Vildagliptin Accord 50 mg Tablett

Ülke: İsveç

Dil: İsveççe

Kaynak: Läkemedelsverket (Medical Products Agency)

Aktif bileşen:

vildagliptin

Mevcut itibaren:

Accord Healthcare B.V.

ATC kodu:

A10BH02

INN (International Adı):

vildagliptin

Doz:

50 mg

Farmasötik formu:

Tablett

Kompozisyon:

laktos (vattenfri) Hjälpämne; vildagliptin 50 mg Aktiv substans

Reçete türü:

Receptbelagt

Ürün özeti:

Förpacknings: Blister, 14 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 112 tabletter; Blister, 56 tabletter; Blister, 90 tabletter; Blister, 60 tabletter

Yetkilendirme durumu:

Godkänd

Yetkilendirme tarihi:

2020-06-30

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
VILDAGLIPTIN ACCORD 50 MG TABLETS
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
The active substance of , vildagliptin, belongs to a
group of medicines called “oral
antidiabetics”.
, 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, 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 WORKS

works by making the pancreas produce more insuli

Ürün özellikleri

1.
NAME OF THE MEDICINAL PRODUCT
Vildagliptin Accord 50 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of vildagliptin.
Excipient with known effect
Each tablet contains 45 mg lactose (anhydrous).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white, round (8 mm diameter), flat, beveled-edge uncoated
tablets debossed with “GF1”
on one side and plain on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 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 in
combination with m