Gluamet 50mg/1000mg film-coated tablets

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

VILDAGLIPTIN, METFORMIN HYDROCHLORIDE

Предлага се от:

Merck Healthcare KGaA Frankfurter Strasse 250, 64293 Darmstadt, Germany

АТС код:

A10BD08

INN (Международно Name):

VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Лекарствена форма:

FILM-COATED TABLET

Композиция:

VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Вид предписание :

POM

Терапевтична област:

DRUGS USED IN DIABETES

Каталог на резюме:

Licence number in the source country: NOT APPLICAPABLE

Статус Оторизация:

Withdrawn

Дата Оторизация:

2020-12-31

Листовка

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
GLUAMET 50 MG/850 MG FILM-COATED TABLETS
GLUAMET 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 GluaMet is and what it is used for
2.
What you need to know before you take GluaMet
3.
How to take GluaMet
4.
Possible side effects
5.
How to store GluaMet
6.
Contents of the pack and other information
1.
WHAT GLUAMET IS AND WHAT IT IS USED FOR
The active substances of GluaMet, vildagliptin and metformin, belong
to a group of medicines called
“oral antidiabetics”.
GluaMet is used to treat adult patients with type 2 diabetes. This
type of diabetes is also known as non-
insulin-dependent diabetes mellitus. GluaMet 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 GLUAMET 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 glu

Данни за продукта

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
GluaMet 50 mg/850 mg film-coated tablets
GluaMet 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.
50 mg/850 mg film-coated tablets: Yellow, ovaloid, film coated tablet
with bevelled edge, plain surface
on both sides
with dimensions of approximately 20.7 x 8.8 mm.
50 mg/1000 mg film-coated tablets: 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
GluaMet 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).
-
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults with normal renal function (GFR_

_ 90 ml/min)_
The dose of antihyperglycaemic therapy with GluaMet 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. GluaMet may be
initiated at either the 50 mg/850 mg
or 50 mg/1000 mg tablet strength twice daily, one tablet in the
morning and the other in the evening.
2
-
For patients inade