Vildagliptin PharOS Tablets 50mg

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

VILDAGLIPTIN

Disponibil de la:

PharOS – Pharmaceutical Oriented Services Limited Lesvou str. (end), Thesi Loggos, Industrial Zone, 144 52 Metamorfossi Attikis,, Greece

Codul ATC:

A10BH02

INN (nume internaţional):

VILDAGLIPTIN 50 mg

Forma farmaceutică:

TABLET

Compoziție:

VILDAGLIPTIN 50 mg

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

DRUGS USED IN DIABETES

Statutul autorizaţiei:

Withdrawn

Data de autorizare:

2018-01-19

Prospect

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

Caracteristicilor produsului

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vildagliptin PharOS 50 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of vildagliptin.
Excipient with known effect: Each tablet contains 21.82 mg lactose
(anhydrous).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to light yellowish, round, flat-faced tablet, debossed with
“50” on one side and plain on
the other, with a diameter of 8 mm ± 0.2 mm.
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
Page 2 of 17
_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