Vildagliptine Hetero 50 mg tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

VILDAGLIPTINE 50 mg/stuk

Beschikbaar vanaf:

Hetero Europe S.L. Viladecans Business Park, Edificio Brasil, Catalunya 83-85 08840 VILADECANS (SPANJE)

INN (Algemene Internationale Benaming):

VILDAGLIPTINE 50 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

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

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
VILDAGLIPTINE HETERO 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 Vildagliptine Hetero is and what it is used for
2.
What you need to know before you take Vildagliptine Hetero
3.
How to take Vildagliptine Hetero
4.
Possible side effects
5.
How to store Vildagliptine Hetero
6.
Contents of the pack and other information
1.
WHAT VILDAGLIPTINE HETERO IS AND WHAT IT IS USED FOR
The active substance of Vildagliptine Hetero, vildagliptin, belongs to
a group of medicines called “oral
antidiabetics”.
Vildagliptine Hetero 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 Hetero 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 HETERO WORKS
Vi

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vildagliptine Hetero 50 mg tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of vildagliptin.
Excipient with known effect: Each tablet contains 30 mg lactose
(anhydrous).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white, round (approx. 8 mm diameter), beveled-edge
tablet. One side is debossed with
“V15”, and the other side with “H”.
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.
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 Vildagliptine Hetero 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 a