Galvus 50mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Vildagliptin

Διαθέσιμο από:

Novartis Pharmaceuticals UK Ltd

Φαρμακολογική κατηγορία (ATC):

A10BH02

INN (Διεθνής Όνομα):

Vildagliptin

Δοσολογία:

50mg

Φαρμακοτεχνική μορφή:

Tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 06010203; GTIN: 5010678907087

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
GALVUS
® 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 Galvus is and what it is used for
2.
What you need to know before you take Galvus
3.
How to take Galvus
4.
Possible side effects
5.
How to store Galvus
6.
Contents of the pack and other information
1.
WHAT GALVUS IS AND WHAT IT IS USED FOR
The active substance of Galvus, vildagliptin, belongs to a group of
medicines called “oral
antidiabetics”.
Galvus 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
Galvus 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 GALVUS WORKS
Galvus works by making the pancreas produce more insulin and less
glucagon. This helps to control
the blood sugar level. This medicine has been shown to re

Αρχείο Π.Χ.Π.

OBJECT 1
GALVUS 50 MG TABLETS
Summary of Product Characteristics Updated 14-May-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Galvus
®
50 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 50 mg of vildagliptin.
Excipient with known effect: Each tablet contains 47.82 mg lactose
(anhydrous).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
White to light yellowish, round (8 mm diameter), flat-faced,
bevelled-edge tablet. One side is debossed
with “NVR”, and the other side with “FB”.
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.
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 vil