Vildagliptin Merck 50mg Tablets

Држава: Малта

Језик: Енглески

Извор: Medicines Authority

Активни састојак:

VILDAGLIPTIN

Доступно од:

Merck Healthcare KGaA Frankfurter Strasse 250, 64293 Darmstadt, Germany

АТЦ код:

A10BH02

INN (Међународно име):

VILDAGLIPTIN 50 mg

Фармацеутски облик:

TABLET

Састав:

VILDAGLIPTIN 50 mg

Тип рецептора:

POM

Терапеутска област:

DRUGS USED IN DIABETES

Статус ауторизације:

Withdrawn

Датум одобрења:

2017-08-07

Информативни летак

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

Карактеристике производа

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vildagliptin Merck 50 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of vildagliptin.
Excipient with known effect: Each tablet contains 10.00 mg lactose
(anhydrous).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to light yellowish, round (6.5 mm diameter), flat faced,
bevelled-edge, plain 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.
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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.
Whe