Zomarist

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

vildagliptin, metformin hydrochloride

Available from:

Novartis Europharm Limited 

ATC code:

A10BD08

INN (International Name):

vildagliptin, metformin

Therapeutic group:

Drugs used in diabetes

Therapeutic area:

Diabetes Mellitus, Type 2

Therapeutic indications:

Zomarist is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone.in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets.in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate.

Product summary:

Revision: 23

Authorization status:

Authorised

Authorization date:

2008-11-30

Patient Information leaflet

43
B. PACKAGE LEAFLET
44
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOMARIST 50 MG/850 MG FILM-COATED TABLETS
ZOMARIST 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 Zomarist is and what it is used for
2.
What you need to know before you take Zomarist
3.
How to take Zomarist
4.
Possible side effects
5.
How to store Zomarist
6.
Contents of the pack and other information
1.
WHAT ZOMARIST IS AND WHAT IT IS USED FOR
The active substances of Zomarist, vildagliptin and metformin, belong
to a group of medicines called
“oral antidiabetics”.
Zomarist is used to treat adult patients with type 2 diabetes. This
type of diabetes is also known as
non-insulin-dependent diabetes mellitus. Zomarist 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
blood, especially after meals. Glucagon triggers the liver to make
sugar, causing the blood sugar level
to rise.
HOW ZOMARIST 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 p

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zomarist 50 mg/850 mg film-coated tablets
Zomarist 50 mg/1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zomarist 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).
Zomarist 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.
Zomarist 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.
Zomarist 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
Zomarist is indicated as an adjunct to diet and exercise to improve
glycaemic control in adults with
type 2 diabetes mellitus:
•
in patients who are inadequately controlled with metformin
hydrochloride alone.
•
in patients who are already being treated with the combination of
vildagliptin and metformin
hydrochloride, as separate tablets.
•
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).
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults with normal renal function (_
GFR ≥ 90 ml/min
_) _
The dose of antihyperglycaemic therapy with Zomarist should be
individualised on the basis of the
patient’s current regimen, effectiveness and tolerability while not
exceeding the maximum
recommended daily dose of 100 mg vildagliptin. Zomarist may be
initiated at either the 50 mg/850 mg
or 50 mg/1000 mg tablet