GLUBEN

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

GLIBENCLAMIDE

Disponible depuis:

DEXCEL LTD, ISRAEL

Code ATC:

A10BB01

forme pharmaceutique:

TABLETS

Composition:

GLIBENCLAMIDE 5 MG

Mode d'administration:

PER OS

Type d'ordonnance:

Required

Fabriqué par:

DEXCEL LTD, ISRAEL

Groupe thérapeutique:

GLIBENCLAMIDE

Domaine thérapeutique:

GLIBENCLAMIDE

indications thérapeutiques:

Control of hyperglycemia in stable, mild, nonketosis prone Glibenclamide responsive type II diabetes mellitus, which cannot be controlled by proper dietary management or when insulin therapy is inappropriate.

Date de l'autorisation:

2014-03-31

Résumé des caractéristiques du produit

1. NAME OF THE MEDICINAL PRODUCT
GLUBEN
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Glibenclamide 5mg.
Excipients : contains lactose monohydrate 133.00mg.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
White, biconvex tablets, scored on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Control of hyperglycemia in stable, mild, nonketosis prone
Glibenclamide
responsive type II diabetes mellitus, which cannot be controlled by
proper dietary
management or when insulin therapy is inappropriate
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 2.5mg to 15mg daily with a usual
initial dose of
5mg daily. Weekly adjustments can be made to increase the dosage to
the
optimal level. Doses of 10mg or less may be taken as a single dose
immediately
before breakfast, but should the daily dose exceed 10mg, the remainder
should
be taken immediately before the evening meal.
The elderly usually require lower dosage.
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.
SECONDARY DOSAGE ADJUSTMENT
As an improvement in control of diabetes is, in itself, associated
with higher
insulin sensitivity, glibenclamide requirements may fall as treatment
proceeds. To
avoid hypoglycaemia, timely dose reduction or cessation of GLUBEN
therapy
must therefore be considered.
Correction of dosage must also be considered, whenever:
- the patients weight changes
- the patients life-style changes
- other factors arise, which cause an increased susceptibility to
hypoglycaemia or
hyperglycaemia.
CHANGEOVER FROM OTHER ORAL ANTIDIABETICS TO GLUBEN