Xiliarx
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
17-08-2023
Produktets egenskaber
(SPC)
17-08-2023
Offentlige vurderingsrapport
(PAR)
07-09-2021
Aktiv bestanddel:
vildagliptin
Tilgængelig fra:
Novartis Europharm Limited
ATC-kode:
A10BH02
INN (International Name):
vildagliptin
Terapeutisk gruppe:
Drugs used in diabetes
Terapeutisk område:
Diabetes Mellitus, Type 2
Terapeutiske indikationer:
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).
Produkt oversigt:
Revision: 23
Autorisation status:
Authorised
Autorisation dato:
2008-11-19
Indlægsseddel
30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
XILIARX 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Xiliarx is and what it is used for
2.
What you need to know before you take Xiliarx
3.
How to take Xiliarx
4.
Possible side effects
5.
How to store Xiliarx
6.
Contents of the pack and other information
1.
WHAT XILIARX IS AND WHAT IT IS USED FOR
The active substance of Xiliarx, vildagliptin, belongs to a group of
medicines called “oral
antidiabetics”.
Xiliarx 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 Xiliarx 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 XILIARX WORKS
Xiliarx works by making the pancreas produce more insulin and less
glucagon. This helps to control
the blood sugar level. Thi
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Xiliarx 50 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of vildagliptin.
Excipient with known effect: Each tablet contains 47.82 mg lactose
(anhydrous).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to light yellowish, round (8 mm diameter), flat-faced,
bevelled-edge tablet. One side is
debossed with “NVR”, and the other side with “FB”.
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 Xiliarx is missed, it should be taken as soon as the
patient remembers. A double dose
should not be taken on the same day.
3
The safety and efficacy of vildagliptin as t
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