Eucreas 50mg850mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Vildagliptin; Metformin hydrochloride

Disponible depuis:

Novartis Pharmaceuticals UK Ltd

DCI (Dénomination commune internationale):

Vildagliptin; Metformin hydrochloride

Dosage:

50mg ; 850mg

forme pharmaceutique:

Tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 06010203; GTIN: 5010678907131

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EUCREAS
® 50 MG/850 MG FILM-COATED TABLETS
EUCREAS
® 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Eucreas is and what it is used for
2.
What you need to know before you take Eucreas
3.
How to take Eucreas
4.
Possible side effects
5.
How to store Eucreas
6.
Contents of the pack and other information
1.
WHAT EUCREAS IS AND WHAT IT IS USED FOR
The active substances of Eucreas, vildagliptin and metformin, belong
to a group of medicines called
“oral antidiabetics”.
Eucreas is used to treat adult patients with type 2 diabetes. This
type of diabetes is also known as non-
insulin-dependent diabetes mellitus.
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
blood, especially after meals. Glucagon triggers the liver to make
sugar, causing the blood sugar level
to rise.
HOW EUCREAS 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. The
substance metformin works by helping the body to make better use of
insulin. This medicine has been
shown to reduce blood sugar, which may he

Résumé des caractéristiques du produit

OBJECT 1
EUCREAS 50 MG/850 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 10-May-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Eucreas
®
50 mg/850 mg film-coated tablets
Eucreas
®
50 mg/1000 mg film-coated tablets
2. Qualitative and quantitative composition
Eucreas 50 mg/850 mg film-coated tablets
Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of
metformin hydrochloride
(corresponding to 660 mg of metformin).
Eucreas 50 mg/1000 mg film-coated tablets
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.
Eucreas 50 mg/850 mg film-coated tablets
Yellow, ovaloid film-coated tablet with bevelled edge, imprinted with
“NVR” on one side and “SEH” on
the other side.
Eucreas 50 mg/1000 mg film-coated tablets
Dark yellow, ovaloid film-coated tablet with bevelled edge, imprinted
with “NVR” on one side and
“FLO” on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Eucreas is indicated in the treatment of type 2 diabetes mellitus:
- Eucreas 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.
- Eucreas 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.
- Eucreas 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 antihy