Melkart 50mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

VILDAGLIPTIN

Available from:

G.L. Pharma GmbH Schlossplatz 1, 8502 Lannach, Austria

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:

2020-03-13

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MELKART 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 Melkart is and what it is used for
2.
What you need to know before you take Melkart
3.
How to take Melkart
4.
Possible side effects
5.
How to store Melkart
6.
Contents of the pack and other information
1.
WHAT MELKART IS AND WHAT IT IS USED FOR
The active substance of Melkart, 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 Melkart 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 MELKART WORKS
Melkart works by making the pancreas produce more insulin and less
glucagon. This helps to control
the blood sugar level. This med

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Melkart 50 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of vildagliptin.
Excipient with known effect:
Each tablet contains 119.59 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off-white round biconvex tablets with a diameter of 8.0 mm ±
0.5 mm..
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.
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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 Melkart 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 metformin
and a thiazolidinedione have not been established.
_Additiona