Vilda Denk 50mg tablets

País: Armenia

Idioma: inglés

Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes activos:

vildagliptin

Disponible desde:

Denk Pharma GmbH & Co. KG

Código ATC:

A10BH02

Designación común internacional (DCI):

vildagliptin

Dosis:

50mg

formulario farmacéutico:

tablets

Unidades en paquete:

(28/4x7/) in blister

tipo de receta:

Prescription

Estado de Autorización:

Registered

Fecha de autorización:

2020-12-30

Información para el usuario

_Vilda Denk 50 mg_
Tablet – oral use
Antidiabetic agent
Active substance: Vildagliptin
Package leaflet:
Information for the user
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 to your doc-
tor or pharmacist. This includes any possible
side effects not listed in this leaflet. See sec-
tion 4.
What is in this leaflet:
1. WHAT VILDA DENK 50 MG IS AND WHAT IT IS
USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
VILDA DENK 50 MG
3. HOW TO TAKE VILDA DENK 50 MG
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE VILDA DENK 50 MG
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Vilda Denk 50 mg is and
what it is used for
The active substance of Vilda Denk 50 mg,
vildagliptin, belongs to a group of medicines
called “oral antidiabetics”.
Vilda Denk 50 mg is used to treat adult patients
with type 2 diabetes. It is used when diabetes can-
not be controlled by diet and exercise alone. It
helps to control the level of sugar in the blood.
Your doctor will prescribe Vilda Denk 50 mg ei-
ther alone or together with certain other antidi-
abetic medicines which you will already be tak-
ing, 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 gluca-
gon.
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 pro-
duction of sugar by the liver, causing the blood
sugar level to rise. The pancreas makes both of
these substances.
How Vilda Denk 50 mg works
Vild

Ficha técnica

1
1.
NAME OF THE MEDICINAL PRODUCT
Vilda Denk 50 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Vildagliptin
Each tablet contains 50 mg vildagliptin.
Excipient with known effect: Each tablet contains 47 mg of lactose
(anhydrous).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off white round flat tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vildagliptin is indicated in the treatment of type 2 diabetes mellitus
in adults:
As monotherapy in patients inadequately controlled by diet and
exercise alone and for whom metformin is
inappropriate due to contraindications or intolerance.
As dual oral therapy in combination with metformin, in patients with
insufficient glycaemic control despite
maximal tolerated dose of monotherapy with metformin, a sulphonylurea,
in patients with insufficient
glycaemic control despite maximal tolerated dose of a sulphonylurea
and for whom metformin is inappropriate
due to contraindications or intolerance, a thiazolidinedione, in
patients with insufficient glycaemic control and
for whom the use of a thiazolidinedione is appropriate.
As triple oral therapy in combination with a sulphonylurea and
metformin when diet and exercise plus dual
therapy with these medicinal products do not provide adequate
glycaemic control.
Vildagliptin is also indicated for use in combination with insulin
(with or without metformin) when diet and
exercise plus a stable dose of insulin do not provide adequate
glycaemic control.
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 admin