Vildagliptine Denk 50 mg tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

VILDAGLIPTINE 50 mg/stuk

Beschikbaar vanaf:

Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 MÜNCHEN (DUITSLAND)

ATC-code:

A10BH02

INN (Algemene Internationale Benaming):

VILDAGLIPTINE 50 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; LACTOSE 0-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD, CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 0-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Vildagliptin

Autorisatie datum:

1900-01-01

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
VILDAGLIPTINE DENK 50 MG TABLETTEN
VILDAGLIPTIN
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, pharmacist or
nurse.
-
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 to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vildaglitine Denk is and what it is used for
2.
What you need to know before you take Vildagliptine Denk
3.
How to take Vildagliptine Denk
4.
Possible side effects
5.
How to store Vildagliptine Denk
6.
Contents of the pack and other information
1.
WHAT VILDAGLIPTINE DENK IS AND WHAT IT IS USED FOR
The active substance of Vildagliptine Denk, vildagliptin, belongs to a
group of medicines
called “oral antidiabetics”.
Vildagliptine Denk is used to treat adult patients with type 2
diabetes. It is used when
diabetes cannot be controlled by diet and exercise alone. It helps to
control the level of sugar
in the blood. Your doctor will prescribe Vildagliptine Denk either
alone or together with
certain other antidiabetic medicines which you will already be taking,
if these have not
proved sufficiently effective to control diabetes.
Type 2 diabetes develops if the body does not make enough insulin or
if the insulin that the
body makes does not work as well as it should. It can also develop if
the body produces too
much glucagon.
Insulin is a substance which helps to lower the level of sugar in the
blood, especially after
meals. Glucagon is a substance which triggers the production of sugar
by the liver, causing
the blood sugar level to rise. The pancreas makes both of these
substances.
HOW VILDAGLIPTINE DENK WORKS
Vildagliptine Denk works by making the

Productkenmerken

1
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Vildagliptine Denk 50 mg tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg vildagliptin.
Excipient with known effect:
Each tablet contains 47 mg lactose (anhydrous).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off white, round, flat tablet (diameter: approximately 8.1
mm), engraved with ΄VLD΄
on one side, plain on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vildagliptin is indicated as an adjunct to diet and exercise to
improve glycaemic control in
adults with type 2 diabetes mellitus:
-
as
monotherapy
in
patients
in
whom
metformin
is
inappropriate
due
to
contraindications or intolerance.
-
in combination with other medicinal products for the treatment of
diabetes, including
insulin, when these do not provide adequate glycaemic control (see
sections 4.4, 4.5
and 5.1 for available data on different combinations).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
When
used
as
monotherapy,
in
combination
with
metformin,
in
combination
with
thiazolidinedione, in combination with metformin and a sulphonylurea,
or in combination with
insulin (with or without metformin), the recommended daily dose of
vildagliptin is 100 mg,
administered as one dose of 50 mg in the morning and one dose of 50 mg
in the evening.
When used in dual combination with a sulphonylurea, the recommended
dose of vildagliptin
is 50 mg once daily administered in the morning. In this patient
population, vildagliptin 100
mg daily was no more effective than vildagliptin 50 mg once daily.
2
_ _
When used in combination with a sulphonylurea, a lower dose of the
sulphonylurea may be
considered to reduce the risk of hypoglycaemia.
Doses higher than 100 mg are not recommended.
If a dose of vildagliptin is missed, it should be taken as soon as the
patient remembers. A double
dose should not be taken on the same day.
The safety and efficacy of vildagliptin as triple oral therapy i