietary measures
alone_._
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage of glibenclamide is governed by the desired blood glucose
level.
The dosage of glibenclamide must be the lowest possible dose which is
effective.
Mistakes, e.g. forgetting to take a dose, must never be corrected by
subsequently taking a larger dose.
The usual total daily dosage is 2.5 to 15 mg daily with a usual
initial dose of 5 mg daily. Weekly adjustments can be
made to increase the dosage to the optimal level.
Doses of 10 mg or less may be taken as a single dose immediately
before/after breakfast, but should the daily dose exceed 10 mg, the
remainder should be taken immediately before/after
the evening meal.
PATIENTS AGED 65 YEARS AND OLDER: starting and maintenance doses of
glibenclamide must be carefully adjusted to
reduce the risk of hypoglycaemia. Treatment should be started with the
lowest available dose and increased gradually if
necessary (see section 4.4).
PAEDIATRIC POPULATION The safety of
Glibenclamide in the paediatric population has not been established.
Currently avaible data are described in sections 4.8 but no
recommendations on a posolgy can be made.
DOSE OMISSION
A physician should be consulted in the event that a dose has not been
taken at the prescribed time, a meal has been
skipped or an extra dose has been taken.
It is very important not to skip meals after the tablets have been
taken.
SE
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