DYANIL TABLET 5 MG

País: Malasia

Idioma: inglés

Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes activos:

GLIBENCLAMIDE

Disponible desde:

DYNAPHARM (M) SDN BHD

Designación común internacional (DCI):

GLIBENCLAMIDE

Unidades en paquete:

100 Tablets; 1000 Tablets

Fabricado por:

DYNAPHARM (M) SDN BHD

Información para el usuario

Consumer Medication Information Leaflet (RiMUP)
DYANIL TABLET 5MG
Glibenclamide (5mg)
1
What is in this leaflet
1.
What DYANIL TABLET 5MG is
used for
2.
How DYANIL TABLET 5MG
works
3.
Before you use DYANIL
TABLET 5MG
4.
How to use DYANIL TABLET
5MG
5.
While you are using it
6.
Side effects
7.
Storage and Disposal
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
1.
What DYANIL TABLET
5MG
is used for
The name of your medicine is
DYANIL TABLET 5MG.
This tablet belongs to a group of
medicines called sulphonylureas.
DYANIL TABLET 5MG is used
to lower blood sugar levels and is
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.
How DYANIL TABLET 5MG
works
Glibenclamide is a hypoglycaemic
agent which is effective when
given by mouth. It acts by
stimulating the release of insulin
from the beta cells of the
pancreatic islets. It is not a
substitute for insulin as it is
effective only in the presence of
functioning islet tissue.
3.
Before you take DYANIL
TABLET 5MG
When you must not use it:
You must not use it if you
•
are allergic (hypersensitive) to
glibenclamide, other
sulphonylureas or any of the
other ingredients in DYANIL
TABLET 5MG (see Product
information section)
•
suffer from early onset or type I
diabetes (requiring insulin)
•
suffer from severe kidney disease
•
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
•
have reduced consciousness or
coma resulting from your
diabetes
This medicine can cause low blood
sugar (hypoglycaemia). Symptoms
include sweating, hunger,
increased heart rate, reduced
consciousness, coma or seizures.
Low
blood
sugar
may
occur
particularly
in
the
following
situations, so pat

Ficha técnica

DYANIL TABLET 5MG
MAL19910070AZ
DESCRIPTION:
TABLET
Colour :
White
Shape
:
Oblong, Flat and Scored
EACH TABLET CONTAINS:
Glibenclamide .................................. 5 mg
PHARMACODYNAMICS:
Glibenclamide is a hypoglycaemic agent which is effective when given
by mouth. It acts by stimulating the
release of insulin from the beta cells of the pancreatic islets. It is
not a substitute for insulin as it is
effective only in the presence of functioning islet tissue.
PHARMACOKINETICS:
About 45% of a 5 mg dose is absorbed after oral administration. After
an oral dose of 5 mg, peak serum
concentrations of about 0.04 mcg/ml are attained in 2 to 4 hours.
Plasma half-life is 3 to 7 hours; half-life
determined from urinary excretion data is about 10 hours. It is widely
distributed throughout the body and
does not appear to accumulate. About 98% is bound to plasma proteins.
It is metabolised by hydroxylation
of the cyclohexyl ring at positions 3 and 4; in the rat, rabbit and
dog, the 3-cis-hydroxy metabolite is
additionally produced; hydroxylated metabolites may be conjugated. In
5 days, 95% of a dose is excreted
in the urine and faeces with about 54% excreted as unchanged drug; of
the 95% excreted about 75% is
found in the faeces and 20% in the urine; excretion of an intravenous
dose is more rapid than that from
either oral or intramuscular doses.
INDICATION:
Non-insulin-dependent diabetes mellitus (type II, maturity-onset
diabetes) whenever dietary treatment
alone proves inadequate.
RECOMMENDED DOSE:
Stabilisation should be instituted by a doctor only.
The tablets are to be swallowed whole with some liquid.
Treatment is started with a daily dose of half a tablet (2.5 mg),
taken immediately before breakfast. If
necessary, raise the dose in increments of 2.5 mg until the blood
glucose levels have been normalised. As
a rule, the maximum effect is obtained with 3 tablets daily, in
exceptional cases 4 tablets daily. A
maximum single dose of 2 tablets (10 mg) should not be exceeded. It is
to be taken before breakfast, any
remai