Daltex 50 mg/1000 mg film-coated tablets

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

VILDAGLIPTIN, METFORMIN HYDROCHLORIDE

Disponível em:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

Código ATC:

A10BD08

DCI (Denominação Comum Internacional):

VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Forma farmacêutica:

FILM-COATED TABLET

Composição:

VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Tipo de prescrição:

POM

Área terapêutica:

DRUGS USED IN DIABETES

Status de autorização:

Authorised

Data de autorização:

2018-02-16

Folheto informativo - Bula

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Package leaflet: Information for the user
Daltex 50 mg/850 mg film-coated tablets
Daltex 50 mg/1000 mg film-coated tablets
vildagliptin/metformin hydrochloride
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 Daltex is and what it is used for
2.
What you need to know before you take Daltex
3.
How to take Daltex
4.
Possible side effects
5.
How to store Daltex
6.
Contents of the pack and other information
1.
What Daltex is and what it is used for
The active substances of Daltex, vildagliptin and metformin, belong to
a group of medicines called
“oral antidiabetics”.
Daltex is used to treat adult patients with type 2 diabetes. This type
of diabetes is also known as non-
insulin-dependent diabetes mellitus.
Daltex is used when diabetes cannot be controlled by diet and exercise
alone and/or with other medicines
used to treat diabetes (insulin or sulphonylureas).
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.
Both insulin and glucagon are made in the pancreas. Insulin helps to
lower the level of sugar in the
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blood, especially after meals. Glucagon triggers the liver to make
sugar, causing the blood sugar level
to rise.
How Daltex works
Both active substances, vildagliptin and metformin, help to control
the level of sugar in the blood. The
substance vildagliptin works by making the pancreas produce more
insulin and less glucagon.

Características técnicas

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Daltex 50 mg/850 mg film-coated tablets
Daltex 50 mg/1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of
metformin hydrochloride
(corresponding to 660 mg of metformin).
Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of
metformin hydrochloride
(corresponding to 780 mg of metformin).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, ovaloid film coated tablet with bevelled edge, plain surface
on both sides with dimensions
of approximately 20.7 X 8.8 mm.
Dark yellow, ovaloid film coated tablets with bevelled edge, plain
surface on both sides with
dimensions of approximately 21.3 X 10.1 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Daltex is indicated in the treatment of type 2 diabetes mellitus:
-
Daltex is indicated in the treatment of adult patients who are unable
to achieve sufficient
glycaemic control at their maximally tolerated dose of oral metformin
alone or who are
already treated with the combination of vildagliptin and metformin as
separate tablets.
-
Daltex is indicated in combination with a sulphonylurea (i.e. triple
combination therapy) as
an
adjunct to diet and exercise in adult patients inadequately controlled
with metformin
and a sulphonylurea.
-
Daltex is indicated in triple combination therapy with insulin as an
adjunct to diet and
exercise to improve glycaemic control in adult patients when insulin
at a stable dose and
metformin alone do not provide adequate glycaemic control.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults with normal renal function (GFR_

_ 90 ml/min)_
The dose of antihyperglycaemic therapy with Daltex should be
individualised on the basis of the
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patient’s current regimen, effectiveness and tolerability while not
exceeding the maximum
recommended daily dose of 100 mg vildagliptin. Daltex may be initiated