Vildagliptin DOC 50mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

VILDAGLIPTIN

Available from:

Doc Generici srl Via Turati, 40-20121, Milano, Italy

ATC code:

A10BH02

INN (International Name):

VILDAGLIPTIN 50 mg

Pharmaceutical form:

TABLET

Composition:

VILDAGLIPTIN 50 mg

Prescription type:

POM

Therapeutic area:

DRUGS USED IN DIABETES

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-02-28

Patient Information leaflet

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

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
_ _
VILDAGLIPTIN DOC 50mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of vildagliptin.
Excipient with known effect:
Each tablet contains 119.59 mg of lactose. For the full list of
excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white round biconvex tablets of approximately 8.0 mm
diameter.
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 monotherapyin 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 sulphonylurea, or in combination with
insulin (with or without
metformin), the recommended daily dose of vildagliptin is 100mg,
administered as one dose of 50mg in
the morning and one dose of 50mg in the evening.
When used in dual combination with a sulphonylurea, the recommended
dose of vildagliptin is 50mg
once daily administered in the morning. In this patient population,
vildagliptin 100mg daily was no more
effective than vildagliptin 50mg 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 VILDAGLIPTIN DOC is missed, it should be taken as soon as
the patient remember. A
double dose should not be taken on the same day.
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The safety and efficacy of vildagliptin as triple oral therapy in
combination with metformin and a
thiazolidinedione have not been established.
_Addi