Sitagliptin Tiefenbacher 25 mg film-coated tablets

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

SITAGLIPTIN

Disponible desde:

ALFRED E. TIEFEMBACHER (GmbH &Co. KG) Van-der-Smissen-Straße 1, 22767 Hamburg, Germany

Código ATC:

A10BH01

Designación común internacional (DCI):

SITAGLIPTIN 25 mg

formulario farmacéutico:

FILM-COATED TABLET

Composición:

SITAGLIPTIN 25 mg

tipo de receta:

POM

Área terapéutica:

DRUGS USED IN DIABETES

Resumen del producto:

Licence number in the source country: NOT APPLICAPABLE

Estado de Autorización:

Withdrawn

Fecha de autorización:

2020-05-14

Información para el usuario

V01 1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTIN TIEFENBACHER 25 MG FILM-COATED TABLETS
sitagliptin
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 or pharmacist
-
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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sitagliptin Tiefenbacher is and what it is used for
2.
What you need to know before you take Sitagliptin Tiefenbacher
3.
How to take Sitagliptin Tiefenbacher
4.
Possible side effects
5.
How to store Sitagliptin Tiefenbacher
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTIN TIEFENBACHER IS AND WHAT IT IS USED FOR
Sitagliptin Tiefenbacher contains the active substance sitagliptin
which is a member of a class
of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4
inhibitors) that lowers blood
sugar levels in adult patients with type 2 diabetes mellitus.
This medicine helps to increase the levels of insulin produced after a
meal and decreases the
amount of sugar made by the body.
Your doctor has prescribed this medicine to help lower your blood
sugar, which is too high
because of your type 2 diabetes. This medicine can be used alone or in
combination with certain
other medicines (insulin, metformin, sulphonylureas, or glitazones)
that lower blood sugar, which
you may already be taking for your diabetes together with a food and
exercise plan.
What is type 2 diabetes?
Type 2 diabetes is a condition in which your body does not make enough
insulin, and the insulin
that your body produces does not work as well as it should. Your body
can also make too much
sugar.
When this happens, sugar (glucose) builds up in the blood. Thi

Ficha técnica

1
1.
NAME OF THE MEDICINAL PRODUCT
Sitagliptin Tiefenbacher 25 mg film-coated tablets
Sitagliptin Tiefenbacher 50 mg film-coated tablets
Sitagliptin Tiefenbacher 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sitagliptin hydrochloride monohydrate, equivalent
to 25 mg sitagliptin.
Each tablet contains sitagliptin hydrochloride monohydrate, equivalent
to 50 mg sitagliptin.
Each tablet contains sitagliptin hydrochloride monohydrate, equivalent
to 100 mg sitagliptin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Round, biconvex, pink film-coated tablet, approximate dimension 6.0
mm.
Round, biconvex, light beige film-coated tablet, approximate dimension
8.0 mm.
Round, biconvex, beige film-coated tablet with, approximate dimension
10.0 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus, sitagliptin is
indicated to improve glycaemic
control:
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 when diet and exercise plus metformin alone do not provide
adequate
glycaemic control.
•
a sulphonylurea when diet and exercise plus maximal tolerated dose of
a sulphonylurea alone
do not provide adequate glycaemic control and when metformin is
inappropriate due to
contraindications or intolerance.
•
a peroxisome proliferator-activated receptor gamma (PPAR
γ
) agonist (i.e. a thiazolidinedione)
when use of a PPAR
γ
agonist is appropriate and when diet and exercise plus the PPAR
γ
agonist alone do not provide adequate glycaemic control.
•
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.
•
a PPAR
γ
agonist and metformin when use of a PPAR
γ
agonist is appropriate and when diet