Alikval Duo 50 mg/1000 mg film-coated tablets

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktivní složka:

VILDAGLIPTIN, METFORMIN HYDROCHLORIDE

Dostupné s:

Egis Pharmaceuticals PLC Kereszturi Ut 30-38 1106 Budapest, Hungary

ATC kód:

A10BD08

INN (Mezinárodní Name):

VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Léková forma:

FILM-COATED TABLET

Složení:

VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Druh předpisu:

POM

Terapeutické oblasti:

DRUGS USED IN DIABETES

Přehled produktů:

Licence number in the source country: NOT APPLICAPABLE

Stav Autorizace:

Authorised

Datum autorizace:

2022-01-04

Informace pro uživatele

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

Charakteristika produktu

1
1.
NAME OF THE MEDICINAL PRODUCT
Alikval Duo 50 mg/850 mg and 50 mg/1000 mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alikval Duo
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).
Each tablet contains 93.5 mg of lactose.
Alikval Duo
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).
Each tablet contains 110 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Alikval Duo
50 mg/850 mg film-coated tablets
Yellow oblong-oval-shaped film-coated tablets with a scoreline on one
side and “VA” on the other
side. Tablet length: 19.4 ± 0.5 mm.
The score line is not intended for breaking the tablet.
Alikval Duo
50 mg/1000 mg film-coated tablets
Dark yellow oblong oval-shaped film-coated tablets with a scoreline in
between ‘V’ and ‘B’ on one
side and with a scoreline on the other. Tablet length: 21.1 ± 0.5 mm.
The score line is not intended for breaking the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alikval Duo is indicated as an adjunct to diet and exercise to improve
glyceamic 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
2
_Adults with normal renal function (GFR _
_≥ _
_90 ml/min) _
The dose of antihyperglycaemic therapy with Alikval Duo should be
individualised on the basis of the
patient’s curr